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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

Recruiting
18 years and older
Female
Phase N/A
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  • Simplified (AI rewritten)

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Overview

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.

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).

Eligibility

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

Study details
    Pregnancy Related

NCT06612320

Assistance Publique - Hôpitaux de Paris

21 October 2025

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