NCT02330887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 5, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2016

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

1.9 years

First QC Date

December 31, 2014

Last Update Submit

June 22, 2021

Conditions

Prenatal Care

Keywords

Maternal MortalityInstitutional Birth RateNeonatal Mortality RatePreterm BirthStillbirthInfant, Small for Gestational AgeNepalImplementation ResearchGlobal Health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Infant Mortality Rate

    1 year

  • Postpartum contraceptive prevalence rates

    1 year

  • Completion percentage of 4 antenatal care visits

    1 year

  • Stillbirth rate

    1 year

  • Perinatal mortality rate

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Intervention Cohort

EXPERIMENTAL

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

Other: Group Antenatal Care

Control Cohort

ACTIVE COMPARATOR

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

Other: Individual Antenatal Care

Interventions

Group Antenatal CareOTHER

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 Cohort
Individual Antenatal CareOTHER

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

Control Cohort

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bayalpata Hospital

Bayaplata, Achham, Nepal

Location

Related Publications (2)

  • 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.

    PMID: 31952543DERIVED

  • 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.

    PMID: 31640770DERIVED

Related Links

MeSH Terms

Conditions

Maternal DeathPremature BirthStillbirth

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal Death

Study Officials

  • David Citrin, PhD, MPH

    Possible

    STUDY DIRECTOR

  • Duncan Maru, MD, PhD

    Possible

    PRINCIPAL INVESTIGATOR

  • Biraj Karmacharya, MBBS, Msc

    University of Washington

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2014

First Posted

January 5, 2015

Study Start

August 1, 2014

Primary Completion

July 10, 2016

Study Completion

July 10, 2016

Last Updated

June 25, 2021

Record last verified: 2021-06

Locations

NE(1)