Molecular Study of the Maternal-fetal Interface Prospectively to the Onset of Preeclampsia Using Single Cell Technology.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

Preeclampsia (PE) is a major obstetric complication with short- and long-term consequences for the mother and the fetus. Early screening tools to reduce its mortality and morbidity, as well as to prevent the life-threatening consequences are needed. Thus, the detection of women at risk of suffering PE is key to apply preventive and treatment strategies. Recently, the maternal contribution to PE based on defective decidualization that prevents the establishment of a functional maternal-fetal interface has been evidenced. The main objective of this study is to identify molecular markers or aberrant maternal-fetal cell types that can be detected early in the development of the disease in chorionic villi collected during gestational weeks 9 to 14. Chorionic villi will be collected from women who have a recommendation for aneuploidy testing. The remaining fragment will be used for this study.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.

• Women over the age of 18 at the time of signing the informed consent form.

• Pregnant women with a single gestation between weeks 9 and 14 of gestation who will undergo a chorionic villus biopsy according to the centre's usual clinical practice.

Locations
Other Locations
Spain
Hospital Clinico Universitario Virgen de la Arrixaca
RECRUITING
Murcia
Hospital Universitario y Politécnico La Fe
RECRUITING
Valencia
Contact Information
Primary
Carla Gómez, BSc, MSc
cgomez@fundacioncarlossimon.com
+34962938210
Backup
Carlos Simón, MD, PhD
Time Frame
Start Date: 2023-11-20
Estimated Completion Date: 2026-06
Participants
Target number of participants: 2084
Treatments
Cases group
Women recruited between 9 and 14 gestational weeks diagnosed with preeclampsia or other complication at the end of pregnancy.
Control group
Women recruited between 9 and 14 gestational weeks without diagnosis of preeclampsia or other complication at the end of the pregnancy
Related Therapeutic Areas
Sponsors
Leads: Carlos Simon Foundation

This content was sourced from clinicaltrials.gov