Knowledge of Pregnant Women Concerning Pertussis, Vaccina... | NCT06114160

Studies
Knowledge of Pregnant Women Concerning Pertussis, Vaccination Against Pertussis and Cocooning Strategy

NCT06114160

Sponsor

Université de Reims Champagne-Ardenne

Status

Unknown status

Last Update Posted

Nov 7, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Pertussis

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

Oct 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

Oct 27, 2023

First Submission Date that Met QC Criteria

Oct 27, 2023

First Posted Date

Nov 2, 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 3, 2023

Last Update Posted Date

Nov 7, 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

In France, it has been recommended since 2022 that pregnant women be vaccinated against pertussis from 20 to 36 weeks' gestation.

This vaccination schedule is inspired by the Anglo-Saxon model and studies showing the effectiveness of this practice.

The aim of this vaccine is to protect the newborn by transferring antibodies from the fetus to the placenta, because Pertussis is a particularly serious disease in newborns.

Detailed Description

The aim is to describe pregnant women's knowledge concerning pertussis, vaccination against pertussis during pregnancy and the cocooning strategy.

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pregnant women		Pregnant women between 20 and 41 weeks of amenorrhoea, primiparous.	Other: Data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data collection	Other	Data collection	pregnant women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recommendation of vaccination against pertussis	Knowledge of pregnant women's concerning recommendation of vaccination against pertussis from 20 to 36 weeks' gestation : does the woman know or not the recommandation concerning the vaccination	day0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant between 20 and 41 weeks of amenorrhea
Primiparous
aged more than 18
Agreed to participate in the study

Exclusion Criteria:

Multiparous
Protected by law (guardianship, guardianship, safeguarding of justice)
Not agreed to participate in this study

Accepts Healthy Volunteers

Yes

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

pregnant women

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
CURRS CURRS	Contact	0326918822	+33	curss@univ-reims.fr

Overall Officials

Name	Affiliation	Role
Pilet Caroline, midwife	CHU de Reims	Principal Investigator

Locations

Not provided

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

Condition Browse Module

MeSH Terms

ID	Term
D014917	Whooping Cough

Ancestor Terms

ID	Term
D001885	Bordetella Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses

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