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

Pregnancy Related Clinical Trial

— RANSPRE-refus  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06322771
• Other study ID #: APHP240376
• Status: Recruiting
• Start date: April 11, 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Yoann Athiel, MD
• Phone: 06 72 24 08 75
• Email: yoann.athiel[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 830
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Pregnancy Related

Intervention

Behavioral:
• Questionnaire
Questionnaire about acceptance
• Questionnaire
Questionnaire about refusal

Locations

Country	Name	City	State
France	Port-Royal Maternity	Paris	IDF

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of acceptations		Day 1
Secondary	Number of refusals		Day 1
Secondary	Demographic characteristics		Day 1
Secondary	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
Secondary	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