NCT04591730

Brief Summary

The primary aim of this study is to evaluate first time father's experience during childbirth in three different maternity hospitals in Lorraine. Secondary aims of this study is to identify domains that need improvement in order to enhance fathers's experience during childbirth.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

October 12, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 12, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2022

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

October 12, 2020

Last Update Submit

February 14, 2023

Conditions

Keywords

FathersChildbirth

Outcome Measures

Primary Outcomes (1)

  • First-time father questionnaire score

    Minimum value of the scale = 1, maximum value = 4, higher score represent a bad experience for the father.

    1 month after birth

Study Arms (3)

Type I maternity

Fathers who experienced a first childbirth in a type I maternity in Lorraine.

Other: First time father questionnaire self-administration

Type II maternity

Fathers who experienced a first childbirth in a type II maternity in Lorraine.

Other: First time father questionnaire self-administration

Type III maternity

Fathers who experienced a first childbirth in a type III maternity in Lorraine.

Other: First time father questionnaire self-administration

Interventions

The first-time father questionnaire will be self-administrated to subjects 1 month post-birth.

Type I maternityType II maternityType III maternity

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Father for the first time.

You may qualify if:

  • First time father after a physiological pregnancy and delivery of a healthy newborn of more than 37 gestational weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternité du CHRU de Nancy

Nancy, Meurthe-et-Moselle, 54000, France

Location

Related Publications (3)

  • Premberg A, Carlsson G, Hellstrom AL, Berg M. First-time fathers' experiences of childbirth--a phenomenological study. Midwifery. 2011 Dec;27(6):848-53. doi: 10.1016/j.midw.2010.09.002. Epub 2010 Oct 16.

  • Premberg A, Taft C, Hellstrom AL, Berg M. Father for the first time--development and validation of a questionnaire to assess fathers' experiences of first childbirth (FTFQ). BMC Pregnancy Childbirth. 2012 May 17;12:35. doi: 10.1186/1471-2393-12-35.

  • Capponi I, Carquillat P, Premberg A, Vendittelli F, Guittier MJ. [Translation and validation in French of the First-Time Father Questionnaire]. Gynecol Obstet Fertil. 2016 Sep;44(9):480-6. doi: 10.1016/j.gyobfe.2016.07.011. Epub 2016 Aug 24. French.

Study Officials

  • Leonore Avercenc, PhD

    CHRU de Nancy

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Midwife, PhD

Study Record Dates

First Submitted

October 12, 2020

First Posted

October 19, 2020

Study Start

October 12, 2020

Primary Completion

April 15, 2021

Study Completion

September 19, 2022

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations