Ethiopia Group Antenatal Care Study at the Health Post Level

Antenatal Care Clinical Trial

— ARC004  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05054491
• Other study ID #: 14448
• Status: Terminated
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: April 2024
• Source: Jhpiego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 540
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Antenatal Care

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Ethiopia	Enashenifalen	Mecha	North Mecha Woreda, West Gojam Zone, Amhara Region

Sponsors (3)

Lead Sponsor	Collaborator
Jhpiego	Addis Continental Institute of Public Health, Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Effectiveness of G-ANC on quality of care	Survey 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	Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery