Ethiopia Group Antenatal Care Study at the Health Post Level

Not Applicable

Terminated

• Conditions: Antenatal Care
• Interventions: Behavioral: Group Antenatal Care

• Registration Number: NCT05054491
• Lead Sponsor: Jhpiego

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-11
• Study First Submitted QC: 2021-09-14
• Study Start: 2021-09-20
• Study First Posted: 2021-09-23
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 540

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group ANC	Group Antenatal Care	Intervention period in stepped wedge design where women are receiving antenatal care in a group setting

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effectiveness of G-ANC on quality of care	Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery	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

Trial Locations

Locations (1)

Enashenifalen; 🇪🇹 Mecha, North Mecha Woreda, West Gojam Zone, Amhara Region, Ethiopia