Ethiopia Group Antenatal Care Study at the Health Post Level

NCT05054491 | Terminated

• 1 other identifier: 14448
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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

Keywords

Ethiopia; Health post; Group ANC

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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

Study Arms (2)

Group ANC

EXPERIMENTAL

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

Behavioral: Group Antenatal Care

Individual ANC (routine)

NO INTERVENTION

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

Interventions

Group Antenatal Care 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

Group ANC

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jhpiego: lead
• Bill and Melinda Gates Foundation: collaborator
• Addis Continental Institute of Public Health: collaborator

Study Sites (1)

Enashenifalen

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

Location

Related Publications (1)

• 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.

  PMID: 39936142 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge design

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: September 23, 2021
• Study Start: September 20, 2021
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

ET (1)