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

Recruiting

• Conditions: Pregnancy Related
• Interventions: Behavioral: Questionnaire

• Registration Number: NCT06322771
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-14
• Study First Posted: 2024-03-21
• Status Verified: 2024-04
• Study Start: 2024-04-11
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 830

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acceptance	Questionnaire	A questionnaire will be given to patients who have agreed to participate in the RANSPRE trial
Refusal	Questionnaire	A questionnaire will be given to patients who have refused to participate in the RANSPRE trial

Primary Outcome Measures

Name	Time	Method
Factors associated with women's refusal	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.

Secondary Outcome Measures

Name	Time	Method
Questionnaire "refusal"	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.
Number of refusals	Day 1
Demographic characteristics	Day 1
Number of acceptations	Day 1
Questionnaire "acceptance"	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.

Trial Locations

Locations (1)

Port-Royal Maternity; 🇫🇷 Paris, IDF, France