Ethiopia Group Antenatal Care Study at the Health Post Level

NCT ID: NCT05054491

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2024-02-28

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.

Conditions

Antenatal Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Group ANC

Intervention period in stepped wedge design where women are receiving antenatal care in a group setting

Group Type: EXPERIMENTAL

Group Antenatal Care

Intervention Type: BEHAVIORAL

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

Individual ANC (routine)

Pre-intervention time period (control period) where the intervention is not being implemented yet (women are receiving individual antenatal care as is currently offered)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Group Antenatal Care

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Addis Continental Institute of Public Health

OTHER

Sponsor Role: collaborator

Jhpiego

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Enashenifalen

Mecha, North Mecha Woreda, West Gojam Zone, Amhara Region, Ethiopia

Countries

Ethiopia

References

Yallew WW, Fasil R, Berhanu D, Wolde K, Teshite D, Sethi R, Yenokyan G, Woldemariam Y, Suhowatsky S, Hyre A, Noguchi L, Worku A. Evaluation of the feasibility, acceptability, and impact of Group Antenatal Care at the health post level on continuation in antenatal care and facility based delivery in Ethiopia using a cluster randomized stepped-wedge design: Study protocol. Gates Open Res. 2025 Jan 31;8:29. doi: 10.12688/gatesopenres.15190.3. eCollection 2024.

Reference Type: DERIVED

PMID: 39936142 (View on PubMed)

Other Identifiers

14448

Identifier Type: -

Identifier Source: org_study_id