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NCT04591730 Clinical Trial

First-time Fathers' Experiences of Childbirth in Lorraine

Fathers Clinical Trial

— PRIMIPERE  

Official title:
First-time Fathers' Experiences of Childbirth in Lorraine.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04591730
Other study ID # 2020PI138
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date October 12, 2020
Est. completion date September 19, 2022

Study information
Verified date February 2023
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 80
Est. completion date September 19, 2022
Est. primary completion date April 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - First time father after a physiological pregnancy and delivery of a healthy newborn of more than 37 gestational weeks. Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• First time father questionnaire self-administration
The first-time father questionnaire will be self-administrated to subjects 1 month post-birth.

Locations
Country Name City State
France Maternité du CHRU de Nancy Nancy Meurthe-et-Moselle

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (3)

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. Erratum In: G — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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