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

Recruiting

• Conditions: Pregnancy Related
• Interventions: Behavioral: Questionnaire about refusal; Behavioral: Questionnaire about acceptance

• Registration Number: NCT06612320
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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).

Study Timeline

• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-24
• Study First Posted: 2024-09-25
• Study Start: 2024-10-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 720

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.

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Exclusion Criteria

None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Refusal	Questionnaire about refusal	Women who refuse to participate to a Randomized Controlled Trial (RCT)
Acceptance	Questionnaire about acceptance	Women who accept to participate to a Randomized Controlled Trial (RCT)

Primary Outcome Measures

Name	Time	Method
Collection of maternal demographic characteristics	Day 1	Age, level of education, profession, geographic origin, health insurance/mutual, marital status The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials.; No score, it is a qualitative analyse.
Collection of obstetric characteristics	Day 1	Parity, obstetric history (first-trimester pregnancy loss, IUFD, perinatal death), pregnancy complications, gestational age... The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials.; No score, it is a qualitative analyse.
Collection of characteristics related to information provided	Day 1	By whom? , with whom? (impact of the companion), when? The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials.; No score, it is a qualitative analyse.

Secondary Outcome Measures

Name	Time	Method
Motivation linked to acceptance	Day 1	Evaluation of motivation linked to acceptance (based on the questionnaire given to women who agree to participate).; No score, it is a qualitative analyse.
Reason for refusing to participate	Day 1	Evaluation of the reason for refusing to participate (based on the questionnaire given to women who refuse to participate); No score, it is a qualitative analyse.

Trial Locations

Locations (4)

APHP - Antoine Béclère hospital - Maternity; 🇫🇷 Clamart, IDF, France

APHP - Louis Mourier hospital - Maternity; 🇫🇷 Colombes, IDF, France

APHP - Trousseau Hospital - Gynecology-Obstetrics-Maternity; 🇫🇷 Paris, IDF, France

APHP - Port-Royal Maternity; 🇫🇷 Paris, IDF, France