Refusal to Participate in a Randomized Trial Involving Pregnancy and Childbirth: Factors Associated With Refusal and Reasons for Refusal and Acceptance (REFWIT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- Determine the acceptance/refusal rate among all women identified, eligible and offered RCT.
Comparison of demographic characteristics between the two groups
- Group 1: women accepting to participate in RCT
- Group 2: women refusing to participate in RCT
- Assessment of motivations for acceptance (based on questionnaire given to women who agree to participate)
- Evaluation of reasons for refusal to participate - obstacles (based on the questionnaire given to women who refuse to participate).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
IDF
-
Clamart, IDF, France, 92140
- APHP - Antoine Béclère hospital - Maternity
-
Colombes, IDF, France, 92700
- APHP - Louis Mourier hospital - Maternity
-
Paris, IDF, France, 75010
- APHP - Trousseau Hospital - Gynecology-Obstetrics-Maternity
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Paris, IDF, France, 75014
- APHP - Port-Royal Maternity
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Acceptance
Women who accept to participate to a Randomized Controlled Trial (RCT)
|
Questionnaire about acceptance
|
|
Refusal
Women who refuse to participate to a Randomized Controlled Trial (RCT)
|
Questionnaire about refusal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Collection of maternal demographic characteristics
Time Frame: 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. |
Day 1
|
|
Collection of obstetric characteristics
Time Frame: 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. |
Day 1
|
|
Collection of characteristics related to information provided
Time Frame: 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. |
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motivation linked to acceptance
Time Frame: 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. |
Day 1
|
|
Reason for refusing to participate
Time Frame: 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. |
Day 1
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yoann Athiel, MD, Port-Royal Maternity - APHP
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP240778
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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