Delivery CareNCT07514195
MOTHER FRİENDLY PRACTİCES AND MATERNAL, FETAL OUTCOMES
An observational study of Delivery Care and Satisfaction With Care, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Delivery Care, Satisfaction With Care
- How many people
- 281 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2025to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Patients aged 18-45
- No chronic diseases
- No acute illnesses
- No pregnancy complications
- Spontaneous pregnancy
- Full-term pregnancy
- Appropriate-for-gestational-age (AGA) infants
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
The Obstetrics Clinics of Sakarya Research and Training Hospital
Sakarya, Adapazarı
About this study
Official title: 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.
Read the 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).
- Conditions
- Delivery Care, Satisfaction With Care
- Keywords
- Maternal satisfaction, Mother-friendly, Maternal outcomes, Fetal outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | where mother-friendly approaches were implemented | |
| Group 2 | where mother-friendly approaches were not implemented |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From delivery to hospital discharge, 1. day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start28 Feb 2025
- Primary completion31 Jul 2025
- Study completion30 Sep 2025
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 Delivery CareStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514195
- Sponsor's protocol ID
- E-43012747-050.04-438233-43
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Keskin Paker M, Beyaz A, Ucar G, Kaya M, Kilic Z, Uslu Yuvaci H. The effects of mother-friendly practices on maternal and fetal outcomes: a multicenter study. BMC Pregnancy Childbirth. 2026 Apr 27;26(1):639. doi: 10.1186/s12884-026-09143-9.
PubMed 42045854
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECTS OF MOTHER FRİENDLY PRACTİCES ON MATERNAL AND FETAL OUTCOMES: A MULTİCENTER STUDY
- ClinicalTrials.gov ID
- NCT07514195
- Acronym / sponsor ID
- E-43012747-050.04-438233-43
- Conditions
- Delivery Care, Satisfaction With Care
- Keywords
- Maternal satisfaction, Mother-friendly, Maternal outcomes, Fetal outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 7 Apr 2026 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –where mother-friendly approaches were implemented |
| Group 2 | – | –where mother-friendly approaches were not implemented |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- Patients aged 18-45
- No chronic diseases
- No acute illnesses
- No pregnancy complications
- Spontaneous pregnancy
Key exclusion criteria (15 listed)
- Individuals over 45 years of age
- Maternal type 1 and 2 diabetes mellitus or gestational diabetes
- Chronic hypertension
- Preeclampsia
- Connective tissue disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite adverse maternal and neonatal outcome
Time frame: From delivery to hospital discharge, 1. day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 42045854Keskin Paker M, Beyaz A, Ucar G, Kaya M, Kilic Z, Uslu Yuvaci H. The effects of mother-friendly practices on maternal and fetal outcomes: a multicenter study. BMC Pregnancy Childbirth. 2026 Apr 27;26(1):639. doi: 10.1186/s12884-026-09143-9.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delivery Care and Satisfaction With Care, run by Sakarya University 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 7 inclusion and 15 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: finished, as of the sponsor's last update on 13 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite adverse maternal and neonatal outcome (time frame: From delivery to hospital discharge, 1. day). 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 NCT07514195, 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 13 Apr 2026.