Understanding why women refuse to participate in a trial for early screening of pre-eclampsia
Women's Refusal to Participate in a Randomized Trial Involving First-trimester Screening for Pre-eclampsia: Factors Associated With Refusal and Reasons for Acceptance and Refusal
This study looks at why some pregnant women choose not to join a trial for early screening of pre-eclampsia to help improve participation in the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 830 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, IDF) |
| Trial ID | NCT06322771 on ClinicalTrials.gov |
What this trial studies
This study aims to identify factors that influence women's decisions to accept or refuse participation in a randomized clinical trial focused on first-trimester screening for pre-eclampsia. It will assess the acceptance and refusal rates among eligible pregnant women and compare demographic characteristics between those who participate and those who do not. Additionally, the study will gather qualitative data through questionnaires to understand the motivations for acceptance and the reasons behind refusals.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women between 11 and 14 weeks of gestation with a monofetal pregnancy.
Not a fit: Patients with a history of pre-eclampsia in previous pregnancies or contraindications to aspirin may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve recruitment strategies for clinical trials, ultimately enhancing the understanding and management of pre-eclampsia.
How similar studies have performed: While this study focuses on refusal factors, similar studies have successfully identified barriers to participation in clinical trials, suggesting that understanding these factors can enhance recruitment efforts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria : Inclusion criteria are the same as for the RANSPRE trial. Any pregnant woman is eligible if: * monofetal pregnancy * between 11 and 14 weeks * legal age * health insurance coverage Exclusion Criteria : Inclusion criteria are the same as for the RANSPRE trial. A history of pre-eclampsia in a previous pregnancy and a contraindication to aspirin are non-inclusion criteria.
Where this trial is running
Paris, IDF
- Port-Royal Maternity — Paris, Idf, France (Recruiting)
Study contacts
- Principal investigator: Yoann Athiel, MD — Port-Royal Maternity - APHP
- Study coordinator: Yoann Athiel, MD
- Email: yoann.athiel@aphp.fr
- Phone: 06 72 24 08 75
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.