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NCT Number: NCT02330887

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

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.

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Key information

Conditions

Prenatal Care Death Female Urogenital Diseases and Pregnancy Complications Fetal Death Maternal Death Obstetric Labor Complications Obstetric Labor, Premature Parental Death Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Stillbirth Urogenital Diseases

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bayalpata Hospital

Bayaplata, Achham, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group Antenatal Care

Other

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.

Individual Antenatal Care

Other

Pregnant women in control village clusters will have individual antenatal care sessions with their healthcare provider.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Stillbirth rate

    Time frame: 1 year

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

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Possible

Other

Collaborators

  • Brigham and Women's Hospital

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 5, 2015
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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