Postpartum Experience by the Second Parent | NCT06152159

Studies
Postpartum Experience by the Second Parent

NCT06152159

Sponsor

Université de Reims Champagne-Ardenne

Status

Unknown status

Last Update Posted

Nov 30, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Postpartum Experience

Interventions

data collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Estimated

Primary Completion Date

Feb 1, 2024Estimated

Completion Date

May 1, 2024Estimated

First Submitted Date

Nov 21, 2023

First Submission Date that Met QC Criteria

Nov 21, 2023

First Posted Date

Nov 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2023

Last Update Posted Date

Nov 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The second parent of a child		The second parent of a child born since minimum 3 months and maximum 6 months.	Other: data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
data collection	Other	Data collection	The second parent of a child

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Day 0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The second parent of a child born since minimum 3 months and maximum 6 months.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Barbe Coralie, DR	Contact	0326913665	+33	coralie.barbe@univ-reims.fr
Parisot Céline	Contact	06.24.98.62.80	+33	celine.parisot@ch-epernay.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ufr Medecine Urca		Reims		51100	France
Université de Reims Champagne Ardenne

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided