Women's Refusal to Participate in a Randomized Trial Involving First-trimester Screening for Pre-eclampsia: Factors Associated With Refusal and Reasons for Acceptance and Refusal

NCT ID: NCT06322771

Last Updated: 2025-09-15

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

COMPLETED

Total Enrollment

472 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-11

Study Completion Date

2024-10-31

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 first-trimester screening for pre-eclampsia. 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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Refusal

A questionnaire will be given to patients who have refused to participate in the RANSPRE trial

Questionnaire

Intervention Type BEHAVIORAL

Questionnaire about refusal

Acceptance

A questionnaire will be given to patients who have agreed to participate in the RANSPRE trial

Questionnaire

Intervention Type BEHAVIORAL

Questionnaire about acceptance

Interventions

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Questionnaire

Questionnaire about acceptance

Intervention Type BEHAVIORAL

Questionnaire

Questionnaire about refusal

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Any pregnant woman is eligible if:

* monofetal pregnancy
* between 11 and 14 weeks
* legal age
* health insurance coverage
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

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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Port-Royal Maternity

Paris, IDF, France

Site Status

Countries

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France

Other Identifiers

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APHP240376

Identifier Type: -

Identifier Source: org_study_id

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