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

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

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.

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).

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