NCT06612320

Refusal to Participate in a Randomized Trial Involving Pregnancy and Childbirth: Factors Associated With Refusal and Reasons for Refusal and Acceptance

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 526 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 about acceptance	Questionnaire about acceptance
BEHAVIORAL	Questionnaire about refusal	Questionnaire about refusal

Timeline

• Start date: 2024-10-31
• Primary completion: 2025-10-28
• Completion: 2025-10-28
• First posted: 2024-09-25
• Last updated: 2026-04-08

Locations

4 sites across 1 country: France