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258

Sundar et al., Int J Med Res Health Sci. 2015;4(2):258-264

International Journal of Medical Research

&

Health Sciences

www.ijmrhs.com Volume4Issue2 Coden: IJMRHS Copyright@2014 ISSN: 2319-5886Received: 27

thJuly 2014 Revised: 5

thDec 2014 Accepted: 5

thJan 2015

Research article

THE INFLUENCE OF PERIPHERAL NEUROPATHY AND PERIPHERAL VASCULAR DISEASE IN THE

OUTCOME OF DIABETIC FOOT MANAGEMENT – A PROSPECTIVE STUDY

Sundar Prakash S1, Krishnakumar

2, Chandra Prabha

3

1Assistant Professor, Department of General Surgery, Meenakshi Medical College and Research Institute, Kanchipuram.

2Final year General Surgery PG, Department of General Surgery, Meenakshi Medical College and Research Institute,

Kanchipuram.3Final year PG, Department of Physiology, Meenakshi Medical College and Research Institute, Kanchipuram

Corresponding author email: [email protected]

ABSTRACT

Objective: Peripheral neuropathy and Peripheral Vascular Disease are the risk factors for the development of diabetic foot.

The aim of this study was to evaluate differences and predictors of outcome parameters in patients with diabetic

foot by stratifying these subjects according to the severity of these risk factors. Materials and methods: This is a

prospective study conducted in 70 patients in the age group of 30-90 years diagnosed as Type II Diabetes with

foot ulcers. After detailed clinical examination the fol lowing tests were conducted in all the patients :

Complete blood count (CBC), Haemoglobin (Hb), Random Blood Sugar (RBS), Erythrocyte Sedimentation rate

(ESR), Chest X-ray(CXR), Electrocardiography (ECG), foot X-ray, pus culture, Ne uropathy te st in g by

Semmes W ein ste in Monofilament Test and Vibration Perception Threshold and Peripheral vascularity

assessment by Duplex Doppler. Then grading of the ulcers was done using Wagner's Grade. The outcome of

the patients was assessed by recording the healing time, mode of surgery and amputation rates of the patients.

Results: A total of 70 patients with diabetic foot were consecutively included into the study (65.7% male, age

(31% in 51-60 years), mean diabetes duration (5.2 years), Ulcer Grade (37% in Grade IV), Foot lesions (45.7% in

toe), Blood sugar levels (64% in 300-400 mg/dl), Neuropathy (84%), Peripheral vascular disease (67%), major

amputation (7%) and mortality (1.4%). Conclusion: All diabetic patients should undergo testing for neuropathy

and peripheral vascular disease apart from doing other tests.

Key words: Diabetic foot, ulcers, neuropathy, peripheral vascular disease.

INTRODUCTION

Complications affecting diabetes are many with

some of the most catastrophic ones affecting the

lower extremities. Levin et al[1]

estimated that 20%

of all hospital admissions for diabetes were the result

of foot problems. Warren et al[2]

in their survey of the

lower extremities amputations found that 91.8% of

amputations were performed secondary to gangrene,necrosis, ulcer, nearly one half of these patients were

diabetics. Apelquist J et al[3]

in their study on

importance of wound classification in the outcome of

diabetic foot ulcer stated that the ulcer was classified

on the basis of superficial, deep, minor or major

gangrene and that the healing rate of superficial

ulcer is (88%) and deep ulcers is(78%) 57%. In

abscess and osteomyelitis it was (57%) and found that

out all there was only marginal difference in primaryhealing rate between the ulcer sites.

DOI: 10.5958/2319-5886.2015.00048.X


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Sundar et al.,

The remarkable pathogenesis of

neuropathy, microvascular and macr

Their process may occur exclusively

together in varying degrees placin

for morbidity such as ulceration

infection. This is especially true if t

changes are combined with a foot d

patients more vulnerable to foot pro

al4

demonstrated that only slight pres

bony deformity, such as a promi

head or a hammer toe lead to ische

ulceration of skin. For this reason

identify the patients at increased

other diabetic complications,

complication of diabetes is neu

causes foot ulceration in diabetic

considerable research; the pathoge

neuropathy remains undeter

hypothesis regarding the etiolo

neuropathy are centered on a

metabolic defects secondary to hig

vascular changes that results in

Evidence for hypoxia as etiology

and includes reduced endoneuri

increased vascular resistance,

endothelial production of nitric

microvascular dysfunction has

implicated, the role of peripheral

remains considerable, as it appea

decrease in total limb blood flow

nerve ischemia. Hence bo

neuropathy and peripheral vascul

commonest etiology in diabetic foot

other risk factors. Tests for n

peripheral vascular diseases wer

outcome was assessed.

Aims and Objectives1. To study the influence of perip

and peripheral vascular disease i

diabetic foot management.

2. To ascertain the risk of peripher

peripheral vascular disease in

with diabetic foot ulcer.

3. Evaluate all patients with diabe

both peripheral neuropathy

vascularity.

4. Assessment of outcome of the diregarding neuropathic/neuroisch

Int J Med Res Health Sc

diabetic foot is

vascular diseases.

r they may occur

patients at risk

, gangrene and

hese pathological

eformity, making

blems. Bauman et

sure over a fixed

nent metatarsal

mic necrosis and

it is necessary to

risk. Apart from

ne long term

ropathy, which

patients, despite

esis of diabetic

ined. Current

gy of diabetic

combination of

er glycaemia and

nerve hypoxia.

is considerable

ial blood flow,

and decreased

oxide. Although

been mainly

vascular disease

rs likely that a

would potentiate

th peripheral

ar disease are the

ulcer, apart from

europathy and

e done and the

heral neuropathy

in the outcome of

l neuropathy and

diabetic patients

tic foot ulcer for

and peripheral

abetic foot ulcers emic status.

MATERIALS AND METH

Prospective study was co

age group of 30 to 90

diabetes with foot ulcer

and surgical units of M

October 2011 to Septe

sought from Ethical Com

were obtained from all th

study group had detail

problem and the foot

detail.

Inclusion criteria

Patients attending MM

Diabetics clinic diagnose

Patients above 30 years.

Not previously diaghaving peripheral vascul

Exclusion criteria

Patients below 30 years o

Non-diabetic foot ulcers.

Previously diagnose

neuropathy and peripher

All patients had under

(CBC), Haemoglobin (

(RBS), Erythrocyte Sedi

ray(CXR), Electrocardiotesting was done us

Monofilament Test (Fi

tested for nerve con

vascularity was assess

Duplex Doppler. After

ulcers was done using

Fig 1:Semmes-Weinste

259

i. 2015;4(2):258-264

ODS

nducted in 70 patients in the

years diagnosed as Type II

attending the diabetic OPD

MCH&RI during the period

ber 2013. Permission was

mittee and Informed consents

e patients. All patients in the

d clinical history of their

ulcers were examined in

CH&RI surgery OPD and

as diabetic foot ulcers.

osed as neuropathy or ar diseases.

f age.

to have peripheral

al vascular diseases.

gone Complete blood count

b), Random Blood Sugar

entation rate (ESR), Chest X-

raphy (ECG). Neuropa thy ing Semmes Weinstein

1&2) and then they were

uction studies. Peripheral

d clinically and also by

all the tests, grading of the

agner's Grade.

in monofilament


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Sundar et al.,

Fig 2:Semmes-Weinstein monofil

Wagner Grading System:

Grade 1: Superficial Diabetic Ulcer

Grade 2: Ulcer extension

1.Involves ligament, tendon, joint ca

2. No abscess or Osteomyelitis

Grade 3: Deep ulcer with abscess or

Grade 4: Gangrene to portion of for

Grade 5: Extensive gangrene of foo

The outcome of the patients

recording the healing time, mode

culture & sensitivity and amputat

patients. All the above data were an

Statistical analysis: All the data we

Graph Pad Prism Version 6.

RESULTS AND OBSERVATION

Sex distribution Out of 70 patients

study, 46 (65.7%) were males and

females patients. Age distribution

the patients above 30 years were incl

patients were between 51 and 70 y

shows the details of age distribution

Fig 3: Age distribution

Duration of diabetes : Out of 70 p

our study majority of the patients ha


ment

psule or fascia

Osteomyelitis

efoot

t

as assessed by

of surgery, pus

ion rates of the

lyzed.

re analyzed using

enrolled for the

24 (34.3%) were

In our study all

luded. 30% of the

ars of age. Fig 3

in our study.

tients enrolled in

d diabetes for 4-6

years (Table 1). The me

5.2 years.

Table 1: Duration of di

Duration

(in year)

Num

of Pat

0-22-4

4-6

6-8

8-10

10-12

12-14

14-16

Distribution of surgeri

problems: Out of 70 p

10 (14.28%) patients haamputations, 2 (2.85%)

amputation, 3(4.3%) ha

like Debridement, I & D,

Table 2: Distribution of

for foot problems

Foot

problems

Minor amputation

Major Amputation

Others*No previous surgeries

*Debridement, I & D, Fa

Predisposing external

patients enrolled in our

had history of minor trau

and ill-fitting foot we

infection, 13 (18.5%) h

4).

Fig 4: Predisposing exteDistribution of grades o

of 70 patients our study d

260

i. 2015;4(2):258-264

an duration of diabetes was

betes

er

ients

(%)

15 21.414 20.0

24 34.3

8 11.4

5 7.4

1 1.4

2 2.8

1 1.4

s done previously for foot

tients enrolled in the study,

d history of previous minor atients had history of major

undergone other surgeries

Fasiotomies etc (Table 2).

surgeries done previously

Number

of Patients

(%)

10 14.2

2 2.9

3 4.3 55 78.6

siotomies, Minor Surgery

risk factors :Out of 70

study, 48 (68.5%) patients

ma due to bare foot walking

r, 3 (4.3%) had toenail

d history of thorn prick (Fig

rnal risk factors f diabetic foot ulcers: Out

iagnosed with foot


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Sundar et al.,

ulceration, grading was done based

grading and most of the ulcers were

between grades II to Grave IV (Fig 5

Fig 5: Distribution of grades of di

Distribution of foot ulcers: Out of

study, 32 (46%) patients had ulcer

and planter surface of toes, 28 (40

plantar surface of foot, metatarsal h

heel and 10 (14.0%) had ulcers in t

(Table 3).

Table 3: Distribution of foot ulcer

Foot lesions Number

of patien

Toe (Dorsal and

Plantar Surface) 32

Plantar, Metatarasal

Head,Mid Foot, Heel 28

Dorsum of Foot 10

Multiple Ulcers 0

Distribution of scores related

values: Out of 70 patients, 45 (64.

Random Blood Sugar values rangi

(Table 4).

Table 4: Distribution of scores rel

sugar values

Blood Sugar

Values (RBS)*

Number

of patient

200-300 15

300-400 45

≥400 10

Distribution of neuropathy: Out

were categorized for neuropathy

Weinstein monofilament. Graph 4

patients suffered from peripheral neu


n Wagner’s

predominantly

).

betic foot ulcers

70 patients in our

ation in the toes

%) had ulcers in

ad, mid foot and

e dorsum of foot

ts

(%)

45.7

40

14.3

0

to blood sugar

%) had elevated

ng from 300-400

ted to blood

s

(%)

21.4

64.3

1.4

f 70 patients, all

using Semmes

shows 59 (84%)

ropathy.

Fig 6: Distribution of n

Distribution of nerve c

our study, majority of th

sensory and motor weakn


scores

Neuropathic

type

N

o

Sensory 5

Motor 2

Sensory (+)

Motor5

Distribution of periphe

In 70 patients, 23 (33

disease while in 47 (67%


scores

Peripheral

Vascular Disease

Present

Absent

Distribution of score

According to our stud

(25.7%) had stenosis of

had occlusion and 2 (2.9


study

B. Mode Duplex

Doppler

Normal

Presence of stenosis

in peripheral arteries

Complete Occlusion

of peripheral arteries

Presence of both

stenosis and occlusion

of peripheral arteries

261

i. 2015;4(2):258-264

uropathy

onduction study scores: In

e patients (89.8%) had both

esses (Table 5).

nerve conduction study

umber

patients

(%)

8.5

3.4

89.8

ral vascular status scores:

) had peripheral vascular

) it was not present(Table 6).

peripheral vascular status

Number

of patients (%)

23 33

47 67

elated to Doppler study:

y, out of 23 patients, 18

peripheral arteries, 3 (4.3%)

) had both (Table 7).

score related to Doppler

Number

of patients (%)

47 67.1

18 25.7

3 4.3

2 2.9


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262


Distribution of score categorized in ulcer groups:

In our study 36 (51.4%) patients had neuropathic foot

lesions and 23 (32.8%) had neuro-ischemia (Table 8).

Table 8: Distribution of score categorized in ulcer

groups

Categories No. of patients (%)

Neuropathic 36 51.4

Neuro-ischemia 23 32.8

Infection (Non-ischemic/

non-neuropathic)11 12.8

Distribution of patients who had undergone

amputations: In our study majority of the patients

who had undergone both minor and major

amputations were in patients suffering from both

neuropathy and ischemia (Table 9). As per our

statistical analysis Chi square test was 21.40, 1 df and

the P value was


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263


Imran S et al11

in their study on frequency of lower

extremity amputations in diabetes with reference to

glycaemia control and Wagner's grades in Karachi

showed the following results. Grade O, 6 patients, 10

in grade I, 13 in grade II, 14 in grade III, 18 in grade

IV and 9 in grade V. Rooh-Ul-Muqim et al12

in their

study on evaluation and management of diabetic foot

by Wagner's classification, out of the 100 cases,

grade O (6), grade I (14), grade II (25), grade IV 30,

grade V (4). In our study the results were Grade O

(1), grade I (1), grade II (24), Grade III (17), grade IV

(26) and grade V (1). This shows that most of our

patients present in later part of the disease. If they

were treated in earlier grades the results would have

been much better. Apelquist J et al3

in their study of

the long term progress for diabetic patients with foot

ulcer observed that the results of patients with lesions

in the Toe (dorsal and Plantar surface) was 51%,

plantar surface, metatarsal head and foot and heel

was 28%, Dorsum of foot 14% and multiple ulcers

was 7%, out of 314 subjects. Reiber et al13

in their

study on the burden of diabetic foot ulcers based on

severity of lesions found that 52% of patients had

lesions in toe (dorsal and plantar surface), 37% had

lesions on plantar, metatarsal head, mid foot and heel

and 11 % in the dorsum of foot. In our study, 46% of

the foot lesions were in the toes (dorsal and plantar

surface) and 40% on the plantar and metatarsal head,

mid foot and heel. This shows that the toes and sole

of feet are vulnerable to ulceration, which signifies

that the diabetic foot needs frequent self-evaluations.

Oyiboso et al14

in their study on the outcome of

diabetic foot ulcers in 194 subjects observed that

67% of the ulcers were due to neuropathy and 26.3%

were neuro-ischemic. Ramani A et al15

in their study

on etiology of diabetic foot ulceration found that

peripheral neuropathy was seen in 78 % of thesubjects and vascular insufficiency was seen in

49.3%. Kumar S et al10

in their study on prevalence

of foot ulceration in type II diabetic patients showed

that the prevalence of neuropathy was 41.6% and

prevalence of PVD was 11%. In their study 20 were

purely neuropathic 13 were neuroischemic, 5 pure

vascular and 5 unclassified.

Mohan et al16

in their study on diabetic foot

ulcerations using measures of ABPI and Doppler

estimated that 21.3% of the subjects were diagnosedto have PVD. Rooh-Ul-Muqim et al

12in their study

on diabetic neuropathy, foot ulceration, peripheral

vascular disease and their potential risk factors

among the patient with diabetes demonstrated that

diabetic neuropathy was found in 36.6% of patients

and PVD in 11.8% of cases. In our study, 84% of the

population had peripheral neuropathy in comparison

with other studies. Our patients in the study

population had higher incidence of peripheral

neuropathy compared to their study. 33% of the

patients had presence of PVD in comparison with

other studies which is higher. In the ulcer groups the

neuropathic ulcer were more common (51.4%),

compared to the group neuro-ischemic (32.87%) and

others (12.8%). In analyzing the outcome of these

patients' in the above three groups the amputation

rates were higher in neuro-ischemic group (69.4%)

when compared to other two groups and the healing

rate was better in the neuropathic group (94%)

compared to neuro-ischemic (87%). This signifies

that the presence of neuropathy increase the chance

of foot ulceration and the presence of ischemia

worsen the presentation and which further affects the

outcome of the ulcer. Hence both play an important

role in the prognosis of the disease apart from other

associated risk factors like higher glycaemia,

infection, osteomyelitis, and deformity. From our

study we confirm that peripheral neuropathy is the

predominant factor for foot ulceration, as the

insensate foot is prone for undue trauma. The

presence of ischemia due to peripheral vascular

disease increases the morbidity and mortality of the

diabetic foot. PVD also increases the amputation

rates and reduces the healing time.

CONCLUSION

Male population (65.7%) is predominantly affected

compared to female (34.3%).

The mean age of patients in the study population

with foot ulceration was between 55 + 5 years.

The mean duration of diabetes was 5.2 years in

patients who suffered from foot ulceration.

Majority of the patients present with foot problems

with G l to G IV (Wagner's Grades).

Most of the ulceration occurs in toes, metatarsal head

and mid foot. It was more common in deformed foot

due to alteration of weight bearing.

Most of the patients had blood sugar values more

than 200. The duration of diabetics more than thelevel of sugar is the cause of foot disease.


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Neuropathy was present in 84% of the population in

the study. Nerve conduction study shows majority of

the patients suffer from both sensory and motor

neuropathy.

33% of the population in the study had peripheral

vascular disease.

51.4% of the ulcer were neuropathic and 32.8%

were neuro-ischemic and 12.8% were due to infection

alone. Total amputation rate was higher (69.4%) in

the neuro-ischemic group, (66.5%) in the infection

group and lowest (11.1%) in the neuropathic group.

Healing rates were higher in neuropathic ulcers

(94%) when compared with neruo-ischemic (87%)

and others (82%).

Control of diabetes with soluble insulin with

combination of antibiotics provides a better result.

Hence apart from routine foot examination, both

neuropathy and peripheral vascularity should be

assessed in all patients with foot ulcerations.

In conclusion "Prevention is better than Cure"

Hence the insensitive diabetic foot should be

protected by proper patient education, early

assessment, which timely management and proper

design of foot wear can avoid further (or) recurrent

foot ulceration.

Conflict of Interest: Nil

REFERENCES

1. Levin M E, O'Neal L W, the Diabetic Foot, 3rd

Ed.

St.Louis CV Mosby Co. 1983; 2, 1-55.

2. Warren R, Kinn R, A survey of lower extremity

amputation for ischemia surgery. 1968; 63; 107-

20.

3 Apelguist J, laasson J, Agardh CD. The

Importance of peripheral pulses, peripheral

edema and local pain for the outcome of diabetic

foot ulcers, Diabetic Med.1990; 7(7); 590-4.

4. Bauman J, Girling J, Brand P Pantar, Pressures

and tropical ulcertations, J Bone Joint Surgery,

1963;45B; 652-73.

5. Aksoy D Y, Gürlek A , Çetinkaya Y, Change in

the Amputation Profile in Diabetic Foot in a

Tertiary Reference Center: Efficacy of Team

Working, Exp Clin Endocrinol Diabetes, 2004;

112(9); 526-30.

6. Unal SN, Birinci H, Baktiroğlu S, Cantez S,Comparison of Tc-99m methylene

diphosphonate, Tc 99m human immune globulin

and Tc-99m-labeled white blood cell scintigraphy

in the diabetic foot, Clinical Nuclear Medicine

2001, 26(12); 1016-21.

7. Al-Mahroos, K Al-Roomi, Diabetic neuropathy,

foot ulceration, peripheral vascular disease and

potential risk factors among patients with diabetes

in Bahrain: a nationwide primary care, Ann Saudi

Med. 2007; 27(1); 25-31.

8. Ahmed SR, Zuberi BF, S Afsar, Frequency of

sensory neuropathy in foot of asymptomatic

type2 diabetic patients using Semmes-Weinstein

monofilament, Pak J Med Sci, Apr-June 2009; 25

(3); 349-52.

9. Nalini Singh, David G. Armstrong, Benjamin A.

Lipsky, Preventing Foot Ulcers in Patients With

Diabetes, JAMA, January 12, 2005; 293 (2); 217-

28

10. Kumar S, Asheha, Parnell LN, Fernando DS,

Tsigos C, Young RJ, The prevalence of foot

ulceration and its correlates in type II diabetic

patients a population based study, Diabetic

Medicine, 1994; 11 (5); 480-84.

11. Imran, Danish, Taherzadeh, Omeed, Anthony,

Use of gallipot for débridement, Plastic &

Reconstructive Surgery, 2004; 113 ( 2) ; 797-98.

12. Rooh-Ul-Muqim, Samson Griffin, Mukhtar

Ahmed, Evaluation and management of diabetic

foot according to Wagner’s classification study of

100 cases, JAMC, 2009; l 4 (3); 234-45.

13. GayleE Reiber, BenjaminA Lipsky, GaryW

Gibbons, The burden of diabetic foot ulcers, The

American Journal of Surgery, 1998, 176(2) (1);

5S – 10S.

14. Oyiboso, Jude E B, Tarawneh I, Nguyen H C,

Armstrong D G, Harkless L B, Boulton A J, The

effect of ulcer size and site, Patient’s age, sex andtype and duration of diabetes on the outcome of

diabetic foot ulcer, Diab Med, 2001; 18 (2); 133-

8.

15. Ramani A, Kundaje GN, Aetiology of diabetic

foot ulceration, J Assoc Physician India, 1990; 38

(11); 843-45.

16. Mohan V, Premalatha G, Sastry NG, Peripheral

vascular disease in non-insulin-dependent

diabetes mellitus in South India, Diabetes

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Subash et al., Int J Med Res Health Sci. 2015;4(2):265-268


&

Health Sciences

www.ijmrhs.com Volume4Issue2 Coden: IJMRHS Copyright@2014 ISSN: 2319-5886Received: 26

thAug 2014 Revised: 15

thSep 2014 Accepted: 25

thJan 2015

Research article

A STUDY ON PRESCRIPTION OF ANTIBIOTICS UTILIZATION IN NEONATAL INTENSIVE CARE

AT A TERTIARY CARE CENTER

Subash KR1, Shanmugapriyan S

2

1Associate Professor, Department of Pharmacology, Sri Padmavathi Medical College for Women, Tirupati,

Andhra Pradesh, India2

Assistant Professor, Department of Pharmacology, Meenakshi Medical college Hospital & Research Institute,Kanchipuram, Tamil Nadu, India

*Corresponding author email: subbu2207@ yahoo.com

ABSTRACT

Introduction: The aim of this study is to analyze the utilization of antibiotics at our neonatal intensive care unit

(NICU). Neonatal sepsis is one of the most common causes of admission in NICU and the causative bacteria and

their respective sensitivity patterns based on the culture sensitive reports helps in achieving the antibiotic policy.

Methods: This study was done after obtaining the approval from Institutional Human Ethical Committee (IHEC)

of Sri Padmavati Medical College Hospital and Research Institute. The study was carried out during the period of February 2013 to April 2013 at Department of Pediatrics, Neonatology division, the total number of antibiotics

used in neonatal intensive care unit (NICU) during the study period was identified and the percentage of the

antibiotic prescriptions, individual and fixed dose drug combinations is evaluated. Results: Ampicillin and

Gentamicin were the maximum (50%) empirically administered followed by the fixed dose combination of

Piperacillin and Tazobactam was used in nearly 16% of the babies. Conclusion: The study concludes the

prescription pattern at our neonatal intensive care unit complies with international studies and standards.

Key words: Antibiotics, Neonatology, Intensive care Unit, Prescription.

INTRODUCTION

The most common groups of drugs prescribed in

hospitals are antimicrobial agents. The major

admission particularly at neonatal intensive care unit

(NICU) is sepsis[1]

. Major neonatal mortality and

morbidity worldwide is due to septicemia is a

recorded fact comprising various systemic infections

of the newborn such as septic shock, meningitis,

pneumonia, arthritis, osteomyelitis, and urinary tract

infections[2]

. Empirical antibiotic therapy should

begin immediately on suspicion of septicemia

followed by cultures and sensitivity, later based onreport reevaluation of antibiotic treatment provided

can be done[3]. Prescriptions and drug utilization

monitoring can identify the problems and provide

feedback to physicians so as to create awareness

about irrational use of drugs[4]

. These studies are

useful for obtaining information about drug usage

patterns and data for future reference to streamline

antibiotic policy5. Currently the data about drug usage

patterns is not satisfactory. There is lack of data on

prescription pattern studies and it is essential to

define prescribing

The present study was designed to assess and procurea data of the prescription pattern in the NICU of Sri

DOI: 10.5958/2319-5886.2015.00049.1


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266


Padmavati Medical College Hospital and Research

Institute to assess the prescriptions pattern in the

context of their adherence to prescription format and

rationality of prescription.

MATERIALS AND METHODS

This study was done after obtaining the approval

from Institutional Human Ethical Committee (IHEC)

of Sri Padmavati Medical College Hospital and

Research Institute. The study was carried out in

collaboration with the Department of Paediatrics,

Neonatology division, The Inclusion Criteria were

Neonates suspected or diagnosed to have sepsis or

probable sepsis in newborn babies admitted in the

NICU. The exclusion criteria includes Neonates with

surgical problems, major congenital malformations,on antibiotics or those whose mothers have received

antibiotics before delivery, were excluded from the

present study. The Study was Prospective and

observational conducted at SPMCH & RI. This study

was done from February 2013 till April 2013. During

this period, newborn babies admitted in the neonatal

intensive care unit diagnosed or suspected to have

sepsis or probable sepsis were analyzed for culture

and sensitivity pattern and choice of empirical

antibiotics. Details of obstetric history, maternal risk

factors, and physical examination were recorded

meticulously. Empirical antibiotics were started after

taking blood for culture and sensitivity and then

changed accordingly.

RESULTS

Gender Distribution male babies were at a slightly

higher preponderance (42.38%) in ratio than female

babies (57.62%) who were treated for neonatal sepsis.

The majority of babies who were admitted 90. %

were preterm as per the gestational age and more than

90% of babies had the onset of sepsis within 72 hrs of

birth .There were 61% Gram negative organism

which included Klebsiella pnemoniae, Escherichia

coli, enterobacter and pseudomonas. The rest 39%

included Gram Positive organisms Staph aureus,

Staph epidermidis in neonatal intensive care unit

during the study period 83% and 9.52% respectively

with 2.38% sterile culture(fig:1). The chief organisms

revealed in blood culture report are Klebsiella

pnemoniae and pseudomonas

The antibiotics used in NICU during the study period

were 6 antimicrobials and 2 fixed drug dose

combinations.They are Ampicillin, Gentamicin,

Cefotaxime, Amikacin, Ciprofloxacin, and

Metronidazole, Piperacillin with Tazobactam and

Imipenem and Cilastin respectively (Table-1).

Fig1: Prevalence of isolated bacteria in neonatal

sepsis

Table 1: Prescription pattern of antibiotics in

NICU

Sl.

No

Antibiotics Number of

Prescription

n =250

%

1 Ampicillin 55 21.73

2 Gentamicin 55 21.73

3 Amikacin 50 20.10

4 Cefotaxime 28 11.43

5 Ciprofloxacin 16 06.52

6 Metronidazole 04 01.63

% -percentage of antibiotic utilization

Table 2: Prescription pattern of Fixed dose drug

combination Antibiotics in NICU

Sl.

No

Antibiotics Number of

Prescriptionn =250

%

1 Piperacillin +

Tazobactam

39 15.76

2 Imipenem +

Cilastin

3 01.08

% -percentage of antibiotic utilization

Among the prescribed antibiotics Ampicillin,

Gentamicin and Amikacin were utilized high at

21.73%, 21.73 and 20.10% respectively, followed byCefotaxime 11.43%, ciprofloxacin 6.52%, and

61%

39%

G.Negative

G.Positive


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Metronidazole 1.63%. Among the fixed Dose drug

combinations piperacillin with tazobactam 15.76%

and Imipenem with cilastin 1.08%.

DISCUSSION

The infant mortality rate of India is 47/1000 livebirths, of which 70 % of deaths is in neonatal period

with sepsis being one of the leading causes of

death[6]

.

In our study, both male and female babies were

equally affected and babies who had late onset

neonatal sepsis were predominantly male. This was

similar to a study conducted by Remington et al[7]

.

The present study revealed 92.85% were preterm as

per the gestational age. This is a main indicator that

preterm babies are more prone for neonatal sepsisthan the term babies and more than 90% of babies

had the onset of sepsis within 72 hrs of birth,

similarly in a study conducted by Sidiropoulus et

al[8]

., neonatal sepsis was much predominant in

preterm babies and showed significant reduction in

mortality rate. In our study also neonatal sepsis rate

was found more than 90 % in preterm and low birth

weight babies.

The blood culture reports established Klebsiella in 4

cases followed by Pseudomonas

in 2 cases. But majorportion of the isolate were sterile, confirming the

chief organisms Klebsiella and pseudomonas in our

neonatal intensive care unit during the study period.

This result adds strength to empirical treatment

provided. This was similar to a study conducted in

Bangalore by Shenoi et al[9]

. Another study done by

Viswanathan et al in 2011 at Vellore, reported

Klebsiella as the chief organism causing neonatal

sepsis followed by Staphylococcus aureus[10]

.

The total numbers of antibiotics used in our NICU

during the study period were 6 individual drug and 2

fixed dose drug combinations. Of the 250

prescriptions, Ampicillin and Gentamicin were the

maximum with each 40 in number as they were

started empirically. This was followed by Amikacin

and Cefotaxime based on the progress of clinical

features like cyanosis, feeding difficulty, breathing

difficulty (grunting), fast breathing (respiratory rate

>60 bpm), abnormal behavior and fever/temperature

>38°C. Ciprofloxacin and metronidazole were

initiated only if the culture and sensitivity report

demands its use and not empirically for a period of 10

days.

The fixed dose combination of Piperacillin and

Tazobactam was used in 29 babies ie for nearly 16%

of the babies. Another fixed dose combination of

Imipenem and Cilastin was given for 2 babies

because of resistant strains. The above prescription

pattern of antibiotics was similar to study on

antibiotic utilization pattern done by Fanos V et

al[11]

.. Another study done by Liem et al[12]

. by

collecting data from all tertiary care NICU s of

Netherlands, reported that 6 out of 10 NICUs used

extended-spectrum penicillins (amoxicillin and

amoxicillin/clavulanic acid), b-lactamase-resistant

and sensitive penicillins (flucloxacillin and

benzylpenicillin, respectively), amino glycosides

(gentamicin and amikacin), cephalosporins(1st and

3rd generation) and glycopeptides (vancomycin and

teicoplanin). The limitations of the study are small

group and seasonal infections may vary where in this

observation is done during a short period and not

throughout the year.

The study of antibiotic utilization pattern showed that

β lactam group of antibiotics, cephalosporins and

amino glycosides were used more in our NICU.

CONCLUSION

The study concludes the prescription pattern at our

neonatal intensive care unit complies with

international studies.

ACKNOWLEDGEMENT

We are thankful to Department of Paediatrics, NICU

Staff and Medical record Section staff of Proposed

Sri Padmavathi medical College – Renigunta for their

co-operation.

Conflict of Interest – Nil

REFERENCES

1. Lawn JE, Cousens S, Zupan J; 4 million neonatal

deaths: Lancet; 2005:365:891 – 900

2. Kaistha N, Mehta M, Singla N, Garg R, Chander

J. Neonatal septicemia isolates and resistance

patterns in a tertiary care hospital of North India.

J Infect Dev Ctries.2009; 41: 55- 7.

3. Yurdakök M. Antibiotic use in neonatal sepsis.Turk J Pediatr 1998; 40: 17- 33.


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4. Pradhan SC, Shewade DG, Shashindren CH, et

al. Drug utilization studies. Natl Med J Ind. 1:

1988, 185-189.

5. Marshner JP, Thurmann P, Harder S, et al. Drug

utilisation review on a surgical intensive care

unit. Int J Clin Pharmacol Ther. 1994, 32:447-51.

6. Park K. Health information and basic medical

statistics. Park‘s textbook of Preventive and

Social Medicine, 21st

ed. 529, 2012.

7. Remington JS, Klein JO. Infectious Diseases of

the Fetus and Newborn Infant 5th Ed. WB

Saunders, Philadelphia 2000; Page no.

8. Boehme U, Sidiropoulos, Muralt GV, et al.

Immunoglobulin supplementation in prevention

and treatment of neonatal sepsis; Pediatric

Infectious disease journal;1986;5: 193-95

9. Shenoi A, Nagesh NK, Maiya PP, Bhat SR,

Subba Rao SD. Multicenter randomized placebo

controlled trial of therapy with intravenous

immunoglobulin in decreasing mortality due to

neonatal sepsis; Indian Pediatr.J; 1999;36 (11)

:1113-8

10. Viswanathan R, Singh AK, Basu S, Chatterjee S,

Sardar S, Isaacs D; Arch Dis Child Fetal

Neonatal Ed. 2012 ;97(3):182-7

11. Fanos V, Cuzzolin L, Atzei A, and Testa M.

Antibiotics and antifungals in neonatal intensive

care units: a review. J Chemother. 2007; 19(1):5 –

20.

12. Liem TBY, Krediet TG, Fleer A, Egberts TCG,

Rademaker CMA. Variation in antibiotic use in

neonatal intensive care units in the Netherlands.

J. Antimicrob. Chemother. 2010 Jun 1;

65(6):1270 – 5.


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Nalini et al., Int J Med Res Health Sci. 2015;4(2):269-273


&

Health Scienceswww.ijmrhs.com Volume 4 Issue 2 Coden: IJMRHS Copyright @2014 ISSN: 2319-5886

Received: 20th Nov 2014 Revised: 10th Jan 2015 Accepted: 16th Mar 2015

Research article

EVALUATION OF RISK FACTORS FOR PRETERM DELIVERY AND CREASY’S RISK SCORING

Anand Nalini I1, *Modi Nikunj K

2, Sharma Hariom M

3

1Professor, Department of Obstetrics and gynecology,

2Assistant Professor, Department of Biochemistry, GGG

Hospital & M P Shah Govt. Medical College, Jamnagar, Gujarat, India3

Professor & Head, Department of Biochemistry, Sir T Hospital & Govt. Medical College, Bhavnagar, Gujarat,

India

*Corresponding author: Modi Nikunj K Email: [email protected]

ABSTRACT

Background: Preterm birth is a poorly understood domain so it is a one of the most serious problem encountered

in case of pregnant women. Because of the incomplete knowledge of biochemical and molecular reasons for

preterm birth, many authors have shown interest in various predicting risk factors of preterm birth. Aim: This

study was undertaken to know risk factors for preterm delivery and to investigate the usefulness of the most

widely used creasy scoring system in identifying the high risk group of women at the tertiary care center of India.

In this study also included observation of perinatal mortality and morbidity associated with preterm deliveries.

Material and Methods: In the present study of 175 women who gave birth to preterm babies, detail history was

taken. Then all the Data were statistically analyzed based on percentage. Result: Preterm delivery is particularly

affected by precipitating of some risk factors (Hb, weight, parity of mother etc.). Conclusion: so we can say that

such risk factors acting as a precipitating factor for preterm deliveries. Awareness of such risk factors is essential

to plan public education programs and to consider appropriate perinatal care options for women at potentially

higher risk for preterm delivery.

Keywords: Preterm birth, Creasy scoring, Perinatal death

INTRODUCTION

One of the most important unresolved issues

currently confronting obstetricians is the prevention

of preterm birth (birth before 37 completed weeks of

gestation). Preterm birth is, worldwide, the most

challenging problem in obstetrics, but the prevention

of prematurity has been difficult and ineffective

because of its multifactorial and partly still unknown

etiology. Identification of those women who are

likely to deliver before term requires use of simple

diagnostic tools that can be applied to both

asymptomatic and symptomatic pregnant women.[1]

Many healthcare providers collect data on pregnantwomen for assessment of preterm birth risk. Current

technology makes possible collection of a plethora of

data, yet a perinatal healthcare provider has no access

to a general, reliable and valid method of preterm

birth assessment.[2]

Babies born before the 34th

week

of pregnancy, have the highest risk for early death

and enduring health problems, but recent research has

shown that even preterm infants (at 34 to 36 weeks of

pregnancy) have greater health risks than full‐term

babies.[3]

The treatment of preterm labor, preterm delivery, and

premature birth are not only major problems in

obstetrics and pediatrics but also have major

economic, psychological, and social impact. Mostexisting methods to assess preterm birth are based on

risk scoring, done manually. These methods are

DOI: 10.5958/2319-5886.2015.00050.8


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between 17% and 38% predictive in determining

preterm birth. This range of accuracy is obviously not

satisfactory. Some authors conclude that-in general-

manual risk screening tools are not sufficient to be

used in the prediction of preterm labor.[2]

To improve

the outcome of these very preterm neonates, we need

to expand our knowledge of the etiology, prevention,

and treatment of preterm labor and preterm delivery.

However, the rate of preterm delivery has not

decreased in the past 30 years Goldenberg et al.,

2008, mainly because of failure to identify the high-

risk group during routine prenatal care.[4]

To identify

women at risk of spontaneous preterm birth,

clinicians use prior preterm birth, multiple pregnancy

and prior cervical surgery as major risk factors.

Useful clinical risk factors in predicting spontaneous

preterm birth in nulliparous women with a singleton

pregnancy are scant, except for a history of prior

cervical surgery.[5]

So the present study was with the aim of first, to see

the effectiveness of the routine creasy risk scoring

system in predicting the high risk group in local

population and second, to find out the common high

risk factors like Hb, weight, parity of mother

associated with preterm labor.

MATERIALS AND METHODS

The department of Obstetrics and Gynecology, of

Shri M. P. Shah Govt. Medical College and Guru

Govindsinh General Hospital, Jamnagar, carried out

the present study. Informed consent was taken from

all individual subjects included into the study. In the

present study of 175 women, who gave birth to

preterm babies (in 1 yr duration) were included and

classified as at low, medium or high risk for preterm

labor according to the Creasy scoring system which is

based on socioeconomic factors, previous medical

history, daily habits, as well as aspects of the current

pregnancy.[6]

This scoring system is extensively used

to identify preterm delivery. Socioeconomic class is

assessed by Prasad’s social classification. All other

term pregnancy was excluded from the study. The

gestational age was assessed from the date of last

menstrual period, provided she had regular ovulatory

cycle previously. In others, clinical examinations like

fundal height date of quickening, appreciation of fetal

heart by stethoscope and ultrasonographicmeasurements were used for gestational age

determination. Anthropometric measurements of the

mother including weight, height were carried out by

using standard techniques. Other data of

socioeconomic status, personal history, past medical

surgical, obstetric history and prenatal care were

collected by interviewing the patients. Hospital

records were also abstracted for relevant data and

used for cross-check the reliability of information

obtained during the interview.

Physical examination, Blood pressure and

hemoglobin by standardized acid haematin method

were also done. Anemia in this study was defined as

hemoglobin < 10 g/dl on one or more occasion.

Chronic or pregnancy induced hypertension was

defined as a blood pressure greater than 140/90

mmHg repeatedly, and, if the women also had

proteinuria than pre-eclampsia was considered to

exist. After delivery the newborn was examined

within 6 hours and fetal maturity was assessed. Then

all the Data were statistically analyzed based on

percentage.

RESULTS

Finding of the present study are as under –

First the relationship with the age of mother (in yrs)

and preterm delivery compared, in that the age group

are divided in < 20 yrs, 21-25 yr, 26-30 yr, 31-35 yr,

36-40 yrs and >40 yrs, out of them majority of

preterm delivery was noticed in 21-25 yrs of age

group. That is of 87 out of 175 preterm deliveries.

Then the incidence was gradually declined with

increase age. Then relationship with the gestational

age of mother (in wks) and preterm delivery

compared (Table 1), in that most of the preterm

deliveries occurred in 31-34 weeks of pregnancy.

Table: 1 Relationship of Gestational age with

Preterm delivery.

Gestational

age (in wks)

No of preterm

delivery

(out of 175)

Percentage

4) multipara. One of the important

relationships of weight and preterm delivery (Table

2), in that 153 preterm delivery seen in < 55 kg wt


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(out of them 28 have < 45 kg wt) and only 22 have

preterm delivery with more than 55 kg weight.

Table: 2 Relationship of Maternal Weight and

Preterm delivery.

Maternal

Weight (in Kgs)

No of preterm

delivery(out of 175)

Percentage

< 45 28 16 %

45-55 85 71.4 %

>55 22 12.6 %

In relation to the antenatal care 118 were unbooked

and 57 were booked. In our study approximately 49%

births were females and 51% males. According to

socio economical class (Table 3), majority of preterm

delivery was noticed in low socioeconomic class

(84.57%) and that is of 148 out of the 175, and

remaining 15.43% from middle class.

Table: 3 Relationship of Socioeconomic class andPreterm delivery.

Socioeconomic

Class

No of preterm

delivery(out of175)

Percentage

High - -

Middle 27 15.4 %

Low 148 84.6 %

In the present study of preterm delivery, 19 cases of

PET – pre eclamptic toxemia, 18 cases of PROM -

premature rupture of membrane, 18 cases of APH

(ante partum haemorrhage), 13 cases of twin

pregnancy, 11 cases of UTI - urinary tract infection,

07 cases of Eclampsia were noticed. While some

cases of fever, heart disease, cerebral malaria,

hydroamnios, jaundice, anemia, congenital

anomalies, uterine anomaly and uterine prolapsed.

And 62 are from the unknown reason. In this study

out of 175, 13 were twin delivered.

5%

81%

14%

0% Hb > 10 g/dl Hb 08 - 10 g/dl Hb < 08 g/dl

Fig1: Relationship of Hb level and Preterm

deliveries.

According to Hb (Fig. 1) only 8 women have preterm

delivery with Hb > 10 g/dl, and rest of the women

with Hb level < 10 g/dl (in that 25 have Hb < 8.0

g/dl).

According to past history 29 have previous h/o of

abortion, 20 have H/o preterm delivery and 09 have

previous H/o both.

In this study, according to creasy risk scoring system

(primi + multi) (Table 4), in that (31 +3 = 34 in low

risk), (21 + 8 = 29 in medium), (24 + 88 = 112 in

high risk).With twin pregnancy (175 + 13 = 188)

child born. Out of them 49 were still birth, 55

neonatal deaths and hence making 104 prenatal

deaths.

Table: 4 Creasy scoring and distribution by

Parity.

Gravida Low

risk

Medium

risk

High

risk

Total

Primi 31 21 24 76

Multi 03 08 88 99

Total 34 29 112 17

DISCUSSION

The importance of preterm delivery as a major public

health problem is easily demonstrated by virtue of its

contribution to total perinatal mortality contributing

50% to 70% of all perinatal deaths in most data

sets.[7]

Early detection of preterm labour is difficult

because initial symptoms and signs are often mild and

may occur in normal pregnancies. Thus, many

healthy women will report symptoms during routine

prenatal visits, whereas others destined for preterm

birth may dismiss the early warning signs as normal

in pregnancy. The traditional criteria for preterm

labour (persistent contractions accompanied by

progressive cervical dilatation and effacement) are

most accurate when contraction frequency is six or

more per hour, cervical dilatation is 3 cm or more,

effacement is 80% or more, membranes rupture, or

bleeding occurs.[8]

Though preterm birth occurs in

approximately 5-15% of all deliveries, it accounts for

the major bulk of perinatal and especially postnatal

deaths. The risk of neonatal morbidity and mortality

mainly depends on the gestational age at delivery.

Survival rate increases with an increasing period of

gestation. In a developing country like ours, where

intensive care facilities are often unavailable,

mortality figures would be much higher at a lower

gestation period at delivery. [1] Some biochemical

markers like fetal fibronectin, the thrombin cascade,


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and maternal salivary estriol measured in

asymptomatic women with and without risk factors

for preterm birth.[8]

In our study majority of preterm births were in

mothers of age group 21-25 years and that was

gradually decreasing with increasing age. It is

comparable to many similar studies like Molly Phillip

et al. and Trivedi et. Al. inspite of very high incident

of prematurity among teenage patients, the total

number of patients in this group remains low because

of decreasing trend of teenage marriage and late age

of marriage. Higher incident of prematurity in the

older patients is likely to be due to malnutrition,

anemia, increase physical work load and increased

incidence of medical and obstetric complications.[9]

Also presence chorioamnionitis, bacterial vaginosis,

urinary tract infection were significantly associated

with preterm labor.[10]

Fibronectin, an extracellular

matrix protein, acts as the “glue” that attaches the

fetal membranes to the underlying uterine decidua. A

positive fibronectin test (50 ng/mL or more) in a

patient with symptoms suggestive of preterm labor

has been associated with an increase in the likelihood

of birth before 34 weeks and birth within 7 – 14 days

of the test.[8]

In our study preterm birth in primipara, multipara and

grand multipara were 43.4%, 53.7% and 2.95%

respectively. This result is somewhat similar to other

work reported on this aspect.[11]

In grand multipara it

is combined effect of parity, preexisting poor

maternal nutrition, anemia less spacing between two

pregnancies, lack of antenatal care, associated

medical and obstetric complication etc. also play a

role. The distributions of preterm births by gestational

age observed in the present study are quite

comparable to those of jose et.al.[10, 11]

The delivery probability profile incorporates data onfetal fibronectin, cervical length by ultrasound and a

past history of preterm delivery to generate standard

pregnancy survival curves. This information might

also help in developing patient-specific strategies to

help prevent prematurity.[12]

It is observed that almost 87.5% preterm births were

from mothers with pregnancy weight of less than 55

kg. in another study from India 52.5% preterm births

were in mothers having weight of less than 45 kg.

Pre-pregnancy weight of mother and weight gainduring pregnancy also affects the birth weight.

[13]

The effect of regular antenatal care on the incidence

of preterm birth observed in the present study is

compared with some of the other studies. Incidence

of preterm birth is markedly less in booked cases as

compared to unbooked cases (who attended less than

3 antenatal care or none). Greenberg noted that

prenatal care had a greater impact on pregnancy

outcome in socially disadvantages women, a group of

women who often obtain less prenatal care.[14]

The

prevention can be based on at risk approach – (a)

Patient at high risk of preterm labour should be

monitored carefully and (b) Patient with warning

signs will go through prophylactic treatment like

antibiotics, tocolytics, bed rest etc. to prevent preterm

birth.

The higher frequency of preterm births in lower

social class might have been due to a number of

factors. More than two thirds of the patients admitted

to our hospital are from these social classes. Secondly

those who are economically at disadvantages might

be worse off as regards health, physique, knowledge

and nutrition. Present study data and that reported by

other studies clearly indicate that socio-economic

status has got direct and profound influence in the

preterm labor and birth.[15, 16, 17]

Anemia has been documented to result in higher

incidence of low birth weight babies as well as higher

preterm births. Anemia could lead to T and B cell

suppression and resulting immune suppression could

lead to increased susceptibility to infection.[18]

Similar results are also reported by kandeparker et al.

with 54% cases having Hb less than 10.0 g%.[11]

In agreement with other studies[19]

we found that

history of previous abortion and previous preterm

delivery increase the risk of preterm delivery in next

pregnancy.

The ability of creasy’s score in predicting Pretermbirth is significant but it also has its limitations when

applied in Indian context, where no. of other

parameters do play a major role in predicting Preterm

birth. This study present that maternal age,

socioeconomic class, parity, past history are

important risk factors for Preterm birth. If added to

the present scoring system they will greatly improve

the predictability of the scoring system in Indian

context. Similar study was also found by another

author in India.

[20]

The total perinatal deaths were 104 (49 still birth + 55

neonatal death) giving an incidence of 55.3 %


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perinatal mortality. As compared to western studies it

is much higher. This is due to the fact that they have

lower rate of preterm birth and much better neonatal

services including intensive care units for preterm

and low birth weight babies. Regarding neonatal

death our results are comparable with Khandeparkar

el al study.[11]

CONCLUSION

Our data in this study shows the correlation with

various risk factors to the preterm birth. From the

present study, it is concluded that to make creasy risk

score more specific and effective in the Indian

context, it should be modified by giving higher score

to women with low socioeconomic status, low

pregnancy weight, physical work during pregnancyand low maternal age. A slightly modified scoring

system needs to be devised for Indian population.

More elaborate information about the components of

the scoring system is required for understanding the

need to devise it in Indian context.

ACKNOWLEDGEMENT – None

Conflict of Interest – Nil

REFERENCES

1. Kore SJ, Parikh MP, Lakhotia S, Kulkarni V,

Ambiye VR. Prediction of risk of preterm

delivery by cervical assessment by transvaginal

ultrasonography. J Obstet Gynecol India 2009;

59(2); 131-35.

2. Jerzy W. Grzymala-Busse. Improving Prediction

of Preterm Birth Using a New Classification

Scheme and Rule Induction. 18-th Annual

Symposium on Computer Applications in

Medical Care (SCAMC), Washington, DC; 19945 – 9; 730 – 34.

3. Martin JA, Hamilton BE, Sutton, P. D., Ventura,

S. J., et al. Births: Final data for 2006. National

Vital Statistics Reports, 2009; 57:7.

4. Jarek Beta, Ranjit Akolekar, Walter Ventura,

Argyro Syngelaki, and Kypros H. Nicolaides.

Prediction of spontaneous preterm delivery from

maternal factors, obstetric history and placental

perfusion and function at 11 – 13 weeks. Prenat

Diagn 2011; 31; 75-83.

5. Gustaaf Albert Dekker, Shalem Y. Lee, Robyn A.

North, Lesley M. McCowan, Nigel A.B.Simpson,

Claire T. Roberts. Risk Factors for Preterm Birth

in an International Prospective Cohort of

Nulliparous Women. PLoS ONE. 2012;7(7);

39154.

6. Fernando Aries. Practical guide to high risk

pregnancy and delivery. 2nd

edition, 1993; 71-96.

7. Hoffman JH, Bakketeig LS. Risk factors

associated with the occurrence of preterm birth.

Clin Obstet Gynecol. 1984; 27; 539.

8. Jay D. Prediction and Early Detection of Preterm

Labor. Elsevier, Obstet Gynecol 2003; 101; 402 –

12.

9. Philips. A study of premature births. Jr. of Obstet

and Gynecol of India. 1970; 20; 66-77.

10. Pandey Kiran, Bhagoliwal Ajay, Gupta Neena,

Katiyar Geetanjaly. Predictive value of various

risk factors for preterm labor. J Obstet Gynecol

India. March / April 2010; 60, 2: 141-45.

11. Kandeparker. Risk factors in prematurity. Jr of

Obstet and Gynecol of India. 1987; 37; 237-42.

12. James Kurtzman. The delivery Probability

Profile: A new tool to predict PTD?

Contemporary OB/GYN; 2008; 5(1) 1-6.

13. Niswander K, Jackson EC. Physical

characteristics of gravida and their association

with birth weight and perinatal death. Am Jr

Obstet Gynecol. 1974; 119; 306.

14. Greenberg R S. The impact of perinatal care in

different social groups. Am Jr Obstet Gynecol.

1983; 145; 797.

15. Mukerjee S,Biswas S. A study of premature birth.

Indian Journal of Pediatric. 1971; 38; 389.

16. Achar ST, Yankauer A: Studies on the

birthweight of South Indian infants. Indian J

Child Health 1962; 11:157-67.

17. Venketachalam P S. Preterm Delivery. Bull

WHO. 1962; 26; 192-01.18. Prema. Immune status of anemic pregnant

women. Br Jr Obstet Gynecol. 1982; 89; 222-5.

19. Main D M. The epidemiology of preterm birth.

Clin Obstet Gynecol. 1988; 31; 521-32.

20. Deka. Significance of risk scoring system in the

identification of pregnant women at high risk for

preterm labour in india. Jr Obstet Gynecol. 1997;

47;487


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Shakya et al., Int J Med Res Health Sci. 2015;4(2):274-280


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Received: 18thNov 2014 Revised: 20th Dec 2014 Accepted: 24th Jan 2015

Research article

ACCURACY OF LOW BIRTH WEIGHT AS PERCEIVED BY MOTHERS AND FACTORS

INFLUENCING IT: A FACILITY BASED STUDY IN NEPAL

*Shakya KL1, Shrestha N

2, Bhatt MR

3, Hepworth S

4, Onta SR

5

1,3Department of Community Medicine and Public Health,

5Dean’s Office, Institute of Medicine, Tribhuvan

University, Kathmandu, Nepal2Valley College of Technical Sciences, Purbanchal University, Kathmandu, Nepal

4

Department of Health, University of Bath, Nepal

*Corresponding author email: [email protected]

ABSTRACT

Introduction: Birth weight is a key predictor for risk of childhood illnesses and chances of survival; however in

developing countries less than half of newborns are weighed at birth. In Nepal, only 36% of children born were

weighed at birth. Nearly two thirds (63%) of deliveries take place at home and birth weight may not be known for

many babies, the mother’s estimate of the baby’s size at birth could be used as an alternative. Aim and

Objective: This study assessed the accuracy of low birth weight as perceived by mothers and factors influencing

whether their perceptions were accurate. Methods: The study wasa facility based descriptive study carried out in

four hospitals with sample size of 1533. Hospital nurses interviewed mothers using a pre-tested tool. Data was

entered into EpiData 3.1 and analyzed using SPSS version 17 software package. Results: A total of 1533 mothers

were interviewed of which 75 did not respond. An overall 75% mothers accurately identified actual low birth

weight; and 25% mother perceived normal for actual low birth weight. Less percent of mothers


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they born at home[1,11,12]

and thus will not have a

recorded birth weight. In the past, most estimates of

LBW for developing countries were based on data

compiled from health facilities, these estimates did not

cover the weight of newborns who were born out of a

health facility

[1]

. Since birth weight may not beknown for many babies, the mother’s estimate of the

baby’s size at birth was also obtained[13]

.

Nepal has taken the percentage of newborns with

LBW as one of the indicators to demonstrate

achievement of nutritional wellbeing, maintenance of

a healthy life and socioeconomic development of the

nation. Many nutritional policies; principles; and

strategies are based on this indicator, such as,

increased nutrition monitoring and counseling

services at antenatal checkup to reduce LBW[2]

.

Hence, it is important to take birth weight of newborn

and, where formal measurements are unavailable,

validate the accuracy of mothers’ perception of birth

weight as a possible alternative source of data.

However, studies on validation on perceived birth

weight is not available for Nepal in our knowledge,

and mother’s perception about the size of baby has

not been properly verified as a reliable estimate of

birth weight. We questioned that is mother’s

perception on weight of newborn is correct? Is her

perception on weight of newborn is affected by her

socio-demographic background? This study aimed to

assess accuracy of birth weight perceived by mothers

against actual birth weight recorded in hospital; and

to find out any associated determinants.

MATERIAL AND METHODS

The study was approved by Institutional Review

Board of Institute of Medicine, Maharajgunj Medical

College. We also received approval from each

hospital board; and consent from each mother before

data collection. Hospital nurses interviewed mothers

once they were comfortable following delivery. After

interviewing, nurses gave information to mothers on

breast feeding; keeping newborn warm, special care

for infants who were LBW using Kangaroo mother

care, family planning, and baby immunization. This

was a hospital based descriptive study, carried from

August 2012 to February 2013. We chose hospitals

for this study as hospitals routinely record weight of

newborn and therefore provided a comparison againstwhich the accuracy of mothers’ perception on LBW

could be assessed. We carried out this study in 4

hospitals: Tribhuvan University Teaching Hospital

(TUTH), and Paropakar Maternity and Women’s

Hospital located in central Kathmandu; Seti Zonal

Hospital in Kailali district, far western region of

Nepal, 723 km away from Kathmandu city; and

Dhulikhel Hospital in Kavre district, 30 km away

from Kathmandu city. We chose these hospitals

purposively to represent geographical scope from far

western plain area to central hill areas.

Women within the reproductive age of 15-45 years

were the target population for this study. The

sampling unit was mothers who were recently

delivered, had completed 37 weeks of gestation,

single not multiple births and having a live birth. The

dependent variable for this study was perceived birth

weight, and independent variables were mothers’ age,

education, and gravida.

Sample size, data collection, management and

analysis: The sample size was calculated using

statistical formula14, 15,

, at 95 percent confidence

level; 25% of LBW based on birth weight by birth

size11

, and 2% confidence interval. Hence, sample

size calculated using this formulae, SS = 1800 For

sample size – finite population, where, population =

10350 (total average deliveries in 4 hospitals);

SS=sample size=1800; the sample size calculated

were1533. The tool was a structured questionnaire

with open and close ended questions. We asked to

mothers on how she felt the weight of her baby; what

her estimation was for NBW measurement in her

idea; and what causes small baby if she felt her baby

was small. Prior to collecting data, we did pre-test of

questionnaire in TUTH hospital and made corrections

as required from pre-test. Hospital nurses who

worked in maternity ward were trained in the study

tool and data collection techniques. Trained hospital

nurses briefed mothers of the objective of study; theninterviewed mothers who met selection criteria using

the pre-tested tool before they were told birth weight

of their newborn baby in their respective duty shift

from August 2012 to September 2013. The actual

birth weight of the newborn was taken from the

hospital maternity register.

Data entry program was developed in EpiData 3.1

and checked for any inconsistencies; analyzed using

the SPSS version 17 computer software package

through running simple frequency, descriptive crosstabulations. Sensitivity and specificity was calculated.

The sensitivity is the proportion of actual LBW in the


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selected sample who are accurately identified as

LBW by the mothers; and the specificity is the

proportion of actual normal birth weight (NBW) of

newborn who are so identified by the mothers[14,16,17,

18].

RESULTS

We interviewed 1533 mothers regarding their

perception on birth weight of newborn, 75 mothers

did not response.

Maternal age and perceived LBW: Referring to

table 2, out of 1458 mothers, 205 (14.1%) mothers

were age


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(sensitivity=0.74 @ 95% CI: 0.69-0.78), and 77%

multigravida mothers (sensitivity=0.77 @95% CI:

0.69-0.83) identified actual LBW.

Table 2: Number of mothers with their profile, perceived low birth weight, and diagnostic indicators

Maternal

Factors

Perception of

mother on

birth weight

Actual

LBW (%)

Actual

NBW (%)

Total

(N=1458)(%)

Diagnostic Indicators

Sensitivity* Specificity*

Age


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LBW (sensitivity=0.75). In other word, 91% mothers

recognized actual NBW (specificity=0.91). Hence, it

showed that fewer mothers could recognize actual

LBW in compare to actual NBW. We would like to

suggest here that the next study could be “why more

mothers could identify NBW rather than LBW?” We

also found that 25% mothers perceived normal for

actual LBW babies which is crucial from a

programmatic viewpoint.

In Nepal, birth weight is still not given a priority by

family. An awareness on LBW among women who

delivered during last year in Nepal was only 12.4%[22]

. A similar kind of study conducted in Cameroon

found that specificity for LBW (92.9%) was much

higher than sensitivity (59.9%) and the negative

predictive value (96.1%) was much higher than the

positive predictive value (44.4%)[23]

. Further analysis

of data from DHS India showed that among babies

who were reported as weighing


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results indicated that mother’s perception on size of

newborn is a good proxy for birth weight12

. Other

surveys such as Multiple Indicator Cluster Surveys,

Pan Arab Project for Child Development and

Reproductive Health Surveys, a question is asked to

the mother regarding the size of her child at birth,

which has been considered as a proxy indicator for

birth weight11

. Further analysis of data from DHS

India suggest that mother’s perception about size at

birth was reasonably reliable[24]

.

As in other developing countries, still two-thirds of

births (63%) take place at home in Nepal[25]. Only

36% of children were weighed at birth as the majority

of births do not take place in a health facility in

Nepal13

. Nepal DHS has been using verbal autopsy

from mothers on their newborn baby’s size; and birth

weight was recorded in the questionnaire if available

from either a written record or the mother’s recall.

Since birth weight may not be known for many

babies, the mother’s estimate of the baby’s size at

birth was also obtained and useful proxy for the

weight of the child[26].

Based on our study, 93% mothers recognized actual

normal birth weight, and 75% mothers recognized

actual LBW, and still 25 percent mothers could not

recognize actual LBW. Hence, perceived birth weight

could be used as proxy indicator when birth weight

data are not available. We noticed that proxy

indicator could be more reliable if mother were

literate, aged ≥20 years. A study conducted in

Cameroon indicated that recall of size, in

Cameroonian women and in other low resource

settings, should be used only in the absence of other

sources of data[27]. A further similar study among

mothers who delivered in home with an intervention

of birth measurement is recommended to cover

broader area and to ensure accuracy of perceived

birth weight.

CONCLUSION

An overall, 75% mothers recognized actual LBW,

and still 25% mothers perceived normal were actual

LBW babies, which is crucial from programmatic

view. A percent of identifying actual LBW was

slightly lower among mothers


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11. Blanc AK, Wardlaw T. Monitoring low birth

weight: an evaluation of international estimates

and an updated estimation procedure. Bull World

Health Organ, 2005; 83(3): 178-85.

12. MoHP NE. ICF International, Nepal

Demographic Health Survey, MoHP, Editor.2011: Kathmandu.

13. Daniel WW. Biostatistics: A Foundation for

Analysis in the health Sciences. Seventh edition

ed.

14. Eng J. Sample size estimation: how many

individuals should be studied? Radiology, 2003;

227(2): 309-13.

15. Bonita R, Kjellstrom BR. Basic Epidemiology.

Second Edition ed. 2006: WHO.

16. Glas AS. The diagnostic odds ratio: a single

indicator of test performance. J Clin Epidemiol,

2003; 56(11): 1129-35.

17. Park K.. Park's Textbook of Preventive and

Social Medicine, ed. 20th. 2009.

18. Kim H. Factors affecting the validity of self-

reported data on health services from the

community health survey in Korea. Yonsei Med

J, 2013;54(4): 1040-8;

19. Yadav H., Lee N. Maternal Factors in Predicting

Low Birth weight Babies. Med J Malaysia, 2013;

68(1): 44-47.

20. Karim E, CG Mascie-Taylor, The association

between birthweight, sociodemographic variables

and maternal anthropometry in an urban sample

from Dhaka, Bangladesh. Ann Hum Biol,

1997;24(5): 387-401.

21. Osrin D. Cross sectional, community based study

of care of newborn infants in Nepal. BMJ, 2002;

325(7372): 1063.

22. Mehata S, Chand, DR. Singh, P. Poudel, S.

Barnett, Nepal Household Survey. 2012.23. Mbuagbaw L, Gofin R. Can recall of birth size be

used as a measure of birthweight in Cameroon?

Paediatr Perinat Epidemiol, 2010;24(4): 383-9.

24. Sreeramareddy CT, Shidhaye RR, Sathiakumar

N. Association between biomass fuel use and

maternal report of child size at birth--an analysis

of 2005-06 India Demographic Health Survey

data. BMC Public Health, 2011; 11: 403.

25. Hirve SS, Ganatra BR. Determinants of low birth

weight: a community based prospective cohortstudy. Indian Pediatr, 1994;31(10): 1221-5.

26. Golding J, Shenton T. Low birth-weight and pre-

term delivery in South-east Asia. The WHO

International Collaborative Study of

Hypertensive Disorders of Pregnancy. Soc Sci

Med, 1990;30(4): 497-502.

27.Tomeo CA. Reproducibility and validity of maternal recall of pregnancy-related events.

Epidemiology, 1999; 10(6): 774-7.


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Kareema et al., Int J Med Res Health Sci. 2015;4(2):281-286


&


Received: 20th Nov 2014 Revised: 10th Dec 2014 Accepted: 30th Jan 2015

Research article

WATER ADSORPTION CHARACTERISTICS OF NEW DENTAL COMPOSITES

Rafed. M Al-Bader1,*Kareema M.Ziadan2, M. S Al-Ajely3

1 PhD. student, College of Dentistry, 2 Professor in polymer physic, Department of Physics, college of science,

University of Basrah, Basrah, Iraq.3 Professor in polymer, Department of Chemistry, college of Education, University of Mosul, Mosul, Iraq.

*Corresponding author email: [email protected]

ABSTRACT

Water sorption of dental composites affects dimensional stability, mechanical properties and bonding strength

with tooth structures. The diffusion coefficient of water through the resin should be identified. Methods: Ten new

composites fillings (M1-M10) were prepared from new Fluoroaluminosilicate powder composition and

BisGMA/TEGDMA together with the related compounds such as tri ethylene glycol dimethacrylate, N,N-

Dimethyl amino ethyl methacrylate and Camphorquinone. Five disk shapes were prepared for each composite

using a stainless steel mold 15 mm in inner diameter and 1 mm in thickness, according to ISO 4049, the curing of

each composite disk for 40 sec. Each disk was immersed separately in water for 90 day all at (37 ±1). Water

sorption and solubility were calculated by using these measurements, Diffusion coefficients were also measured

with the solution of Fick’s second law. Results: The water sorption (g/mm3) after 90 day immersion ranged from14.98 g/mm3 (±0.90) for M10 to 36.81g/mm3 (±0.46) for M6. The solubility ranged from 3.3 g/mm3 (±0.90) for

M6 to 8.55 g/mm3 (±0.31) for M7, the equilibration time for water sorption was reached at 20 day. M6 had the

highest diffusion coefficient 6.25 ×10-9 cm2 /s (±3.46). Conclusion: This investigation revealed that M6 composite

filling was the best one due to the lowest water solubility while the other investigated fillings showed moderate to

high solubility values but all are in accordance with the International Standard ISO 4049.

Keywords: Water sorption, Solubility, Composites, Diffusion coefficient, Calcium Fluoroaluminosilicate.

INTRODUCTION

Materials left for long time in the oral environment

will undergo an interaction with oral fluids. Visible

light-curable polymeric composites are now routinely

used as filling materials for dental restorations. These

materials are based on polydimethacrylate matrix

resins along with silane-coated inorganic fillers. They

possess many advantages such as mechanical

properties comparable to commercial dental

amalgams and dental ceramics, excellent esthetic

quality and the ability to bond to enamel surface.

However, in aqueous environment they absorb water

and release unreacted components.

There are two different mechanisms that occur when

the previously mentioned dental restorative materials

are exposed to or stored in water: the first is gaining

weight from water uptake, and the second is losing

weight from dissolution in water[1].Water sorption has been studied in several glassy

polymers used in dentistry. Composite resins[2,3], soft

lining and poly(methyl methacrylate) denture bases[4]

have all been shown to absorb water and, at the early

stages, this sorption follows Fick’s law of diffusion.Studies have mostly been focused on determining the

water sorption characteristics of epoxy-based

polymers [5-7]. However, data are scanty on the resins

that are employed as adhesives for bonding to

hydrated dentin.The importance of composite-water interaction has

been acknowledged in the ISO standard 4049 which

DOI: 10.5958/2319-5886.2015.00052.1


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states that the maximum values for water sorption and

concurrent solubility for resin-based materials

(composites and cements). In order to comply with

this ISO standard, resin-based materials must

have water sorption and solubility values equal or

lower than 40 micrograms per cubic millimeter

(sorption) and 7.5 micrograms per cubic millimeter

(solubility) for specimens 15 mm in diameter and 1

mm thick [8].

Fluoride (F-) releasing restoratives are frequently

studied because the F- ions could increase the

dissolution resistance of the tooth structure, enhance

remineralization and hinder demineralization[9,10].

Efforts have been made to develop a composite

consist of an aluminosilicate glass matrix modified

with other elements, and they contain large quantities

of fluorine. Calcium Fluoroaluminosilicate glass

powder is treated with a fluoride in an amount of

from 0.01 to 5 parts by weight based on 100 parts by

weight of the glass powder, The Calcium

Fluoroaluminosilicate glass powder of the

investigation is improved in not only physical

properties such as crushing strength but also mixing

workability without impairing the inherent

characteristics thereof for the dental use[11]. So

Calcium Fluoroaluminosilicate glass will be suitable

as filler for resin-based dental composites because itis interact with the bone structure makes them useful

materials for bone replacement in implants, naturally

radiopaque and highly resistant to moisture.

The aim of the present study is to determine the water

sorption characteristics of light-cured resins made

from new composites of Calcium Fluoro

aluminosilicate glasses filler with various weight

ratios.

MARERIAL AND METHODS

The compositions of the 10 composite resins tested,

The ethoxylated bisphenol A glycol dimethacrylate

Bis_GMA was purchased from Sigma Aldrich (UK)

and TEGDMA (triethylene glycol dimethacrylate)

manufactured from Sigma Aldrich (UK), N , N -

Dimethyl aminoethyl methacrylate (DMAEMA) and

camphor Quinone (CQ) were purchased from Aldrich

(UK), Those materials were used to prepare the

monomer phase.

Calcium fluoroaluminosilicate glass was synthesizedand sintered in our laboratory [12]. It was ball-milled

and sieved to powder with a particle size < 25 μm.

The particle size distribution was measured using a

BET analysis (CHEMBET 3000 QUANTA

CHROME). The average particle size was 2.64 μm.This Calcium fluoroaluminosilicate glasses was

treated with γ -methacryloxypropyltrimethoxy-silane(γ-MPS) known as A-174 which was supplied bySigma Aldrich (UK).

Preparation of composite: Ten types composites

formulations,containing the resins BisGMA/TEGD

MA in a w/w ratio of 70/30 as the base resins. Resins

were activated for visible light polymerization by CQ

(0.5 wt %) and DMPT (0.5 wt %). Matrix resins were

loaded (76 wt% ~ 60% Vol) and were then silanized.

This Calcium Fluoroaluminosilicate glasses hand

mixing. The compositions of the studied dental

composites are shown in Table 1. Water absorption

was determined on disc specimens, 15 mm diameter

and 1 mm thick, for up to 90 days using the method

outlined in ISO 4049. The discs were prepared

between glass plates and were cured by exposure to

dental curing lamp for 40sec on each side. Samples

were measured, weighed and placed in individual

sealed containers of water at 37ºC. The specimens

were removed from the storage water at regular

intervals, blotted dry and re-weighed. After 90 days

specimens were placed in a desiccator containing dry

silica gel and re-weighed at regular intervals over aperiod of 2 weeks.

Table1: Composition (W%) of Calcium Fluoro-

aluminosilicate Glass

Glass SiO2 Al2O3 CaF2 Al2PO4 AlF3 NaF

M1 22 18 22 15 23

M2 22 19 10 39 13 7

M3 29 16.6 34.2 9.9 5.3 5

M4 35 25 20 8 6 6

M5 39.52 23.6 13.65 3.62 9.7 9.91

M6 24.3 27.5 14.0 19.1 15.1

M7 33.9 17.5 8 15 10 15.6

M8 56.5 33.5 10

M9 48.9 29.1 15 7

M10 36.3 22 12 9 14.3 6.4

Preparation of specimens: Water sorption and

solubility tests were determined according to the

specification standard for composite (ISO 4049:

2000). Specimen discs approximately 15±0.2 mm in

diameter and 1±0.1 mm in thickness were fabricated


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in an aluminum mold between two glass slides they

were irradiated for 40sec on each side using a quartz – tungsten – halogen light-curing unit (Optilux 500,Demetron Research Corporation, Danbury, CT,

USA). The light-curing unit had an exit-window

diameter of 8 mm and was operated at 400 mW/cm2

with the curing tip placed 1 mm from the glass plate.

Four specimen discs were prepared for each for the

ten experimental resin formulations. The thickness of

the samples was measured accurately at three points

using a micrometer. Also their diameters were

measured, and their volumes were then calculated in

mm3.

water sorption and solubility: All the specimens

were placed in a desiccator and transferred in a

preconditioning oven at 37ºC. After 24 hrs they were

removed, stored in the desiccator for 1 hr and

weighted to an accuracy of 0.0001 g using a KERN

770 Germany. This cycle was repeated until a

constant mass (m0) was obtained. Following, the

discs were immersed in distilled water at 37ºC. At

fixed time intervals they were removed, blotted dry to

remove excess water, weighted and then back to the

water. The time intervals were more during the first

four day, preceding daily as the uptake slowed at

ijmrhs vol 4 issue 2

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