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Clinical Trials in Spain / NCT06232668
Recruiting Observational

Molecular Study of the Maternal-fetal Interface in Preeclampsia.

NCT06232668 · tracked via the Priya Life Science Spain tracker
Sponsor
Carlos Simon Foundation
Phase
Observational
Started
2023-11-20
Last updated
2026-10-06

Condition(s) studied

Preeclampsia

Investigational drug(s) / intervention(s)

Maternal-fetal interface biopsy and peripheral blood collection in cases groupMaternal-fetal interface biopsy and peripheral blood collection in control group

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.

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.

Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • To charactize the molecular profile of the maternal-fetal interface between 9 and 15 weeks of gestation in healthy and preeclamptic pregnancies — From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks
    Differentially expressed genes between control vs preeclampsia group at the level of cell types/subtypes

Trial sites (4)

FacilityCityRegionStatus
Hospital General Universitario Dr. Balmis Alicante Alicante Recruiting
Hospital Clinico Universitario Virgen de la Arrixaca Murcia Murcia Recruiting
Hospital Universitario de Canarias Santa Cruz de Tenerife Santa Cruz de Tenerife Recruiting
Hospital Universitario y Politécnico La Fe Valencia Valencia Recruiting

Other trials for the same condition

Association of Assisted Reproductive Technologies Parameters With the Perinatal Outcome Recruiting
NOPE37: Angiogenic Factors for Managing Term Preeclampsia Recruiting
Study of Maternal and Fetal Cardiovascular Function in Hypertensive States of Pregnancy Recruiting
sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term. Recruiting
Optimizing the Use of Aspirin for the Prevention of Preeclampsia Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06232668 on ClinicalTrials.gov ↗ ← All trials in Spain