PregnancyNCT07407309
Antenatal Delivery Room Visit and Companion Support in Labor
A study testing Antenatal Delivery Room Visit and Companion Support in people with Pregnancy and Labor and Childbirth, run by Nilgun Avci at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Labor and Childbirth
- What is being tested?
- Antenatal Delivery Room Visit and Companion Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 31 May 2025
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- High-risk pregnancy diagnosis
- Planned or emergency cesarean section
- Sensory or cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
State Obstetrics and Gynecology Hospital, Istanbul
Istanbul, Istanbul, 34010
About this study
Official title: 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.
- Conditions
- Pregnancy, Labor and Childbirth
- Being tested
- Antenatal Delivery Room Visit and Companion Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal Delivery Room Visit and Companion SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Comfort During Childbirth
Maternal comfort assessed using the Childbirth Comfort Questionnaire.
Measured: Within the first 2 hours after birth
Secondary outcomes (1)
Adaptation to Childbirth (Midwife Assessment)
Adaptation to childbirth assessed by midwives using the Midwife Evaluation of Childbirth Adaptation Scale.
Measured: Within the first 2 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Dec 2024
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nilgun Avci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nilgun Avci, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407309
- Sponsor's protocol ID
- Delivery Room Visit and Compan
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antenatal Delivery Room Visit and Companion Support During Labor on Maternal Comfort and Adaptation to Childbirth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07407309
- Acronym / sponsor ID
- Delivery Room Visit and Compan
- Conditions
- Pregnancy, Labor and Childbirth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Nilgun AvciUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 12 Feb 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antenatal Delivery Room Visit and Companion Support | Experimental | Behavioral: Antenatal Delivery Room Visit and Companion SupportParticipants 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. |
| Control Group | No intervention | –Participants received standard maternity care without an antenatal delivery room visit and without continuous companion support during labor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- High-risk pregnancy diagnosis
- Planned or emergency cesarean section
- Sensory or cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antenatal Delivery Room Visit and Companion SupportParticipants 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. | Behavioural | Antenatal Delivery Room Visit and Companion Support |
Primary outcome
Maternal Comfort During Childbirth
Time frame: Within the first 2 hours after birth
Maternal comfort assessed using the Childbirth Comfort Questionnaire.
1 secondary outcome
Adaptation to Childbirth (Midwife Assessment)
Time frame: Within the first 2 hours after birth
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 12 Feb 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Antenatal Delivery Room Visit and Companion Support in people with Pregnancy and Labor and Childbirth, run by Nilgun Avci 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 5 inclusion and 3 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 12 Feb 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?
Maternal Comfort During Childbirth (time frame: Within the first 2 hours after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2026.