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

Sponsor
Possible (Other)
Overall Status
Completed
CT.gov ID
NCT02330887
Collaborator
Brigham and Women's Hospital (Other)
2,184
1
2
23.3
93.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Group Antenatal Care
  • Other: Individual Antenatal Care
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
2184 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Group Antenatal Care: The Power of Peers for Increasing Skilled Birth Attendance in Achham, Nepal
Actual Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Jul 10, 2016
Actual Study Completion Date :
Jul 10, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Cohort

We will use a cohort of 60 women from intervention village clusters for the group antenatal care intervention.

Other: Group Antenatal Care
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.

Other: Individual Antenatal Care
Pregnant women in control village clusters will have individual antenatal care sessions with their healthcare provider.

Outcome Measures

Primary Outcome Measures

  1. Institutional Birth Rate [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.

Secondary Outcome Measures

  1. Infant Mortality Rate [1 year]

    We expect the infant mortality rate to be 5% lower among the babies from the intervention cohort women compared to control.

  2. Postpartum contraceptive prevalence rates [1 year]

    We expect the postpartum contraceptive prevalence rate to be 5% higher among the intervention cohort women compared to control.

  3. Completion percentage of 4 antenatal care visits [1 year]

    We expect that 5% more women in the intervention cohort will complete all 4 antenatal care visits compared to the control.

  4. Stillbirth rate [1 year]

    We expect that the stillbirth rate will be 5% lower among the intervention cohort compared to control.

  5. Perinatal mortality rate [1 year]

    We expect that the perinatal mortality rate will be 5% lower among the intervention cohort compared to control.

  6. Combined infant mortality and stillbirth rate [1 year]

    We expect that the combined infant mortality and stillbirth rate will be 5% lower among the intervention cohort compared to control

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bayalpata Hospital Bayaplata Achham Nepal

Sponsors and Collaborators

  • Possible
  • Brigham and Women's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Possible
ClinicalTrials.gov Identifier:
NCT02330887
Other Study ID Numbers:
  • GroupANCnyaya
First Posted:
Jan 5, 2015
Last Update Posted:
Jun 25, 2021
Last Verified:
Jun 1, 2021

Study Results

No Results Posted as of Jun 25, 2021