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

Assistance Publique - Hôpitaux de Paris526 enrolled

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.

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 Type

OBSERVATIONAL

Enrollment

526

Conditions

Pregnancy Related

Interventions

Questionnaire about acceptanceBEHAVIORAL

Questionnaire about acceptance

Questionnaire about refusalBEHAVIORAL

Questionnaire about refusal

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Collection of maternal demographic characteristics

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.

Time frame: Day 1

Collection of obstetric characteristics

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.

Time frame: Day 1

Collection of characteristics related to information provided

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.

Time frame: Day 1

Secondary Outcomes

Motivation linked to acceptance

Evaluation of motivation linked to acceptance (based on the questionnaire given to women who agree to participate). No score, it is a qualitative analyse.

Time frame: Day 1

Reason for refusing to participate

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.

Time frame: Day 1

Data from ClinicalTrials.gov

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