- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07280000
Effect of a Respectful Maternity Care-Based Action Plan in Postpartum Care on Maternal and Neonatal Outcomes
December 1, 2025 updated by: ilayda sel
The Effect of the Action Plan Developed Within the Framework of Respectful Maternity Care in Postpartum Care on Maternal and Neonatal Outcomes
This study will examine whether a Respectful Maternity Care-based action plan can improve the quality of postpartum care and maternal and newborn outcomes.
Nurses and midwives will receive a three-day interactive training about respectful, evidence-based postpartum care.
After training, a unit-level action plan will be implemented, including supportive visits, educational materials, and feedback meetings.
Women receiving routine postpartum care before the intervention will be compared with women receiving care after implementation.
Outcomes will include respectful maternity care experiences, maternal satisfaction, exclusive breastfeeding at 6-8 weeks, maternal mental health, mother-infant bonding, and postpartum complications.
The goal of this study is to promote respectful, high-quality postpartum care and improve the health and well-being of mothers and newborns.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
500
Phase
- 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 Contact
- Name: İlayda Sel Bilim, MSc, RN
- Phone Number: +90 530 844 95 27
- Email: ilayda.sel@iuc.edu.tr
Study Contact Backup
- Name: İlkay Güngör Satılmış, Prof.
- Phone Number: 27205 +90 212 224 2618
- Email: ilkay.gungorsatilmis@iuc.edu.tr
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Bakırköy Dr. Sadi Konuk Training and Research Hospital
-
Contact:
- Bakırköy Dr. Sadi Konuk Training and Research Hospital
- Phone Number: +90 212 414 71 71
- Email: istanbuleah3.biis@saglik.gov.tr
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Postpartum women aged 18 years and older
- Gave birth at 37-42 gestational weeks (vaginal or cesarean)
- Have a single, healthy newborn
- No chronic medical conditions
- No history of high-risk pregnancy or fetal complications
- No communication barriers (e.g., visual or hearing impairment)
- Able to speak and understand Turkish
- Literate and able to read and write in Turkish
Exclusion Criteria:
- Development of maternal or neonatal complications during the postpartum follow-up period
- Inability to reach the mother at the 8-week postpartum follow-up
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control: Routine Postpartum Care
Participants in this arm will receive routine postpartum care practices currently provided at the study site, without exposure to the respectful maternity care training or action plan components.
Usual clinical care protocols and standard postpartum follow-up procedures will be applied.
|
|
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Experimental: Intervention: Respectful Maternity Care Action Plan
Participants in this arm will receive postpartum care delivered by nurses and midwives trained in the Respectful Maternity Care (RMC) Action Plan.
The intervention includes structured training for postpartum professionals, implementation of evidence-based respectful maternity practices, and application of the developed RMC program content and postpartum care forms.
Care will emphasize dignity, privacy, informed consent, emotional support, newborn bonding, breastfeeding support, and person-centered communication.
|
This intervention involves a structured Respectful Maternity Care (RMC) training program for nurses and midwives, followed by the implementation of an evidence-based RMC action plan during postpartum care.
The training includes modules on dignity, privacy, informed consent, effective communication, emotional support, newborn bonding and breastfeeding support, and person-centered postpartum practices.
Participants in the intervention arm will receive postpartum care according to the RMC guidelines and structured care forms developed for the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respectful Maternity Care Score
Time Frame: Baseline (within 24 hours postpartum) and 6 weeks postpartum
|
Respectful maternity care will be assessed using the Respectful Maternity Care (RMC) scale, which evaluates dignity, privacy, informed consent, emotional support, communication, and person-centered postpartum practices.
Higher scores indicate higher levels of respectful maternity care.
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Baseline (within 24 hours postpartum) and 6 weeks postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal Satisfaction with Postpartum Care
Time Frame: At discharge (within 48 hours postpartum)
|
Maternal satisfaction with postpartum care will be assessed using a validated postpartum satisfaction questionnaire, measuring perceptions of communication, emotional support, involvement in care, and overall satisfaction with hospital postpartum services.
Higher scores indicate greater satisfaction.
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At discharge (within 48 hours postpartum)
|
|
Postpartum Depression Score
Time Frame: 6 weeks postpartum
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Depressive symptoms will be evaluated using the Edinburgh Postpartum Depression Scale (EPDS).
Higher scores indicate higher depressive symptoms.
A cutoff score of ≥13 suggests risk of postpartum depression.
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6 weeks postpartum
|
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Adherence to Evidence-Based Postpartum Care Practices
Time Frame: Immediately postpartum (within 24 hours)
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A structured postpartum care checklist will be used to evaluate compliance with respectful and evidence-based postpartum care practices (privacy, informed consent, emotional support, newborn bonding, breastfeeding support, early mobilization, postpartum monitoring).
Higher scores indicate greater adherence to evidence-based guidelines.
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Immediately postpartum (within 24 hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: İlayda Sel Bilim, MSc, RN, Istanbul University - Cerrahpasa
- Study Chair: İlkay Güngör Satılmış, Prof., Istanbul University - Cerrahpasa
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.
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 (Estimated)
December 10, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
December 1, 2025
First Submitted That Met QC Criteria
December 1, 2025
First Posted (Actual)
December 12, 2025
Study Record Updates
Last Update Posted (Actual)
December 12, 2025
Last Update Submitted That Met QC Criteria
December 1, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISB-WH-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No, individual participant data (IPD) will not be shared.
Due to ethical considerations and the sensitive nature of maternal and postpartum health data, participant confidentiality will be strictly protected.
Only aggregated results will be published, and data access will remain restricted to the study team in accordance with ethical approval.
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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