Group Antenatal Care: The Power of Peers for Increasing Skilled Birth Attendance in Achham, Nepal

June 22, 2021 updated by: Possible
In rural Nepal, the major drivers of underutilization of skilled birth attendance are poverty, poor social support and inadequate birth planning. Drawing from similar programs that have been shown to improve maternal and neonatal outcomes, we have designed a group antenatal care program that uses a participatory learning and action process to engage women in identifying and solving problems accessing maternity care services and create a supportive social network. We plan to test a group antenatal care program that will change antenatal care in three major ways: 1) conduct care in a group setting with women matched by gestational age, 2) incorporate participatory learning and action, and 3) provide expert and facilitated peer counseling.

Study Overview

Status

Completed

Conditions

Detailed Description

The group antenatal care intervention aims to improve rates of institutional birth and ANC care completion via improving acceptability of group care, maternal and neonatal health knowledge, self-efficacy, social support, and birth planning.

Objective 1: Assess the effect of group antenatal care on institutional birth rates through a prospective study using community household census data. Secondary outcomes will be completion of basic ANC package; neonatal mortality rate; percentage of preterm births; percentage of stillbirths; and percentage of small-for-gestational age (SGA) births.

  • Hypothesis 1: Group ANC will increase institutional birth rates by 5% over one year.
  • Hypothesis 2: Group ANC will increase completion of 4 ANC visits by 5% over one year.
  • Hypothesis 3: Group ANC will reduce infant mortality rate by 5% over one year.
  • Hypothesis 4: Group ANC will reduce the postpartum contraceptive prevalence rate by 5% over one year.
  • Hypothesis 5: Group ANC will reduce the stillbirth rate by 5% over one year.
  • Hypothesis 6: Group ANC will reduce the perinatal mortality rate 5% over one year.
  • Hypothesis 7: Group ANC will reduce the combined infant mortality and stillbirth rate by 5% over one year.

Objective 2: Assess the mechanisms of implementation of group antenatal care through quantitative participant survey measures, qualitative focus group discussions and key informant interviews.

  • Hypothesis 1: Group antenatal care will be acceptable to participants and providers, and preferred to individual care.
  • Hypothesis 2: Group antenatal care will increase pregnant patients' access to and utilization of delivery services through improved knowledge, self-efficacy, social support and birth planning.

Objective 3: Report on key aspects of the implementation process: costs, human resources, logistics, and fidelity of the group antenatal program to model content and participatory processes.

Study Type

Interventional

Enrollment (Actual)

2184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Achham
      • Bayaplata, Achham, Nepal
        • Bayalpata Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Age 15-49 years old
  • Resident of 14 village clusters in study site
  • Intervention cohort: less than 24 weeks' gestation prior to first group antenatal care session.

Exclusion Criteria:

  • Intervention cohort: more than 24 weeks' gestation prior to first group antenatal care session.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Cohort
We will use a cohort of 60 women from intervention village clusters for the group antenatal care intervention.
The group antenatal care intervention will match pregnant women by gestational age in the intervention village clusters and assign them to peer group sessions facilitated by local healthcare clinic staff.
Active Comparator: Control Cohort
We will use a cohort of 60 women from control village clusters as an active comparison.
Pregnant women in control village clusters will have individual antenatal care sessions with their healthcare provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Institutional Birth Rate
Time Frame: 1 year
We expect the number of pregnant women from intervention village clusters who give birth at a healthcare facility to increase by 5% compared to control.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant Mortality Rate
Time Frame: 1 year
We expect the infant mortality rate to be 5% lower among the babies from the intervention cohort women compared to control.
1 year
Postpartum contraceptive prevalence rates
Time Frame: 1 year
We expect the postpartum contraceptive prevalence rate to be 5% higher among the intervention cohort women compared to control.
1 year
Completion percentage of 4 antenatal care visits
Time Frame: 1 year
We expect that 5% more women in the intervention cohort will complete all 4 antenatal care visits compared to the control.
1 year
Stillbirth rate
Time Frame: 1 year
We expect that the stillbirth rate will be 5% lower among the intervention cohort compared to control.
1 year
Perinatal mortality rate
Time Frame: 1 year
We expect that the perinatal mortality rate will be 5% lower among the intervention cohort compared to control.
1 year
Combined infant mortality and stillbirth rate
Time Frame: 1 year
We expect that the combined infant mortality and stillbirth rate will be 5% lower among the intervention cohort compared to control
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: David Citrin, PhD, MPH, Possible
  • Study Chair: Biraj Karmacharya, MBBS, Msc, University of Washington
  • Principal Investigator: Duncan Maru, MD, PhD, Possible

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

July 10, 2016

Study Completion (Actual)

July 10, 2016

Study Registration Dates

First Submitted

December 31, 2014

First Submitted That Met QC Criteria

December 31, 2014

First Posted (Estimate)

January 5, 2015

Study Record Updates

Last Update Posted (Actual)

June 25, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

June 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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