Coqueluche-Vac: Knowledge of Pregnant Women Concerning Pertussis, Vaccination Against Pertussis and Cocooning Strategy

Sponsor

Université de Reims Champagne-Ardenne (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06114160

Collaborator

(none)

500

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pertussis	Other: Data collection

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
pregnant women Pregnant women between 20 and 41 weeks of amenorrhoea, primiparous.	Other: Data collection Data collection

Arm

Intervention/Treatment

pregnant women

Pregnant women between 20 and 41 weeks of amenorrhoea, primiparous.

Other: Data collection

Data collection

Outcome Measures

Primary Outcome Measures

recommendation of vaccination against pertussis [day0]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Université de Reims Champagne-Ardenne

Investigators

Principal Investigator: Pilet Caroline, midwife, CHU de Reims

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Université de Reims Champagne-Ardenne

ClinicalTrials.gov Identifier:

NCT06114160

Other Study ID Numbers:

2023_RIPH_015_Coqueluche-Vac

First Posted:

Nov 2, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Université de Reims Champagne-Ardenne

cocooning strategy

pertussis

pregnancy

vaccination against pertussis

Additional relevant MeSH terms:

Whooping Cough

Study Results

No Results Posted as of Nov 7, 2023