- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06965283
- Original Trial
The Effect of Integrating Postpartum Family Planning Intervention With Maternal & Child Health Services (PPFP MCH)
The Effect of Integrating Postpartum Family Planning Intervention With Maternal & Child Health Services on Modern Postpartum Contraceptive Use and Service Improvement in Northeast Ethiopia
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Amhara
-
Dese, Amhara, Ethiopia
- Dessie Comprehensive specialized Hospital
-
Dese, Amhara, Ethiopia
- Dessie referral Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Active Comparator: This arm will be given the multiple behaviour change intervention
The intervention package includes:
|
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
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
Sponsor
Collaborators
Investigators
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID 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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Postpartum Family Planning
-
Jacaranda HealthHarvard School of Public Health (HSPH); Jhpiego; IPSOSRecruitingPostpartum Family PlanningKenya
-
Stanford UniversityCompletedPostpartum Contraception | Family PlanningUnited States
-
Rush University Medical CenterUniversity of Illinois at Chicago; AllianceChicagoCompletedContraception | Family Planning | PostPartumUnited States
-
Services Institute of Medical Sciences, PakistanCompletedPostpartum Contraception | Family Planning | Reproductive HealthPakistan
-
Aga Khan UniversityCompletedPostpartum Family PlanningPakistan
-
JhpiegoUnited States Agency for International Development (USAID); Bill and Melinda...CompletedPregnancy | Contraception | Contraceptive Usage | Prenatal Care | Postpartum Family PlanningEthiopia
-
Population Services InternationalActive, not recruitingAntenatal Care | Postpartum Family Planning | Pre-conceptual Care | Adolescent Maternal HealthKenya
-
John James ParkerClínica de Familia La Romana, Dominican RepublicEnrolling by invitationMental Health | Care Coordination | Family Planning | Primary Care | Postpartum CareDominican Republic
-
Inonu UniversityThe Scientific and Technological Research Council of TurkeyCompletedFamily PlanningTurkey
-
Boston UniversityUnited States Agency for International Development (USAID); Pharmaceutical...Completed
Clinical Trials on Providing training and Mentoring
-
Marmara UniversityCompletedLife Skills | Peer MentoringTurkey
-
T.C. ORDU ÜNİVERSİTESİCompleted
-
Fenerbahce UniversityActive, not recruiting
-
Selcuk UniversityCompletedKangaroo Care TrainigTurkey
-
Aynur Erçek KarciNot yet recruitingPelvic Floor Awareness
-
Karadeniz Technical UniversityCompletedSelf Efficacy | Perception, Self | Traumatic BirthTurkey (Türkiye)
-
Samsung Medical CenterCompletedType 1 DiabetesKorea, Republic of
-
University of California, Los AngelesNational Institute of Mental Health (NIMH); Human Sciences Research CouncilCompletedTuberculosis | Human Immunodeficiency Virus | Acquired Immune Deficiency SyndromeSouth Africa
-
Soochow UniversitySuzhou Center for Disease Control and PreventionActive, not recruitingChildren | Intervention | Obesity & OverweightChina
-
Aileen BergströmForteRecruiting