- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06968117
- Original Trial
Exploration of Pregnant Women's Reluctance Toward COVID-19 Vaccination
May 12, 2025 updated by: Centre Hospitalier de Gonesse
This study aims to explore the reasons behind the reluctance of pregnant women to get vaccinated against COVID-19.
With the ongoing pandemic, it has become essential to understand the concerns that women have regarding the COVID-19 vaccine, especially during pregnancy.
Pregnant women are at a higher risk of severe complications from COVID-19, including premature birth, preeclampsia, and the need for intensive care.The goal of this research is to identify the barriers that prevent pregnant women from getting vaccinated, whether they are based on fears, misconceptions, or a lack of information.
By understanding these concerns, healthcare providers can have better conversations with their patients and provide accurate, evidence-based information to help them make informed decisions about their health and the health of their unborn child.Through interviews and visual methods, the study seeks to gather valuable insights into the emotional and psychological aspects of vaccine hesitancy among pregnant women.
These findings will help develop a tool to assist healthcare providers in addressing vaccine hesitancy effectively, ensuring that women are given all the necessary information to make the best decision for their health and the well-being of their baby.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Gonesse, France
- France
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
The study participants will be selected from pregnant women attending pregnancy follow-up consultations, those who have visited the Gynecology-Obstetrics emergency department for any reason, and those hospitalized in the diabetes or high-risk pregnancy (GHR) departments or in postpartum care services.
Participants must be over 18 years old and able to provide informed consent.
Description
Inclusion Criteria:
- During pregnancy follow-up consultations,
- Following their visit to the Gynecology-Obstetrics emergency department, regardless of the reason,
- Hospitalized in the diabetology department or in the high-risk pregnancy (HRP) or postpartum care department.
Exclusion Criteria:
- The patient is over 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Pregnant women participating in the study on COVID-19 vaccination hesitancy.
This group consists of pregnant women, recruited during prenatal consultations, hospital admissions, or visits to obstetric emergencies.
The aim is to explore their perceptions and hesitations regarding COVID-19 vaccination.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The rate of vaccine hesitancy among pregnant women, assessed through a standardized questionnaire.
Time Frame: January 2021-April 2023
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January 2021-April 2023
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2021
Primary Completion (Actual)
January 1, 2023
Study Completion (Actual)
January 1, 2023
Study Registration Dates
First Submitted
May 12, 2025
First Submitted That Met QC Criteria
May 12, 2025
First Posted (Actual)
May 13, 2025
Study Record Updates
Last Update Posted (Actual)
May 13, 2025
Last Update Submitted That Met QC Criteria
May 12, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0025_MATERNITE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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