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
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 14, 2024
Trial Information
Current as of August 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking to understand why some women choose not to participate in a study that screens for pre-eclampsia during the first trimester of pregnancy. Pre-eclampsia is a condition that can cause high blood pressure and other health issues during pregnancy, and early screening can help manage these risks. The researchers want to find out what factors influence women's decisions to join or refuse to join the trial, as well as the reasons behind their choices.
To be eligible for this trial, women must be pregnant with one baby, be between 11 and 14 weeks along, be of legal age, and have health insurance coverage. Women who have had pre-eclampsia in a previous pregnancy or have certain health issues that prevent them from taking aspirin cannot participate. Those who join the study will be screened for pre-eclampsia and will help researchers gather important information that could improve care for future pregnancies.
Gender
FEMALE
Eligibility 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.
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, Idf, France
Patients applied
Trial Officials
Yoann Athiel, MD
Principal Investigator
Port-Royal Maternity - APHP
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported