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 (RANSPRE-refus)

September 8, 2025 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  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 (Actual)

472

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • IDF
      • Paris, IDF, France, 75014
        • Port-Royal Maternity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Women identified and eligible to participate in the RANSPRE trial within the Port-Royal maternity ward and having their T1 ultrasound scan within the maternity ward will be included.

Description

Inclusion Criteria :

Inclusion criteria are the same as for the RANSPRE trial.

Any pregnant woman is eligible if:

  • monofetal pregnancy
  • between 11 and 14 weeks
  • legal age
  • health insurance coverage

Exclusion Criteria :

Inclusion criteria are the same as for the RANSPRE trial. A history of pre-eclampsia in a previous pregnancy and a contraindication to aspirin are non-inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Refusal
A questionnaire will be given to patients who have refused to participate in the RANSPRE trial
Behavioral: Questionnaire
Questionnaire about acceptance
Behavioral: Questionnaire
Questionnaire about refusal
Acceptance
A questionnaire will be given to patients who have agreed to participate in the RANSPRE trial
Behavioral: Questionnaire
Questionnaire about acceptance
Behavioral: Questionnaire
Questionnaire about refusal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors associated with women's refusal
Time Frame: Day 1
The primary objective is to assess whether there are factors associated with women's refusal to participate in the RANSPRE randomized clinical trial.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic characteristics
Time Frame: Day 1
Day 1
Number of acceptations
Time Frame: Day 1
Day 1
Number of refusals
Time Frame: Day 1
Day 1
Questionnaire "acceptance"
Time Frame: Day 1

Evaluation of motivations linked to acceptance (based on the questionnaire given to women who agree to participate)

The secondary objective is to qualitatively assess the reasons for acceptance of participation.
Day 1
Questionnaire "refusal"
Time Frame: Day 1

Evaluation of the reasons for refusing to participate - obstacles (based on the questionnaire given to women who refuse to participate).

The secondary objective is to qualitatively assess the reasons for refusal of participation.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC Necker Cochin, France

Investigators

  • Principal Investigator: Yoann Athiel, MD, Port-Royal Maternity - APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2024

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP240376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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