Refusal to Participate in a Randomized Trial Involving Pregnancy and Childbirth: Factors Associated with Refusal and Reasons for Refusal and Acceptance (REFWIT)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Pregnancy Related

Treatments: Behavioral: Questionnaire about refusal; Behavioral: Questionnaire about acceptance

Study type: Observational

Funder types: Other

Identifiers

NCT06612320

APHP240778

Details and patient eligibility

About

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.

Full 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).

Enrollment: 720 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

720 participants in 2 patient groups

Acceptance

Description:

Women who accept to participate to a Randomized Controlled Trial (RCT)

Treatment:

Behavioral: Questionnaire about acceptance

Refusal

Description:

Women who refuse to participate to a Randomized Controlled Trial (RCT)

Treatment:

Behavioral: Questionnaire about refusal