ENT 1133 UIE2

En 171 4129 TS 010 662

AUTHOR Banta, David; ThickEr, Stsphen B.TITLE costs and Benefit )t Elzctronic Fetal Monitoring:

'Review of the Literature. NCHSP fa search ReportSeries.

INSTITUTIJN Center for Dis as Control (DH"EW/PHS) Atlant a, Ga.;National Cen Hsalth Ssrvic search(DREW /PETS), Hya.t .sville, Md.

REPORT NO VIEW-PBS-79-324 NCH F -79 -91PUB DATE Apr 79NOTE 40p.AVAILABLE RP tI NCHSR Public ns and Information Eranch, 3700

East -West Highway room 7-44, Hyattsville, Maryland20762 (no clla

E4 RS PRICEDESCRIPTOR S

IDENTIFIERS

ABSTRACT

MF01/PCO2 Plus Po tags.*Birth: Clinical Diagnosi, *Copt Eff iveness;'Enfant Mortality; *Modical Care Evaluation; *MedicalTreatment; *Quality Control; *RisK;Electronic Fetal Monitoring

EafitY

This r,7Tort focus electronic fetal monitoring(EFM) - -a technology that was dev=loped during the 19603 and hasrapidly spread into use in clinical ohstetrics. The rceport includes areview of the extensive pu bl shed lit erature on FFh1 and relatedsubjects- also contains original calculations concerning thetechnique' s specificity an d seas i iv ity, its predictive value asdiagnostic t est, and the financial is t cia tied with itspotential sic s. ( Author/MP)

****** ***Reproduc

* *** ***by EDES are the best that can be made

from the original document.* * * * * * * * * * * * ** * *x * * * * * * **

EDUCATION A WELFARENATIONAL INiTITUTE OP

EDUCATION

THIS DOCUMENT HAS BEEN REPRO.01/CEO EXACTLY dA R C IV O FROMTHE PERSON OR DPGANIzATiON ORIGIN-

TiNG IT POIN TS Or VI Evd OR OPINIONSTATED DO NOT NECESSARILY EPRE-EN T OFFICiAL NATIONAL INSII TE OFOUCATION POSi TV% OR POLICY

Cr% Costs andBenefits ofElectronicFetal

1-1Monitoring:A Review ofthe Literature

U.S DEPARTMENT OF HEALTH, EDUCATION. AND WELFAREPublic Health ServiceOffice of Health Research, Statistics, and TechnologyNational Center for Health Services Research

National Center for Health Servlcee Research

Fisaearch Report Series

The Research Report Series is published by the NationalCenter for Health Services Research (NCH ISR ) to pro-vide significant research reports in their entirety. ResearchReports are developed by the principal investigators who

conduct the research, and are directed to selected usersof health services research as part of a continuingNCHSR efTurt to expedite the dissemination of new

vluclge resulting from its project support.

Abatrect

This report focuses on electronic fetal monitoring

( EFM technology that was developed during the1960s and has rapidly spread into use in clinical ob-

rics. The report includes a review of the extensivepublished literature on EFIvf and related subjects. It also

contains original calculations concerning the technique'sspecificity and sensitivity, predictive value as a diagnostic

test, and the financial costs associated with its potential

risks.

RESETRIES

:CH RC PORT

Costs andBenefits ofElectronicFetalMonitoring:A Review ofthe Literature

H. David Banta, M.D., M.P.H.National Center for Health Services ResearchCurrently: Office of Technology AssessmentCongress of the United States,Washington, D.C.

Stephen B. Thacker, M.D.Bureau of EpidemiologyCenter for Disease ControlAtlanta, Georgia

April, 1979

U.S. Department of Health, Education, and Welfare

Public Health ServiceOffice of Health Research, Statistics, and TechnologyNational Center for Health Services Roseercn

DREW' Publication No (PHS) 79-3245

This NCHSR Research Report was written by H. David

Banta, M.D., M.P.H., and Stephen 13. Thacker, M.D.

Although Dr. Banta started this study while employed

by the Office of Technology Assessment (OTA.), most

of his work on the project was done during his tenure

on the NC.IISR staff in 1978. He has returned to OTA.

Dr. Thacker was asked to participate in the literature

anal sis and the development of the cost figures because

f his epidemiological expertise. He is employed by thePublic liealth Service's Center for Disease control.

The authors wish to thank Tan Chalmers, 114.D, Mar-

shall Goldberg, M.D., Raymond Neutra, Judith

Rooks, M.S., M.P.H., and Carl Tyler, kf.D., for their

criticisms and suggestions; Thomas Hodgson, PhD,, for

his help with the cost estimates; and Linda Burton, for

clerical assistance.Additional copies of this report can be obtained on re-

quest from the NCHSR Publications :mid Information

Branch, 3700 East-West Highway, Room 7-44, Hyatts-

ville, MD 20782 (Tel.: 301/436.8970) . Other currentNCPISk publications are announced on the last pages

of this publication.The views expressed in this publication are those of

the authors, and no official endorsement by the National

Center for Health Services Research is intended orshould be inferred.

Library of Congress Catalog Card No. 79-600037

Foreword

This report focuses on electronic fetal monitoring(EFM) a technology that was developed during the1960s and has rapidly spread into use in clinical ob-stetrics. The report includes a review of the extensivepublished literature on El q11 and related subjects, aswell as original calculations concerning the technique'sspecificity and sensitivity, predictive value as a diagnostictest, and financial costs.

Only recently have controlled clinical trials made itpossible to try to answer questions about the benefits,risks, and costs of EFM, whose use is becoming increas-ingly controversial. EFM is an interesting case study inview of the current policy debate concerning the evalua-ation and control of medical technology. Although EFMis an important technique, it has even greater significanceas an example of how little is known about many tech-nologies used in medical practice. For instance, thereis not much information available on the costs andbenefits ofEYM in a clinical setting, and research invest-ments in that area have been pitifully small. Becausethere are few formal mechanisms for determining whichmedical technologies should be evaluated, almost anymedical technology can be introduced into the healthsystem for immediate purchase and use. With the lack

of consumer and provider responsibility for the costs ofmedical technology, regulatory constraints have not beenan effective mechanism for assuring that medical tech-nology is well- evaluated before it is placed on the market.

Although the results of this study are controversial,I believe that they are well-grounded in the scientificliterature, and that this report is a significant contributionto the literature on medical technology. Because of the

professional associations of the authors while the studywas in progress, this report represents the result of col-laboration between three Federal health agencies: theNational Center for Health Services Research, the OFfieeof Technology Assessment, and the Center for DiseaseControl. We are happy to be associated with such aneffort.

Gerald l osenthal, Ph.D.DirectorNational Center for Health Services Research

April, 7

Introduction

Electronic fetal monitoring (EFM) is an obstetric tech-nique developed in the 1960s. Although it is available invirtually every delivery room in this country (1-4), its

use as a medical procedure has become controversial.Questions about its efficacy, safety, and cost have been

raised by women's groups, in recent newspaper articles

(5-6), in U.S, Congressional hearings (7) and in themedical literature (8-9). The ethical implications ofEFM also have been debated (10).

Today, EFM is done either externally, using ultra-

sound, internally by attaching electrodes directly to the

fetus to monitor the electrocardiogram (ECG), or bysequential use of both techniques prior to and after rup-ture of the amniotic sac. In internal monitoring, a cath-eter is used to monitor uterine contractions. While EFMtechnology was evolving in this country, fetal scalp blood(FSH) sampling (to determine the pH of the fetal blood)

was being developed simultaneously in Germany. It wasnot long before the two procedures were paired, and FSBsampling has gradually become an integral part of EFM

(11-12) .When first used, EFM was applied largely to high-

risk pregnant women, and some continue to advocate itsuse primarily for that group (1314). However, an in-creasing number of obstetricians favor EFM of all pa-tients in labor, and many institutions in this country(1,15-21) and elsewhere (22-24) do EFM routinely. As

would be expected in light of such rapid dissemination,surveys of physicians in 1970 (25) and 1976 (26) havefound a high degree of acceptance of the procedure,with the latter survey showing that 77 per cent of thephysicians surveyed believe that all labors should bt,,

monitored electronically. In the USSR, Doppler ultra-

sound monitoring has aroused great interest (27), andin Germany 58 percent of the institutions surveyed in

1971 tried to electronically monitor all patients in labor

(26).However, the spread of EFM is part of the increasing

dependence on technology in medical practice. Questions

about the use of new technology in obstetrics have beenraised both by women's groups and some physicians(8,29-32) who point out that birth is a normal process.

This paper examines the evidence concerning the

efficacy and safety of EFM by reviewing the English-language literature and makes some calculations on its

cost.

Contente

iv Introduction

1 History of fetal monitoring

2 Quality of diagnostic information

FHR monitoring

4 FSB pH monitoring

EFM combined with FSB sampling

Predictive value

Impact on outcomes

Preventable stillbirths and neonatal deaths

High risk

Infant and perinatal mortality

11 Brain damage

13 Summary

Maternal outcomes

Fetal risk from EFM

Maternal risk from EFM

14 Maternal reaction to EFM

16 The future of EFM

Costs of EFM

18 Concluslo

19 Tables

20 References

History of fetal monitoring

Biblical references may be found to fetal movements orsigns of fetal distress in utero. In 1679, the passage ofneconium was mentioned as a "certain sign of death."ether books in the 1700s and 1800s merely identified itas a warning sign. By the 1700s, signs of life or death ofthe unborn child were clearly described in midwiferytextbooks (38). In 1793, it was noted that the pulse of

the fetus could be felt in the presenting parthead,foot, or cord.

DeKergaraclec first described obstetric auscultation asa potentially important diagnostic tool in 1821 (33) . Herioted that by auscultation one could detect fetal life, lie,and distress during labor, and he described fetal brady-cardia as a sign of distress (34). In 1838, Nagele asso-ciated head compression with bradycardia (35). Kennedypublished his Observations on Obstetric Auscultation in1843, which described the delay in recovery of the FFIRafter a contraction as a warning sign (34). In 1885,Breyer identified head compression, placental insuffi-

ciency, and anoxia as causes of fetal bradycardia (35).In 1893, Von Winckle established criteria for the diag-nosis of fetal distress: a FHR of > 160 or <120 (34).

Attempts to record the fetal heart tones were madeby Pestalozza in 1891, Seitz in 1903 and by I- Iofbauer

and Weiss in 1908 (36). Strassrnan and Hussey re-ported success in recording fetal heart tones in 87 percent of 52 patients in 1938 (29). Crerner used a vaginalelectrode to obtain a fetal ECG tracing in 1906 (29).

During the late 1030S and 1940s an increasing numberof investigators began to take an interest in PHIt moni-toring, and a great deal of work was done with new-born rabbits (34) and with fetal lambs (34-35). In thepost -World War II period, electronics developed rapidly,and an ultrasonic Doppler device was available by 1964.

In fact, in 1974 Hehre stated that abdominal recordinghad not advanced in 25 years (37).

In 1957, Hon first reported the successful recordingof the fetal EGG for the abdomen (38). In 1959, Honobserved profound bradycardia on a dying fetus andalso noted that manipulation of the prolapsed cord causedcardiac irregularities and bradycardia (39). In 1960,

Hon described a clinical FFIR monitor. However, abetter method of recording was necessary. According toilehre (37), Hon conceived the idea of an electrode to

pass through the cervix and clip to the fetal head to

record the ECG, made a prototype in his home work-shop, and appeared in the delivery suite at 3:00 a.m.for the initial test. The electrode was successful (40)and became the basis for presently used EFM devices.The major iinprovement was a spiral electrode developedby Hon in 1972 (41).

13y 1969, EEM by ultrasound and by direct EGGmonitoring had begun to diffuse rapidly (4) . Hon andCaldero-Barcia were the most active investigators, de-scribing a variety of changes in the Eflit and correlatingthem with clinical states. Working independently, thesetwo men devised different schemes for interpreting FHRpatterns. Because of the resulting confusion, they agreeden a standard terminology in the 1970s (37).

Soling had found FMK monitoring to be nonspecific,aod in 1961 he reported a technique for FSB sampling(42), in this technique, a scalpel is passed through thecervix, and a small wound is made M the baby's scalp.A sample of blood is then collected in a capillary tubeand analyzed for acid-base parameters. It is possible todo measurements such as glucose and electrolytes fromscalp samples, but only pH, PO2, and PCO2 are routinelydone. Saline has demonstrated that pH alone provides asnotch information as the three tests together. ESI3 sam-pling has become widely accepted throughout the devel-oped world, and has remained essentially unchanged since.

Today FHIt monitoring is done either externally, usingultrasound, internally with ECG, or these two techniquesare used sequentially in individual pregnancies prior toand after rupture of the amniotic sac. There exist nonational figures on the use of EFM equipment. In par-ticular, there is no data on the relative use of these twomodalities. Koh reported that 37.8 per cent oftronically monitored patients in his institution are fol-lowed only externally, 11.2 per cent are only internallymonitored, while both techniques are used in 51.0 percent of,deliveries (43). Quilligan reported that internalmonitoring is probably more generally used (

By 1972 an estimated 1000 EFM systems were in usein the United States. In a survey in 1976 Of 360 pro-grams with residencies in obstertics, 278 of 279 respond-tints reported the use of EFM (2). We believe that thevast majority of obstetrics services now have nmequipment, and that over half of the labors are moni-tored electronically.

Quality of diagnostic nformation

2 Although the ultimate measure of efficacy is improvedpatient outcome, such improvement is often assumed fordiagnostic procedures if the information obtained is re-

liable and valid. Therefore, evaluating the efficiency ofEFM includes considering the quality of the informationobtained. Two indices are used: changes in FFIR andchanges in the pH of the FSB.

FHR monitoring

The changes in the FFIR with a uterine contraction,generally referred to as periodic FFIR changes, have been

extensively studied ( 17,34,43 -46). Early bradycardia or"deceleration," which has been attributed to fetal headcompression, is a normal finding that occurs more or lesssimultaneously with the development of the contraction.Late deceleration is slowing of the FFIR that begins afterthe peak intensity of the uterine contraction and extends

the period between contractions. It is consideredan abnormality caused by uteroplacental insufficiency.Another abnormal FHR pattern, variable deceleration,occurs out of phase with the contractions, and is con-sidered to be due to umbilical cord compression (46).Both late and variable decelerations often can be elimi-nated by changes in position, maternal oxygen therapy,or cessation of oxytocin, which by itself can produceabnormal FHR patterns (47-48). Either can be ominousif they persist. There is a normal fluctuation of FHRduring labor and loss of these beat-to-beat (47) varia-dons can signal danger to the fetus, as can cardiac ar-rhythrnias. Putting these abnormalities together, Beardclassified nine abnormal states. Extensive work with ani-mals, with dying fetuses, and with fetuses with clinicalfetal distress confirms that these patterns are often indica-tive of fetal distress (50). Gabert and Stenchever foundthat variable or late decelerations appeared in 38 to42 per cent of high-risk labors (51).

Monitoring by auscultation provides only a small partof the information on fetal status that is availablethrough other methods (1,16,19,34,37,46,52-54). For ex-ample, Kelly and Kulharni state that traditional moni-toring samples only 1 to 2 per cent of the informationon fetal status and uterine efficiency (55). Moreover, alarge collaborative study showed that FHR alterationsdetected by auscultation were only clearly indicative ofserious difficulty at the extremes (56). Strong agreementhas been documented between auscultation and EFMfor severe variable decelerations, the most ominous find-ing (57). However, agreement was not good for lessserious patterns, and beat-to.beat variability and latedecelerations could not be determined by auscultation.Because of these facts, EFM is often considered to besuperior to auscultation. At the same time, there arethose that feel that even late decelerations can be detectedwith the fetoscope (58), but not reliably (59). Yet, the

0

actual value of this added information must be evaluated.The most reliable and valid method of following the

9-1R is by internal monitoring of the fetal ECG (53) .The mother's ECG is sometimes picked up, especially

if the fetus dies unexpectedly (60-6l ). External moni-toring by Doppler ultrasound is not as reliable (17, 62-

63). Women who are obese, uncomfortable, or experienc-

ing a crisis arc often difficult to monitor externally, andthus the technique of ten fails just when the data arepresumed to he most needed. This difficulty with externalmonitoring has prompted the shift to the internal moni-

tor. Likewise, phonocardiography cannot compare tointernal monks:ging of the fetal ECG in either reliability

or validity (45).The validity of EFN.1 has been studied by comparing it

to the infant's Apgar score at birth, The Apgar scoreis probably the most accurate routinely available measureof newborn status, but does have problems of validity.At the extreme, with scot-es of 0 or 1, it predicts death or

morbidity quite well. However, in the middle ranges,from 5,7, it is not such a valid measure (61), Apgarscores have also been correlated with clinically diagnosedfetal asphyxia, but asphyxia does not necessarily lead to

a low Apgar score. In one study only 10 per cent of thefetuses with moderate asphyxia had low Apgar scores

at birth, although 80 per cent of those with seecreasphyxia had a low Apgar score (65), At the same time,

clinical decisions ti ust be made on the best measuresavailable. and the evaluative literature of EI'M dependsheavily on the Al gar score.

Using Apgar scores to predict the outcome, EFNf is

not a precise measure of fetal distress (66). In a studyof 719 deliveries, Gilbert and Stenchever found 8.6 per

cent false negatives (normal FHR tracing with Apgar<6) and 33.7 per cent false positives (abnormal Fliptracing with Apgar (51) . The former gives one afalse sense of reassurance, whereas the latter could lead

to inappropriate interference with the labor, especiallycesarean section. Schitrin and Dame made similar ob-servations, finding that a normal FFIR pattern predicted

a high Apgar score with 93 per cent accuracy, but that

the abnormal pattern was much less specific, predicting

with only 43 per cent accuracy with the one minuteApgar and only 20 per cent accuracy with the five minute

Apgar (66). They concluded, ". . it appears that the

major value of FUR monitoring lies in the prediction of

an apparently normal neonate regardless of the level ofhis heart rate." (Mired: et al reported numbers of in-

fants horn depressed with different FMK patterns; their

figures show a clear lack of specificity (67). Saldana andhis colleagues found that less than 50 per cent of fetuses

manifesting variable deceleration evidenced any clinical

correlates, and that deceleration was also nonspecific(68). Shenker reported that 68 per cent of the babieswith late deceleration were horn without signs of depres-

sion (69) , Thomas found that only half the fetuses withlate deceleration had other signs of cbrnpromise (70).

i finally, Goodlin found that deceleration patterns alone

led to diagnoses of fetal distress in 4.5 times as manyinfants as vvere subsequently confirmed by overall clini-cal evaluation and Apgar score (71).

FSB pH monitoring

4 Fetal distress can also be defined by changes in the FSB

pH, although defining the normal range fur FSB pH hasproven difficult. Approaches have included looking atthe pH determinations of normal and abnormal bahies

as defined by Apgar scores, EF71 patterns, and finical

status. 'Twelve studies verc reviewed by I.uniky et ;IIwho found that the lower limit of normal was usually,

a p_H of 7.22 to 7.27, but that nue study had a normal

as low as 7.15, These investigators suggested 7.25 as thecut-off point (72). Sating carried out the largest studies,

and found normal infants with FSB pH values as low as7.21 (52). By using two standard deviations from themean to define limits of normality, Saling's group sug-gested that 7.20 to 7.2-1 be considered as pre-pathologic,and below 7.20 as definitely pathologic

Studies show that the FSB pl I accurately reflects the

acid-base balance of the fetus (52,7-1). Sa ling comparedcapillary and umbilical cord blood pH, and found a low

incidence of error, which he stated could lead to un-necessary operative interference in 2.2 per cent of infants(52). He also concluded that capillary blood gave reli-

able information about the acid-base balance of the fetus.

On the other hand, other investigators found IST3 sam-pling to be less reliable, and that a fetus with a normal

FSB pH had a I in 7 chance of being misdiagnosed asacidotic (75). In addition, technical problems with FSB

sampling due to maternal position, drugs such as oxy-tocin, peripheral vasoconstriction in the fetus, scalpedema and mechanical errors can produce pI l alterations

(65,76-77).FSB pH has also been correlated with Apgar score.

The rates of false negatives (normal pH with low Apgar)vary front 6 per cent (78) to nearly 50 per cent (511), but

usually range from 10 per rent to 25 per cent (Table 1).

At the same time, false positives (abnormal pH withnormal Apgars), are found in much greater numbers,

ranging as high as 84.6 per cent (81), and usually

found in 20 per cent to 50 per cent of FSB pH readings(Table 1). Similar FSB pH readings are found in fetuses

with and without distress with significant overlap (81,83). Roux et al observed five fetuses who had a normal

FSB pH shortly before birth but were depressed (84).Caldeyro-Barcia found a lower oxygen saturation withtype H dips in the. FFIR record (late decelerations), butthe ranges overlapped considerably (85).

Investigators have found poor correlation betweenFSB pH and FUR patterns except in norrnals and theseverely hypoxic fetus (86) Another group found thatonly 23 per cent of variable decelerations and 34 per centof delayed deceleration patterns were associated with a FSBpi I 7-_a=7.25 (87) . These investigators concluded that themajor value of FIER monitoring was to identify the un-stressed normal fetus or the fetus in severe distress, sincethere was less than a 10 per cent chance of abnormalFSB pH with a normal 'jilt, tracing. They also noted,"When fetal pH determinations are not available, a largenumber of records would be read incorrectly and a highcesarean section rate could be expected." This lack ofcorrelation between FSB sampling and FHR patternsas well as the lack of diagnostic precision of both EFMand FSB pH is in part clue to a wide variety of termi-nologies and techniques (12,17,47) , and the inconsistenttiming of FSB sampling relative to delivery.

EFM combined with FSB sampling

The lack of nsitivity and spe y* of both tests hasled to their more frequent use together. Beard examinedthe results of using both EFM and FSB pH in this

manner in 270 high-risk patients. Of the 68 of thesepatients who had iow Apgar scores (<7) di Lill ill, 46had perfectly normal FHR tracings and normal FSB

pH sampling, and only 22 of the 68 were abnormal onboth tests. Seventeen patients were abnormal on both

tests but had normal Apgar scores at birth. Therefore,even when used together the tests are imprecise with44 per cent false positives and 19 per a nt false negatives(50).

In summary, results reported largely using Apgar scoreas the validation for test results show that 'both FHRrecording and FSB sampling, used separately and together,

have alarming rates of false positives and false negatives

even in the most skilled hands. Many authors havereported correlations of abnormal FER patterns (such

as late decelerations) and low Apgar scores (89) , clinical

status at birth with pH (90), and so on But it shouldbe noted that few of the authors whose figures are quoted

tow ...nitiviof and %:nori fici Iv of th eornr.1 1

dure to question the value of these techniques. However,

other investigators explicitly recognize the diagnosticinaccuracy of FUR monitoring (71,91) and the high

false-positive rate (92). The physiologic basis for FIIRchanges is not known (93).

" Sensitivity is the extent to which fetuses that are abnormalare correctly classified. Specificity is the extent to which normals

are correctly classified.

Predictive value

6 The predictive value (PV) of a diagnostic procedure suchas EFM relates sensitivity and specificity to the occur-rence of the disease or condition in the population studied

(94). The PV of a positive test is the percentage ofthe time that a positive test denotes a true abnormality.Similarly, the PV of a negative test is the percentage ofthe time that a negative test will detect a person who isactually unaffected by the disease or condition.

Table 2 displays a variety of predictive values over arange of sensitivities and specificities. The three preva-lence rates listed for demonstration represent current esti-mates of neonatal mortality (10.20/1000 live births)and 5 minute Apgar scores less than 7 (about 5 per cent)

(21,51,95).Assuming that the sensitivity of EFM is 80 per cent

and the specificity is 90 percent (Table 2), the PV of a

negative or normal test is 99.5 per cent. This suggests

that a normal tracing very accurately predicts a favorableoutcome in the infant. However, such a conclusion re-flects the low prevalence of the clisease rather than thequality of the test as a diagnostic tool. The PV of thenormal test would remain over 99 per cent even if thespecificity were as low as 50 per cent.

Assuming relatively high rates of sensitivity of 80 percent and specificity of 90 per Cent, the PV of a positive

or abnormal test is only 14.0 per cent. This indicatesthat an abnormal EFM pattern incorrectly predicts Writ-come 86 percent of the time. Finally, if the neonatalmortality were to decrease to 10/1000, the PV of anahnre tracing and the utility of EFM would alsodecline.

Even if neonatal asphyxia were to cause a preventabledisability in 5 per cent of infants, and all of those couldbe detected by EFM, the PV of an abnormal test wouldstill be only 50 percent, meaning that half of abnormaltests would provoke inappropriate anxiety or unnecessaryintervention. When trying to predict an uncommon eventlike neonatal mortality, the large number of false positivesfound with EFM limits its clinical application. A diagnos-tic tool must be very specific (>99 more (7). The im.pact on EFM on CSR is difficult to evaluate.

One type of institutional report found the EFM groupto have a consistently higher CSR than the auscultatedgroup (20-21,55,109-111). For example, Paul reported

7 per cent of deliveries ending in cesarean sections in

the auscultated group, with 16 percent ending in cesareansections in the EFM group (20). Another type of reporthas shown doubling of the CSR after the introductionof EFM (15,26,43,47,112 -11G). A typical result is re-ported by Koh and his colleagues, who found a CSRof 6.4 per cent in 1971 and 12.5 per cent in 1973 (43).These rises are steady and do not generally level off bythe time of the report.

Two institutions in Britain reported decreases in theCSR after the introduction of UM (116-117). Beardand his coworkers, for example, found a decrease from9 percent in 1972 to 53 per cent in 1974, and reportedthat this was due to the addition of FSB sampling toEFIvl, a technique that the author felt avoided incorrectdiagnosis of fetal distress, thereby avoiding unnecessarycesarean sections (1 16). In Germany, Baling reported nochange in CSR after the introduction of FSB (52).

However, before-and-after studies such as those citedabove fail to account for secular trench that might explainthe rise of CSR independently of EFM. In addition, theseresults are complicated by the fact that high-risk preg-nancies arc more likely to end in cesarean section and arealso more likely to result in increased perinatal morbidityand mortality.

Perhaps the most impressive result was obtained intwo randomized, controlled, clinical trials (RCTs) from

Colorado. In the first study, one high-risk group wasmonitored by auscultation and had a CSR. of 6.6 percent, and the other was monitored electronically and

had a rate of 16.5 per cent (see below) (118). A secondRCT assigned 690 high-risk women to one of threestudy groups: auscultated, EFM, and EFM with FSBsampling (102). Once again, the route of delivery wassignificantly different in the three groups: 6 per cent ofthe auscultated group was delivered by cesarean section,whereas 18 percent of the EFM and 12 per cent of theEFM and FSB sampled had a cesarean section. Thus,FSB sampling did apparently prevent some unnecessarycesarean sections, but the combined procedure was stillassociated with a doubling of the CSR. Two other RCTsalso showed more than a doubling of the CSR in theEFM group compared to the auscultated group (119-120).

Despite these results, Ent is not entirely responsiblefor the increase in cesarean. sections, Indications for

11 d.

cesarean section such as breech presentation have beenliberalized markedly in the past decade. Hughey attemptedto analyze one institution's experience and found thatthe rise from 5.5 per cent in 1969 to 10.8 per cent in

1975 was largely due to breech deliveries and to the

diagnosis of dystocia, which increased nom 10 per 1000deliveries to 37 per 1000. Only 18 per cent of primary

cesarean sections at most were found attributable to thediagnosis of fetal distress (121 ). Paul and Hon found adecrease in cesarean sections for fetal distress after intro-duction of EFM, although the overall CSR increased(25). Haddad and Lundy, on the other hand, recorded

a striking increase in primary cesarean section for cepha-lopelvic disproportion (CPD) (2-fold), breech (50-fold) ,

as well as fetal distress (70-fold). In that hospital, CPDwas the indication for nearly 50 per cent of the cesareansections, while fetal distress was the second most frequent

indication (17 per cent) (99). Similarly, other investi-gators have found fetal distress and breech presentations

to be the primary causes of increased numbers ofcesarean section in their institution (21,55,122-126). AnRCT determined that 60 per cent of the increase incesarean sections with EFM was due to the diagnosis offetal distress (127).

The complex causes for the rise in CSR have beendiscussed in a recent report (127). These causes include

CPD, breech, fetal distress, repeat cesarean section, alter-

ations in residency training programs, the more interven-

tionistic stance of the obstetric community, and the fi-nancial incentives which may encourage cesarean sections.

The reported increase in the diagnosis of CPD as anindication for cesarean section is difficult to explain.Using specific criteria, 0.Driscoll et al found that CPDoccerred in about 2 per cent of 1000 primigravid labors

(128). Yet, in many reports CPD is the primary causeof cesarean section and is the primary indication for

to 12 of the operative procedures. Fetal distress, onthe other hand, while increasing markedly as an indica-

tion, accounts for only about 1/6 of the primary indica-

tions for cesarean section. Nevertheless, data from theRCTs (102,118=120) suggest that half of the rise in theCSR could be attributed to EFM and, thereby, onewould assume fetal distress. This inconsistency could be

explained by a change in attitude of the obstetrician to-wards the delivery with the increased mechanization asso-ciated with EFM (129-130).

Impact on outcomes

Preventable stillbirths and neonatal deaths. The useof EFM is based on the supposition that diagnosing fetaldistress and intervening aggresively can make a significantdifference in perinatal mortality and morbidity. Thissection examines causes of stillbirth and neonatal deathto determine if some deaths are preventable.

High risk. Since most pregnancies have a favorableoutcome, high-risk pregnancies are routinely singled outfor special care. Goodwin developed a high-risk scoringsystem which included obstetric history, present preg-nancy, and gestational age as well as known risk fac-tors such as breech presentation and rneconium staining(131). Goodwin's score correlates with Apgar scores,but unexpected events often do occur (132). Many otherinvestigators have developed their own systems (11,17,-96,120,133-136), and report from 16 to 50 per cent oftheir patients as high-risk. Unfortunately, a significantproportion of perinatal deaths cannot be predicted bya high-risk score.

One study showed that 30 percent of patients ac-counted for 60 per cent of abnormal outcomes ( 137).`This is consistent with findings that 18 per cent ofpatients classified as high-risk prenatally, were reclas-sified as low-risk based on iritrapartum factors, while20 per cent initially classified as low-risk were reclassi-fied as high-risk based on intraparturn factors. The lattergroup suffered a 24.3 per cent neonatal morbidity anda perinatal mortality rate of 35 per 1000 (134). Fetaldistress and abnormal FHR. tracings during labor aremore common among fetuses with intrauterine growthretardation, the small-for-gestational-age fetus (138-140). EFYI is suggested as routine for this group (141),ivhich suffers increased rates of death and illness; inparticular, neurologic sequelae such as cerebral palsy.abnormal EEG, and learning difficulties (152). Manage-ment of this group is difficult, and a high CSR is to beexpected (140). At the same time, early delivery bycesarean section frequently leads to respiratory distresssyndrome ( RDS) ( 140) (see below).

Baird and his co-workers examined the clinical rec-ords of more than 1000 stillbirths to determine the causeof death (143) and found, as others have (23), thatprematurity is the major contributor to stillbirth; they

concluded that skillful intervention could lessen risk inup to 46 per cent of the patients studied. Prematurityis also the major contributor to neonatal mortality(23,144-145).

Other investigators have examined specific causes ofperinatal mortality_ . A large collaborative study exam-ined 03 full-term stillbirths and found definite causesin 4-3, few avoidable with EFM. The remaining 40deaths could not be explained, although 10 of these 40had fetal bradycardia and 15 had fetal tachycardia(146).

Alberm n, in a study of causes of perinatal mortalityamong over 16,000 deaths, found the most commoncauses for stillbirth were intrapartum factors such aslabor, cord complications, and placental complications(29.9 per cent), and antepartum factors such as

placental infarction (24.2 per cent), congenital vial-formation (21 per cent), and toxemia (9.6 per cent).Intraparturn factors included both acute fetal distress,where prompt and effective intervention can save thebaby, and chronic fetal distress, where the outcome isgenerally not expected to be favorable. Intraparturncomplications were especially associated with multiparity,thus reducing parity through birth control has perhapshad the greatest effect. In the neonatal group, over 40per cent of deaths were related to immaturity; 28,2 percent to intraparturn factors; 18 per cent to congenitalmalformations (147). The contribution of multiplecauses to perinatal mortality found here and in otherstudies (148) underscores the fact that there is a lim-ited number of cases where intervention during laborand delivery could be expected to be helpful.

Infant and perinatal mortality. The most frequentlydescribed outcome from EFM is a decrease in infant andperinatal mortality rates. Rates for the entire UnitedStates dropped from 29.2 per 1000 in 1950, to 20.0 in1970, and to an estimated 14.0 in 1977. Similarly, thedeath rate of infants 28 days of age has fallen from13.0 per 1000 in 1973 to an estimated 9.8 in 1977 ( 149-150) . Perinatal mortality fell from 32.5 in 1950 to 20.1in 1973 (151). The neonatal mortality rate in New YorkCity fell from 20 in 1962 to 15 in 1971 (107). Reporteddeaths due to asphyxia of the newborn fell 25 per centfrom 1976 to 1977 (149).

A large proportion of this fall in infant and perinatalmortality has been attributed to the introduction ofEFM (15,20,23,26,47,51,87,108,114-116,121,152-153 )Perinatal mortality rates typically have been reported

as around 50 per 1000 until 1969, when the use of EFMbecame widespread, and then progressively falling to

21 per 1000 in 1974 (20). Paul, and Hon comparedmortality rates among infants over 1500g and found thatthe high-risk, EFM patients did slightly better than thelow-risk, non -EFM patients, but that the difference was

not statistically significant (154). Ros.vever, these re-sults are not completely consistent with those of otherstudies. Some investigators, for example, have foundeither no difference or a slight rise in death rate duringthe period after introduction of EFIvl (43,113).

These impressive results are subject, however, to avariety of questions. Increased attention at delivery by

itself may improve noeriatal morbidity and mortality.The use of contraception and abortion, better nutrition,better prenatal and obstetrics care, and patient educa-

tion (many of these made available because of increas-

ing public funds) have led to fewer births, lower aver-age parity, fewer very young and vet), old inegienitwomen, and fewer infants under 2500g (3,18,84,107,121,155). Data from one study showed a marked drop inneonatal and perinatal mortality prior to the introduc-tion of EFM with no significant change subsequent tothe widespread use of EFM in that institution (99).Within obstetric practice itself, amniocentesis, broadenedindications for cesarean section, better management of

complications, improved anesthesia and resuscitation.

use of the lecithin-sphingomyelin (1,/.5) ratio to deter-mine fetal maturity, analysis of urinary estriols, andimproved delivery technique have probably contributed

to decreased mortality (15,20,84,121)

In addition, the comparability of populations and

the relative quality of obstetric care are not explicitlydescribed in these before-and-after studies, and one must

be concerned that an unequal distribution of possibleconfounding factors such as precipitous deliveries might

be reflected in neonatal morbidity and mortality figures.Interpretation of these results is complicated further by

the fact that EFM often only involves high-risk pa-

tients and the differential impact of EFM on high- andlow-risk patients is not clearly delineated.

A few reports break down Its by birth weight,

to examine the common assertion that EFM is mostuseful in low birth weight babies. In one study low birthweight accounted for 60 per cent of neonatal mortality,and the UN fetuses in this group did better (154). Twoother groups reported substantial falls in intrapartumstillbirth associated with EFM, but these findings wereinconclusive because of small sample size and lack ofcontrols (22,156). Observations in Vermont supported aconclusion of possible benefit in the low birth weightgroup. Perinatal death rates from 1965 to 1975 wereunchanged in that state in the over 2500g group, while

falling significantly in that period in the low birthweight group (157) .

recognized in the obstetric community that these

results do not constitute scientific proof of benefit ofEFM in reducing death (84,158-159), and that RCTsare necessary to resolve the questions (1,18,20,24,44).Only four RCTs have been carried out to date.

The first R.CT was performed in Colorado by Haver-

liamp and his coworkers among 433 high-risk pregnantwomen (118). The patients were randomly assignedeither to an ansrultatcd group or an EFM group (FSB

sampling was not done). Infants <1500g were ex-cluded from the study. Both groups were cared for bythe same' obstetrical staff. The ausculated group had

internal EFI'vl done, but the results were not accessible

to those caring for the patients. The pediatric housestaff determined Apgar scores. Neonatal mortality wasnoted, and infant morbidity during the first 72 hours

was recorded. The records from the pediatric clinicreviewed at six weeks. The two groups were very

similar in outcome, but as mentioned above, the EFMgroup had a CSR of 16.5 per cent, compared with theCSR of 6.6 per cent in the ausculated group.

The study conclusions have been criticized for several

reasons. First, in early labor 16 late decelerations orsevere variable decelerations were observed in the EFMgroup, while only five were seen in the ausculatedgroup. This raised the question of comparability of thetwo groups. Secondly, the study design required ratherclose ritirsepatient contact in the ausculated group. For

this reason critics have felt that the outcomes mayreflect more the intensity of nurse-patient relationship

than the relative impact of auseulation versus EFM.

Purthermore, the study was not a hlind study, so thatinvestigator bias and the Hawthorne effect* could haveinfluenced the results. Finally, and perhaps most impor-tant, the findings were consistent with a small degreeof benefit which might not be found in a clinical trialof this size (see below).

Haverkarrip and his coworkers subsequently under-took a second trial among 690 women randomly placedinto three groups: ausculated, EFM, and EFM withP.S13 sampling (see above) (102). In response to thecriticism about the intensity of nursing care in the

ausculated group during the previous trial, all womenwere attended by individual study nurses. Fetal dis-

tress was diagnosed by standard techniques, and in thePSB-sampled group, a pH value of 7 was consideredas an indication for immediate delivery. Again, thestudy was not blind. The three groups were quite sim-ilar in make-up by demographic characteristics andpregnancy status. The outcomes of the three groups,measured by a variety of techniques, were similar,except for an increased CSR in both UM groups asnoted previously.

A third clinical trial was done in Australia on 350high risk patients randomly allocated to a control orintensive care" group. The control group was managed

by ausculation, the intensive care group by EFM andFSB sampling_ The two groups were similar by severalmeasures of risk (120). The number of neurologicsequelae was significantly higher in the control group(13 vs. 2). In addition, the pH, PO2 and the PCO, doneat delivery on cord blood were significantly better in theintensive care group. However, perinatal mortality andApgar scores were not significantly different betweenthe two groups, and there was a significant increase inthe maternal infection rate in the study group. TheCSR was 22.3 per cent in the study group and 13.7per cent in the control group. However, six patients inthe study group had had previous cesarean section,and when they were removed, the difference in CSRwas not significantly different.

''This refers to an improvement in outcome that is independentof the nature of a specific intervention and is a product of con-cerned observation-

This study, done in a center where EFIvi has beenextensively investigated, was not a blind study, and wassubject to investigator bias as well as Hawthorne ef-fect. Indeed, (luring the study one of the eight partici-pating obstetricians withdrew his patients because hefelt it was unethical not to provide EFIvt. Moreover, thefact that the study group had six patients who had hada previous cesarean section while the control groupapparently had none raises the question of compara-bility of the two groups. Finally, there was a potentialascertainment bias in that FSII sampling was availableto the control group only during regular laboratoryhours (I. Chalmers, personal communication).

Finally, an RCT done in England studied &FM in 504low-risk patients who were randomized into an auscul-tated group and an EFM with FSB sampling group(119) , The two groups were treated by the same ob-stetric staff. There were no significant difference in thetwo groups in outcome on a variety of measures_ Flow-ever, the CSR in the EFM group was more than doublethat in the ausculated group. The authors concluded thatthere were no beneficial or harmful effects as a directresult of the use of EFM. Like the other three RCTs,this study was not done in a double blind fashion, andthe sample size was such that small differences in ratescould not be detected.

Consequently, the four controlled clinical trials havemethodologic problems and possibly conflicting conclu-sions as to the benefits and complications of EFM. It isnoteworthy that all four RCTs showed no benefit attrib-utable to EFM in terms of perinatal mortality. Neutraet al took another approach, retrospectively studying thedata from a group of 16,529 live-born infants deliveredat a large hospital over a seven-year period. They foundthat failure to use EFM increased the risk of neonataldeath 1.4 times, but that use of E'FM in the 24 per centof labors with demonstrable risk factors would avert 83per cent of the potentially preventable neonatal deaths(160). This finding of a small decrease in risk could beconsistent with the RCT findings of no decrease, sincea result this small would require a study of more than100,000 women to find a statistically significant differ-ence. In addition, the non-EFM patients in die low-riskgroup had somewhat lower neonatal death rates than didthe EFM patients, so the small decrease in mortality (5

babies that could have been saved) found in this groupcould be an artifact of the model. The study does give

evidence of some benefit in terns of mortality from EFM

in selected patients.an response to these recent findings of little or no

decrease in mortality from EFM, proponents have argued

that the benefit is hard to evaluate because perinatalmortality is low (43,50). Supervision of active labor alone

might reduce perinatal mortality rates by only 2.8 per1000 live births, whereas the management of maternal

disease, fetal malnutrition, RDS and infections coulddiminish the rate by 6.6 per 1000 live births (161) . The

rieonatal period may be the critical risk period, and theaeonatologist may prove to be most responsible for

improved neonatal mortality rates (7).

alrain damage. The association between complications of

pregnancy and subsequent motor and intellectual impair.

ment of the child has been made in numerous investiga-

tions, and it has been estimated that 10 per cent of mental

retardation is attributable to avoidable antenatal and

early postnatal complications (1E1,162). llyposia is a

major cause of anteparturn and intrapartarn death (29),and an estimated 60 per cent of cerebrally-impairedchildren have undergone a phase of hypoxia and acidosis(23,50,84,163). Experimental brain damage in monkeys

has been attributed to hypoxia (164). Investigators rec-ognize that a study with long-term follow-up of infants

is necessary to demonstrate this benefit (20,35,62), butmany seem to agree with Quilligan (1). 14e argued thatsuch a study would be very difficult to do, would take at

least 1500 births and 7 to 10 years follow-up to achieve95 percent confidence limits, and then the results would

be questionable because of lack of good outcome rneasurrs

for the child. Quilligan and Paul estimated that 44,0C1',mentally retarded infants are born each year, with about

half of the severely retarded individuals having caustive

factors associated with delivery. As a result, they estimatethat universal EFM could save $2 billion a year in care

for the handicapped (164).However, these assumptions have been seriously ques-

tioned (29,44,142.165). Cerebral palsy or brain damage

is usually related to prepartum or other events, not

irstraparturn asphyxia (8,166). Several British atrisk

registers have been unable to deinoinstxate sequelac of

hypoxia at birth (29). In addition, the le inns rikeys

produced by intraparturn hypoxia are not similar to those

of cerebral palsy (29) . Primate work demonstrates thatthe threshold severity of asphyxia required to producebrain injury is so close to that which causes fetal deaththat fetal asphyxia usually either leads to no apparentneurologic sequelae or causes death of the fetus (167-16e). This 'all-or-nothing' effect is suggested by severalauthors (3,29,168) and is supported by monkey studiesshowing no pathologic brain damage 3 to 9 months aftercontrolled asphyxia. (169). Studies of infants who had hadhypoxia around the time of birth found no differencesfrom control groups in physical or mental score at 8

months to 4 years of age (170-171).A collaborative study followed 14,115 children from

birth and examined them at one year of age. Only 1.9per cent had a definite neurologic abnormality, Of thosewith a 5-minute Apgar score of 3 or less, a finding con-sidered to indicate severe depression of the infant, only7.4 per cent had a definite neurologic abnormality atone year (64). In another study, 15 children who hadhad laainata Ap,gar scores of -4-3 at birth were examinedon the average of 22.4 months after birth. Neurologicexaminations were normal in 10, two were borderlineabnormal, and three were abnormal ( 1172). The threeabnormal children also had had intrauterine growthretardation. The authors concluded that the prognosisfor asphyxiated infants is good. Thus, neurologic ab-

normality is an uncommon sequela to labor and delivery,

even when the baby is depressed at birth- These studiesalso point to low birth weight at the important indicatorof low scores and a possible confounding variable in thesearch for causes of cerebral palsy.

Thomson et al compared 31 children tr &th severe birthasphyxia (Apgar at 1 minute equal to zero, or at 5 min-utes a score of <4) with 31 normal controls matchedfor sex, birth weight, gestational age, and social class,

and completed neurologic and psychologic follow-up at5 to 10 years of age (173). Definite neurologic abnormal-

were found in three cases, although one of thesehad satisfactory school performance despite bilateraldeafness. There were no significant differences betweencases and controls in numbers of children with borderlineneurologic abnormalities, psycholinguistic quotient and

12 abilities, and Bender- Gestalt (although cases showedbetter than average performance more frequently). Thepresence of a neurologic abnormality seemed to be re-lated only to time required for the infant to obtainspontaneous respiration and to abnormal behavior in ther,oratqi as50ciation wit!. Litt hweight, gestational age, social class, duration of fetaldistress, Apgar score, and cardiac arrest.

Two other controlled studies, following mature infantsor a year in one and 2-5 years in the other, measured

:ieveral physical, psychological, neurologic, and behavioralcharacteristics. Neither showed significant long-term im-pact of intraparturn fetal asphy%ia 65,174). Such resultssuggest that if the asphyxia of a mature fetus is notsevere enough to cause noticeable cerebral injury andresidual disability, then more subtle changes will not hemanifested. Indeed, t FM may lead to rescue of theseriously ill infant with cerebral palsy or severe anomalies(8), and result in prolonged hospitalization before aninevitable early death.

Summary

The evidence for benefit from EFM is contradictory andconfined to a small decrease in mortality among high-risk

patients, particularly low birth weight patients, However,

EFM with or without FSB sampling has been compared

ttr autkuitaiiun iL, only four FICT::. With 441,-

that auscultation is of some benefit, it must be considered

a strong possibility that EFM is no better than ausculta-

don. Indeed, Good lin and Haesslein have concluded that

in a well-screened, healthy population, EFM adds little

except to increase the CSR (8).

Maternal outcomes. In physical terms, EFM is of nobenefit to the mother. Maternal mortality is very low, and

instead of reducing risk, EFM increases risk to the mother

(see below). EFM can, however, be of psychologicalbenefit to some patients (see below).

Fe'fal risk from EFM. The most immediate risk to the

infant from EFM is laceration by either the electrode(21,94,175-176) or by the knife that punctures the scalp

(177) - If arnniotorny is done for internal monitoring, aprolapsed cord can result (17). Hemorrhage occurs in

about 0.3% of cases (4, 13,71,84,178-179), and has been

reported as arterial on one occasion (180). Scalp ab-

scesses are fairly common, occurring in about 0.1 to 4.5

per cent (4,97,178,181-187). Severe sequelae includerectal-vaginal laceration (188), fatal hemorrhage (189),

subgaleal abscess (190), osteomyelitis of the skull (191-

192 ), gonococcal abscess (193-194), persistcn bacteremia

(195) and fatal bacterial and herpetic sepsis (196-197).

It is unknown whether or not ultrasound has long term

effects, although clinical opinion and limited experimentalevidence (198-199) suggest that it is of no risk to themother or infant at currently used levels. Indeed, experi-

ments have shown no evidence of chromosomal damage(200-201), or of changes in the EEC, of newborns (202)

after ultrasound exposure. The Fe:A and Drug Admin-tratiort is currently unwilling to say that ultrasound is

without risk, and is initiating long-term follow-up studies

of children as a first step to determine whether ultra-

sound is safe for the fetus (203).Several clinical (95,163,204-205) and basic research

(206-208) studies indicate that there are physiologic

differences between babies delivered by cesarean section

and those delivered vaginally. The short- and long-term

implications of such differences are less evident, althoughdelivered by cesarean section have a greater risk ofmorbidity and mortality (205).

The risks to the infant as a result of cesarean section

center on RDS and hyaline membrane disease (HMO)(138,209-211). RDS is most common before 36 weeks

of gestation, but occurs more frequently among babies

delivered abdominally, even when controlling for gesta-

tional age (211). Some investigators feel that the bulkof RDS related to cesarean section is composed of thebenign syndrome, transient tachypnea of the newborn(212). Others point out that if the fetal lung is mature,as determined by tests such as the L/S ratio, there willbe no RDS (14,213.212) , although other factors may beinvolved (215). Neither of these issues has been carefully

studied by RCT, so the association of RDS and cesareansection must continue to be a concern. Certainly, in theemergent setting of fetal distress, L/S ratios become lessuseful in the decision-making equation.

Separation of mothr.r and infant may interfere withbonding and later maternal behavior (216). EFM doesnot directly interfere with bonding, although the mech-

anized approach to birth and the separation engendered

by the increased maternal morbidity following surgerymay interfere. There has been at least one study suggest-ing an increase in child abuse among children following

early postpartum separation (217).

Maternal risk from EFM. Mortality and morbidity arehigher among women undergoing EFM. Lacerations of

the mother or the placenta from the electrodes can occur(84,218), and uterine perforations from the catheter havebeen reported (21,219-220) . Cesarean section is associated

with a maternal mortality rate 3 to 30 times that foundamong vaginally delivered mothers (221-224). Of course,women who are delivered abdominally often have inde-pendent risk factors that contribute to or cause death.The individival contribution of mode of delivery has notbeen specified, but a study done in Rhode Island indi-

cated that four of the nine deaths reported in associationwith cesarean section could be attributed to the method

of delivery (224).Cesarean section also leads to morbidity and mortality

(2.23,225 -231) associated with anesthesia (232-233),

14 anesthetic psychosis (234 -235) tract infectionsecondary to foley catheters, operative trauma to otherorgans (236), supine hypotension (237-238), pulmonaryembolus (239), sepsis (240), wound healing, hernia,bowel obstruction, hemorrhage, respiratory infection, andpneumonia, In addition, in the United States the opera-tion usually assures a second operation if another preg-.nancy occurs (128). Finally, there is an increase in lowbirth weight babies subsequent to cesarean section (1!)7).

Both EFM and cesarean section increase the risk ofmaternal infection (55,109,118, 219, 242-248) , althoughthe independent effect of EFM has not been adequatelydescribed (243,247). For example, Gibbs found that 87of 132 women monitored internally with ruptured stem.branes had intrauterine infection (243). Bacteremia hasbeen associated with both EFM and cesarean section(249). In another study women with EFM and cesareansection had a rate of uterine infection of 40.4 per cent;those with only a cesarean section bacl a rate of 20.4per cent; those with EFM vaginal deliveries had a rate of2.7 per cent: and women without EFM who deliveredvrtgirolly had a rate of 1 4 per root (109). Hagen reporteda 33.5 per cent overall rate of febrile morbidity withcesarean section, varying from 17 per cent in those withno labor and no EFM to 32.9 per rent in those withlabor but no EFM to 54.4 per cent in those who hadEFM labor prior to cesarean section (246). The rate ofinfection increases the longer UM continues (244,245).

The increase in febrile morbidity has led to anothersituation which complicates the issue of maternal andchild care during and following delivery. There is indi-cation that rates of febrile morbidity are lowered byantibiotic prophylaxis (250-258). This places the motherat risk of antibiotic side effects, fosters the growth ofresistant organisms, and complicates care of the newborn.

Maternal reactions to EFIVIL In the medical literaturematernal reactions are usually expressed through theobstetrician (51). Some physicians and nurses state thatmothers should be taught to accept EFM (161,259).EF1.1 can cause anxiety (91), but lo,nly wuolcu sifteranxiety during labor, and EFM properly explained to thepatient may reduce maternal concern (120). Somewomen complain of discomfort with the electrode, butoverall acceptance has been good (260). External EFIvIis more acceptable than internal EFM, especially for pre-pared childbirth patients (15), although even externalEFM interferes with Lamaze techniques (261).

Replacing nursing care with electronic devices couldhe excpected to produce negative reactions. Haverkampet al noted: "Very close physical contact with the patientwas necessary for the nurse to auscultate fetal heart tonesadequately. This was not true to the same degree withthe monitored group. Nursing attention to the gravidawith respect to maternal comfort, emotional support, and'laying on of hands' could have a significant impact onthe fetus. , . The authors have the impression that theepacsoring pcyrhologiral arninThpre rreated by personalnurse interaction and the absence of the recording ma-chine in ausculated patients contributed to the exrellentinfant outcome in auscultated patients" (118 ), Indeed,

growing minority of women are demanding deliverywithout interference and are turning to midwives andhome delivery to find such human support (9).

Only two groups have systematically approached tliequestion of patient acceptance. In 1970, Itoux et al

reported that 23 per cent of patients experienced majordiscomfort, 24 per cent were frightened of the equipnieTitand objected to the excessive pain, and there were diffi-culties in 50 per cent because of technical problems orlack of cooperation. On the other hand, 92 per cent likedthe medical and paramedical support associated withEFM. Fourteen per cent said that they would not beelectrically monitored again (84).

The second study which consisted of structured inter-views with 25 women found that 14 have overall positiveresponses to EFM monitoring, and 10 had mixed 43rnegative responses (202). Women with a problem in aprevious pregnancy were more positive. The positivegroup stressed the comfort and protection, relievedanxiety, and the electronic monitor as an aid in corn-

munication, husband wife interactions, andThe negtaive group developed competitive feelings to-

ward the electronic monitor, found it a source of dis-comfort, annoyance, anxiety, and fear. Women tvho had

had prior uncomplicated labors and healthy childrenespecially tended to resent the mechanization (263) .

A negative maternal reaction could have an adverse

effect on the fetus. Monkey studies suggest catecholantine

release provoked by maternal stress leads to bradveardia

and hypotension in the fetus, subsequently causing epi-

sodic aggravation of underlying fetal asphyxia (264).

The physiologic response to maternal anxiety could, for

example, explain the higher rate of abnormal Ff-IN.

patterns during early labor in the EFM patients in the

first Colorado RCT.

15

The future of EFM

10 Improvements in EFM, both in technique and interpre-tation, are possible. One may soon be able to use telemetryto reliably record the fetal ECG from the mother's abdom-en, obviating the need for direct electrodes (5,265). If not,fetal scalp electrodes can be improved (24). ImprovedDoppler ultrasound may make external monitoring morereliable (265). Better indirect methods for monitoringuterine contractions are being developed (267).

A great deal of work is being done to improve inter-pretation of ERR tracings. Improving display and alarmsystems will be helpful (24,198,268-269), and curvesgenerated by the EFM are being studied to gain a betterunderstanding of them (270-272). These studies can beused to develop computer interpretation of the tracings,which is already approximately as accurate as a trainedexpert (273-277). Continuous pH monitoring with glasselectrodes may become routine (28,45,278-279). Remotemonitoring by telemetry is becoming more and morereliable and would allow more free movement by thewoman in labor (24,27,267,280282).

Finally, a variety of other methods of monitoring havebeen suggested as having promise. These include moni-toring Iota! arousal ( 58,9R1 fetal movements ( 272,284-285), fetal respiration (35,286-288), and fetal EEG(274,289-290). It has also been suggested that monitor-ing all of pregnancy is necessary (28) , or that fetal bloodtesting before labor might be useful (267). On thematernal side, monitoring decidual or encloinetrial bloodflow has been suggested (291). Uterine hypoperfusionis another potential indicator of fetal distress (292).

Costs of EFM

The costs of EFM may be estimated by examining bothdirect and indirect costs (Table 3). The direct costs arethe medical care costs of delivering EFM services them-selves. The indirect costs are those of complications affect-ing either mother or child from EFM, including the addi-tional medical care costs front associated cesarean section.As discussed previously, some newborns and mothers dieafter EFM and delivery. In addition, morbidity resultsfront such conditions as scalp abscess and RDS in theinfant and pelvic infection in the mother.

In estimating the direct costs of EFM, it is assumedthat one half of the 3,2 million deliveries per year areelectronically monitored, and that the use of EFM adds$50 to the cost of each delivery. Direct costs independentof FSR sampling had previously been estimated at $33.50(164).

The number of cesarean sections done in the UnitedStates has risen from 160,000 in 1965 to 353,000 in 1975,an increase of 193,000 (105). Based on the RCTs, halfof these additional cesarean sesctions, or 96,500, can beattributed to EFM. The additional cost if a cesareansection is done instead of a normal delivery has beenestimated to he $2300.

If 1.6 million deliveries were electrically monitored, anincidence of scalp abscess of 0.5 per cent would result in8,000 abscesses. A scalp abscess requires 10 days of hos-pitalization for the infant (186), or an additional 7 days.It is estimated that the hospitalization of a newborncosts $100 a day; the cost of physician services, antibiotics,and so forth is disregarded.

The incidence of RDS in cesarean sections is about5 per cent, so 4825 cases would result from 96,500operations, However, about 1255 cases would have re-sulted from vaginal delivery (211), so 3570 cases can beattributed to EFM. It costs between $2700 and $3400to treat a case of RDS, whether the infant dies or not(209-210). A figure of $3000 per case is used in thisanalysis.

The incidence of death from RDS is 1.3 per cent(129), so 96,500 cesarean sections would result in 1255deaths. If one assumes that 20 per cent of the 1255 casescalculated above would have died in any case followingvaginal delivery (211), 1000 deaths can be attributedto EFM. A cost can be put on these deaths by using thepresent value of lifetime earnings approach, discounting

at 10 per cent. The value of lifetime earnings for amale under the age of one year is $37,659 and for afemale $29,802 (292). It is assumed that the deaths archalf male and half female.

A significant amount of morbidity results from cesarean

seciimi. 4itively uncorciiiion complicatiom: suell a her-niation, thromboplalehitis, and so forth have not been

projected. However, the rate of maternal infection i5

quite high (40 per cent) and results in an average of

six additional days of hospitalization (294). Using $190

a day as the cost of the hospital beds and ignoring physicclan and drug costs (295), this morbid event costs $44

million a year.Three per cent of vaginally delivered women who are

electronically monitored become infected (109) aboutdouble the rate in vaginal deliveries without EFM. Anadditional 19,500 infections result front 1.5 million EFMdeliveries. This group stays an estimated three additional

days in the hospital at a cost of $11.1 million, again dis-

regarding the cost of physician services and drugs.The maternal mortality attribu table to cesarean section

is 3.1 per 10,000 (22,1), Thus, 30 deaths result from96,500 cesarean sections, Using the present value of life-time earnings approach, assuming that these women areage 30.34, and using a 10 per cent discount rate, thecost of these deaths is $114,057 each (293).

The estimate of total cost of $41 I million per yearcompares to $80 million spent annually for all publicand private childhood immunization programs (A. Hin-

man, personal communication).Although evidence that EFM prevents mental retarda-

tion is lacking, this contention cannot be completelyignored. At the same time, one cannot dismiss the possi-

bility that EFM keeps alive infants destined to live with

intellectual handicaps who might otherwise have died.Because the data are not available to allow an accurate

estimate of the cost or benefit to society of EFM with

regard to mental retardation, such estimates have notbeen included in the cost analysis of EFM. Nonetheless,increases or decreases in the number of mentally retardedchildren born could have a profound effect on the cal-culations presented in this section.

Severe mental retardation has been estimated to costsociety approximately $250,000 during the lifetime ofeach affected individual ; milder handicaps cost an esti-

mated $30,000 per patient (164). If I per cent of live-born children suffer measurable mental retardation, 30,-non 4urh infants will hr born in this country each year,half of them with severe impairments. The cost to society

of these infants is then a little more than $4 billion overtheir lifetimes. (These calculations were done in 1974,

so inflation would make them considerably higher now).It has been estimated that up to one-half of mental re-tardation can be eliminated if serious intrapartum as-phyxia is detected, immediate delivery is successfully un-dertaken, an appropriate postpartum resuscitation andcare is employed (1M) . This would save society about$2 billion over the lifetime of those handicapped indi-viduals. On the other hand, an increase of 50 per centof those with mental retardation would cost about $2billion for those individuals. Without further study, theeffect of EFM on the costs of mental retardation to the

society cannot be estimated.

17

Conclusions

18 EFM was developed to prevent damage to the fetus,especially from asphyxia, during labor and delivery. Em-pirical work has demonstrated that it is possible to recordaccurately the FHR either by ultrasound or by directECG-monitoring. hi recent yea's, FS; pH sampling bypuncture of the fetal scalp has become part of the moni-toring procedure. Auscultation of the fetal heart has beenreplaced by interpretation of patterns in the electronically-recorded FFIR. The obstetric literature reflects the com-monly held belief in medicine that more informationwill lead to a better outcome. The technical advancesrequired and the demonstration that reliable recordingcould be done seems to have blinded most observers tothe fact that this additional information will not neces-sarily produce better outcomes. Nonetheless, many ob-stetricians justify the procedure because they believe itto be a reliable indicator of normality.

Careful review of the literature indicates little increasedbenefit from EFM compared to auscultation. This is notsurprising, given the lack of precision of EFM for thediagnosis of fetal distress, and the general difficulty inseparating =mai fetal sties during labor from fetaldistress. If EFM has benefit, it appears to be for lowbirth weight infants, but no RCT of its use in this grouphas been carried out.

The risk from EFM is substantial, especially but notwholly through the increased CSR that its use apparentlyengenders. We estimate the addition to the annual costof childbirth to be $411 million if 50 per cent of deliv-eries are monitored electronically.

Because of these risks and costs, a few signs of dissenthave appeared (8,14,29,296). Hohe, for example, takesthe cautious view expressed by his own patients in cootplications, and it is unfair to subject all patients to theroutine use of EFM (9). In light of the increasing con-cern with the costs of medical care, all of society, es-pecially the medical profession, must be concerned withthe widespread use of an expensive technology such asEFM in the absence of scientific evidence as to its benefits.

of tables

Table 1. Diagnostic precision of fetal scalp blood sampling using Apgar score as the measure of outcome.*

SourceFalse negativas ) Falaa paaltivea ria Sensitivity 1 %) Specificity

d, Flishle, et al. (1971) (50)minute Apgar <7, pH <7.25

e, at al. (1970) (79)ay., minute Apgar, pH <7,20

art (1969) (80)minute Apgar <7, pH <7.25

a Rama and Merkatz (1970) (78)minute Apgar <7, pH <7.20

279

295

208

19.1

13.9

23.6

9,0

42.1

30.3

42.2

56.7

32.4

82.6

30.6

44.8

92,4

89.4

90.1

90.5

Khazin, and Paul (1969) (81)'0' minute Apgar <7, pH X7.2 214 15.4 69.2 39.0 79.2

minute Apgar <7 214 5.8 84.6 47.1 77,7

III (1968) (82)minute Apgar <7, pH <7 20 .

od, at al, (1967) (54)w' minute Apgar <7, pH <7.20

78

118

10.2

47.4

55.6

21.7

57.1

28.6

84.1

90.9

it In many studies have head recalculated because of inaccurate eatimat

ble 2. Predictive values of a diagnostic test oval a range

4* pf sensitivities and specificities when actual prevalenceof a condition varies from 1 to 5 per cent.

PrevalanceRate

PredictiveValue

Sensitivity Spec !icily Nogallve f%

PredictiveValue

Poaltive (3/4)

ionatal Mortality1) 10/10002) 20/19003) 20/10004) 20/1000

bnormal 5" ApgarScore5) 50/1000

80 90 99.8 7.5

50 90 99.6 3.9

80 80 9 ^.5 7.6

90 99.5 14.0

95 95 99.7 50.0

also positives and false negatives.

Table 3. Estimated financial cost of fatal monitoring,1977-1978, United States.

Direct Cost of Monitoring

Direct Cost of Cesarean Sections . . .. $222 million

Indirect Costs of Fetal Monitoring-Neonatal

Neonatal MorbidityScalp Abscess . . . .. ............ $5.6 million

Respiratory Distress Syndrome $10.7 million

Neonatal Mortality ... ... .. $34,2 million

Indirect Costs of Fetal Monitoring-Maternal

Maternal MorbidityGeneral Morbidity from Cesarean Section

Maternal Infection from Cesarean Section $44 million

Matelnal infection from Fetal Monitoring . $11.1 million

Maternal Mortality ......... .. . . ..... $3.4 million

$80 million

$411 million

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il,' lila', Ii I.iisuui,' ,S',sul/u,',n ,l,'cl,, ,uf Jiullial

);, I'iiO-lSIl. 1971,

I(l. ( c It .ini WI. I 'iliwr'. ''Iis' i'l,ti,,ti1ii1iii Ii,us1ijt,ii-;,,i1uuiii'ui uui,i(itii,tI iiuli'i'ti,iit luu ilic;t.sjt'e'

I .tj u. iii iii 'tilt I iit, I taI 1d I't'5 'I IIlt'Fi(ll it

/iii 'I,,! if I )/j,/,'(i,i a,,,! ('i,e 0/01!)' I 26, 1:1-37,

11176.

I I H, I lill, I ),I,_ ''I"'t,iI IinliiIoritig, a o'ttns1,'livt' ,'valii-limit'' .I!Iuipisutc ,11,d1 in' 55, 179-181

Iii. I link, l.\, c :llI,I SIL',iiill('itfll'p iii fi'tal lurat't

t';tii' '.t1t'rtt Iutl'liL!, I:t)uiut', 1. Iiisi'liiti' Ii;tIti't'rIs.''nj,,tc in, /ui, un! if ( )buI,'trji.0 (uuicl (;vnl'uologY

I 25, 2 11-305. 1171.

112. 1 iI,ii, I IA ,.'iil MA. Steitrlir'vit. I'.,li'c'ttttnic:

I ,'tiI ii uuurli(rilitig is a Twit tie ui;i,'tii's itt ii oh-stuIi'it' sl'Ivi(',', a liii 4l't/ t'('Itill't.' .'1upi'riuii Journalof ( )/)ui','(pi,u ,'u,t(/ (,'l'lI,'frilou,sl' I 10, 931-537, 197-I,

II'). I'I,'u'i, (... I'. I Ii'jukiti, I), (3ti,siultii, at ;iI. 'Fcialituiur,ili ,,'ji i itt I,tin,r.'' Jon uiuuj of the i\'qIuJ,ial

thu/nt,, 'i si's ,utiou, (ill. 195-197, 1976.

ill. 'I'lj,tuuti, I't., itidl'l SIieIIf'v, ''/\ri ittcI,a.; of letutl

it I;tluusu,r." Jour,uul of ()/,,ft'trjrc tu,td

( 1flfn uIru,,'v of (lit' Ihiloii (5',ap,iuu,ia,'uiiI/, 711,

7(12-71(6. 1971,

I IS. :'iui;il,i, J, 'Fetal oi,ullitorini4 ii, :i i'unntiiirtily Itos-

I)1tI ( )b,lu(ru., (ulid ()'netalO/,,'y 51), 269-274,

977.

I Itl, l),';u,uI, I'!,, \'., I','I'. I'diiigturu, :ittd j, SiI1ar,It, "'I'Iiei15,-i, uI t',iulilid' iutT;,1ett tutu luid1tliI(itlilL rut, c'lirsj-

;iI ut';i( t irp,' (,'u,ui(uibuu(io,,, ((1 (YIit'(f1lOL,1')' u,zil

)b,tet,ju :1, I 1-21, 1977.

I 7 !'iiiiiuuuini.s, !S,( and Ii, I.iu'Isprtri;un, '''lisp ,',ui,lijr,pcI

iii' uil 'itdiuutiucuu14t;tjili' :,nicl 'sInI isIur,I suiiiplirsg in

I uuuuuiiioritug tiur' fituts in Idior,'' Journal of Oh-((I Ti1 V a,, ci (;yn (U' so lfiL'' of lit a 11 ri/i c/i Co ipi liii) it

rs'alfi, 79, 11l{i-112t1, 1972,

II)) I Ltverkttuup, ;\l ),, I hE. 'IlloIllIusoru, J, C., Mc'l'ce,

at :uI, '''Iii,' ecil,i;,tinzt iif c'lsniinu,nils 15'i;tl hic;irt

i;utr' iriiuiIoriiii in IngIi-rik pregri;ttu'','. .'Imeric-n,z

juu, sun! of ( )h.,t,'tri.0 aim' Cvii t'eolo,,uy 125, 110-317,

1976,

9, K,'Euu, L\I., RI, I'arsciiis, (,F, i,awt',rui'r, ct al'',\t, /tss,sluui'tit of d'dutltirSiuoil% fetal Iiptrt rate

tli'uiuit(uI rig in, l;uluuul','' 4 mans an Jounrual of Oh-

spit 1U uiiti ('i'rierIngy 1:11, 526-532, 1970.121), Rim, I'.. A, Cli;tri, I. Anderson, it al ''Con-

tr,uIIu',i trial of (intl iflti'tiSive ai','.'' ,'llIleni('nn

jruu Flu 'F! s'f 0/Juts'! Tie S lii! Gviieeolagv 126, 470-176,

I ¶176.

121, I Iuigluiv, XII,. RE. I;tpata, '1W, XIc'Ehiii, cC al'''I'Iu' elicit of fetal rrtiiruitoiirtg on the irie-icIe-ec

'if ,'u'';ir,'ait sri-tim,,'' Ob.,telri,'c (.17111 Cyneiulogy

19, 51:1-518. 1977.

22, I'.i1u;tg'or-giuuui, ,\.. XI ,\Ia,soii, K Sr'Itati, it iii,

''51,,'i'itli,,'(l 1u'rirstt;tl 1:111': it,i1act c-sfl perinatcl

i uior'ta lity.'' (,'a,i,d,an Medical 4ssacis'itj,t JouTnalI 16, 506-507, 1977.

23

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3 4

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9-15 echetek, W.J., T. Horiguchi, and T.F. Dillon."Puerperal morbidity and internal fetal monitor-ing." American Journal of Obstetrics and Gyne-colog) 119, 230-232, 1 974.

2-16. Ila en, 1), -Nlaternal febrile morbidity associatedwith fetal nionitorin!g and cesarean section." Ob.sletrics and Gynecology -16, 260-262, 1975.

2-17. (;i1ths, Ross 1),M, Jones, and C.J. Wilder. "Internalmonitoring and maternal infection following- cesar-ean section." Obstetrics and Gynecology 52, 193-197, 1978.

2-Ill. Ledger, W. J. -Complications associated with in-vasive monitoring," Seminars in Perinatology 2,187-194, 1978.

2-19. Ledger, W.J., NI. Forman, C. Gee, et al. "Bac-tereinia cut art ohstr, ic-t,;ynecologic service." Amer.ican Journal of Ohstctric.s and Gynecology 121,205-212, 1975.

250. Allen, J.F. Rampone, and C.R. Wheeless.-Cse of a prophylactic antibiotic in elective majorgynecologic operations." Obstetrics and Gynecology39, 218-224, 1972.

251, Choc la G.W. and M,E. Platt. "Wound infectionsand systemic: antibiotic prophylaxis in gynecologicsurvey, Obstetrics. and Gynecology 51, 123-127,

1978,252, Gibbs, R.S,, A.H. Decherney, and RA{ Schwarz.

"Prophylactic antibiotics in cesarean section : A

double-blind study." American Journal of Obstet-rics and Gynecology 114, 1018- 1053, 1972,

253, Hilliard, G., and R, Harris. "Utilization of anti-biotics for preventional symptomatic postpartuminfections." Obstetrics and Gynecology 50, 285-287,1977,

254. Keettel, W. and L. Plass. "Prophylactic adtninition of penicillin to obstetric patients." Journal of

the American Medical Association 142, 324-328,28 1950.

255. Morn, 71,, amid Andrews, "P thylactic anti-biotics in cesarean section," Obstetrics and Gyne-cology 44, 688-692, 1974.

256. Greens, 5,, F. Sambbi, and F. Bishop. "Prophylac-tic antibiotics in high-risk cesarean section." Ob-stetrics and Gynecoloey 51, 569-572, 1978,

257. Nforrison, J.C Coxwell, B.S, Kennedy, etal. "The use of prophylactic antibiotics in patientsundergoing cesarean section surgery." Obstetrics

and GynecoloEy I36, 425-428, 1973.

256. Rothharcl, \1, J., V. Mayer. A, Wystepek, et al."Prophylactic antibiotics in cesarean section," Ob-

d Gynecology 45, 421-424, 1975.

259. Weissberg. SAL. N.L. Edwards, and J.A. CYLe"Prophylactic antibiotics in cesarean section.stetrics arid Gynecoloay 38, 290-293. 197 I.

260. Chagnon, 14., and C,I.. Deldenbrand. "Nursesundertake direct and indirect fetal monitoring at acommunity hospital," journal of Obstetric, Gyn-

ecologic and Neonatal Nursing 3, 41-46, 1974.

261, Manley, J.W., and R.I.. Newman. "Fetal monitor-ing experiences in a private hospital," Missouri

Medicine 70, 310 -316, 1973.

262. Afriat, C., and B.S. Schifrin. "Sources of error in

fetal heart rate monitoring." Journal of Obstetric,

Gynecologic and Neonatal Nursing, I Is-15s, 1976.

263. Youngs, D.D., and M.N. Starkman. "Psychological

and physiological aspects of electronic fetal monitor-ing." Primary Care 3, 691-700, 1976.

264. Starkman, M.N. "Psychological responses to the

use of the fetal monitor during labor." Psycho-

matic Medicine 38, 269.277, 1976.

265, Myers, R. "Maternal psychological stress in fetal

asphyxia," American Journal of Obstetrics and

Gynecology 122, 47 -59, 1975.

266, Leventhal, J., W. Brown, J. Weiss, et al. "A nmethod of fetal heart rate monitoring," Obstet

and Gynecology 45, 494 -500, 1975.

267. Lauersen, KM. Hochberg, M.E. George,et al. "A new technique for improving the Dopplerultrasound signal for fetal heart rate monitoring."American Journal of Obstetrics and Gynecology 128,

300, 1977.

268. Electronics in perinatal studies. i Medical En-L;inecring 4, 120-121, 1969.

269_ Barwin, B. N., A. Dempsey, and G.D. Hurteau."Graphic monitoring of labour." Canadian MedicalAssociation Journal 115, 1089-1090, 1976.

271). Latsen, J.F., P. Jaszezak, F.V. Jorgensen, et al.

"Video display system for fetal and maternal moni-

toring." Acta Obs-tetricia et Gynecologice Scancli-

nat,ica 55, 267-270, 1976.271. -Morgenstern, f., FL, Albrecht, J. Bokelman, et al.

`Computed clip-parameters derived from digitizedFliR-curves, 1. The describing parameters and the

method of digitizing." Journal of Perinatal Medi-

cine 2. 1974.

272. Chik, I... V. J. Hirsch, kJ. Sokol, et al. "Temporalcharacterization of intrauterine pressure data,"American Journal of Obstetrics and Gynecology120, 496 -501, 1974.

273. Tournaire, M., G. Sturbois, A. Ripoche, et al.

"Evaluation of the fetal state by automatic analysisof the heart rate, 2., Deceleration areas and urnbili-

ry blood pH." Journal of Perinatal Medi-cine 4, 118-130, 1976.

274. ftuldleston, J.F., H.W. Perlis, J. Macy, Jr., et al.

prediction of fetal oxygenation by an on-linecomputer analysis of fetal tt c'nitor' output." Amer-ican journal of Obstetrics and Gynecology 128, 599-

605, 1977.

275. Chik, 1.., J. Sokoy, M.G. Rosen, et al, "Computerinterpreted fetal monitoring data." Journal of Pedi-

atrics 90, 985-989, 1977.276. Crawford, IS. "A critical account of the 'Confi-

dential Enquiries' report." Proceedings of the Royal

Society of Medicine 67, 905-909, 1974.277. Tournaire, M., S.Y. Yen, N. Forsythe, et al. "A

study of fetal heart rate deceleration areas." Ob-

stetrics and Gynecology 42, 711-717, 1973.

278. Wade, NLE., P.J. Coleman, and S.C. White. "Acomputerized fetal monitoring system." Obstetrics

and Gynecology 48, 287-291, 1976.279. Stamm, 0., P. Latscha, P. Janecek, ct al. "Develop-

ment of a special electrode for continuous sub-

cutaneous pH measurement in the infant scalp."American Journal of Obstetrics and Gynecology124, 193 -195, 1976.

280. Jacobson, L., 0. Lagren. "Transcutaneous 'moni-toring of PO, in different skin areas in the neonateand in the scalp of the fetus during labor, meth-odological and physiological observations." ActaObstetricia et Gynecologica Scandinavica Supple-ment 66, 55-68, 1977.

281. Serr, D.M. "Methods for recording the continuousfetal heart rate and uterine contractions." Clinicsin Obstetrics and Gynecology 1, 169-190, 1974.

282. Klapholz, FL, and K. Suzuki, "Evaluation of theModel 78100A adult telemetry unit for use in fetalheart rate monitoring." Journal of ReproductiveMedicine 18, 79-82, 1977.

3G

283. Roux, J.F., M.R. Newman, and J.E. O'Gureck."The value and limitations of fetal monitoring andtransvaginal telemetry and conventional wires sys-tem." International Journal of Gynaecology andObstetrics 10, 199.201, 1972.

284-. Sakahc, N., T. Arayama, and T. Suzuki. "Humanfetal evoked response to acoustic stiniulation."Acta Oto-Laryngologica Supplernentunt 252, 2936, 1969.

285. Sadovsky, E., and W.Z. Polishuk. "Fetal move-ments in utero, nature, assessment, prognostic value,

timing of delivery." Obstetrics and Gynecology 50,

49-54, 1977.286. Pearson, J.F., and J.13. Weaver. "Fetal acti. ity and

fetal well-being: An evaluation." British MedicalJournal 1, 1305-1307, 1976.

287. Marsal, K., G. Gennser, G.A. Hansson, et al. "Newultrasonic device for monitoring foetal breathingmovements." Bio-Medical Engineering 11, 47.52,

1976.

288. Meire, H.B., and T. Wheeler. "Ultrasound record-ing of fetal hreathirir " British Journal of Radi-ology 48, 477-480, 1975,

289. Tremewan, D.R. Aickin, and J.J. Tait."Ultrasonic monitoring of fetal respiratory move-ment." British Medical journal I, 1434-1435, 1976.

290. Sokol, R. J., M.G. Rosen, and L. Chik. "Fetal elec-troencephalographic monitoring related to infantoutcome." American Journal of Obstetrics andGynecology 127, 329-330, 1977.

291, Figueroa-Longo, J.G., J.J. Poseiro, L.O. Alvarez,et al. "Fetal electrocardiagram at term labor ob-tained with subcutaneous fetal electrodes," A rneri-

can Journal of Obstetrics and Gynecology 96, 556-564, 1966.

292 Akerlund, M., L.P. Bengtsson, and A.M. Carter."A technique for monitoring endoructrial or deci-dual blood flow with an intrauterine thennistorprobe." Acta Obstetricia et Gynecologica Scandi-navica 54, 469-477, 1975.

293. Goodlin, R.C. "Intrapartum fetal heart rate re-sponses and plethysrnographic pulse." AmericanJournal of Obsterics and Gynecology 110, 210.224,

1971.294. Green, J., and R. Wenzel. "Postoperative wound

infection." Annals of Surgery 185 (3), 264-268,1977.

295. "1977-1978 comparisons show little change (Hospi-tal Indicators). Hospitals 52, 53-56, 1978.

296. Hellegers, AE. "Fetal monitoring and neonataldeath rates" (Editorial). New England journal ofMedicine 299, 357-358, 1978.

Current NCHSR Publications

30 National Center for Health Services Research publica-tions of interest to the health community are available onrequest to NCHSR, Publications and InformationBranch, 3700 East-West Highway, Room 7-44, Hyatts-ville, MD 20782 (telephone: 301/436-8970). Mail re-quests will be facilitated by enclosure of a self-addressed,adhesive-backed mailing label. These publications alsoare available for sale through the National TechnicalInformation Service (NTIS), Springfield, VA 22161(telephone: 703/557-4650). PB and HRP numbers inparentheses are NTIS order numbers. Publications whichare out of stock in NCHSR are indicated as availableonly from NTIS. Prices may be obtained from the NTISorder desk on request.

Research Digests

The Research Digest Series provides overviews of signifi-cant research supported by NCFSR. The series describeseither ongoing or completed projects directed towardhigh priority health services problems. Issues are pre-pared by the principal investigators performing the re-search, in collaboration with NCHSR staff. Digests areintended for an interdisciplinary audience on healthservices planners, administrators, legislators, and otherswho make decisions on research applications.

(HRA) 76-3144 Evaluation of a Medical Information SystemIn a Community Hospital (PB 264 353) .

(HRA) 76 -3145 Computer-Stored Ambulatory Record(COSTAR) (P8 268 342)

(HRA) 77-3160 Program Analysis of Physician ExtenderAlgorithm Projects (PB 264 610, availableNTIS only)

(HRA) 77-3161 Changes in the Costs of Treatment ofSelected Illnesses, 1951-1964-1971 (HRP0014596)

(HRA) 77-3163 Impact of State Certificate-of-Need Laws onHealth Care Costs and Utilization (PB 264352)

(HRA) 77-3164 An Evaluation of Physician Assistants InDiagnostic Radiology (PEI 266 507, avail-able NTIS only)

(HRA) 77 -3166 Foreign Medical Graduates: A ComparativeStudy of State LIcensure Policies (PB 265233)

(HRA) 77-3171

(HRA) 77-

Analysis of Physician Price and Output De-cisions (PB 273 312)

73 Nurse Practitioner and Physician AssistantTraining and Deployment (P8 271 000,available NTIS only)

Automation of the Problem-Oriented Medi-cal Record (PB 266 881, available NTISonly)

(HRA) 77-3177

(PHS) 78-3190 Uncertainties of Federal Child Health Poli-cies: Impact In Two States (PB 283 202)

Research Summaries

The Research Summary Series provides rapid accessto significant results of NCHSR-supported research proj-ects. The series presents executive summaries preparedby the investigators at the completion of the project.Specific findings are highlighted in a more concise formthan in the final report. The Research Summary Seriesis intended for health services administrators, planners,and other research users who require recent findingsrelevant to immediate programs in health services.

(HRA) 77-3162 Recent Studies In Health Services Re-search, Vol. 1 (July 1974 through December1 976) (PB 266 460)

(HRA) 77-3183

(HRA) 77-3176

(PHS) 78-3193

(PHS) 78-3201

(PHS) 78-3187

(PHS) 78-3192

Recent Studies in Health Services Re-search, Vol. II (CY 1976) (PB 279 198)

Quality of Medical Care Assessment UsingOutcome Measures (PB 272 455)

Optimal Electrocardiography (PB 281 558)

A National Profile of Catastrophic Illness(PB 287 291)

Criterion Measures of Nursing Care Quality(PB 287 449)

Assessing the Quality of Long-Term Care

Policy Research

The Policy Research Series describes findings from theresearch p_ rogram that have major significance for policyissues of the moment. These papers are prepared bymembers of the staff of NCHSR or by incleperrient

a

vestigators. The series is intended specifically to inform

those in the public and private sectors who must con-sider, design, and implement policies affecting the de-livery of health services.

(HRA) 77-3182 Controlling the Cost of Health Care (PB 288885)

Research Reports

The Research Report Series provides significant research

reports in their entirety upon the completion of theproject. Research Reports are developed by the principalinvestigators who conducted the research, and are di-

rected to selected users of health services research as

part of a continuing NCHSR effort to expedite the dis-semination of new knowledge resulting from its project

support.

(HRA) 76-3143 Computer-Based Patient Monitoring Sys-tems (PB 266 508)

(HRA) 77-3152 How !.awyers Handle Medical MalpracticeCases (HRP 0014313)

(HRA) 77 -3159 An Analysis of the Southern CalitsiniaArbitration Project, January 1036 throughJune 1975 (HRP 0012466)

(HRA) 77-31 Statutory Provisions for Binding Arbitrationof Medical Malpractice Cases (PB 264 409,

available NTIS only)

(HRA) 77-3184 1960 and 1970 Spanish Heritage Populationof the Southwest by county (PB 280 656,available NTIS only)

(HRA) 77-3188 Demonstration and Evaluation of a TotalHospital Information System (PB 271 079)

(HRA) 77 -3189 Drug Coverage under National Health In-surance: The Policy Options (PB 272 074)

(PHS) 78 -3204 Experiments in interviewing Techniques:Field Experiments in Health Reporting (PB

276 080, available NTIS only)

(PHS) 78-3211 Emergency Medical Technician Perform-ance Evaluation (PB 285 961)

(PHS) 79-3217 Evaluation of Child Abuse DemonstrationProjects, 1974-77, Vols. 1 and 2

(PHS) 78 Needed Research in the Assessment and

Monitoring of the Quality of Medical Care

(PB 288 826)

Research Management

The Research Management Series describes program-matic rather than technical aspects of the NCHSR re-search effort. Information is presented on the NCHSR

goals, research objectives, and priorities; in wit:lawn,this series contains lists of grants and contracts, andadministrative information on funding. Publications inthis series are intended to bring basic information onNCHSR and its programs to research planners, adminis-trators, and others who arc involved with the allocationof research resources.

(PHS) 79-3220 Emergency Medical Systems Research

Projects, 1978

(PHS) 79-3241 NCHSR Research Priorities

Research Proceedings

The Research Proceedings Series extends the availability

of new research announced at key conferences, symposia

and seminars sponsored or supported by NCHSR. In ad-

dition to papers presented, publications in this series

include discussions and responses whenever possible. Theseries is intended to help meet the information needs ofhealth services providers and others who require direct

access to concepts and ideas evolving from the exchangeof research results.

(HRA) 76.3138 Women and Their Health: Research Impli-cations for a New Era (PB 264 359, avail-able NTIS only)

(HRA) 76-3150 Intermountain Medical Malpractice (PB 268344, available NTIS only)

(HRA) 77-3154 Advances in Health Survey Research Meth-ods (PB 262 230)

(HRA) 77-3181 NCHSR Research Conference Report onConsumer Self-Care in Health (PB 273 811)

(HRA) 77 -3186 International Conference on Drug and

Pharmaceutical Services Reimbursement(PB 271 386)

(PHS) 78.3195

(PHS) 78.3227

(PHS) 78.3207

(PHS) 7

Emergency Medical Services: ResearchMethodology (PEI 279 096)

Effects of the Payment Mechanism on theHealth Care Delivery System

Health Survey Research Methods, SecondBiennial Conference

208 Drug Coverage Under National Health In-surance

(PHS) 79.3209

(PHS) 79.3228

Health Services Research In Puerto Rico

A National Conference on Health Policy.

Planning, and Financing the Future ofHealth Care for Blacks in America

Program Solicitations

(HRA) 77-3196

(PHS) 78-3224

Conference Grant Information

Grants for Dissertation Research Support

BIBLIOGRAPHIC DATASHEET

1. Report No.NCHSR 79-91

3. Recipient Accession No.

4. Title and Subtitle

COSTS AND BENEFITS OF ELECTRONIC FETAL MONITORING: A REVIEWOF THE LITERATURE; NCHSR Research Report Series

5. Report Dale

April 1979

7. Authons;H. David Banta and Stephen B. Thacker

R. Performing Organization Rept.1;41

9. Performing Organization Name and AddressNational Center for Health Services Research, OASH, PHS, DREW

Division of Intramural Research3700 East-West HighwayHyattsville, MD 20782

10. Protect/Task/Work Unit No,- --

11, Contract /Grant No

N/A

12. Sponsoring Organization Name and AddressDHEW, PBS, GASH, National Center for Health Services Research3700 East-West Highway, Room 7-44 (Pubs. and Info. Br.)

Hyattsville, MD 20782(Tel.: AC 301/436-8970)

13. Type of Report & PeriodCovered Staff PaperCompleted Dec. 1978.

14,

15. Supplementary NotesDREW Pub. No. (PHS) 79-3245.Library of Congress Catalog No. 79600037.

16. AbstractsThis report focuses on electronic fetal monitoring (EFM) -- a technology that was de-veloped during the 1960s and has rapidly spread into use in clinical obstetrics. The

report includes a review of the extensive published literature on EF'M and related

subjects, as well as original calculations concerning the technique's specificity and

sensitivity, predictive value as a diagnostic test, and financial costs associated

with its potential risks.

17. Key Words and 1locument Analysis, 70. Descri

15. Su -lementa Notes (cont'd.)Office of Technology Assessment (OTA).

his tenure on the NCHSR staff in 1978.participate because of his epidemi-Dr. Thacker is employed by the Public

necessarily represent approval orNational Center for Health Servicesand Welfare.

analysison medical technologyassessment

Dr. Banta began this study while employed by theMost of his work on the project was done duringHe has returned to OTA. Dr. Thacker was asked toological expertise in analyzing the literature.Health Service's Center for Disease Control.

NCHSR publication of research findings does notofficial endorsement of research findings by theResearch or the Department of Health, Education,

17b. Identifiers/Open-Ended Terms

Health services research Cost/benefit

Electronic fetal monitoring Literature

Medical technology Technology

Health care costs

17c. COSATI Field Group

. Availability StatementReleasable to the public. Available from the

National Technical Information Service, Springfield,21VA 22161. (Tel.: AC 703/557-4650)

19. Security Class (ThisReport)

21. No. of PagesEat.: 31

security Class (ThisPage

UNCLASSIFIED

22. Price

FORM 14713.3$ V to-Oai ENDORSED BY ANSI AND UN ES __ THIS FORM AY BE REPRODUCED LISCOMM.00 .P74