- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07407309
Antenatal Delivery Room Visit and Companion Support in Labor
Effects of Antenatal Delivery Room Visit and Companion Support During Labor on Maternal Comfort and Adaptation to Childbirth: A Randomized Controlled Trial
This study evaluated whether an antenatal visit to the delivery room combined with companion support during labor improves comfort and adaptation to childbirth among pregnant women. The childbirth environment and lack of familiarity with the delivery room may increase anxiety and reduce comfort during labor. Supportive interventions before and during labor may help women adapt more positively to the childbirth process.
In this randomized controlled trial, pregnant women were assigned either to an intervention group that received an antenatal delivery room visit and continuous companion support during labor, or to a control group that received standard maternity care without these interventions. Maternal comfort and adaptation to childbirth were assessed using validated measurement tools after birth.
The results of this study aim to support evidence-based maternity care practices and highlight the importance of antenatal preparation and continuous support during labor to enhance women's childbirth experiences.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34010
- State Obstetrics and Gynecology Hospital, Istanbul
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 18 years and older
- Gestational age between 24 and 40 weeks
- Planning a vaginal birth at the study hospital
- Able to communicate in Turkish
- Volunteered to participate and provided informed consent
Exclusion Criteria:
- High-risk pregnancy diagnosis
- Planned or emergency cesarean section
- Sensory or cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Antenatal Delivery Room Visit and Companion Support
Participants received an antenatal visit to the delivery room prior to labor and continuous companion support during the labor process, in addition to standard maternity care.
|
Participants received an antenatal visit to the delivery room prior to labor and continuous companion support during the labor process, in addition to standard maternity care.
|
|
No Intervention: Control Group
Participants received standard maternity care without an antenatal delivery room visit and without continuous companion support during labor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal Comfort During Childbirth
Time Frame: Within the first 2 hours after birth
|
Maternal comfort assessed using the Childbirth Comfort Questionnaire.
|
Within the first 2 hours after birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adaptation to Childbirth (Midwife Assessment)
Time Frame: Within the first 2 hours after birth
|
Adaptation to childbirth assessed by midwives using the Midwife Evaluation of Childbirth Adaptation Scale.
|
Within the first 2 hours after birth
|
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
- Delivery Room Visit and Compan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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