Family RelationsNCT03260959
Experience of the Father Following the Announcement of a First Pregnancy
An observational study of Family Relations and Behavior, run by Hospices Civils de Lyon at 5 sites in France.
Trial summary
Experience of the father following the announcement of a first pregnancy Its context, immediate reactions and actions. Possible impact of this moment of life a few months or years later? Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Family Relations, Behavior
- What is being tested?
- Interview by hierarchical evocation's Method
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 5 sitesFrance
- Study dates
- 10 Jul 2017to 10 Nov 2017
- 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 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Male having been the father of at least one pregnancy whatever the outcome (pregnancy pursued, or abortion)
Who may be able to join
- Male having been the father of at least one pregnancy whatever the outcome (pregnancy pursued, or abortion)
Who cannot join
- Patients with severe or neurological psychiatric disorders inducing significant cognitive impairment
- Patients who do not master the French language
- Patients who cannot give free and informed consent (guardianship, curatorship, safeguard of justice ...)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Cabinet de médecine générale
Beynost, 01700
Cabinet de médecine générale
Crémieu, 38460
Cabinet de médecine générale
Lyon, 69008
Cabinet de médecine générale
Vallon-Pont-d'Arc, 07150
Cabinet de médecine générale
Vaugneray, 69670
About this study
Experience of the father following the announcement of a first pregnancy Its context, immediate reactions and actions. Possible impact of this moment of life a few months or years later?
- Conditions
- Family Relations, Behavior
- Being tested
- Interview by hierarchical evocation's Method
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview by hierarchical evocation's MethodBehavioural
Interview to describe the experience of the man during the announcement of a pregnancy that it is expected or not.
| Study group | Role | What they receive |
|---|---|---|
| Father | Male having been the father of at least one pregnancy whatever the outcome (pregnancy pursued, or abortion) Receives: Behavioral: Interview by hierarchical evocation's Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview by hierarchical evocation's method
Experience of the man during the announcement of a pregnancy that it is expected or not, without identification of an average answer, but description of the diversity of situations, contexts, felt, taken of decision and actions.
Since this study is observational and descriptive, it does not have a primary judgment criterion, the aim being to describe the studied population. However, according to the method of hierarchical evocation, it can be said that the average frequency of occurrence of the words and their average polarity index will be some outcome measure.
Measured: 30-45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start10 Jul 2017
- Primary completion10 Nov 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family RelationsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260959
- Sponsor's protocol ID
- 69HCL17_0073
- Status last verified
- Aug 2017
- First submitted
- 22 Aug 2017
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience of the Father Following the Announcement of a First Pregnancy
- ClinicalTrials.gov ID
- NCT03260959
- Acronym / sponsor ID
- 69HCL17_0073
- Conditions
- Family Relations, Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 24 Aug 2017 (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.
Experience of the father following the announcement of a first pregnancy Its context, immediate reactions and actions. Possible impact of this moment of life a few months or years later?
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Father | – | Behavioral: Interview by hierarchical evocation's MethodMale having been the father of at least one pregnancy whatever the outcome (pregnancy pursued, or abortion) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male having been the father of at least one pregnancy whatever the outcome (pregnancy pursued, or abortion)
Key inclusion criteria (1 listed)
- Male having been the father of at least one pregnancy whatever the outcome (pregnancy pursued, or abortion)
Key exclusion criteria (3 listed)
- Patients with severe or neurological psychiatric disorders inducing significant cognitive impairment
- Patients who do not master the French language
- Patients who cannot give free and informed consent (guardianship, curatorship, safeguard of justice ...)
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 |
|---|---|---|
| Interview by hierarchical evocation's MethodInterview to describe the experience of the man during the announcement of a pregnancy that it is expected or not. | Behavioural | Father |
Primary outcome
Interview by hierarchical evocation's method
Time frame: 30-45 minutes
Experience of the man during the announcement of a pregnancy that it is expected or not, without identification of an average answer, but description of the diversity of situations, contexts, felt, taken of decision and actions. Since this study is observational and descriptive, it does not have a primary judgment criterion, the aim being to describe the studied population. However, according to the method of hierarchical evocation, it can be said that the average frequency of occurrence of the words and their average polarity index will be some outcome measure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Family Relations and Behavior, run by Hospices Civils de Lyon at 5 sites 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 3 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: finished, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interview by hierarchical evocation's method (time frame: 30-45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2018.