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

NCT ID: NCT02330887

Last Updated: 2021-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-01

Study Completion Date

2016-07-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prenatal Care

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention Cohort

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

Group Type EXPERIMENTAL

Group Antenatal Care

Intervention Type 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.

Control Cohort

We will use a cohort of 60 women from control village clusters as an active comparison.

Group Type ACTIVE_COMPARATOR

Individual Antenatal Care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Individual Antenatal Care

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Possible

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Citrin, PhD, MPH

Role: STUDY_DIRECTOR

Possible

Duncan Maru, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Possible

Biraj Karmacharya, MBBS, Msc

Role: STUDY_CHAIR

University of Washington

Locations

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Bayalpata Hospital

Bayaplata, Achham, Nepal

Site Status

Countries

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Nepal

References

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Harsha Bangura A, Nirola I, Thapa P, Citrin D, Belbase B, Bogati B, B K N, Khadka S, Kunwar L, Halliday S, Choudhury N, Schwarz R, Adhikari M, Kalaunee SP, Rising S, Maru D, Maru S. Measuring fidelity, feasibility, costs: an implementation evaluation of a cluster-controlled trial of group antenatal care in rural Nepal. Reprod Health. 2020 Jan 17;17(1):5. doi: 10.1186/s12978-019-0840-4.

Reference Type DERIVED
PMID: 31952543 (View on PubMed)

Thapa P, Bangura AH, Nirola I, Citrin D, Belbase B, Bogati B, Nirmala BK, Khadka S, Kunwar L, Halliday S, Choudhury N, Ozonoff A, Tenpa J, Schwarz R, Adhikari M, Kalaunee SP, Rising S, Maru D, Maru S. The power of peers: an effectiveness evaluation of a cluster-controlled trial of group antenatal care in rural Nepal. Reprod Health. 2019 Oct 22;16(1):150. doi: 10.1186/s12978-019-0820-8.

Reference Type DERIVED
PMID: 31640770 (View on PubMed)

Related Links

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http://hsdg.partners.org/

Healthcare Systems Design Group

Other Identifiers

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GroupANCnyaya

Identifier Type: -

Identifier Source: org_study_id

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