The Effectiveness of Joint Provision of Community Group-based Family Planning Counseling with Routine Individual Counseling Provided to Perinatal Women on Postpartum Contraception Acceptance
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 598
- Locations
- 2
- Primary Endpoint
- Magnitude (percentage) of postnatal women who use any contraceptive method; 2. The percentage of each contraceptive method (choices) utilized by postnatal women
Study Overview
Brief 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:
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Will postpartum women in the intervention group (joint provision of individual and community group-based counseling) be more likely to use contraception?
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Percent of postnatal women who receive any method from the intervention group.
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Percent of postnatal women who receive any method from the control group.
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Will postpartum women in the intervention group, subject to an intervention group, prefer highly effective contraceptive methods?
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Percent of postnatal women who receive highly effective methods from the intervention group.
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Percent of postnatal women who receive low-effective methods from the control group.
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Percent of postnatal women who receive highly effective methods from the control group.
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Percent of postnatal women who receive low-effective methods from the intervention group.
Detailed Description
Introduction
World Health Organizations recommend postpartum family planning as a critical component of health care that has the potential to meet women's desire for contraception and save millions of maternal and infant lives in low- and middle-income countries. It recommends that after "a woman gave birth," she should avoid pregnancy for at least two years prior to the next pregnancy to ease the maternal, prenatal, and infant risks. It is also an important determinant of women's ability to exercise their reproductive autonomy and a key facilitator of gender equality and women's empowerment. Additionally, it is a key to achieving global public health goals, such as the Sustainable Development Goals on sexual and reproductive health.
Therefore, it is crucial to start using contraception as soon as possible after giving birth because it lowers the risk of an unwanted pregnancy and prolongs the time between pregnancies, which benefits both mothers and newborns' health. Contraceptive plans should optimally be initiated as part of prenatal care and counseling, especially as many methods can be provided at the time of delivery or during the hospital stay. When contraceptive counseling is offered during both the prenatal and postpartum periods, the prevalence of postpartum contraceptive use, including the use of more effective methods, is highest, especially when it is offered in group-based compared to individual counseling. Maternal and infant mortality can be prevented by combining prenatal care, family planning, postpartum care, vaccination, and nutrition programs as an integrated service.
Methods
This study is designed as a two-arm, unblinded, cluster randomized controlled trial with baseline and follow-up measurements. Perinatal women among the study participants will be randomly assigned to each arm. One arm includes routine individual family planning counseling only, and the other group includes joint provision of community group-based counseling with routine individual counseling. The trial protocol will be developed, delivered, and reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study participants will be women with near-term, term, and post-term pregnancies and postnatal women who live in the West Shoa Zone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 49 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Inclusion Criteria
- •Prenatal women in their late pregnancy (near term, term, and post-term pregnancy)
- •Women who will be in the postpartum time at the endline questionnaire
- •Women who will live in the selected address for 1 year after delivery
Exclusion Criteria
- •Clients who are in unstable medical states and who are unable to converse without assistance
- •Women whose postpartum time will be above 1 year at the endline questionnaire
- •Women who are not available at the selected address for the next 1 year for the endline questionnaire
Outcomes
Primary Outcomes
Magnitude (percentage) of postnatal women who use any contraceptive method; 2. The percentage of each contraceptive method (choices) utilized by postnatal women
Time Frame: Recruitment to end of the study: 1 year
Based on the data obtained from a quantitative questionnaire filled out by each participant, the magnitude of postpartum contraception among postnatal women will be determined at the baseline questionnaire (T0) and at the endline questionnaire (12 months later). Use will be dichotomized into the use of any method versus nothing used. The survey question will be: Do participants currently using any method on a regular basis to space between pregnancies? If they do, then the investigator will pass on to the second question on the method choices. Women's contraceptive preferences for intervention and control populations will be collected at the mentioned time points. Preferences will be dichotomized into more effective and less effective methods. Choices will also be grouped by tiers based on their effectiveness (tier 1, tier 2, and tier 3). The effect of group vs. individual counseling on the use of and preferences for postpartum contraception will then be assessed by using odds ratios.
Secondary Outcomes
No secondary outcomes reported