Factors influencing women's decisions to participate in pregnancy-related clinical trials
Refusal to Participate in a Randomized Trial Involving Pregnancy and Childbirth: Factors Associated with Refusal and Reasons for Refusal and Acceptance
This study looks at why some women choose to join or not join pregnancy-related clinical trials in France to better understand their decisions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 720 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 4 sites (Clamart, IDF and 3 other locations) |
| Trial ID | NCT06612320 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the factors associated with women's refusal to participate in a randomized clinical trial focused on pregnancy and childbirth in France. It will assess the acceptance and refusal rates among eligible women and compare demographic characteristics between those who accept and those who refuse participation. Additionally, the study will evaluate motivations for acceptance and reasons for refusal through questionnaires administered to both groups of women.
Who should consider this trial
Good fit: Ideal candidates for this study are women who have been offered participation in a randomized trial related to their pregnancy or childbirth.
Not a fit: Patients who are not offered participation in any randomized trials related to pregnancy or childbirth will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of barriers to participation in clinical trials, leading to improved recruitment strategies and better representation of pregnant women in research.
How similar studies have performed: While studies on participation factors in clinical trials exist, this specific focus on pregnancy-related trials is less common, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: None
Where this trial is running
Clamart, IDF and 3 other locations
- APHP - Antoine Béclère hospital - Maternity — Clamart, Idf, France (Recruiting)
- APHP - Louis Mourier hospital - Maternity — Colombes, Idf, France (Not_yet_recruiting)
- APHP - Trousseau Hospital - Gynecology-Obstetrics-Maternity — Paris, Idf, France (Not_yet_recruiting)
- APHP - Port-Royal Maternity — Paris, Idf, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Yoann Athiel, MD — Port-Royal Maternity - APHP
- Study coordinator: Yoann ATHIEL, MD
- Email: yoann.athiel@aphp.fr
- Phone: 0158414363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.