NCT06232668 Molecular Study of the Maternal-fetal Interface in Preeclampsia.
| NCT ID | NCT06232668 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Carlos Simon Foundation |
| Condition | Preeclampsia |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,084 participants |
| Start Date | 2023-11-20 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,084 participants in total. It began in 2023-11-20 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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).
Contact & Investigator
Tamara Garrido, PhD
PRINCIPAL INVESTIGATOR
Fundación Carlos Simon para la investigación en salud de la mujer
Frequently Asked Questions
Who can join the NCT06232668 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preeclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06232668 currently recruiting?
Yes, NCT06232668 is actively recruiting participants. Contact the research team at cgomez@fundacioncarlossimon.com for enrollment information.
Where is the NCT06232668 trial being conducted?
This trial is being conducted at Alicante, Spain, Madrid, Spain, Murcia, Spain, Santa Cruz de Tenerife, Spain and 1 additional location.
Who is sponsoring the NCT06232668 clinical trial?
NCT06232668 is sponsored by Carlos Simon Foundation. The principal investigator is Tamara Garrido, PhD at Fundación Carlos Simon para la investigación en salud de la mujer. The trial plans to enroll 2,084 participants.