NCT06322771

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 472 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

Summary

The main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving first-trimester screening for pre-eclampsia. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate.

Detailed description

1. Determine the acceptance/refusal rate among all women identified, eligible and offered RCT. 2. Comparison of demographic characteristics between the two groups * Group 1: women accepting to participate in RCT * Group 2: women refusing to participate in RCT 3. Assessment of motivations for acceptance (based on questionnaire given to women who agree to participate) 4. Evaluation of reasons for refusal to participate - obstacles (based on the questionnaire given to women who refuse to participate).

Conditions

• Pregnancy Related

Interventions

Type	Name	Description
BEHAVIORAL	Questionnaire	Questionnaire about acceptance
BEHAVIORAL	Questionnaire	Questionnaire about refusal

Timeline

• Start date: 2024-04-11
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2024-03-21
• Last updated: 2025-09-15

Locations

1 site across 1 country: France