NCT06062667

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2023

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

September 22, 2023

Last Update Submit

October 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    15 days

Study Arms (2)

experimental group

EXPERIMENTAL

Fathers will accompany their husbands during the birth process

Other: accompany the birth

Control group

NO INTERVENTION

routine maintenance

Interventions

Fathers will accompany their husbands during the birth process

experimental group

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsFather
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Spouses of primiparous pregnant women who had spontaneous pregnancies and were admitted to the delivery room for normal labor were included in the study.

You may not qualify if:

  • women without husbands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Betül Uncu

Istanbul, 34320, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2023

First Posted

October 2, 2023

Study Start

March 1, 2023

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

October 28, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations