Postpartum ExperiencePostPartum2ndPNCT06152159
Postpartum Experience by the Second Parent
An observational study of Postpartum Experience, run by Université de Reims Champagne-Ardenne at 2 sites in France.
Trial summary
Many studies have been performed on mothers and their postnatal experiences. Unfortunately, studies about the second parent are very rare. Second parent is yet an essential figure in the parent-child triad and a real support for the mother. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postpartum Experience
- What is being tested?
- data collection
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Dec 2023to 1 May 2024
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The second parent of a child born since minimum 3 months and maximum 6 months.
Who may be able to join
- Males and females
- Second parent of a child born living for at least 3 months and at most 6 months
- Major
- Agreeing to participate in the study
Who cannot join
- Minors
- Protected by law (guardianship, curatorship, safeguarding of justice)
- Not agreeing to participate in this study
- Parents of stillborn children
- Refusing to participate in the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Ufr Medecine Urca
Reims, 51100
Université de Reims Champagne Ardenne
Reims, 51100
About this study
Many studies have been performed on mothers and their postnatal experiences. Unfortunately, studies about the second parent are very rare. Second parent is yet an essential figure in the parent-child triad and a real support for the mother.
The postpartum period is a time of intense restructuring and upheaval, both physically and psychologically. Studies have shown that almost 13% of fathers suffer from depression.
Read the detailed description
The main objective is to describe the postpartum experience of the second parent.
- Conditions
- Postpartum Experience
- Being tested
- data collection
- Keywords
- postpartum experience, second parent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
Data collection
| Study group | Role | What they receive |
|---|---|---|
| The second parent of a child | The second parent of a child born since minimum 3 months and maximum 6 months. Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience of the postpartum by the second parent
This experience of the postpartum by the second parent will be evaluated by a Likert scale with 5 proposals:
Very good experience/ Good experience/ Lived/neutral/ Bad experience/ Very bad experience
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum ExperienceStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152159
- Sponsor's protocol ID
- 2023_RIPH_018_PostPartum-2ndP
- Acronym
- PostPartum2ndP
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Experience by the Second Parent
- ClinicalTrials.gov ID
- NCT06152159
- Acronym / sponsor ID
- PostPartum2ndP / 2023_RIPH_018_PostPartum-2ndP
- Conditions
- Postpartum Experience
- Keywords
- postpartum experience, second parent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 30 Nov 2023 (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.
Many studies have been performed on mothers and their postnatal experiences. Unfortunately, studies about the second parent are very rare. Second parent is yet an essential figure in the parent-child triad and a real support for the mother.
The postpartum period is a time of intense restructuring and upheaval, both physically and psychologically. Studies have shown that almost 13% of fathers suffer from depression.
Detailed description
The main objective is to describe the postpartum experience of the second parent.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The second parent of a child | – | Other: data collectionThe second parent of a child born since minimum 3 months and maximum 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The second parent of a child born since minimum 3 months and maximum 6 months.
Key inclusion criteria (4 listed)
- Males and females
- Second parent of a child born living for at least 3 months and at most 6 months
- Major
- Agreeing to participate in the study
Key exclusion criteria (5 listed)
- Minors
- Protected by law (guardianship, curatorship, safeguarding of justice)
- Not agreeing to participate in this study
- Parents of stillborn children
- Refusing to participate in the study
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 |
|---|---|---|
| data collectionData collection | Other | The second parent of a child |
Primary outcome
Experience of the postpartum by the second parent
Time frame: Day 0
This experience of the postpartum by the second parent will be evaluated by a Likert scale with 5 proposals: Very good experience/ Good experience/ Lived/neutral/ Bad experience/ Very bad experience
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Experience, run by Université de Reims Champagne-Ardenne at 2 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbe Coralie, DR (0326913665 ext. +33, coralie.barbe@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience of the postpartum by the second parent (time frame: Day 0). 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 30 Nov 2023.