Effect of Joint Provision of Community Group-based Counseling with Individual Counseling on Postpartum Contraception

NCT06766409 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 598

Last updated 2025-01-14

No results posted yet for this study

Summary

The aim of this trial is to assess the effectiveness of joint provision of community group-based demonstration counseling methods with routine individual family planning counseling provided to prenatal and postnatal women on postpartum contraception acceptance in the West Shoa Zone, Oromia, Ethiopia. A two-arm cluster randomized control trial will be conducted to compare the routine individual facility-based family planning counseling with the joint provision of individual and community group-based counseling with a process of arranged demonstration on the later part. The study will be conducted from March 1, 2025, to May 30, 2026. A sample of 598 women (21 women per 28 clusters) will be selected by a two-stage (stratification and clustering) sampling. A structured questionnaire will be used to collect the data. The data will be entered into STATA (V16). A goodness of fit test using Pearson's chi-square and a multicollinearity test will be checked. Multinomial logistic regression will be used for analysis.

The main questions it aims to answer are:

1. Will postpartum women in the intervention group (joint provision of individual and community group-based counseling) be more likely to use contraception?

1. Percent of postnatal women who receive any method from the intervention group.
2. Percent of postnatal women who receive any method from the control group.
2. Will postpartum women in the intervention group, subject to an intervention group, prefer highly effective contraceptive methods?

1. Percent of postnatal women who receive highly effective methods from the intervention group.
2. Percent of postnatal women who receive low-effective methods from the control group.
3. Percent of postnatal women who receive highly effective methods from the control group.
4. Percent of postnatal women who receive low-effective methods from the intervention group.

Conditions

  • Postpartum Contraception

Interventions

BEHAVIORAL

A community group-based demonstration counseling method

At the community level, a perinatal woman in the intervention arm will get individual family planning counseling along with group-based counseling that includes a planned demonstration of all possible techniques.

BEHAVIORAL

An individual family planning counseling

The control group's pregnant and postpartum women will simply get standard individual FP counseling in accordance with Ethiopian national recommendations.

Sponsors & Collaborators

  • St. Paul's Hospital Millennium Medical College, Ethiopia

    lead OTHER

Principal Investigators

  • Zewdie Aderaw Alemu, PhD · St. Paul's Hospital Millennium Medical College, Ethiopia

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-03-31
Completion
2026-05-31

Countries

  • Ethiopia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06766409 on ClinicalTrials.gov