- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02330887
Group Antenatal Care: The Power of Peers for Increasing Skilled Birth Attendance in Achham, Nepal
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Achham
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Bayaplata, Achham, Nepal
- Bayalpata Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Cohort
We will use a cohort of 60 women from intervention village clusters for the group antenatal care intervention.
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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.
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Active Comparator: Control Cohort
We will use a cohort of 60 women from control village clusters as an active comparison.
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Pregnant women in control village clusters will have individual antenatal care sessions with their healthcare provider.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
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.
|
1 year
|
Completion percentage of 4 antenatal care visits
Time Frame: 1 year
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We expect that 5% more women in the intervention cohort will complete all 4 antenatal care visits compared to the control.
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1 year
|
Stillbirth rate
Time Frame: 1 year
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We expect that the stillbirth rate will be 5% lower among the intervention cohort compared to control.
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1 year
|
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.
|
1 year
|
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
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: David Citrin, PhD, MPH, Possible
- Study Chair: Biraj Karmacharya, MBBS, Msc, University of Washington
- Principal Investigator: Duncan Maru, MD, PhD, Possible
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GroupANCnyaya
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