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

Prenatal Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330887
• Other study ID #: GroupANCnyaya
• Status: Completed
• Phase: N/A
• Start date: August 1, 2014
• Est. completion date: July 10, 2016

Study information

• Verified date: June 2021
• Source: Possible
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2184
• Est. completion date: July 10, 2016
• Est. primary completion date: July 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Nepal	Bayalpata Hospital	Bayaplata	Achham

Sponsors (2)

Lead Sponsor	Collaborator
Possible	Brigham and Women's Hospital

Country where clinical trial is conducted

Nepal, 

Outcome

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

External Links

•   Healthcare Systems Design Group
•   Possible