NCT07407309

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable pregnancy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 6, 2026

Last Update Submit

February 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maternal Comfort During Childbirth

    Maternal comfort assessed using the Childbirth Comfort Questionnaire.

    Within the first 2 hours after birth

Secondary Outcomes (1)

  • Adaptation to Childbirth (Midwife Assessment)

    Within the first 2 hours after birth

Study Arms (2)

Antenatal Delivery Room Visit and Companion Support

EXPERIMENTAL

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.

Behavioral: Antenatal Delivery Room Visit and Companion Support

Control Group

NO INTERVENTION

Participants received standard maternity care without an antenatal delivery room visit and without continuous companion support during labor.

Interventions

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.

Antenatal Delivery Room Visit and Companion Support

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • High-risk pregnancy diagnosis
  • Planned or emergency cesarean section
  • Sensory or cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Obstetrics and Gynecology Hospital, Istanbul

Istanbul, Istanbul, 34010, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
phD

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 12, 2026

Study Start

December 1, 2024

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations