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

NCT05234229 | Completed

• 1 other identifier: 2021PI087
• Study Type: observational
• Target: 254
• Locations: 1 country
• Sites: 1

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

Keywords

immunization; cocooning

Outcome Measures

Primary Outcomes (2)

• Prevalence of influenza vaccination

  To determine the rate of influenza immunization in immediate postpartum women and caregivers at the Nancy University Maternity Hospital in 2022 .

  4 months

• Prevalence of pertussis vaccination

  To determine the rate of pertussis immunization in immediate postpartum and caregivers at the Nancy University Maternity Hospital in 2022

  4 months

Secondary Outcomes (4)

• awareness of own vaccination status

  4 months

• Knowledge about vaccination

  4 months

• opinion on vaccination during pregnancy

  4 months

• readiness to receive pertussis and influenzae immunization

  4 months

Study Arms (2)

covagrip women in immediate post partum

women in immediate post partum

Other: Survey

Caregivers

health care personnel

Other: Survey

Interventions

Survey OTHER

Collection of immunization status by questionnaire

Caregivers; covagrip women in immediate post partum

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Maternite Regionale Universitaire CHRU NANCY

Nancy, Lorraine, 54035, France

Location

MeSH Terms

Conditions

Whooping Cough

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jean Michel HASCOET

  Maternité Régionale Universitaire CHRU NANCY

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 10, 2022
• Study Start: March 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: October 30, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)