Factors Associated With Continuation of Exclusive Breastf... | NCT05650684

Studies
Factors Associated With Continuation of Exclusive Breastfeeding Until the Post-natal Visit

NCT05650684

Sponsor

Université de Reims Champagne-Ardenne

Status

Unknown status

Last Update Posted

Dec 16, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Breastfeeding

Interventions

data collection

Countries

Not provided

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

Dec 2022

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

Jan 1, 2023Estimated

Primary Completion Date

Apr 1, 2023Estimated

Completion Date

Jul 1, 2023Estimated

First Submitted Date

Dec 6, 2022

First Submission Date that Met QC Criteria

Dec 6, 2022

First Posted Date

Dec 14, 2022Actual

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

Dec 14, 2022

Last Update Posted Date

Dec 16, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Breastfeeding promotes the health of mother and her child, and remains the reference in terms of infant nutrition. World Health Organization recommends exclusive breastfeeding for the first six months. This recommended duration is not respected in France with a median duration of breastfeeding in France at 3 months.

Detailed Description

The aim is to study factors associated with continuation of exclusive breastfeeding until the post-natal visit.

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
"exclusive breastfeeding" group		Women initiating exclusive breastfeeding after birth	Other: data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
data collection	Other	continuation of exclusive breastfeeding until the post-natal visit (6 to 8 weeks after birth)	"exclusive breastfeeding" group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
breastfeeding	number of women practicing or not exclusive breastfeeding until postnatal consultation (6 to 8 weeks after birth)	Day 0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primiparous and multiparous women
women who have initiate breastfeeding
women aged 18 and more
agreeing to participate in the study

Exclusion Criteria:

women whose newborn has been in intensive care unit
women with a multiple pregnancy

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Mother initiating exclusive breastfeeding after birth

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
CURRS CURRS	Contact	0326918822		currs@univ-reims.fr

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001942	Breast Feeding

Ancestor Terms

ID	Term
D005247	Feeding Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

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