NCT06968117

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

May 12, 2025

Last Update Submit

May 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The rate of vaccine hesitancy among pregnant women, assessed through a standardized questionnaire.

    January 2021-April 2023

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • The patient is over 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

France

Gonesse, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2025

First Posted

May 13, 2025

Study Start

November 1, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

May 13, 2025

Record last verified: 2025-05

Locations