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  

Pregnancy Related Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Pregnancy Related

• NCT number: NCT06322771
• Study type: Observational
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Yoann Athiel, MD
• Phone: 06 72 24 08 75
• Email: yoann.athiel@aphp.fr
• Status: Recruiting
• Start date: April 11, 2024
• Completion date: March 2025