Ethiopia Group Antenatal Care Study at the Health Post Level (ARC004)

Jhpiego

Status: Terminated

Conditions: Antenatal Care

Treatments: Behavioral: Group Antenatal Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05054491

14448

Details and patient eligibility

About

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.

Enrollment: 540 patients

Sex: Female

Ages: 15 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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540 participants in 2 patient groups

Group ANC

Experimental group

Description:

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

Treatment:

Behavioral: Group Antenatal Care

Individual ANC (routine)

No Intervention group

Description:

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