RecruitingNCT06232668

Molecular Study of the Maternal-fetal Interface in Preeclampsia.

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


Sponsor

Carlos Simon Foundation

Enrollment

2,084 participants

Start Date

Nov 20, 2023

Study Type

OBSERVATIONAL

Conditions

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 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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This research study is investigating the biology of the placenta (the organ connecting mother and baby) in pregnancies affected by preeclampsia — a serious condition involving high blood pressure during pregnancy. The goal is to better understand what causes it. **You may be eligible if...** - You are over 18 years old - You are pregnant with a single baby, between 9 and 15 weeks of pregnancy - You are already scheduled to have a chorionic villus biopsy (a routine prenatal test) as part of your care **You may NOT be eligible if...** - You are carrying twins or more - Your pregnancy is not progressing normally (e.g., miscarriage or foetal death) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREMaternal-fetal interface biopsy and peripheral blood collection in cases group

Maternal-fetal interface tissue (chorionic villi and decidua) will be collected from women who have a recommendation for aneuploidy testing, and the remaining fragment will be used for this study and peripheral blood collection in cases group. Clinical data will be compiled.

PROCEDUREMaternal-fetal interface biopsy and peripheral blood collection in control group

Maternal-fetal interface tissue (chorionic villi and decidua) will be collected from women who have a recommendation for aneuploidy testing, and the remaining fragment will be used for this study and peripheral blood collection in control group. Clinical data will be compiled.


Locations(5)

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

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NCT06232668


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