Clinical trial NCT05054491: Ethiopia Group Antenatal Care Study at the Health Post Level
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Antenatal Care
Keywords: Ethiopia
Health post
Group ANC
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Addis Continental Institute of Public Health
First posted: 2021-09-23
Enrollment: 540
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Acceptability of G-ANC at the health post level
timeFrame: Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery
measure: Feasibility of G-ANC at the health post level
timeFrame: Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery
measure: Effectiveness of G-ANC on continuation of ANC
timeFrame: Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery
Secondary outcomes:
measure: Effectiveness of G-ANC on quality of care
timeFrame: Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery
Other outcomes:
Locations:
city: Mecha
country: Ethiopia
facility: Enashenifalen
state: North Mecha Woreda, West Gojam Zone, Amhara Region
Study officials:
References: