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RECRUITINGOBSERVATIONAL

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.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - Patients whose written willing to sign a consent form 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 willing to sign a consent form 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. Who Should NOT Join This Trial: - Women with multiple pregnancy. - Non-evolving pregnancies (including delayed abortion/foetal orbit). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

PROCEDURE

Maternal-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.

PROCEDURE

Maternal-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