Postpartum CareNCT07280000
Effect of a Respectful Maternity Care-Based Action Plan in Postpartum Care on Maternal and Neonatal Outcomes
A study testing Respectful Maternity Care Training and Action Plan in people with Postpartum Care and Maternal Health Care, run by ilayda sel at 1 site in Turkey (Türkiye).
Trial summary
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. 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 Care, Maternal Health Care, Newborn Health
- What is being tested?
- Respectful Maternity Care Training and Action Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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
Who cannot join
- Development of maternal or neonatal complications during the postpartum follow-up period
- Inability to reach the mother at the 8-week postpartum follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul
Bakırköy Dr. Sadi Konuk Training and Research Hospital, +90 212 414 71 71, istanbuleah3.biis@saglik.gov.tr
About this study
Official title: 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.
- Conditions
- Postpartum Care, Maternal Health Care, Newborn Health, Postpartum Depression (PPD), Breastfeeding, Quality of Care
- Being tested
- Respectful Maternity Care Training and Action Plan
- Keywords
- Respectful Maternity Care, Postpartum Care, Maternal Health, Newborn Health
- Medical subject headings
- Depression, Postpartum, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respectful Maternity Care Training and Action PlanBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control: Routine Postpartum Care | No intervention | 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. |
| Intervention: Respectful Maternity Care Action Plan | Experimental | 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. Receives: Behavioral: Respectful Maternity Care Training and Action Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respectful Maternity Care Score
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.
Measured: Baseline (within 24 hours postpartum) and 6 weeks postpartum
Secondary outcomes (3)
Maternal Satisfaction with Postpartum Care
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.
Measured: At discharge (within 48 hours postpartum)
Postpartum Depression Score
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.
Measured: 6 weeks postpartum
Adherence to Evidence-Based Postpartum Care Practices
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.
Measured: Immediately postpartum (within 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start10 Dec 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum CareStudies 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
- This is a quasi-experimental, controlled before-after study with two parallel groups. Postpartum women receiving routine care before the training and action plan implementation constitute the control group, and postpartum women receiving care after the intervention constitute the intervention group.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ilayda sel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ilayda sel, Bandırma Onyedi Eylül University
- Investigators
- İlayda Sel Bilim, MSc, RN, Principal investigator, Istanbul University - Cerrahpasaİlkay Güngör Satılmış, Prof., Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280000
- Sponsor's protocol ID
- ISB-WH-02
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Bohren MA, Vogel JP, Hunter EC, Lutsiv O, Makh SK, Souza JP, Aguiar C, Saraiva Coneglian F, Diniz AL, Tuncalp O, Javadi D, Oladapo OT, Khosla R, Hindin MJ, Gulmezoglu AM. The Mistreatment of Women during Childbirth in Health Facilities Globally: A Mixed-Methods Systematic Review. PLoS Med. 2015 Jun 30;12(6):e1001847; discussion e1001847. doi: 10.1371/journal.pmed.1001847. eCollection 2015 Jun.
PubMed 26126110
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Action Plan Developed Within the Framework of Respectful Maternity Care in Postpartum Care on Maternal and Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT07280000
- Acronym / sponsor ID
- ISB-WH-02
- Conditions
- Postpartum Care, Maternal Health Care, Newborn Health, Postpartum Depression (PPD), Breastfeeding, Quality of Care
- Keywords
- Respectful Maternity Care, Postpartum Care, Maternal Health, Newborn Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- ilayda selUniversity, hospital or other
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Dec 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 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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a quasi-experimental, controlled before-after study with two parallel groups. Postpartum women receiving routine care before the training and action plan implementation constitute the control group, and postpartum women receiving care after the intervention constitute the intervention group.
| Arm | Type | Receives |
|---|---|---|
| Control: Routine Postpartum Care | No intervention | –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. |
| Intervention: Respectful Maternity Care Action Plan | Experimental | Behavioral: Respectful Maternity Care Training and Action PlanParticipants 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Development of maternal or neonatal complications during the postpartum follow-up period
- Inability to reach the mother at the 8-week postpartum follow-up
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 |
|---|---|---|
| Respectful Maternity Care Training and Action PlanThis 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. | Behavioural | Intervention: Respectful Maternity Care Action Plan |
Primary outcome
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.
3 secondary outcomes
Maternal Satisfaction with Postpartum Care
Time frame: At discharge (within 48 hours postpartum)
Postpartum Depression Score
Time frame: 6 weeks postpartum
Adherence to Evidence-Based Postpartum Care Practices
Time frame: Immediately postpartum (within 24 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Results publication: PubMed 26126110Bohren MA, Vogel JP, Hunter EC, Lutsiv O, Makh SK, Souza JP, Aguiar C, Saraiva Coneglian F, Diniz AL, Tuncalp O, Javadi D, Oladapo OT, Khosla R, Hindin MJ, Gulmezoglu AM. The Mistreatment of Women during Childbirth in Health Facilities Globally: A Mixed-Methods Systematic Review. PLoS Med. 2015 Jun 30;12(6):e1001847; discussion e1001847. doi: 10.1371/journal.pmed.1001847. eCollection 2015 Jun.
- Individual participant dataSharing planned: No. 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.
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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.
İlayda Sel Bilim, MSc, RN principal investigator
Istanbul University - Cerrahpasa
İlkay Güngör Satılmış, Prof. study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respectful Maternity Care Training and Action Plan in people with Postpartum Care and Maternal Health Care, run by ilayda sel at 1 site in Turkey (Türkiye).
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 8 inclusion and 2 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: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İlayda Sel Bilim, MSc, RN (+90 530 844 95 27, ilayda.sel@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respectful Maternity Care Score (time frame: Baseline (within 24 hours postpartum) and 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07280000, which also lists 1 linked publication.
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 12 Dec 2025.