NCT06114160

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

October 27, 2023

Last Update Submit

November 3, 2023

Conditions

Pertussis

Keywords

cocooning strategypertussispregnancyvaccination against pertussis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

pregnant women

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

Other: Data collection

Interventions

Data collectionOTHER

Data collection

pregnant women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pregnant women

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Whooping Cough

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Bordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Pilet Caroline, midwife

    CHU de Reims

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbe Coralie, DR

CONTACT

0326913665coralie.barbe@univ-reims.fr

CURRS CURRS

CONTACT

0326918822curss@univ-reims.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 2, 2023

Study Start

December 1, 2023

Primary Completion

February 1, 2024

Study Completion

May 1, 2024

Last Updated

November 7, 2023

Record last verified: 2023-10