- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04591730
First-time Fathers' Experiences of Childbirth in Lorraine (PRIMIPERE)
February 14, 2023 updated by: AVERCENC Léonore, Central Hospital, Nancy, France
First-time Fathers' Experiences of Childbirth in Lorraine.
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Meurthe-et-Moselle
-
Nancy, Meurthe-et-Moselle, France, 54000
- Maternité du CHRU de Nancy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Father for the first time.
Description
Inclusion Criteria:
- First time father after a physiological pregnancy and delivery of a healthy newborn of more than 37 gestational weeks.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Type I maternity
Fathers who experienced a first childbirth in a type I maternity in Lorraine.
|
The first-time father questionnaire will be self-administrated to subjects 1 month post-birth.
|
|
Type II maternity
Fathers who experienced a first childbirth in a type II maternity in Lorraine.
|
The first-time father questionnaire will be self-administrated to subjects 1 month post-birth.
|
|
Type III maternity
Fathers who experienced a first childbirth in a type III maternity in Lorraine.
|
The first-time father questionnaire will be self-administrated to subjects 1 month post-birth.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First-time father questionnaire score
Time Frame: 1 month after birth
|
Minimum value of the scale = 1, maximum value = 4, higher score represent a bad experience for the father.
|
1 month after birth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Gynecol Obstet Fertil Senol. 2023 Feb;51(2):153. French.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 12, 2020
Primary Completion (Actual)
April 15, 2021
Study Completion (Actual)
September 19, 2022
Study Registration Dates
First Submitted
October 12, 2020
First Submitted That Met QC Criteria
October 12, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
February 15, 2023
Last Update Submitted That Met QC Criteria
February 14, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020PI138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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