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Ethiopia Group Antenatal Care Study at the Health Post Level

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05054491
Acronym
ARC004
Enrollment
540
Registered
2021-09-23
Start date
2021-09-20
Completion date
2024-02-28
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antenatal Care

Keywords

Ethiopia, Health post, Group ANC

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.

Interventions

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

Sponsors

Bill and Melinda Gates Foundation
CollaboratorOTHER
Addis Continental Institute of Public Health
CollaboratorOTHER
Jhpiego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Stepped wedge design

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of G-ANC at the health post levelLess than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after deliverySatisfaction survey to understand satisfaction with G-ANC
Feasibility of G-ANC at the health post levelLess than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after deliveryDocumentation of number of G-ANC sessions facilitated by by health extension workers to measure feasibility
Effectiveness of G-ANC on continuation of ANCLess than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after deliverySurvey of self-reported number of ANC visits to document effectiveness of continuing ANC

Secondary

MeasureTime frameDescription
Effectiveness of G-ANC on quality of careLess than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after deliverySurvey 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

Countries

Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026