Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Recruiting · NCT06232668 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 maternal-fetal interface tissue (chorionic villi + decidua) collected during gestational weeks 9 to 15. Maternal-fetal interface biopsy will be collected from women who have a recommendation for aneuploidy testing. The remaining fragment will be used for this study.
Who can take part
Inclusion criteria
- 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 15 of gestation who will undergo a chorionic villus biopsy according to the centre's usual clinical practice.
Exclusion criteria
- Women with multiple pregnancy.
- Non-evolving pregnancies (including delayed abortion/foetal orbit).
Where it is running
5 locations listed.
- Hospital General Universitario Dr. Balmis - Alicante, Alicante, Spain
- Hospital Universitario de Torrejón - Madrid, Madrid, Spain
- Hospital Clinico Universitario Virgen de la Arrixaca - Murcia, Murcia, Spain
- Hospital Universitario de Canarias - Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain
- Hospital Universitario y Politécnico La Fe - Valencia, Valencia, Spain