Postpartum Family PlanningPPFP MCHNCT06965283
The Effect of Integrating Postpartum Family Planning Intervention With Maternal & Child Health Services
A study testing Providing training and Mentoring in people with Postpartum Family Planning and Modern Contraceptive Use, run by Jimma University at 2 sites in Ethiopia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Family Planning, Modern Contraceptive Use
- What is being tested?
- Providing training and Mentoring
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 607 participants
- Where
- 2 sitesEthiopia
- Study dates
- 30 Mar 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Ethiopia2 sites
Dessie Comprehensive specialized Hospital
Dessie, Amhara
Dessie referral Hospital
Dessie, Amhara
About this study
Official title: 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.
Read the 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.
- Being tested
- Providing training and Mentoring
- Keywords
- Modern contraceptive use, Postpartum family planning, Service integration, Maternal & child health services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Providing training and MentoringBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| This arm will be given the multiple behaviour change intervention | Active comparator | 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 Receives: Behavioral: Providing training and Mentoring |
| The non intervention group were not given the intervention. Standard care will be continued | No intervention | Usual care can be continued. No intervention can be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modern postpartum contraceptive use
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.
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start30 Mar 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Family PlanningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All postpartum mothers who come to the hospital for labor/delivery, infant immunization, PMTCT (Prevention of Mother-to-Child Transmission), postnatal care (PNC), or under-five childcare services will be screened and counseled for postpartum family planning (PPFP). Those who decide to use a modern contraceptive method will either be referred to family planning units or provided with their chosen method directly. Postpartum mothers who do not initially decide to use a modern contraceptive method will receive additional counseling during their next visit. The intervention will be implemented by nurses and midwives working in selected maternal and child health units. These healthcare providers will receive a three-day PPFP training session delivered by a senior obstetrician-gynecologist, public health expert, and maternal/reproductive health specialist, all of whom are certified Training of Trainers. Coaching and mentoring will also be provided to ensure they acquire adequate knowledge.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jimma University
- Sponsor type
- University, hospital or other
- Collaborators
- Wollo University
- Responsible party
- Principal investigator, Delelegn Tsegaye, Jimma University
- Investigators
- Gurmesa Tura Professor, PhD, Study director, Jimma UniversitySisay Eshete Assistant professor, Msc, Study chair, Wollo UniversityGetabalew Tsegaye Mr., Bsc, Study director, Unaffilated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965283
- Sponsor's protocol ID
- JUIH/IRB/0474/25
- Other IDs
- Jimma UNiversity
- Acronym
- PPFP MCH
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The result of this study will be published at reputable journal. So the data can be accessed in the published paper.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Integrating Postpartum Family Planning Intervention With Maternal & Child Health Services on Modern Postpartum Contraceptive Use and Service Improvement in Northeast Ethiopia
- ClinicalTrials.gov ID
- NCT06965283
- Acronym / sponsor ID
- PPFP MCH / JUIH/IRB/0474/25
- Keywords
- Modern contraceptive use, Postpartum family planning, Service integration, Maternal & child health services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- Jimma UniversityUniversity, hospital or other
- Collaborators
- Wollo University
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All postpartum mothers who come to the hospital for labor/delivery, infant immunization, PMTCT (Prevention of Mother-to-Child Transmission), postnatal care (PNC), or under-five childcare services will be screened and counseled for postpartum family planning (PPFP). Those who decide to use a modern contraceptive method will either be referred to family planning units or provided with their chosen method directly. Postpartum mothers who do not initially decide to use a modern contraceptive method will receive additional counseling during their next visit. The intervention will be implemented by nurses and midwives working in selected maternal and child health units. These healthcare providers will receive a three-day PPFP training session delivered by a senior obstetrician-gynecologist, public health expert, and maternal/reproductive health specialist, all of whom are certified Training of Trainers. Coaching and mentoring will also be provided to ensure they acquire adequate knowledge.
| Arm | Type | Receives |
|---|---|---|
| This arm will be given the multiple behaviour change intervention | Active comparator | Behavioral: Providing training and MentoringThe 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 |
| The non intervention group were not given the intervention. Standard care will be continued | No intervention | –Usual care can be continued. No intervention can be given |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Providing training and MentoringThe 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 | Behavioural | This arm will be given the multiple behaviour change intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- It showed on postpartum family planning integration and its effect on modern contraceptive useLink provided by the sponsor.
- Individual participant dataSharing planned: No. The result of this study will be published at reputable journal. So the data can be accessed in the published paper.
Related trials for Postpartum Family Planning
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Mental and Reproductive Health Integration and Access
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gurmesa Tura Professor, PhD study director
Jimma University
Sisay Eshete Assistant professor, Msc study chair
Wollo University
Getabalew Tsegaye Mr., Bsc study director
Unaffilated
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Providing training and Mentoring in people with Postpartum Family Planning and Modern Contraceptive Use, run by Jimma University at 2 sites in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modern postpartum contraceptive use (time frame: Up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.