Influenza and Pertussis Vaccination Status of Women in Immediate Postpartum and Caregivers

NCT ID: NCT05234229

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 254 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-10-30

Brief Summary

Pertussis is a bacterial respiratory infection caused by Bordetella pertussis. Highly contagious, it is potentially serious and even fatal in infants under 6 months of age. The immunity acquired through vaccination is very limited in time, requiring regular booster shots. There is a passive protection of the newborn by the maternal-fetal transmission of maternal antibodies, but it is brief. The infant's first vaccination is given at 2 months of age and immunity is not acquired until the second injection at 4 months of age. The booster at 11 months of age is essential to prolong this immunity.

In order to protect infants under 6 months of age, France has recommended since 2004 the cocooning strategy, which consists of vaccinating people likely to be in close contact with the infant during this period. This vaccination is therefore proposed to adults who are planning to have children, to the entourage of pregnant women, and in the immediate post-partum period for the mother (and people who were not vaccinated during pregnancy). This strategy was put in place following the international recommendation of a forum of scientific experts, the Global Pertussis Initiative.

In France, vaccination against pertussis is not currently recommended during pregnancy. There is no contraindication to vaccination during pregnancy and it is recommended in many countries.

Influenza is a viral respiratory infection caused by Myxovirus influenzae, which is highly contagious.

In France, vaccination against influenza is recommended for pregnant women, regardless of the trimester of pregnancy. It is also recommended for the entourage of infants under 6 months of age with risk factors for severe influenza.

There are few recent data in the scientific literature regarding influenza and pertussis vaccination coverage among pregnant or postpartum women in France. In addition, the COVID19 pandemic has recently reopened the debate on vaccination of the general population and caregivers. Knowing the current status of vaccination coverage among pregnant women and caregivers, their knowledge and fears regarding vaccination could help improve the information provided by healthcare staff.

Conditions

Pertussis/Whooping Cough; Influenza Viral Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

covagrip women in immediate post partum

women in immediate post partum

Survey

Intervention Type: OTHER

Collection of immunization status by questionnaire

Caregivers

health care personnel

Survey

Intervention Type: OTHER

Collection of immunization status by questionnaire

Interventions

Survey

Collection of immunization status by questionnaire

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Person having received complete information about the research and not opposed to the study.
• Hospitalization in the post-partum service and within the last 5 days of delivery.
• women. caregivers

Exclusion Criteria

• Female under 18 years of age,
• Woman under legal protection,
• Delivery of a stillborn child,
• Premature delivery < 35GA,
• Hospitalized newborn,
• Women who doesn't speak french.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Jean-Michel HASCOET

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean Michel HASCOET

Role: STUDY_DIRECTOR

Maternité Régionale Universitaire CHRU NANCY

Locations

Maternite Regionale Universitaire CHRU NANCY

Nancy, Lorraine, France

Countries

France

Other Identifiers

2021PI087

Identifier Type: -

Identifier Source: org_study_id