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)

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: Pregnancy Related
• Intervention / Treatment: Behavioral: Questionnaire; Behavioral: Questionnaire

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	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		Day 1
Number of acceptations		Day 1
Number of refusals		Day 1
Questionnaire "acceptance"	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"	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

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC Necker Cochin, France
• Investigators: Principal Investigator: Yoann Athiel, MD, Port-Royal Maternity - APHP

Study record dates

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: Pregnancy; Clinical trial; Pre-eclampsia; Factors; Refusal; Reasons
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Behavior; Treatment Adherence and Compliance; Health Behavior; Pre-Eclampsia; Treatment Refusal; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• 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