The Effect of Integrating Postpartum Family Planning Intervention With Maternal & Child Health Services (PPFP MCH)

May 7, 2025 updated by: Delelegn Tsegaye, Jimma University

The Effect of Integrating Postpartum Family Planning Intervention With Maternal & Child Health Services on Modern Postpartum Contraceptive Use and Service Improvement in Northeast Ethiopia

This study aims to explore the effectiveness of integrated package interventions within maternal and child health services in improving modern postpartum contraceptive use in northeast Ethiopia. Its primary objective is to enhance the utilization of postpartum contraceptive methods to reduce unmet needs for these methods in the Amhara region of Ethiopia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

One of the advantages of this intervention study is that the provision of postpartum family planning (PPFP) services will not be limited to a few points of contact but will instead be integrated into the entire maternal care continuum. However, many studies in other countries have not used quasi-experimental or intervention study designs.

This pre/post-test interventional study with a control group employs extended observation and intervention periods, along with repeated measurements at the aggregate/population level. This approach will better capture changes in postpartum family planning (PPFP) integration and the factors influencing the use of integrated PPFP services.

This dissertation research project will contribute to various stakeholders. For health professionals and managers, it will enhance their knowledge and skills regarding the impact of integrating PPFP with maternal health services and its role in improving maternal and child health. It will also identify facilitators and barriers to PPFP integration with maternal and child health services.

Healthcare providers will gain leadership and communication skills in client-centered counseling and its effect on postpartum contraceptive use. The study highlights the importance of provider-led PPFP counseling and interventions for postpartum mothers visiting health facilities for maternal and child care services.

Reproductive-age mothers will benefit from this study by gaining access to modern contraceptives immediately after childbirth and up to 12 months postpartum. This will improve their health and their children's well-being by enabling them to space or limit births as desired. PPFP use, as shown in prior studies, significantly reduces maternal and neonatal morbidity and mortality by preventing unintended pregnancies.

Donors and non-governmental organizations (NGOs) can use these findings to strengthen healthcare systems through targeted support, including regular mentoring, logistics, and capacity-building training for providers and management teams.

Researchers will benefit from this study's findings as a baseline for future research, leveraging its recommendations and addressing its limitations. The project aims to assess the effect of integrating PPFP with maternal and child health services (e.g., postnatal care, delivery, PMTCT, immunization, and under-five childcare) and to identify the level of integration, facilitators, and barriers.

Policymakers, the Ethiopian Ministry of Health, and regional health bureaus can use these findings to design strategies aligned with the Sustainable Development Goals (SDGs), particularly reducing unmet PPFP needs. One SDG targets improved maternal health through integrated maternal and child health services, which this study supports by promoting PPFP use and advancing maternal and neonatal health outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
607

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
    • Amhara
      • Dese, Amhara, Ethiopia
        • Dessie Comprehensive Specialized Hospital
      • Dese, Amhara, Ethiopia
        • Dessie referral Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria

  • Postpartum mothers who gave birth one year preceding the survey
  • All postpartum mothers who come for maternal and child health services(PMTCT, PNC, labor, delivery, under 5 OPD care and immunization services and post-partum women units)

  • Those mothers whose age are between 18- 49 years old Exclusion criteria

    • Those participants who were seriously ill
    • Mentally unable to communicate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: This arm will be given the multiple behaviour change intervention

The intervention package includes:

  1. PPFP refresher training for maternal and child health (MCH) providers across all MCH units (labor/delivery, postnatal care [PNC], immunization, PMTCT [Prevention of Mother-to-Child Transmission], and under-five childcare clinics).
  2. Weekly mentoring (internal and external) led by senior gynecologists, obstetricians, and midwives at intervention hospitals. Mentoring sessions use anatomical models to address knowledge and skill gaps. MCH service coordinators also participate in training sessions to facilitate coaching and monitoring.
  3. Standardized training modules based on guidelines developed by the Ethiopian Ministry of Health.
  4. Monthly supportive supervision of PPFP services, conducted jointly by MCH unit coordinators and hospital management teams. This ensures early identification of bottlenecks and prompt resolution of challenges.
  5. Monitoring of contraceptive methods and other materials availability
Behavioral: Providing training and Mentoring
The intervention packages are providing postpartum family planning training at each MCH units, Using WHO PPFP counseling toolkit, mentoring health care provider to fill knowledge and skill gap, contraceptive logistic availability, and regular supportive supervision
No Intervention: The non intervention group were not given the intervention. Standard care will be continued
Usual care can be continued. No intervention can be given

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Modern postpartum contraceptive use
Time Frame: Up to six months

The primary outcome measure is modern postpartum contraceptive use, assessed via interviewer-administered questionnaires. Data were collected using standardized, pre-tested tools by trained midwives with prior data collection experience.

Quantitative data will be analyzed using STATA 17 software with a Generalized Estimating Equation (GEE) model. The outcome variable was evaluated by measuring the effectiveness of the intervention package, which was delivered by trained healthcare providers across selected maternal and child health (MCH) units. These units included labor/delivery, immunization, postnatal care (PNC), PMTCT (Prevention of Mother-to-Child Transmission), and under-five child outpatient services.

The study followed a pre/post-intervention design: a baseline assessment was conducted first, followed by a six-month intervention period, and a post-intervention assessment. The intervention's effect will be evaluated using difference-in-differences analysis.
Up to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jimma University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wollo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gurmesa Tura Professor, PhD, Jimma University
  • Study Chair: Sisay Eshete Assistant professor, Msc, Wollo University
  • Study Director: Getabalew Tsegaye Mr., Bsc, Unaffilated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JUIH/IRB/0474/25
  • Jimma University (Other Grant/Funding Number: Jimma University Institute of Health School Of Graduate Studies)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The result of this study will be published at reputable journal. So the data can be accessed in the published paper.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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