FathersPRIMIPERENCT04591730

First-time Fathers' Experiences of Childbirth in Lorraine

An observational study of Fathers and First Birth, run by Central Hospital, Nancy, France at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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. Read more about this study

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Fathers, First Birth
What is being tested?: First time father questionnaire self-administration
How many people: 80 participants
Where: 1 siteFrance
Study dates: 12 Oct 2020to 19 Sep 2022
Phase: Observational
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 18 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Study population: Father for the first time.

Who may be able to join

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

Who cannot join

Trial locations and contacts

1 site in 1 country.

France1 site

Maternité du CHRU de Nancy
Nancy, Meurthe-et-Moselle, 54000

Other trials in France

About this study

Official title: 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.

Conditions: Fathers, First Birth
Being tested: First time father questionnaire self-administration
Keywords: Fathers, Childbirth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04591730
Study group	Role	What they receive
Type I maternity		Fathers who experienced a first childbirth in a type I maternity in Lorraine. Receives: Other: First time father questionnaire self-administration
Type II maternity		Fathers who experienced a first childbirth in a type II maternity in Lorraine. Receives: Other: First time father questionnaire self-administration
Type III maternity		Fathers who experienced a first childbirth in a type III maternity in Lorraine. Receives: Other: First time father questionnaire self-administration

What is being measured

The primary outcome is the main question the study is designed to answer.

First-time father questionnaire score
Minimum value of the scale = 1, maximum value = 4, higher score represent a bad experience for the father.
Measured: 1 month after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 202019 Sep 2022

First posted19 Oct 2020
Study start12 Oct 2020
Primary completion15 Apr 2021
Study completion19 Sep 2022

Why it stopped: Completion failure

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for FathersStudies of the same condition, open and under way.
More trials run by Central Hospital, Nancy, FranceThe 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04591730
Sponsor's protocol ID: 2020PI138
Acronym: PRIMIPERE
Status last verified: Feb 2023
First submitted: 12 Oct 2020
Last updated: 15 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 20956030
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.
PubMed 22594834
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.
PubMed 27568411

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fathers trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: First-time Fathers' Experiences of Childbirth in Lorraine.
ClinicalTrials.gov ID: NCT04591730
Acronym / sponsor ID: PRIMIPERE / 2020PI138
Conditions: Fathers, First Birth
Keywords: Fathers, Childbirth
Study type: Observational
Recruitment status: TerminatedReason stopped: Completion failure
Enrolment: 80 participants (actual)
Lead sponsor: Central Hospital, Nancy, FranceUniversity, hospital or other
Study start: 12 Oct 2020 (actual)
Primary completion: 15 Apr 2021 (actual)
Study completion: 19 Sep 2022 (actual)
First posted: 19 Oct 2020 (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.

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 design

Observational model: Case only
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Type I maternity	–	Other: First time father questionnaire self-administrationFathers who experienced a first childbirth in a type I maternity in Lorraine.
Type II maternity	–	Other: First time father questionnaire self-administrationFathers who experienced a first childbirth in a type II maternity in Lorraine.
Type III maternity	–	Other: First time father questionnaire self-administrationFathers who experienced a first childbirth in a type III maternity in Lorraine.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Father for the first time.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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
First time father questionnaire self-administrationThe first-time father questionnaire will be self-administrated to subjects 1 month post-birth.	Other	Type I maternity, Type II maternity, Type III maternity

Primary outcome

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.

Results and safety

The study was stopped early (reason given: Completion failure). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
Results publication: PubMed 20956030Premberg 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.
Results publication: PubMed 22594834Premberg 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.
Results publication: PubMed 27568411Capponi 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.
Individual participant dataSharing planned: No

Related trials for Fathers

Recruiting
Online Feeding Education for Fathers of Children With Feeding Problems
Feeding Problems, Parent Training
Recruiting
Fathers and Babies (FAB) Research Study
Perinatal Mental Health, Fathers
Not yet recruiting
Effectiveness of GEMPO E-Education on Fathers' Self-Efficacy and Ability in Newborn Care
Fathers' Self-Efficacy and Ability in Newborn Care
Active, not recruiting
Determining the Effectiveness of Working Out Dads to Reduce Mental Health Difficulties in Fathers of Young Children
Mental Health Issue
Not yet recruiting
Mobile Prenatal Education for Expectant Fathers and Its Effects on Bonding, Stress, Breastfeeding and Marital Satisfaction
Breastfeeding Attitudes, Breast Feeding

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.

Leonore Avercenc, PhD study director

CHRU de Nancy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Fathers and First Birth, run by Central Hospital, Nancy, France at 1 site in France.

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: stopped early, as of the sponsor's last update on 15 Feb 2023. 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 France. 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 was stopped early (reason given: Completion failure). Results are not available in the source record.

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?

First-time father questionnaire score (time frame: 1 month after birth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04591730, which also lists 3 linked publications.

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 15 Feb 2023.