Birth, FirstNCT06062667
The Effect of Fathers' Birth Experience on Paternal Attachment and Parenting Perception: Randomized Controlled Trial
A study testing accompany the birth in people with Birth, First, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
In recent years, fathers have become increasingly involved in research, but research on fathers still lags behind research on mothers. During the transition to parenthood, a complex network of relationships emerges between father, mother and baby. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Birth, First
- What is being tested?
- accompany the birth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 Oct 2023
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Spouses of primiparous pregnant women who had spontaneous pregnancies and were admitted to the delivery room for normal labor were included in the study.
Who cannot join
- women without husbands
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Fathers' Bırth Experıence On Paternal Attachment And Parentıng Perceptıon: A Randomızed Controlled Study
In recent years, fathers have become increasingly involved in research, but research on fathers still lags behind research on mothers. During the transition to parenthood, a complex network of relationships emerges between father, mother and baby. During the process of becoming parents, mothers and fathers begin to bond with their unborn children. The prenatal period is hypothesized to be predictive of later postnatal attachment and perception of parenting. Paternal involvement at birth is associated with positive child health outcomes and parental well-being.
- Conditions
- Birth, First
- Being tested
- accompany the birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accompany the birthOther
Fathers will accompany their husbands during the birth process
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Fathers will accompany their husbands during the birth process Receives: Other: accompany the birth |
| Control group | No intervention | routine maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
The father-baby bonding of fathers who accompany their spouses in the delivery room is higher than fathers who do not accompany their spouses in the delivery room.
Primiparous pregnant women who had spontaneous pregnancies and were admitted to the delivery room for normal labor were included in the study. In determining the groups, participants were assigned to the Fathers Who Accompany the Birth (G1) and Fathers Who Did Not Accompany the Birth (G2) groups using web-based randomization (Randomizer.org). Pregnant women and their spouses in both groups who volunteered to participate in the study had the "Information Form" filled in after admission to the delivery room, and fathers filled out PAAQ and SPPRS. Two weeks after birth, the mother and father were contacted. PPAQ and SPPRS data were obtained from fathers and EPDS data were obtained from mothers.
Information Form (IF), Paternal Antenatal Attachment Questionnaire (PAAQ), Self-Perception of Parental Role Scale (SPPRS), Postnatal Paternal-İnfant Attachment Questionnaire (PPAQ) Edinburg Postnatal Depression Scale (EPDS)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Mar 2023
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth, FirstStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Uncu, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062667
- Sponsor's protocol ID
- 2022/285
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2023
- Last updated
- 28 Oct 2024
- 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 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Fathers' Bırth Experıence On Paternal Attachment And Parentıng Perceptıon: A Randomızed Controlled Study
- ClinicalTrials.gov ID
- NCT06062667
- Acronym / sponsor ID
- 2022/285
- Conditions
- Birth, First
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 2 Oct 2023 (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.
In recent years, fathers have become increasingly involved in research, but research on fathers still lags behind research on mothers. During the transition to parenthood, a complex network of relationships emerges between father, mother and baby. During the process of becoming parents, mothers and fathers begin to bond with their unborn children. The prenatal period is hypothesized to be predictive of later postnatal attachment and perception of parenting. Paternal involvement at birth is associated with positive child health outcomes and parental well-being.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: accompany the birthFathers will accompany their husbands during the birth process |
| Control group | No intervention | –routine maintenance |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Spouses of primiparous pregnant women who had spontaneous pregnancies and were admitted to the delivery room for normal labor were included in the study.
Key exclusion criteria (1 listed)
- women without husbands
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 |
|---|---|---|
| accompany the birthFathers will accompany their husbands during the birth process | Other | experimental group |
Primary outcome
The father-baby bonding of fathers who accompany their spouses in the delivery room is higher than fathers who do not accompany their spouses in the delivery room.
Time frame: 15 days
Primiparous pregnant women who had spontaneous pregnancies and were admitted to the delivery room for normal labor were included in the study. In determining the groups, participants were assigned to the Fathers Who Accompany the Birth (G1) and Fathers Who Did Not Accompany the Birth (G2) groups using web-based randomization (Randomizer.org). Pregnant women and their spouses in both groups who volunteered to participate in the study had the "Information Form" filled in after admission to the delivery room, and fathers filled out PAAQ and SPPRS. Two weeks after birth, the mother and father were contacted. PPAQ and SPPRS data were obtained from fathers and EPDS data were obtained from mothers. Information Form (IF), Paternal Antenatal Attachment Questionnaire (PAAQ), Self-Perception of Parental Role Scale (SPPRS), Postnatal Paternal-İnfant Attachment Questionnaire (PPAQ) Edinburg Postnatal Depression Scale (EPDS)
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 28 Oct 2024.
- 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 accompany the birth in people with Birth, First, run by Istanbul University - Cerrahpasa 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 1 inclusion and 1 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 28 Oct 2024. 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?
The father-baby bonding of fathers who accompany their spouses in the delivery room is higher than fathers who do not accompany their spouses in the delivery room. (time frame: 15 days). 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 28 Oct 2024.