NCT07280000

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

December 1, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

December 10, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

December 1, 2025

Last Update Submit

December 1, 2025

Conditions

Keywords

Respectful Maternity CarePostpartum CareMaternal HealthNewborn Health

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (within 24 hours postpartum) and 6 weeks postpartum

Secondary Outcomes (3)

  • Maternal Satisfaction with Postpartum Care

    At discharge (within 48 hours postpartum)

  • Postpartum Depression Score

    6 weeks postpartum

  • Adherence to Evidence-Based Postpartum Care Practices

    Immediately postpartum (within 24 hours)

Study Arms (2)

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.

Behavioral: Respectful Maternity Care Training and Action Plan

Interventions

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.

Intervention: Respectful Maternity Care Action Plan

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study includes postpartum individuals who are biologically female.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Development of maternal or neonatal complications during the postpartum follow-up period
  • Inability to reach the mother at the 8-week postpartum follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Depression, PostpartumBreast Feeding

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersFeeding BehaviorBehavior

Study Officials

  • İlayda Sel Bilim, MSc, RN

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR
  • İlkay Güngör Satılmış, Prof.

    Istanbul University - Cerrahpasa

    STUDY CHAIR

Central Study Contacts

İlayda Sel Bilim, MSc, RN

CONTACT

İlkay Güngör Satılmış, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant (Women Health and Diseases Nursing)

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 12, 2025

Study Start

December 10, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

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.

Locations