Vaccinate Against Covid-19NCT06968117
Exploration of Pregnant Women's Reluctance Toward COVID-19 Vaccination
An observational study of Vaccinate Against Covid-19 and Reluctance Pregnant Women's, run by Centre Hospitalier de Gonesse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaccinate Against Covid-19, Reluctance Pregnant Women's
- Type of treatment
- Vaccines
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2021to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- The patient is over 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of vaccine hesitancy among pregnant women, assessed through a standardized questionnaire.
Measured: January 2021-April 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Nov 2021
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccinate Against Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Gonesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968117
- Sponsor's protocol ID
- 0025_MATERNITE
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Pregnant Women's Reluctance Toward COVID-19 Vaccination
- ClinicalTrials.gov ID
- NCT06968117
- Acronym / sponsor ID
- 0025_MATERNITE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier de GonesseUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- The patient is over 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The rate of vaccine hesitancy among pregnant women, assessed through a standardized questionnaire.
Time frame: January 2021-April 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccinate Against Covid-19 and Reluctance Pregnant Women's, run by Centre Hospitalier de Gonesse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of vaccine hesitancy among pregnant women, assessed through a standardized questionnaire. (time frame: January 2021-April 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.