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Clinical Trials/NCT05054491
NCT05054491
Terminated
Not Applicable

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

Jhpiego1 site in 1 country540 target enrollmentSeptember 20, 2021
ConditionsAntenatal Care

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Antenatal Care
Sponsor
Jhpiego
Enrollment
540
Locations
1
Primary Endpoint
Effectiveness of G-ANC on continuation of ANC
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2021
End Date
February 28, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Sequential
Sex
Female

Investigators

Sponsor
Jhpiego
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Effectiveness of G-ANC on continuation of ANC

Time Frame: Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery

Survey of self-reported number of ANC visits to document effectiveness of continuing ANC

Acceptability of G-ANC at the health post level

Time Frame: Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery

Satisfaction survey to understand satisfaction with G-ANC

Feasibility of G-ANC at the health post level

Time Frame: Less than or equal to 20 weeks gestation at enrollment into study up to 6 weeks after delivery

Documentation of number of G-ANC sessions facilitated by by health extension workers to measure feasibility

Secondary Outcomes

  • 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 Sites (1)

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