NCT07514195

Brief Summary

The "mother-friendly hospital" model aims to enhance care quality by avoiding unnecessary, non-evidence-based interventions and supporting natural physiological processes from early pregnancy to postpartum. This study evaluated the impact of mother-friendly hospital criteria on labor pain, maternal satisfaction, and maternal and fetal outcomes. Mother-friendly hospital practices emphasizing minimal intervention and physiologic support reduce labor pain, improve maternal satisfaction, and enhance neonatal outcomes. Implementing mother-friendly approaches ensures safe, high-quality, mother-centered maternity care. The results of our study showed that mother-friendly approaches increased maternal satisfaction during the childbirth process and reduced pain scores. These results revealed that mother-friendly practices not only improve the childbirth experience of women but also contribute positively to maternal and neonatal health. Therefore, supporting and expanding the integration of mother-friendly approaches into the healthcare system is of great importance for improving the quality of obstetric services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
281

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

March 30, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

Maternal satisfactionMother-friendlyMaternal outcomesFetal outcomes

Outcome Measures

Primary Outcomes (1)

  • Composite adverse maternal and neonatal outcome

    A composite outcome including at least one of the following: cesarean delivery, postpartum hemorrhage, severe perineal trauma, low 5-minute Apgar score (\<7), or NICU admission.

    From delivery to hospital discharge, 1. day

Study Arms (2)

Group 1

where mother-friendly approaches were implemented

Group 2

where mother-friendly approaches were not implemented

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women receiving care at participating centers, aged 18-45 years, with singleton pregnancies at ≥37 weeks of gestation. Participants must be planning to deliver at the study hospital and provide informed consent. Women with multiple gestations, major maternal comorbidities (e.g., pre-existing diabetes, hypertension, cardiac disease), or known fetal anomalies are excluded. The study population represents a prospective cohort of patients exposed to routine mother-friendly practices in a multicenter clinical setting.

You may qualify if:

  • Patients aged 18-45
  • No chronic diseases
  • No acute illnesses
  • No pregnancy complications
  • Spontaneous pregnancy
  • Full-term pregnancy
  • Appropriate-for-gestational-age (AGA) infants

You may not qualify if:

  • Individuals over 45 years of age
  • Maternal type 1 and 2 diabetes mellitus or gestational diabetes
  • Chronic hypertension
  • Preeclampsia
  • Connective tissue disease
  • Smoking during pregnancy
  • Preterm birth (gestational age \<37 weeks)
  • small-for-gestational-age infants (birth weight \< 2 SD)
  • neonatal asphyxia (APGAR score \<7 at 1 and 5 minutes)
  • malformations, chromosomal disorders, and congenital infections
  • women with signs of chorioamnionitis (fever, leukocytosis, abdominal pain, foul-smelling discharge) more than 12 hours after EMR
  • chronic kidney and liver disease
  • hematological disorders
  • Should not be administered to individuals with a pacemaker
  • Should not be administered to patients with epilepsy, transient ischemic attacks, or a history of cerebrovascular events

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Obstetrics Clinics of Sakarya Research and Training Hospital

Sakarya, Adapazarı, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 7, 2026

Study Start

February 28, 2025

Primary Completion

July 31, 2025

Study Completion

September 30, 2025

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations