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)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Pregnancy Related

Treatments

Behavioral: Questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT06322771

APHP240376

Details and patient eligibility

About

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.

Full description

Determine the acceptance/refusal rate among all women identified, eligible and offered RCT.
Comparison of demographic characteristics between the two groups
- Group 1: women accepting to participate in RCT
- Group 2: women refusing to participate in RCT
Assessment of motivations for acceptance (based on questionnaire given to women who agree to participate)
Evaluation of reasons for refusal to participate - obstacles (based on the questionnaire given to women who refuse to participate).

Enrollment

472 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.