Ethiopia Group Antenatal Care Study at the Health Post Level

Study Overview
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Brief Summary
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The purpose of this study is to determine the acceptability, feasibility, and effectiveness of a group antenatal care (G-ANC) model introduced at the health post level compared to usual antenatal care (ANC) among women who report intention to receive ANC at the health post level.

Official Title
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Evaluation of the Feasibility, Acceptability and Impact of Group-based Antenatal Care at the Health Post Level on Continuation in Antenatal Care and Facility-based Delivery in Amhara, Ethiopia Using a Cluster Randomized Step-wedge Design

Conditions
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Antenatal Care

Intervention / Treatment
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* Behavioral: Group Antenatal Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum age of 15 years at the time of enrollment; pregnant 15-17 year-olds will be treated as emancipated/mature as per local regulations Gestational age less than or equal to 20 weeks at the time of enrollment determined by last menstrual period (LMP), pelvic exam, fundal height, quickening, ultrasound, and/or timing of fetal heart tones and pregnancy test Pregnant women able and willing to provide adequate locator information Planning to reside at their current location for at least 10 months Agree to participate in the study and continue ANC at health post Willing to participate and consent to follow up for up to 6 weeks post-delivery Are willing to receive group antenatal care at the health post level (during the intervention period) Exclusion Criteria: Women who plan to travel away from the study site for more than four consecutive weeks during ANC or after 6 weeks post-delivery Women who are unable provide consent Women who have any condition that in the opinion of the investigator or designee, would complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Stepped wedge design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group ANC<br>Intervention period in stepped wedge design where women are receiving antenatal care in a group setting | Behavioral: Group Antenatal Care<br>* Group ANC is an integrated approach that incorporates physical assessment, education and skill development, and peer support and takes a broader, more holistic, woman-centered approach to traditional antenatal care<br>|
| No Intervention: Individual ANC (routine)<br>Pre-intervention time period (control period) where the intervention is not being implemented yet (women are receiving individual antenatal care as is currently offered) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of G-ANC at the health post level | Satisfaction survey to understand satisfaction with G-ANC | Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery | 
| Feasibility of G-ANC at the health post level | Documentation of number of G-ANC sessions facilitated by by health extension workers to measure feasibility | Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery | 
| Effectiveness of G-ANC on continuation of ANC | Survey of self-reported number of ANC visits to document effectiveness of continuing ANC | Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of G-ANC on quality of care | Survey of self-reported quality of care elements received during ANC to understand role of G-ANC on improving elements of quality of care during ANC | Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ethiopia, Health post, Group ANC