Refusal to Participate in a Randomized Trial Involving Pregnancy and Childbirth: Factors Associated with Refusal and Reasons for Refusal and Acceptance
NCT ID: NCT06612320
Last Updated: 2024-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
720 participants
OBSERVATIONAL
2024-10-31
2025-10-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Acceptance
Women who accept to participate to a Randomized Controlled Trial (RCT)
Questionnaire about acceptance
Questionnaire about acceptance
Refusal
Women who refuse to participate to a Randomized Controlled Trial (RCT)
Questionnaire about refusal
Questionnaire about refusal
Interventions
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Questionnaire about acceptance
Questionnaire about acceptance
Questionnaire about refusal
Questionnaire about refusal
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Yoann Athiel, MD
Role: PRINCIPAL_INVESTIGATOR
Port-Royal Maternity - APHP
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Alexandre Vivanti
Role: backup
Laurent MANDELBROT
Role: backup
Jeanne SIBIUDE
Role: backup
Aude GIRAULT, MD
Role: primary
Other Identifiers
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APHP240778
Identifier Type: -
Identifier Source: org_study_id
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