Pregnancy RelatedREFWITNCT06612320
Refusal to Participate in a Randomized Trial Involving Pregnancy and Childbirth: Factors Associated With Refusal and Reasons for Refusal and Acceptance
An observational study of Pregnancy Related, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
The main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving pregnancy and childbirth in France. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Questionnaire about acceptance and Questionnaire about refusal
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 526 participants
- Where
- 4 sitesFrance
- Study dates
- 31 Oct 2024to 28 Oct 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study will be offered to all women who have been offered to participate in a randomized trial relating to their pregnancy and/or childbirth in participating services.
Who may be able to join
- The study will be offered to all women who have been offered to participate in a randomized trial relating to their pregnancy and/or childbirth in participating services.
Who cannot join
- None
Trial locations and contacts
4 sites in 1 country.
France4 sites
APHP - Antoine Béclère hospital - Maternity
Clamart, IDF, 92140
APHP - Louis Mourier hospital - Maternity
Colombes, IDF, 92700
APHP - Trousseau Hospital - Gynecology-Obstetrics-Maternity
Paris, IDF, 75010
APHP - Port-Royal Maternity
Paris, IDF, 75014
About this study
The main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving pregnancy and childbirth in France. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate.
Read the detailed description
- Determine the acceptance/refusal rate among all women identified, eligible and offered RCT.
- Comparison of demographic characteristics between the two groups
- Group 1: women accepting to participate in RCT
- Group 2: women refusing to participate in RCT
- Assessment of motivations for acceptance (based on questionnaire given to women who agree to participate)
- Evaluation of reasons for refusal to participate - obstacles (based on the questionnaire given to women who refuse to participate).
- Conditions
- Pregnancy Related
- Being tested
- Questionnaire about acceptance, Questionnaire about refusal
- Keywords
- Refusal, clinical trial, factors, reasons, pregnancy, pre-eclampsia
- Medical subject headings
- Treatment Refusal, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire about acceptanceBehavioural
Questionnaire about acceptance
Questionnaire about refusalBehavioural
Questionnaire about refusal
| Study group | Role | What they receive |
|---|---|---|
| Acceptance | Women who accept to participate to a Randomized Controlled Trial (RCT) Receives: Behavioral: Questionnaire about acceptance | |
| Refusal | Women who refuse to participate to a Randomized Controlled Trial (RCT) Receives: Behavioral: Questionnaire about refusal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of maternal demographic characteristics
Age, level of education, profession, geographic origin, health insurance/mutual, marital status The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials.
No score, it is a qualitative analyse.
Measured: Day 1
Collection of obstetric characteristics
Parity, obstetric history (first-trimester pregnancy loss, IUFD, perinatal death), pregnancy complications, gestational age… The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials.
No score, it is a qualitative analyse.
Measured: Day 1
Collection of characteristics related to information provided
By whom? , with whom? (impact of the companion), when? The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials.
No score, it is a qualitative analyse.
Measured: Day 1
Secondary outcomes (2)
Motivation linked to acceptance
Evaluation of motivation linked to acceptance (based on the questionnaire given to women who agree to participate).
No score, it is a qualitative analyse.
Measured: Day 1
Reason for refusing to participate
Evaluation of the reason for refusing to participate (based on the questionnaire given to women who refuse to participate)
No score, it is a qualitative analyse.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start31 Oct 2024
- Primary completion28 Oct 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Yoann Athiel, MD, Principal investigator, Port-Royal Maternity - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612320
- Sponsor's protocol ID
- APHP240778
- Acronym
- REFWIT
- Status last verified
- Apr 2026
- First submitted
- 6 Sep 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refusal to Participate in a Randomized Trial Involving Pregnancy and Childbirth: Factors Associated With Refusal and Reasons for Refusal and Acceptance
- ClinicalTrials.gov ID
- NCT06612320
- Acronym / sponsor ID
- REFWIT / APHP240778
- Conditions
- Pregnancy Related
- Keywords
- Refusal, clinical trial, factors, reasons, pregnancy, pre-eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 526 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 25 Sep 2024 (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.
The main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving pregnancy and childbirth in France. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate.
Detailed description
- Determine the acceptance/refusal rate among all women identified, eligible and offered RCT.
- Comparison of demographic characteristics between the two groups
- Group 1: women accepting to participate in RCT
- Group 2: women refusing to participate in RCT
- Assessment of motivations for acceptance (based on questionnaire given to women who agree to participate)
- Evaluation of reasons for refusal to participate - obstacles (based on the questionnaire given to women who refuse to participate).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance | – | Behavioral: Questionnaire about acceptanceWomen who accept to participate to a Randomized Controlled Trial (RCT) |
| Refusal | – | Behavioral: Questionnaire about refusalWomen who refuse to participate to a Randomized Controlled Trial (RCT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be offered to all women who have been offered to participate in a randomized trial relating to their pregnancy and/or childbirth in participating services.
Key inclusion criteria (1 listed)
- The study will be offered to all women who have been offered to participate in a randomized trial relating to their pregnancy and/or childbirth in participating services.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire about acceptanceQuestionnaire about acceptance | Behavioural | Acceptance |
| Questionnaire about refusalQuestionnaire about refusal | Behavioural | Refusal |
Primary outcome
Collection of maternal demographic characteristics
Time frame: Day 1
Age, level of education, profession, geographic origin, health insurance/mutual, marital status The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials. No score, it is a qualitative analyse.
Collection of obstetric characteristics
Time frame: Day 1
Parity, obstetric history (first-trimester pregnancy loss, IUFD, perinatal death), pregnancy complications, gestational age… The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials. No score, it is a qualitative analyse.
Collection of characteristics related to information provided
Time frame: Day 1
By whom? , with whom? (impact of the companion), when? The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials. No score, it is a qualitative analyse.
2 secondary outcomes
Motivation linked to acceptance
Time frame: Day 1
Reason for refusing to participate
Time frame: Day 1
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 8 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Yoann Athiel, MD principal investigator
Port-Royal Maternity - APHP
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Assistance Publique - Hôpitaux de Paris at 4 sites 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 1 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 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Collection of maternal demographic characteristics (time frame: Day 1). The study lists 3 primary outcomes in all. 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 8 Apr 2026.