Clinical trial NCT05234229: Influenza and Pertussis Vaccination Status of Women in Immediate Postpartum and Caregivers
Official title: Influenza and Pertussis Vaccination Status of Women in Immediate Postpartum and Caregivers in the Maternity Hospital of Nancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pertussis/Whooping Cough
Influenza Viral Infections
Keywords: immunization
cocooning
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 254
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women over 18 years old, delivery after 35GA and healthcare staff of the University Maternity Hospital of Nancy in 2022. Person having received complete information about the research and not opposed to the study.

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.


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.

Primary outcomes:
measure: Prevalence of influenza vaccination
timeFrame: 4 months
measure: Prevalence of pertussis vaccination
timeFrame: 4 months
Secondary outcomes:
measure: awareness of own vaccination status
timeFrame: 4 months
measure: Knowledge about vaccination
timeFrame: 4 months
measure: opinion on vaccination during pregnancy
timeFrame: 4 months
measure: readiness to receive pertussis and influenzae immunization
timeFrame: 4 months
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternite Regionale Universitaire CHRU NANCY
state: Lorraine
Study officials:
affiliation: Maternité Régionale Universitaire CHRU NANCY
name: Jean Michel HASCOET
role: STUDY_DIRECTOR
References: