- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07514195
MOTHER FRİENDLY PRACTİCES AND MATERNAL, FETAL OUTCOMES
THE EFFECTS OF MOTHER FRİENDLY PRACTİCES ON MATERNAL AND FETAL OUTCOMES: A MULTİCENTER STUDY
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.
Study Overview
Status
Conditions
Detailed Description
This prospective study included term pregnant women delivering between February and June 2025 at Sakarya Research and Training Hospital (Group 1, with mother-friendly practices) and Ümraniye Research and Training Hospital (Group 2, without such practices). Exclusion criteria were maternal age >45 years, chronic systemic disease, preeclampsia or gestational diabetes, prolonged rupture of membranes with infection, preterm birth (<37 weeks), and small-for-gestational-age infants (<2 SD). Maternal characteristics, labor interventions, non-pharmacological methods, postpartum hemorrhage, labor duration, pain levels using the Visual Analog Scale (VAS), and fetal outcomes (birth weight, Apgar scores, NICU admission) were recorded. Maternal satisfaction was assessed in the first postpartum hour using the Birth Satisfaction Scale.
A total of 281 women were included (Group 1: 136, Group 2: 145). Groups were similar in age, BMI, education, employment, gestational week, labor duration, and postpartum hemorrhage (p>0.05). Latent phase, active phase, and postpartum VAS scores were significantly lower in Group 1 (p<0.001). Maternal satisfaction scores were higher in Group 1 (p<0.001). NICU admissions were lower in Group 1 (2.9% vs. 9.7%, p=0.022), and first- and fifth-minute Apgar scores were higher (p<0.001).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Adapazarı
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Sakarya, Adapazarı, Turkey (Türkiye)
- The Obstetrics Clinics of Sakarya Research and Training Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18-45
- No chronic diseases
- No acute illnesses
- No pregnancy complications
- Spontaneous pregnancy
- Full-term pregnancy
- Appropriate-for-gestational-age (AGA) infants
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Group 1
where mother-friendly approaches were implemented
|
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Group 2
where mother-friendly approaches were not implemented
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite adverse maternal and neonatal outcome
Time Frame: From delivery to hospital discharge, 1. day
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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.
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From delivery to hospital discharge, 1. day
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- E-43012747-050.04-438233-43
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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