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

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

720 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-10-31

Brief Summary

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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

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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).

Conditions

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Pregnancy Related

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acceptance

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

Questionnaire about acceptance

Intervention Type BEHAVIORAL

Questionnaire about acceptance

Refusal

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

Questionnaire about refusal

Intervention Type BEHAVIORAL

Questionnaire about refusal

Interventions

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Questionnaire about acceptance

Questionnaire about acceptance

Intervention Type BEHAVIORAL

Questionnaire about refusal

Questionnaire about refusal

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

APHP - Louis Mourier hospital - Maternity

Colombes, IDF, France

Site Status NOT_YET_RECRUITING

APHP - Trousseau Hospital - Gynecology-Obstetrics-Maternity

Paris, IDF, France

Site Status NOT_YET_RECRUITING

APHP - Port-Royal Maternity

Paris, IDF, France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Yoann ATHIEL, MD

Role: CONTACT

0158414363

Marie Benhammani-Godard

Role: CONTACT

0158411190

Facility Contacts

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Alexandre Vivanti, MD

Role: primary

Alexandre Vivanti

Role: backup

Laurent MANDELBROT, MD, PhD

Role: primary

Laurent MANDELBROT

Role: backup

Jeanne SIBIUDE, MD

Role: primary

Jeanne SIBIUDE

Role: backup

Aude GIRAULT, MD

Role: primary

Yoann ATHIEL, MD

Role: backup

Other Identifiers

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APHP240778

Identifier Type: -

Identifier Source: org_study_id

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