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Page 1: Process Document - pdf.usaid.gov

Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler01

Process Document

Strengthening Fetal Heart Monitoring During Labor Through Use of Standard Handheld Doppler

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ContentsAcronyms .................................................................................................................04

executive summAry ................................................................................................05

introDuction ...........................................................................................................07

BAseline ................................................................................................................... 11

trAining mAteriAl DeveloPment AnD cAPAcity BuilDing ................................ 12

results .................................................................................................................... 15

intervention FinDings ........................................................................................... 16

chAllenges ............................................................................................................. 21

scAlABility AnD sustAinABility...........................................................................22

WAy ForWArD ...........................................................................................................22

Annexures ...............................................................................................................23Annexure 1: Baseline report & Findings ...................................................................... 23

Annexure 2: Agenda for the training session ............................................................. 25

Annexure 3: Poster for Fetal heart rate monitoring using handheld Doppler ............. 27

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler04

CHC community health centersC-SeCtion cesarean sectionCtG cardiotocogramDH District hospitalFDA Food and Drug AdministrationFHR Fetal heart rateHiV HumanImmunodeficiencyVirusiUD intra uterine DeathLGH laerdal global healthMC medical collegeMD mission DirectorM&e monitoring & evaluationMo MedicalOfficerMiS management information systemMoHFW ministry of health and Family WelfareMoU memorandum of understandingnHM national health missionoBG obstetric and gynecologyot operation theatrePW Pregnant WomanRiMS rajendra institute of medical sciencesRoP report on ProposalsSBA skilled Birth AttendanceSDH sub District hospitalSoP standard operating ProtocolsUSAiD united states Agency for international DevelopmentWHo World health organization

Acronyms

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler05

Fetal Heart Rate monitoring is crucial for the early detection of fetal distress and prevention of stillbirths. The WHO standard protocol advises monitoring of FHR every 30 minutes in the active first stage of labor and every 5 minutes in the second stage of labor. FHR is usually monitored by a Pinard/Laennec stethoscope or the use of a hand-held Doppler device and Cardiotocogram (CTG). CTG machines are the gold standard for monitoring women in labor, however they are expensive and reduce the moth-er’s mobility. Affordable devices, such as the Pinard and simple, handheld dopplers are time-consuming, not designed for con-tinued monitoring, and require experienced users to accurately detect and measure FHR. FHR monitoring according to guide-lines is often not done due to lack of staff or equipment and contribute to the non-adher-ence to guidelines. Addressing this problem could help to save newborn lives.

Prioritizing improved fetal heart rate mon-itoring during intrapartum care the USAID Vriddhi project demonstrated the use of a handheld standard doppler device designed for both continuous and intermittent mon-itoring. The initiative was anchored in the Government of India’s ‘LaQshya – Labor Room Quality Improvement Initiative’ strengthening care around birth in Labor Rooms and Mater-nity OTs.

The device was introduced at 3 levels of pub-lic health facilities (CHC FRU, District Hos-pital and Government Medical College), total 7 facilities across the states of Jharkhand, Odisha and Uttarakhand. Prior to implemen-tation a rapid assessment of the situation

conducted by the project defined baseline values for - the frequency of FHR monitoring in the facilities vis-à-vis the MoHFW guide-lines and detection level of abnormal FHR and helped to understand the users perspec-tives, knowledge and skills, available devic-es, and challenges faced by them.

The intervention was introduced in August 2019. Implementation started after a short training on WHO standard for FHR monitor-ing and the use of the device. Implementation data using, qualitative and quantitative meth-ods, were collected every month and through-quarterly assessments in November 2019 and February 2020 (just before the COVID-19 pan-demic). A qualitative assessment during the pandemic studies effect on FHR monitoring.

Data from the intervention period shows; the device is being used for FHR monitoring in all levels of intervention sites and frequency of FHR monitoring has improved significantly. During the COVID-19 pandemic although the case load decreased the impact of the inter-vention continued. There was a non-signifi-cant decline in the frequency of FHR monitor-ing and no difference in detection of abnormal FHR, stillbirths and asphyxia as compared to the pre-pandemic intervention period.

The intervention demonstrated that intro-duction of appropriate technology; a reliable, easy to use device empowered health provid-ers. The user friendly design features of the device ensured its acceptability and use by providers as well as improved experience of beneficiaries, allowing the pregnant women to move around during labor and take pre-ferred position during childbirth with the de-

executive Summary

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler06

vice securely strapped to their abdomens and continue to hear their baby’s heartbeat.

Comprehensive planning was a key facilitator that helped demonstrate early results. Two states have planned scale up of the interven-tion across their aspirational districts with government funds.

Figure 1. The implementation process

Development of Concept and

Implementation Plan- Jan-Feb 19

2nd Quarterly Assessment -

Feb 20

Utility of Device Assessment During COVID-19 - June 20

1st Quarterly Assessment -

Nov 19

Project Data Collection

Completed-Dec 2020

Monthly Data Collection from -

Sep 19

Transition to State

Jan-Mar 2021

Development of Tools & Baseline Data Collection -

Mar-Jul 19

MoU with Manufacturer, Device

Procurement, Training, March-Aug 19

A key challenge in implementation was to en-sure an adequate number of functional devic-es for monitoring all pregnant women in labor in the identified high case load facilities. To overcome this the project signed a MoU with the manufacturers of the device, for ensuring smooth procurement, maintenance and trou-bleshooting support.

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler07

introductionThe quality of care at birth can determine outcomes for the mother and baby, it may even prevent death. Childbirth is a normal physiological process, a time when both mother and newborn are vulnerable and at risk. Complications during childbirth can re-sult in many preventable newborn deaths and underlie half of all stillbirths and a quarter of neonatal deaths. There are evidence-based practices which if implemented with quali-ty and at scale can effectively mitigate this problem. Intrapartum Fetal Heart Rate (FHR) monitoring for early detection of abnormal FHR and timely obstetric interventions is one such proven critical practices.

Increase in institutional delivery has not translated into reduction in mortality and at delivery points has often been dealt with at the cost of quality. This prompted the Gov-ernment of India (GoI) to launch several initi-atives to improve the quality of health care, notable among these is LaQshya the nation-al Labor Room (LR) and maternity Operation Theatre (OT) quality improvement initiative. There are several proven, effective, evi-dence-based interventions which are cen-tral to the quality improvement efforts. FHR monitoring during labor is one such critical intervention which needs strengthening in low resource settings (WHO).

The SITUATION As part of its technical support to strength-en quality of care around birth, status of im-plememntation and the practice of intrapar-tum FHR monitoring was assessed by United States Agency for International Development (USAID) supported Vriddhi project across a cross-section of public health facilities in 3

states, Jharkhand, Odisha and Uttarakhand. The World Health Organization (WHO) recom-mendations for FHR monitoring; listening to the fetal heart rate immediately after a con-traction and counting the FHR for a full min-ute at least once every 30 minutes during the active first phase and every 5 minutes during the second stage of labor – were used as the quality benchmarks for the assessment.

The findings revealed that FHR monitoring was in practice in all places assessed but there were inadequacies in practice and knowledge across all facilities - Medical College (MC), Dis-trict Hospitals (DH) and Community Health Centers (CHCs). FHR was not monitored at the recommended frequency in accordance with standard guidelines. It was observed that FHR was monitored once for 70% of labor cases, but only a third of the providers maintained recommended frequency during first stage of labor and none for the second stage. Except one, none of the service providers knew of the standard protocol of monitoring every 5 min-utes during second stage. Besides there were issues related to the use of the devices, the stethoscope and simple handheld dopplers that are available in these facilities.

IDeNTIFyINg A SOlUTIONFHR monitoring during labor is a complex process. The multi-faceted challenges faced included several inter-related problems such as understaffing, high case loads, time con-straints, use of affordable devices that com-promise reliability and accuracy. All of these contribute to poor compliance with standard guidelines and limit usefulness of FHR moni-toring for detecting abnormal FHR and taking early action.

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler08

Desk review revealed that measuring FHR is time consuming (Takes upto 5 minutes per read-ing), measurements are not reliable because handheld doppler reading maybe fluctuating/inaccurate, or it is difficult to hear and locate FHR when using stethoscopes. Moreover, staff competence and experience can influence the accuracy of these measurements. Cardiotoco-gram is considered the gold standard for fetal heart rate monitoring, it is reliable and accurate but its high cost restricts its use universally in public health facilities, it is available only in the higher facilities. Other challenges including un-derstaffing, overcrowding and timeconstraints were also reported. Clearly an innovation was needed that could overcome challenges of ma-jor resource constraints, skilled human resourc-es in the recommended numbers with time on hand- can help save newborn lives.

Keeping in mind the current challenges, based on technical evaluation of various devices for FHR monitoring vis-à-vis accuracy, robust-ness and design, a device of proven efficacy, globally recognized and quality certified was identified for trial in public health settings.

A CEA certified and FDA approved handheld doppler was selected for introduction in se-lected public health facilities. The selected device was found to be affordable and ad-

dressing several constraints to FHR monitor-ing. The device “Fetal Heart Rate Monitor” is a product of Laerdal Global Health (LGH). Rigor-ous trials have generated evidence of its reli-ability and utility to detect abnormal FHR even in resource constrained settings.

The selected solution - a standard handheld doppler with its technical edge, user friendly in-terface for providers, ease of use for beneficiary has the potential to transform the scenario and empower health workers to save newborn lives.

Literture review also revealed that the same device had been used in other coutries in re-search mode successfully leading to improved monitoring during labor.

OBJeCTIVeS OF INTerVeNTION1. To assess the feasibility of the Standardized

Handheld Doppler device for use in public health settings, its reliability, robustness and acceptability

2. To improve monitoring of FHR as per protocols 3. To improve detection of abnormal FHR

In addition it was envisaged that experiences gained with the use of selected device may as-sist in guiding state decision makers in deciding further scale up and also guide them in terms of logistic needs in a public health setting.

FeATUreS OF The SeleCTeD DeVICe• It uses a 9 crystal doppler ultrasound sensor that detects FHR in less than 5 seconds over a

wider area, • It can differentiate between maternal and fetal heart beat and display both for

comparison• It measures, analyzes and displays the FHR on a monitor along-with an audible sound. A

traffic signal system in the display indicates normal/abnormal FHR • It has an alarm function that alerts mothers and providers in case of prolonged abnormal FHR.

• It can be used handheld for intermittent monitoring or strapped on to mother for continuous monitoring. It also displays 30-min histogram.

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler09

Figure 2. Theory of change with indicators, inputs, outputs, outcomes, goals & assumptions explained

# of faclilities with Fhr monitoring device# of Fhr monitoring device per level of facilities

Introduce Fhr monitoring device at various levels of facilities

• Availability of adequate number of Fhr monitoring device

• Providers know how to use the device

• Providers accept the new device

• Required resources (gel, batteries) and infa (power for charging ) available

• Improved ease of monitoring Fhr

• Improved beneficiary experience (Mobility, position of choice)

• The FHR monitoring device has minimum downtime and seamless maintenance

• Resources available

• Improved accuracy of FHR monitoring

• Easier to interpret abnormal Fhr

• Continues use of FHR monitoring device

• FHR monitoring device replaces other tools

• Prompt action on detection of abnormal Fhr

Providers use to monitor Fhr

Improved monitoring of Fhr

Improved Identification of abnormal FhrImproved obstetric outcomes

Number of cases where Fhr monitoring device is used Average time taken for recording Fhr

#PW monitored using Fhr monitoring device% PW monitored for Fhr a per protocols (1st Stage)

% PW where abnormal Fhr identified % PW (with abnormal Fhr) AVD% emergency CS # referrals

Inputs Outputs Outcome goal

Indi

cato

rsAs

sum

ptio

ns

TheOry OF ChANge

FHR Monitoring device being used for continuous monitoring of FHR in CHC Ratu, Jharkhand

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler10

Figure 3. Roles of the three stakeholders

DeVelOPINg IMPleMeNTATION PlANShared understanding about the implemen-tation model for the intervention started with high level meetings with the technical division of Government of India and key stakeholders in the project states. Vriddhi team had a series of meetings with senior officials including Health Secretary, MD NHM and State Program Officers to introduce the concept and seek state part-nership for the intervention. Facilities were proposed and after getting state approval, the action moved to the next level, the District Of-ficials, Medical Superintendent, Head of Ob-stetric and Gynecology (OBG) department and

Facility In-Charges were sensitized for the in-tervention. After all stakeholders were onboard implementation plans were firmed up.

FACIlITy SeleCTIONThe facilities were identified from the aspi-rational districts*, based on delivery load and convenience. Three levels of care were repre-sented by Medical College (Tertiary), District Hospital (Secondary) and CHC (Primary), to un-derstand how the device would address vari-ous challenges at each level. The proposed fa-cilities were agreed upon with the respective states before starting the intervention.

PrOJeCT Vriddhi TeChNICAl PArTNerNatioNal team• Conceptualize the intervnetion • Develop training and monitoring protocols • Liaise with partnersState teamS• Advocacy with state, district and facility• Organizing and conducting training activities• Data collection baseline, monthly & endline mentoring• Handholding of facilities dissemination of findings

STATe NhM IMPleMeNTINg PArTNer• Agree to implement the

intervention• Give access to selected facilities • Mobilize line staff and other

resources • Participate in trainings,

mentoring and review• Review the intervention

lAerDAl glOBAl heAlTh TeChNOlOgy PArTNer• Donate the devices for

intervention• Contributed in developing

training resources • Provide resource persons in

traininigs• Support maintenance of the

devices

improved FHr moNitoriNg

aNd pregNaNcy outcome

FOrgINg A PArTNerShIP Vriddhi Project entered into partnership with the device manufacturer Laerdal Global Health vide a Memorandum of Understanding (MoU) that defined the roles and responsibil-ities for each party. The LGH donated Fetal Heart Rate monitoring devices, for use in

public health facilities for the intervention. It also supported capacity building for the product use and backend maintenance of the device. The project as technical partner liaised with state governments to set up a three-way collaboration. Roles of the various stakeholders are detailed in Figure 3 below.

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler11

table 1. Facilities Selected for the intervention

State Facility level average Monthly Delivery loaD (2018-19)

Jharkhand

RIMS (Rajendra Institute of Medical Sciences) Medical College 730

Chaibasa DH District Hospital 176

Ratu CHC 200

UttarakhandHaridwar DH District Hospital 450

Manglore CHC 103

odishaKandhmal DH District Hospital 302

Baliguda SDH 111

BaselineA baseline assessment of FHR monitoring prac-tices was done in the identified facilities across the three states of Jharkhand, Odisha and Ut-tarakhand (March to June 2019). The study used mixed method approach to assess FHR moni-toring practices, assess knowledge and skills of providers and understand challenges and issues.

A set of tools including provider interview and beneficiary interview schedules, structured observation questionnaire were prepared for the assessment. A purposive sample of 3-4 service providers per facility was selected for interviews, and 3-4 non-complicated labor cases per facility were observed, depending on willingness of the pregnant woman and service provider. The following methods were used for data collection:

record review included LR register, OT Reg-ister, sample case sheets/partograph for data on Emergency C sections, referrals, assisted deliveries, cases where FHR monitoring docu-mented, live births and total deliveries.

*Aspirational Districts: The Government of India has identified 117 districts, which lag national averages on socio-economic indicators, for accelerating improvement through intensive efforts in 5 thematic areas including health and nutrition. It is aspired that improvement in these districts will accelerate improvement in human development in India.

Key informant interviews were used to cap-ture the current practice of FHR monitoring, challenges and difficulties faced.

observation of practice with the help of an observation checklist was done to verify the interview data.

Findings• FHR monitoring process had several lacunae

according to standard guidelines. • Only 15% of total labor cases were moni-

tored more than 4 times. • 7 out of 27 cases observed were monitored

every half hour during active labor in first stage • No labor case monitored as per the recommend-

ed every 5 minutes in second stage of labor. Details of baseline report and findings are at-tached as Annexure 1.

Devices used and associated challenges • Stethoscopes and handheld dopplers were the

most often used devices. The Medical College used stethoscopes while DH and CHC used

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler12

handheld dopplers in most cases followed by stethoscope. CTG was being used in one DH.

• Average time taken for one reading was shorter when using a stethoscope (1.5 to 2.5 minutes) than when using a doppler (3.5 to 4.1 minutes).

• Challenges in the use of stethoscope were

low audibility, expertise required to locate FHR, issues in repairs. Challenges reported for doppler were difficulty in locating FHR, fluctuating/inaccurate reading, insufficient numbers of doppler per total daily labor cas-es, battery replacement and storage.

A one-day orientation based on partogram filling as per Skilled Birth Attendance (SBA) package of the country kickstarted the inter-vention. The training content focused on FHR monitoring protocols, included live hands on practice on the use of the device and oriented the participants on the M&E tools. The training was interactive and practical devoting ample time to the use of the device and highlighting its special features such as digital display of fetal heart rate, mother’s heart rate and alert system when FHR becomes abnormal. A total of 95 healthcare providers were trained. The agenda for the training session is attached as Annexure 2.

In Jharkhand, the training was conducted at RIMS OBG department. Medical College fac-ulty, residents (Both senior and junior) and labor room staff nurses were divided in two groups to be trained in 2 batches. In Odisha the training was arranged at DHH Kandhamal. In Uttarakhand the training was arranged at

training Material Development and Capacity Building

table 2. training details

oBg SpecialiSt MeDical oFFicer (Mo) StaFF nUrSe

Jharkhand 8 (Faculty)7 (Senior Residents)

3 (MO)33 (Junior Residents)

9

odisha 5 12

Uttarakhand 2 2 14

Chainrai Women's Hospital, Haridwar. Details of participants are provided in Table 2.

Project district teams visited the implement-ing facilities regularly for follow up, hand-holding and onsite training as well as monthly data collection. Labor room in-charge were reached telephonically for continued follow up to ensure smooth operations.

Training on use of FHR device at RIMS, Ranchi in Jharkhand

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DISTrIBUTION OF DeVICeSIt was decided to equip each facility with an optimum number of FHR monitoring devices to cover all the deliveries in the labor room. The number of devices per facility was de-termined on the basis of the number of la-bor tables in the facility plus few extra for patients not in active labor.

The devices were handed over to the medical officer and LR sister at the end of the training. For RIMS they were handed over to Head of the OBG department.

MONITOrINg & eVAlUATION The monitoring and evaluation plan and pro-tocols for the intervention were developed immediately after conceptualizing the inter-vention. Baseline assessment in the pre-in-tervention period (March 19 to June 19) was followed up with quarterly assessments (Us-ing the same tools) to track progress, change of practices and user and client perceptions. Data from labor room records were collected monthly.

Primary data related to frequency of fetal heart rate monitoring and detection of abnor-mal FHR in each cases were collected from the case sheets (Including partographs).

Quarterly Data: Implementation phase started in September 2019 and qualitative data was collected every three months after that - in November 2019 and February 2020. The onset of COVID-19 pandemic put a stop to the quar-terly assessment as in person field work was restricted. Nevertheless, a rapid assessment was done remotely to find out the effect of the pandemic on FHR monitoring. Data collected through telephonic interviews with a sample of health providers in April to June 2020 was

Figure 4. Number of Devices distributed to the Facilities

10

5

46

4

5

3

compared with program data for the period of January to March 2020.

monthly Data: Project team visited facilities every month starting September 2019, to collect data, handhold staff and troubleshoot problems. Data on Frequency of FHR monitoring, detecting abnormal FHR, total deliveries, total C-sections were collected from case sheets and labor room records. Monthly data collection started with the commencement of baseline assessment in March 2019. The pre-implementation phase (March to June 2019) is treated as baseline and data from September 2019 onwards is consid-ered as implementation data.

For the baseline period data were collected by analyzing all the case sheets. For the inter-vention period, Jharkhand and Odisha used randomly chosen sample case sheets but Uttarakhand continued to review all the case sheets. Due to travel restrictions,during the pandemic, data from facilities in the remote district of Kandhamal in Odisha was collected through a trained local resource.

RIMS Chaibasa DH Ratu Haridwar DH

Manglore CHC Kandhmal DH Baliguda SDH

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler14

table 3. number of sample case sheets reviewed per month

Facility no oF SaMple caSe Sheet checkeD per Month

riMS 120

chaibasa Dh 100

ratu 50

haridwar Dh All Cases (Range maxm533- min 313)

Manglore chc All Cases (Range maxm 228- min 115)

kandhmal Dh 100

Baliguda SDh 60

From January 2020, at 5 months of interven-tion, additional details were included in the data elements - actions taken in cases iden-tified with abnormal FHR, women who came for delivery at an advanced stage (Delivered within 1 hour of admission).

Monthly data was uploaded in the online database of the Vriddhi project for analysis in real time.

Addressing concerns and issues in the use of

table 4. Addressing issues with the device

iSSUeS action taken to aDDreSS the iSSUeS

Positioning the device, recording maternal heart rate instead of FHR, false readings e.g. FHR reading for IUD case

Refresher training for demonstration of correct positioning, hands-on practice for staff with instructions-place the sensor probe for a longer duration (If possible continuous) on mother’s abdomen to nullify any confounding sound In case of low FHR, always check using maternal heart rate sensors to rule out uterine souffle

Non-availability of gel, charger malfunction Follow up with authorities to ensure supply and with LGH on the technical snag

Convincing the mother to use the device strapped on during the labor Mothers were encouraged to use the device strapped on when frequent monitoring was required

Newly posted staff unable to use the device Repeat training at the facility during monthly visit by project team

Display was showing FHR but without the accompanying fetal heart sound

Faulty devices were promptly withdrawn and the project team liaised with LGH for immediate replacements

device: Throughout the intervention period project team mentored and handheld the fa-cility staff to use the device and monitor FHR as per protocols. This support helped to ensure that the device was accepted and used at the facilities, even during the COVID-19 pandemic.

The problems as they arose and solutions are summarized in Table 4.

ANM Munni Devi using Standardized Handheld Doppler for monitoring FHR at CHC Ratu, Ranchi

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FINDINgS OF The QUArTerly QUAlITATIVe ASSeSSMeNT Change in practices was observed early, after 3 months of intervention. There was marked improvement in compliance to protocols, per-ceptions of users and beneficiaries. Some changes observed include:

Protocol Compliance• 50% Monitored as per protocols in first stage

of labor. • 40% Monitored as per protocol in second

stage of labor.• 100% readings documented - 80% docu-

mented in case sheets, 55% in partographs & 36% both in case sheet and partograph.

Time taken per reading reduced to 1 min from 5 min at baseline.

nurse’s feedback • 21/24 of providers reported reliable readings

and ease of use.• 1-7/24 reported challenges:

• Difficulty in using device in case of twins (2);• Low sound volume (7); • Difficulty in tying belt on women with larger

build (1); • Need to have a separate device for HIV + PW

as cleaning belt becomes cumbersome (1); • Device picks up erroneous FHR even in cas-

es of IUD (1).

Beneficiary feedback• 100% Device used on cases, observed most

for intermittent monitoring (73-80%), re-maining for continuous monitoring.

• Mothers monitored continuously with device strapped to abdomen appreciated being able to move around and hear baby’s heartbeat.

Results

• All mothers found fetal heart sound reas-suring.

Fhr MONITOrINg DUrINg COVID-19 lOCkDOWN IN FACIlITIeS USINg hANDhelD DOPPlerIn March 2020, there was a national shutdown due to COVID-19 Pandemic and a strong pos-sibility that the routine maternal and newborn health care services would be impacted. Al-though, travel restrictions put an end to in per-son hand-holding support, the project contin-ued remote support using telephone and other modes of digital communication. Responding to the pandemic the project developed and dis-seminated e-training on infection prevention, cleaning and disinfection of the device, and the need to do this between every use.

A rapid assessment was conducted to under-stand service provider’s experience of monitor-ing practices during the pandemic. Telephonic interviews were conducted with service provid-ers and program data was compared between COVID-19 lockdown period (April-June 2020) and the previous three months (Jan-March 2020).

Pregnant Woman in second stage of labor wears the FHR monitoring device

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler16

Although there was a decrease in the case load during lockdown the improved practic-es from the implementation period continued through the pandemic. The frequency of mon-itoring, rates of abnormal FHR detection, still-births and asphyxia occurrence were com-parable to the earlier implementation period. Infection prevention protocol was followed in all facilities. It came out that, the handheld Doppler was used by four facilities to contin-uously monitor pregnant women because this reduced the need for repeated interactions and risk. Study participants reported that strapping the belt for continuous monitor-ing reduced exposure to suspected COVID-19 cases. Only two participants felt that strap-ping could increase the risk of infection. Use

A total of 22,579 deliveries were covered un-der the intervention (Sep 2019 to Sep 2020).

Frequency of FHR monitoring and rate of cases detected with abnormal FHR increased signifi-cantly in all the states. Cases never monitored declined in all states, but the biggest reduction occurred in Uttarakhand and Odisha at the CHC level. In the Medical College the baseline values of cases never monitored were considerably lower even at baseline, thus the change in this indicator was insignificant. Frequency of moni-

toring > 3 or 4 times increased in all the facilities except in DH Haridwar, this was probably due to the poor documentation practice in this facility.

Findings for the three indicatorsi. percent cases detected with abnormal FHRii. percent cases never monitored with abnormal

FHR iii. percent cases monitored >3 times; in the inter-

vention period of September 2019 to Septem-ber 2020 are summarized according to state, type of facility and at individual facility below:

intervention Findings

Table 5. Indicators that changed significantly in the intervention period (Sep 19-Sep 20)

inDicator BaSeline Mean % intervention Mean % SigniFicant at 95% ci

Birth Asphyxia detected at Medical College 7.93 12.67 P=0.005

Abnormal FHR detected at DH 5.94 10.78 P=0.023

Abnormal FHR detected at CHC 3.61 6.66 P=0.033

FHR never monitored at DH 7.98 2.70 P=0.004

FHR never monitored at CHC 14.72 1.67 P=0.00

FHR Monitored for 3-4 times at CHC 13.27 18.70 P=0.05

FHR Monitored >4 times at DH 13.23 27.22 P=0.03

Staff nurse cleans the FHR device with clean cloth and disinfectant between use

of the Doppler for FHR detection not only con-tinued during COVID-19 pandemic but was also perceived to help reduce risk of transmission.

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State wise Changes

Jharkhand Odisha Uttarakhand Total

Baseline Mar-Jun 19 Intervention Sep'19 to Sep'20

8.5%11.4%

2.7% 3.3% 3.0%5.2%

14.4%

7.3%

Changes by type of Facility

MC Dh ChC All Facilities

Baseline Mar-Jun 19 Intervention Sep'19 to Sep'20

9.1%

14.6%

5.0% 3.6%5.3% 5.2%

7.3%7.0%

Changes by intervention Facility

ChC rATU DhChAIBASA

rIMS Dh kANDhAMAl

SDh BAlIgUDA

ChCMANglOre

DhhArIDWAr

Baseline Mar-Jun 19 Intervention Sep'19 to Sep'20

5.4%9.1%

3.2%1.1%

10.0%

17.3%14.6%

7.5%

10.9% 10.6%

3.0% 2.4% 3.5% 3.2%

Figure 5. Percent Cases detected with Abnormal FHR

Figures 5, 6 and 7 - Graphically present changes in key indicators in the implementation period against baseline– i) Percent Cases detected with Abnormal FHR, ii) Percent cases never moni-tored for FHR and iii) Percent cases monitored > 3 times for FHR.

N= Sample Number of cases analysed: For baseline, sample case sheets checked (Mar-Jun 19)=5682. For Intervention period (Sep 19 -Sep 20) = 12,213

Change in Percent Cases Detected with Abnormal FHR

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler18

State wise Changes

Jharkhand Odisha Uttarakhand Total

Baseline Mar-Jun 19 Intervention Sep'19 to Sep'20

3.7%1.0%

13.0% 14.2%

3.0%

9.8%

1.9%3.4%

Changes by type of Facility

MC Dh ChC All Facilities

Baseline Mar-Jun 19 Intervention Sep'19 to Sep'20

2.1% 0.8%

9.6%

14.1%

1.5%

9.8%

3.4%4.8%

Changes by intervention Facility

ChC rATU DhChAIBASA

rIMS Dh kANDhAMAl

SDh BAlIgUDA

ChCMANglOre

DhhArIDWAr

Baseline Mar-Jun 19 Intervention Sep'19 to Sep'20

7.4%2.1%

11.9%16.1%

2.1%1.8%0.8%2.3% 1.9%0.4%

20.2%

1.0%

11.6% 6.9%

Figure 6. Percent Cases never monitored for FHR

Change in Percent Cases never Monitored

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler19

State wise Changes

Jharkhand Odisha Uttarakhand Total

Baseline Mar-Jun 19 Intervention Sep'19 to Sep'20

49.4% 53.3%

25.6% 27.9% 22.3%

35.6%

66.3%38.5%

Figure 7. Percent Cases Monitored > 3 times for FHR

Changes by type of Facility

MC Dh ChC All Facilities

Baseline Mar-Jun 19 Intervention Sep'19 to Sep'20

50.7% 49.4%

27.3%

43.9%

55.9%

35.6% 38.5%28.7%

Changes by intervention Facility

ChC rATU DhChAIBASA

rIMS Dh kANDhAMAl

SDh BAlIgUDA

ChCMANglOre

DhhArIDWAr

Baseline Mar-Jun 19 Intervention Sep'19 to Sep'20

37.3%50.7%

17.2%

49.5%

67.7%65.5%

49.4%51.3%59.8%57.9%

47.8% 52.9%

19.3%10.4%

Change in Percent Cases Monitored > 3 times for FHR

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler20

Women who were admitted in advanced stage of labor (Delivered within 1 hour of admission)Detailed analysis of 4,430 sample cases showed that 26% women delivered within 1 hour of admission, the highest in Uttarakhand - 45% (figure 13). At DH Haridwar 40% cases and at CHC Manglore 56% delivered within 1 hour of admission. This explains Uttara-khand’s high data values for FHR never mon-itored and low frequency of monitoring during both baseline and intervention period.

C-Sections performed in abnormal FHR cases 451 abnormal FHR cases were detected among the sample case sheets analyzed. Of these emer-gency C Section was performed in 44.3% of the cases. At 66.9% Jharkhand had the highest val-ues on this indicator, probably due to inclusion of RIMS Medical College, which reported. 84% emergency C-sections for cases of abnormal FHR. Significantly CHC Ratu also reported 78% emergency C-sections for abnormal FHR cases.

Abnormal FHR Cases referred outOnly 2% of abnormal FHR cases were re-ferred. There was no referral of abnormal FHR cases in Jharkhand. In Uttarakhand 25% cases of abnormal FHR were referred out the maximum were from DH Haridwar (30%).

Figure 8. Women who delivered within one hour of admission

Jharkhand Odisha Uttarakhand Total

18.6% 19.2%

45.0%

26.0%

Figure 9. Emergency C-Sections in Abnormal FHR cases

Jharkhand Odisha Uttarakhand Total

66.9%

16.9%21.4%

44.3%

Figure 10. Abnormal FHR cases referred out

Jharkhand Odisha Uttarakhand Total

0.0% 1.1%

25.0%

2.0%

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler21

The device was well accepted and used in all facilities, yet there were challenges.1. Documentation - FHR was recorded but dur-

ing mentoring visits it came to light that it was often not entered in the case sheets and partograph, or in the LR register. This was seen when the load was high and also when women came in advanced stage of labor. This remained a persistent issue in CRW Haridwar, where observation con-firmed regular FHR monitoring but the pro-ject Management Information System (MIS) did not reflect this because of poor docu-mentation .

2. Documenting FHR when using the device for continuous monitoring - In many facili-ties especially of CHC level, the device was used strapped on for continuous monitor-ing during second stage of labor. However, the practice was not documented and FHR

readings at 5/10 minutes interval were not entered. This was especially seen at CHC Ratu.

3. Due to the powerful sensors the device is able to pick up FHR over a large area, this was a challenge in case of twin pregnancies as two distinct FHRs could not be meas-ured.

4. The loss of fetal heart sound volume in 11 of the 40 devices was a challenge. However, all devices were replaced promptly by Laer-dal Global Health and based on the feedback they are also reviewing the device hardware and design to improve this feature.

5. Feedback from ObGyn specialists for en-hancing the design to include measure-ment of uterine contractions and displaying the readings along with the FHR was shared with Laerdal Global Health. The agency is working on improving design of the device.

ChallengesFigure 11. Birth Asphyxia in cases of abnormal FHR

ChC rATU DhChAIBASA

rIMS Dh kANDhAMAl

SDh BAlIgUDA

ChCMANglOre

DhhArIDWAr

11.1%

43.6%

8.5%

23.5% 25.8%

37.5%

5.0%

Abnormal FHR cases with Birth asphyxiaAcross the facilities birth asphyxia occurred in 23% abnormal FHR cases. The highest were at DH Chaibasa (43.6%) followed by CHC Manglore (37.5%).

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler22

Engaging with stakeholders from the very start of the intervention, regular reporting particularly the early evidence of change helped to convince the officials of the use-fulness of this intervention for subsequent adoption by state.

Reliable and accurate measurements of FHR and the ease of use are the advantages of the device that have moved states to scale up the intervention to additional districts. Vriddhi is now supporting states to procure stand-ard hand held doppler devices through state

Scalability and Sustainabilityresources. Two of the implementing states have approved National Health Mission (NHM) budgets to procure the devices.

Strengthening of FHR monitoring and Par-tograph use are already part of the national LaQshya program and have been included in the Rapid Quality Improvement cycles at facilities.

A standard fetal doppler device such as hand-held Doppler is likely to improve FHR moni-toring because it is a reliable and easy way of recording FHR.

Vriddhi will continue to provide technical support for the initiative till completion of the project. The project state and district teams will extend the necessary support to ensure smooth transition of the intervention in the implementing facilities.

Vriddhi will support the states to procure

standard fetal doppler, approved in 2 im-plementation states, by preparing technical specifications for procurement.

Learnings from the pilot are being document-ed and will be disseminated in the partner states and at national level.

Way Forward

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler23

Baseline Assessment of Fetal heart rate monitoring during child birth in selected facilities in Aspirational Districts of Jharkhand, odisha and uttarakhand.

An assessment was conducted by USAID Vriddhi project in 7 facilities in selected aspirational dis-tricts of Uttarakhand, Jharkhand and Odisha to understand 1) the frequency of FHR monitoring in the facilities, 2) the devices used for FHR monitoring and their challenges, and 3) detection level of abnormal FHR. Facilities selected were across all tiers: medical college (N=1), district hospital (N=3), CHC (N=3). Data were sourced through a) record review, b) interview with providers, c) observation of labor cases. Available records (case sheets) from March to June 2019 were used.

FINDINgSFrequency of Monitoring• Although monitoring at least once was done for 70% of labor cases, frequency decreased for

more than one time monitoring.• Only 7 out of 21 providers were observed to be monitoring in the correct frequency during first

stage of labor (Every 30 minutes) while none did so for the second stage (Every 5 minutes).• Except one, none of the service providers knew of the standard protocol of monitoring every 5

minutes during active stage.

Annexures ANNexUre 1 - BASelINe rePOrT & FINDINgS

Devices used and challenges in use• Stethoscopes were used for half of the labor cases observed and dopplers for the other half.

The Medical College used stethoscopes while DH and CHC used handheld dopplers in most cas-es followed by stethoscope. CTG was seen to be used in one labor case in a DH.

• Average time taken for one reading was shorten when using a stethoscope (Ranged from 1.5 to 2.5 minutes) than when using a doppler (3.5 to 4.1 minutes).

Frequency of monitoring FHR as per standard guideline (Interview and observation data)StageS oF laBor once every

hoUronce every 30 MinUteS

once every 15 MinUteS

once every 5 MinUteS

only at aDMiSSion

any other MiSSing

interview (n=26)*

Stage 1 4 18 4

Stage 2 3 8 1

oBServation (n=27)

Stage 1 (n=14+7**) 2 7 0 0 4 7 1

Stage 2 (n=6+7**) 4 2 0 2 4 1

*Interview questions have multiple choice responses, so frequencies do not add up to N** An additional 7 observers observed both stage 1 and stage 2

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler24

• Challenges in the use of stethoscope were low audibility, expertise required to be used, issues in re-pairs. Challenges reported for doppler were difficulty in locating FHR, fluctuating/inaccurate read-ing, insufficient numbers of doppler per total daily labor cases, battery replacement and storage.

types of device used at facility levels and average time taken for one reading*

Device MeDical college DiStrict hoSpital chc

ObservationN (time taken)

InterviewN (time taken)

ObservationN (time taken)

InterviewN (time taken)

ObservationN (time taken)

InterviewN (time taken)

Stethoscope (time taken) 4 (2.5 min) 5 (1.5 min) 4 (2 min) 3 (1.5 min) 2 (1.5 min)

Doppler 6 (3.5 min) 1 (7 min) 7 (4.1 min) 5 (6.5 min)

ctg 1 (5 min)*Table does not show combinations of devices

Detection of abnormal FHR and action taken• Detection of abnormal FHR was 3-5% of total deliveries. For the majority of these cases, C section

was performed in all three types of facilities, the majority being in the medical college (68%). Re-ferrals were done mostly from CHC, while assisted deliveries were low across all facilities.

Facility level detection of abnormal FHR and action taken

Facility level total Delivery total c Section n (%*)

total Detection oF aBnorMal Fhr

c-Section oF aBnorMal Fhr caSeS

reFerralS oF aBnorMal Fhr caSeS

aSSiSteD Delivery oF aBnorMal Fhr caSeS

District hospital 3291 424 (13%) 159 (5%) 87 (55%) 18 (11%) 6 (4%)

chc 1786 225 (13%) 60 (3%) 22 (37%) 15 (25%) 0

Medical college 2233 976 (44%) 75 (3%) 51 (68%) 0 1 (1%)

CONClUSIONMonitoring of FHR is not done in the desired frequency in accordance with standard guidelines despite the introduction of hand held doppler. Furthermore, providers reported challenges in using dopplers which may be due to using non standardized dopplers. The introduction of stand-ardized doppler which is globally recognized and approved would improve usage and acceptance of the device as it overcomes the existing challenges reported. It is also expected to improve compliance in monitoring, and thus, improve neonatal outcomes.

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler25

ANNexUre 2 - AgeNDA FOr The TrAININg SeSSION

USe oF hanDhelD Doppler For iMproveD qUality oF care DUring laBoragenDa For Facility level training

Date: venUe: Dh level FacilityDUration 1 Day

ScheDUle SeSSion MethoDology reSoUrce perSon

Inaugural session: 9:30- 10:00

9:30- 10:00Inauguration Introduction of participants

Large Group

Opening of session HOD

Session 1: Context setting (10:00 to 11:30) (90 minutes)(Small group facilitation)

1. Monitoring during labor 2. Use of partograph to monitor labor 3. Place of FHR in partograph4. Devices used to monitor FHR5. Why should we use handheld doppler for FHR monitoring?

OUtCOMe OF SeSSION: 1. Arrive at consensus on advantages of regular monitoring of labor2. Demonstrate correct use of partograph with emphasis on monitoring of FHR for fetal wellbeing 3. Arrive at a consensus on common challenges for monitoring FHR in every labor as per guidelines4. Arrive at a consensus that a standard handheld doppler would improve FHR monitoring

10:00 10:15

Monitoring of laborAdvantages of monitoring labor Need for monitoring woman in labor And challenges faced in complying to protocols

VIPP cardsGroup Discussion

Vriddhi

10:15 10:45Monitoring labor using partograph Place of FHR in partographDiscuss common challenges in monitoring of FHR

Demonstration through chartDocument readingDiscussion

Vriddhi

10:45 11:00 Practice plotting on a partograph Case study Vriddhi

11:00 11:15What are the different devices used for FHR recording? Advantages & Disadvantages of CtG; Stethoscope; hand held doppler

Chart Vriddhi

11:15 11:30Why should we use handheld doppler for FHR monitoring?• Importance of standard device • Introduce 'FHR Monitoring Device'

Power point;Group Discussion; VIPP cards

Vriddhi

Tea Break - 11:30 – 11:45 (15 minutes)

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler26

Session 2: Product Training 11:45 – 13:00 (75 minutes)

1. How to use FHR Monitoring Device or Handheld Doppler?2. How to maintain device?

OUtCOMe OF SeSSION:• Participants will develop an understanding on how FHR monitoring device works• Develop an understanding on how to interpret various functions of FHR monitoring device

11:45 12:45

How to use FHR monitoring device?• Introduction to parts of FHR monitoring device• Interpreting various signals and alarms

(Abnormal FHR, Lost signal, differentiating FHR & MHR etc) • Response to alarms

Demonstration on FHR monitoring deviceDocument – Laerdel User manual Laerdel – Flip chartFilm on use of FHR monitoring device

Laerdel

12:45 13:00Maintenance of deviceCharging of battery, maintenance of abdominal belt, trouble shooting

Laerdel User manual Laerdel

Session 3: Practicing use of FHR monitoring device on PW 13:00 – 13:45 (45 minutes)(Small group facilitation)

to apply what has been learned in actual clinical settings and reinforce learnings

13:00 13:45

Demonstration of use of device in clinical setting• Introduction of FHR monitoring device to PW• Remembering to use Gel• Comparing FHR with MHR using FHR monitoring device• Attaching the belt• Taking FHR reading and filling in partograph• Responding to alarm

Hands on use in actual setting / Laerdel Vriddhi

Lunch 13:45 to 14:30 hours (45 Minutes)

Session 4: Operationalizing the use of FHR monitoring device in your facility 14:30– 16:00 (Large Group)

14:30 15:15

Implementation modalities • When to use the device on PW• Handing over of devices• Identifying nodal person at facility• Support by Vriddhi Project staff

Power pointDiscussionDocument reading

Vriddhi

15: 15 15:45

M&e Protocol- • Collection of data • Monthly reports • Quarterly report

Power pointDiscussionSharing formats

Vriddhi (M&e)

15:45 16:00 Questions for clarifications

Tea (16:00 - 16:15)

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler27

ANNexUre 3 - POSTer FOr FeTAl heArT rATe MONITOrINg USINg STANDArD hANDhelD DOPPler

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Strengthening Fetal Heart Monitoring During Labor through Use of Statandard Handheld Doppler28

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DISCLAIMER: This document is made possible by the generous support of the American People through the United States Agency for International Development (USAID). The contents are the responsibility of IPE Global Limited and do not necessarily reenact the views of USAID or the United States Government.

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