Clinical trial NCT02330887: Group Antenatal Care: The Power of Peers for Increasing Skilled Birth Attendance in Achham, Nepal
Official title: Group Antenatal Care: The Power of Peers for Increasing Skilled Birth Attendance in Achham, Nepal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prenatal Care
Keywords: Maternal Mortality
Institutional Birth Rate
Neonatal Mortality Rate
Preterm Birth
Stillbirth
Infant, Small for Gestational Age
Nepal
Implementation Research
Global Health
Lead sponsor: Possible
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2015-01-05
Enrollment: 2184
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Institutional Birth Rate
timeFrame: 1 year
Secondary outcomes:
measure: Infant Mortality Rate
timeFrame: 1 year
measure: Postpartum contraceptive prevalence rates
timeFrame: 1 year
measure: Completion percentage of 4 antenatal care visits
timeFrame: 1 year
measure: Stillbirth rate
timeFrame: 1 year
measure: Perinatal mortality rate
timeFrame: 1 year
measure: Combined infant mortality and stillbirth rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Bayaplata
country: Nepal
facility: Bayalpata Hospital
state: Achham
Study officials:
affiliation: Possible
name: David Citrin, PhD, MPH
role: STUDY_DIRECTOR
affiliation: Possible
name: Duncan Maru, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Biraj Karmacharya, MBBS, Msc
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.