Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06466512 |
| Other study ID # |
PR-24008 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2024 |
| Est. completion date |
January 31, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
International Centre for Diarrhoeal Disease Research, Bangladesh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background (brief):
1. Burden: Maternal and neonatal mortality continue to be a serious public health problem
in Bangladesh. Facility-based healthcare services reduce the probability of preventable
causes of maternal and neonatal death. Community clinics (CCs) are located closer to the
community than other healthcare facilities are. However, only 2.8% of all CCs are ready
to provide antenatal care (ANC) and 2.4% of these facilities are ready to provide
delivery services. Despite the wide acceptance of midwifery care for ANC and delivery
services, they are posted only up to the Upazila Health Complexes and at selected Union
Health and Family Welfare Centers.
2. Knowledge gap: There is a dearth of evidence on whether the utilisation of ANC, normal
vaginal delivery, and postnatal care (PNC) services can be increased if midwives are
assigned to CCs to provide these services.
3. Relevance: Midwives were trained to provide antenatal and postnatal care, conduct normal
deliveries, and manage CC-specific pregnancy-related complications. Midwives are posted
up to union-level facilities, and the Government of Bangladesh has a strategic plan to
enable selective community clinics for normal delivery services in addition to antenatal
and postnatal care.
Hypothesis (if any): N/A
Objectives: This study aims to assess the feasibility, adoption, acceptability,
appropriateness, fidelity, coverage, and possible barriers and enablers of introducing
Midwifery-embodied Community Clinic (MCC) model in selected community clinics of Bangladesh.
Methods: We will implement a Midwifery-embodied Community Clinic (MCC) model in two CCs of
the Baliakandi sub-district of Rajbari district. Trained midwives will provide ANC, select
low-risk pregnant women, conduct their normal deliveries, and provide PNC services in CCs,
while the CHCP will provide essential newborn care during NVD. High-risk mothers will be
referred to the upper level of healthcare facilities for managment. In addition, counselling
services will be provided to mothers by the Health Assistants and Family Welfare Assistants
during their domiciliary visits. Transport services using the ambulances of the Upazila
Health Complex will be integrated into the model to transport patients to the CCs and
upper-level healthcare facilities in case of emergencies.
Outcome measures/variables: The outcome measures will be feasibility, adoption,
acceptability, appropriateness, fidelity, coverage, and possible barriers and enablers of the
MCC model.
Description:
Study design and setting:
This is a feasibility study in which a Midwifery-embodied Community Clinic (MCC) model will
be introduced in two Community Clinics (CCs) located in the Baliakandi sub-district of the
Rajbari District of the Dhaka division of Bangladesh. Rajbari district lies between 22º40'
and 23º50' North latitudes and between 89º19' and 90º40' East longitudes (19). The total area
of the district is 1092.28 sq. km and the Baliakandi sub-district is 229 sq. km (19). It has
22 Community Clinics in 7 unions covering 258 villages (20, 21). The total population of the
Baliakandi sub-district is 207,086, of which 103,411 are females (19). The proportion of home
deliveries in the Baliakandi sub-district is around 21% (22). The model will be implemented
in the Delua and Sonapur Community Clinics of Narua and Nawabpur unions of Baliakandi
sub-district which are located approximately 12km away from the Baliakandi Upazila Health
Complex (Nearest CEmONC facility).
Steps of the study
1. Pre-implementation period 1.1 Stakeholder engagement We will engage potential
stakeholders from the beginning of the study. These stakeholders will include personnel
from the government, development partners, and technical bodies.
1.2 Baseline data collection Before the implementation of the MCC model, we will conduct
household survey and health facility assessment. We will adopt both qualitative and
quantitative approaches to collect data.
1.2.1 Household survey We will enrol all women with a history of childbirth in the last
12 months of the survey period and will agree to participate in the household survey. We
will conduct key informant interviews (KII) with the the program managers, technical
experts, and local level government personnel. We will also conduct in-depth interviews
with the service providers and care receivers.
1.2.2 Health Facility Assessment We will conduct a health facility assessment at the
baseline of the study to identify gaps in the necessary medicines, equipment, and
logistics so that the necessary resource allocation can be ensured and the facilities
become ready to provide ANC, normal delivery, and PNC services.
1.3 Capacity development of the service providers After ensuring key stakeholder
engagement from the beginning of the study, we plan to implement the MCC model. The OGSB
will train the study midwives on ANC, NVD, and PNC and the CHCPs on Essential Newborn
Care (ENC). Healthcare providers will receive specific hands-on training following
national guidelines suitable for CCs (24). HAs and FWAs will be briefed on the
availability of maternal healthcare services and essential newborn care in community
clinics.
2. Implementation period 2.1 Facility-level interventions We will prepare CCs and ensure
the supply and maintenance of the necessary logistics, equipment, and medicine during
the implementation period, so that these facilities can provide antenatal and postnatal
care and conduct normal vaginal deliveries. We will train midwives, and CHCPs on ANC,
NVD, ENC, PNC, and CC-specific complication management. The HAs and FWAs will be briefed
on their roles and responsibilities regarding the availability of midwifery-embodied
maternal and newborn healthcare services in the community clinics, and helping the
mothers and their families on the BPCR plan.
The Maternal Health Standard Operating Procedure (SOP) recommends tier-specific management of
mothers during the antepartum, intrapartum, and postpartum periods, while the Comprehensive
Newborn Care Package (CNCP) recommends tier-specific newborn care and complication
management. Healthcare providers will follow recommendations specific to community clinics to
provide ANC, delivery, ENC, and PNC services. Midwives will identify high-risk and low-risk
mothers, refer high-risk women to the Upazila Health Complex for further management and
provide scheduled antenatal and postnatal care to low-risk women.
The ANC and PNC services will be provided during routine working hours. The delivery service
will be available on a 24/7 on-call basis. Midwives will conduct deliveries of low-risk
mothers who want to have their deliveries in CCs. Otherwise, they will be encouraged to
choose from any of the higher levels of healthcare facilities equipped with the resources to
manage obstetric cases properly. During normal vaginal delivery, midwives will conduct the
delivery, and closely observe the mothers and their newborns for at least six hours
postpartum. If any complications develop, they will provide initial management, stabilize the
mothers and refer them to higher-level healthcare facilities. The CHCPs will be responsible
for providing essential newborn care to newborns following delivery, and if any complications
develop, they will provide appropriate resuscitation to the newborn and referral.
Service data (ANC, NVD, ENC, and PNC) will be recorded in government-approved service
registers (ANC, EmONC, and PNC registers). This information will be collated monthly in the
monthly reporting form.
Community-level interventions The HAs and FWAs will inform pregnant women and their families
about the availability of the ANC, NVD, ENC, and PNC services at their nearest CCs and
strengthen birth preparedness and complication management (BPCR) plans. Thus, they will have
a BPCR plan that will help them make prompt decisions about where to go, from whom to seek
care, and how to reach the target facilities. This combined counselling of midwives during
ANC, and HAs and FWAs during domiciliary services will address the first delay, the delay in
decision-making.
2.3 Integration of transport system The ambulance service available in the Baliakandi Upazila
Health Complex will be utilised upon receiving authorisation from the UH&FPO. Local transport
will also be integrated and a list will be prepared which will be given to pregnant women.
Pregnant women will call the drivers if they develop any sign of labour or any danger sign.
The available drivers will transport the pregnant woman to their preferred healthcare
facility for delivery and the complicated cases (mother or newborn) to the referral facility
following CC-specific stabilisation. The place of delivery will depend on the preferences of
the pregnant women and their family members. This mechanism will reduce the second delay, the
delay of transport.
At present, the Baliakandi Upazila Health Complex has one functional ambulance for patient
services. We will make a list of key contact person(s) and transport drivers, including the
ambulance drivers of Baliakandi Upazila Health Complex (UHCs), nearby health facilities, and
local transport drivers, and populate them among community people through the patients
seeking services at the CCs and through the community health workers and data collectors
while conducting household surveys. Through this study, we will invest in strengthening care
coordination between CCs and high-level facilities as a part of the Birth Preparedness and
Complication Readiness (BPCR) plan.
2.4 Local government-level interventions A coordination committee will be formed with the
UH&FPO, the focal person of the CG-CSG members, CHCPS, midwives, HAs, FWAs, drivers of the
ambulance, and owners of the local transport. icddr,b will encourage the organisation of
monthly coordination committee meetings where the service registers will be reviewed, service
delays will be accounted for, barriers and challenges of the implementation of different
activities of the model will be identified and addressed, and experiences will be discussed.
This monthly discussion will create accountability among midwives, CHCPs, HAs, FWAs, and
transport drivers to the focal person of the CG-CSG members at the community level and the
UHFPO at the facility level for task achievement and timely response. The pre-assignment of
services to specific service providers and regular coordination committee meetings will
address the third delay; the delay in the initiation of the service in the healthcare
facility.
2.5 Midline data collection During the midline data collection period, we will conduct
semi-structured observations of the activities of midwives and unstructured observation of
the CHCPs, HAs, and FWAs. We will also conduct in-depth interviews to collect the opinion of
care receivers and service providers. We will identify gaps and operational challenges in
introducing the model in the community clinics and take the necessary steps to solve the
problems.
Post-implementation period 3.1 Endline survey We will conduct an end-line survey using a
mixed-method approach to assess the feasibility of introducing the MCC model into the routine
health system of Bangladesh. In-depth Interviews (IDI) and key informant interviews (KII)
will be conducted with respondents to understand the adoption, acceptability,
appropriateness, fidelity, coverage, barriers and enablers of the MCC model.
3.2 Dissemination of the findings We plan to organize a dissemination workshop with
policymakers and relevant stakeholders to communicate the study findings and translate them
into policies and practices. This will be an in-person workshop in which participants will be
allowed to discuss the findings. In addition to this dissemination, we plan to develop
scientific manuscript(s) and publish them in peer-reviewed journal(s) to translate this
knowledge into other similar settings. We will also develop a policy brief.
Data collection Health facility assessment We will assess the availability, readiness, and
functionality of community clinics at the baseline of the study to identify the gaps and
ensure necessary resource allocation for ANC, PNC, and NVD service provision.
Household survey Household surveys will be conducted to assess the coverage of maternal
health and essential newborn healthcare services among the primary stakeholders in the
catchment areas of the selected community clinics. Information on care-seeking behaviour,
antepartum, intrapartum, and postpartum service utilisation of the consenting respondents
will be obtained to get baseline and end-line estimates. Relevant data collection instruments
previously used in similar evaluations and the Bangladesh Demographic and Health Surveys
(BDHS) will be further adapted for the planned data collection. Trained data collectors will
collect data.
Service register data extraction We will extract data from the service registers used to
capture ANC, NVD, ENC, PNC, and routine work of the healthcare providers of the community
clinics to evaluate the fidelity of the model.
Qualitative interviews We will conduct in-depth interviews with the service receivers, and
care providers, and key-informant interviews with the policymakers, technical experts,
UH&FPO, and focal persons of the Community Group and Community Support Group members to
understand the feasibility, adoption, appropriateness, barriers and enablers of the
implementation of the model. Data collectors trained on qualitative research will conduct the
interviews.
Data quality checks, storage and access During data collection, the data records will be
checked by members of the management team. All individual identifiers will be removed from
the data to be anonymised. The data will be stored on a Secure Server, which is automatically
backed up to an off-site location after collection. The data stored on this secure server
will be encrypted so that they can only be accessed by those with the correct encryption key,
which will only be available to members of the immediate research team working on the
analysis of the data. Fully anonymised data will be shared in line with the open-access
requirements of peer-reviewed journals.
Sample size:
Household survey We will follow the convenient sampling technique to recruit the study
participants. We will include all recently delivered women in the catchment areas of the
selected community clinics who have a history of birth outcome in the past 12 months of the
survey period. A sample size of 60 to 120 is required to adjust the precision of the sample
size of this pilot/ feasibility study (25). The annual birth rate in Bangladesh is 20/1000
live births in rural areas and each CC coverage is around 6000-8000 population (13). In
addition, according to recent estimates from the Baliakandi Health and Demographic
Surveillance data, 400-450 women, on average, became pregnant per month in Baliakandi.
Distributing this across seven unions, around 57-65 women got pregnant per union per month in
Baliakandi. We anticipate that we will be able to enrol 70 participants.
Qualitative interviews We will conduct in-depth interviews with 8±2 pregnant women about
their ANC experiences, 8±2 recently delivered women about their delivery experiences, and 8±2
women about their PNC experiences who will receive the respective services from the selected
community clinics. We will also interview 8±2 key informant, and 8±2 service providers. We
will employ an emergent sampling strategy. An emergent sampling strategy will ensure that we
can respond to the unexpected and provide the flexibility to sample additional participants
where necessary to fulfil the research objectives.
Data analysis Quantitative analysis All data will be assigned an appropriate identifier to
maintain their anonymity. Quantitative data will be stored in Microsoft Excel, and STATA 15.0
will be used for performing the analysis. We will use descriptive statistics as appropriate
(frequency, mean, standard deviation, etc.). We will perform multivariable logistic analysis
to assess the changes in their service utilization (ANC, normal vaginal delivery, and PNC
services) among the study participants of the catchment population of the community clinics.
Qualitative analysis A thematic analysis approach will be adopted to analyze the qualitative
data. All the interviews and field notes will be recorded and transcribed verbatim.
Transcription will be performed by the respective interviewers immediately after the
interviews. Upon preparing the transcriptions of interviews, all of the data will be coded by
the researchers based on the a-priori codes (e.g. feasibility, adoption, acceptability,
appropriateness, fidelity, and barriers and enablers). To establish inter-coder reliability,
a minimal set of interviews will be coded by different researchers to ensure that the codes
and coding process are well understood, and that everyone is on the same page in terms of
understanding the concepts. Upon establishing inter-coder reliability, a master code list
will be generated, based on which the rest of the transcripts will be coded. The researcher
will also search for inductive codes that can explain these themes. For all inductive codes,
formal discussions with all coders and co-investigators will be organised to ensure
uniformity in the analysis. The next step in the analysis will be to generate summaries of
codes based on similarities and contrasts and analyse them using a thematic framework. The
theoretical orientation would be phenomenological, in which the phenomena of interest would
be the topics being documented. Data will be analysed using NVivo software.
