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Influenza and Pertussis Vaccination Status of Women in Immediate Postpartum and Caregivers (COVAGRIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05234229
Recruitment Status : Recruiting
First Posted : February 10, 2022
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Jean-Michel HASCOET, Central Hospital, Nancy, France

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.


Condition or disease Intervention/treatment
Pertussis/Whooping Cough Influenza Viral Infections Other: Survey

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influenza and Pertussis Vaccination Status of Women in Immediate Postpartum and Caregivers in the Maternity Hospital of Nancy
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
covagrip women in immediate post partum
women in immediate post partum
Other: Survey
Collection of immunization status by questionnaire

Caregivers
health care personnel
Other: Survey
Collection of immunization status by questionnaire




Primary Outcome Measures :
  1. Prevalence of influenza vaccination [ Time Frame: 4 months ]
    To determine the rate of influenza immunization in immediate postpartum women and caregivers at the Nancy University Maternity Hospital in 2022 .

  2. Prevalence of pertussis vaccination [ Time Frame: 4 months ]
    To determine the rate of pertussis immunization in immediate postpartum and caregivers at the Nancy University Maternity Hospital in 2022


Secondary Outcome Measures :
  1. awareness of own vaccination status [ Time Frame: 4 months ]
    To determine the awareness of own vaccination status (yes; no; unknown) in immediate postpartum women regarding their influenza and pertussis immunization

  2. Knowledge about vaccination [ Time Frame: 4 months ]
    To determine the rate of right answers to a questionnaire about knowledge of influenza and pertussis vaccination, and the possibility of vaccination during pregnancy.

  3. opinion on vaccination during pregnancy [ Time Frame: 4 months ]
    To determine the rate of differences in vaccination coverage and knowledge among postpartum women and healthcare staff.

  4. readiness to receive pertussis and influenzae immunization [ Time Frame: 4 months ]
    to answer the readiness (yes; no; already vaccinated) to receive immunization after answering the questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05234229


Contacts
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Contact: Jean Michel HASCOET, MD +33383342934 j.hascoet@chru-nancy.fr
Contact: Eva GREINER, MD +33383344376 e.greiner@chru-nancy.fr

Locations
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France
Maternite Regionale Universitaire CHRU NANCY Recruiting
Nancy, Lorraine, France, 54035
Contact: Jean-Michel HASCOET, MD    +33 383 342 934      
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Study Director: Jean Michel HASCOET Maternité Régionale Universitaire CHRU NANCY
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Responsible Party: Jean-Michel HASCOET, Professor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT05234229    
Other Study ID Numbers: 2021PI087
First Posted: February 10, 2022    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jean-Michel HASCOET, Central Hospital, Nancy, France:
immunization
cocooning
Additional relevant MeSH terms:
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Influenza, Human
Whooping Cough
Virus Diseases
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses