Not a traditional drug phase: Maternal-fetal interface biopsy and peripheral blood collection in cases group for Preeclampsia
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.
Official registry: https://clinicaltrials.gov/study/NCT06232668 · Carlos Simon Foundation · enrollment listed as 2,084
What this phase means
This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.
They plan to enroll about 2,084 people at 4 sites. Taking part typically means a procedure as part of the study plus check-ins.
Official title (unrewritten)
Molecular Study of the Maternal-fetal Interface Prospectively to the Onset of Preeclampsia Using Single Cell Technology.
Interventions: Maternal-fetal interface biopsy and peripheral blood collection in cases group, Maternal-fetal interface biopsy and peripheral blood collection in control group, Maternal-fetal interface biopsy and peripheral blood collection in cases group, Maternal-fetal interface biopsy and peripheral blood collection in control group
Primary outcome (registry wording): To charactize the molecular profile of the maternal-fetal interface (chorionic billi and decidua) between 9 and 15 weeks of gestation in healthy and preeclamptic pregnancies
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Women only
- Women who meet at least one of the following criteria at the time of inclusion:
- Phase 1 (first trimester): Pregnant women between 9 and 15 weeks of gestation who are scheduled to undergo chorionic villus sampling (CVS) as part of the center's routine clinical practice
- Phase 2 (delivery): Women with an ongoing pregnancy, regardless of gestational age and without the requirement of having participated in Phase 1, who are willing to donate placental and maternal blood samples following delivery
Who the registry excludes
- Women with multiple pregnancy
- Non-evolving pregnancies (including delayed abortion/foetal orbit)
Public study contact (from the registry)
Érika Ortiz, BSc, MSc
clinicalstudies@fundacioncarlossimon.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
4 listed- Hospital General Universitario Dr. Balmis — Alicante, Alicante, Spain (recruiting)
- Hospital Clinico Universitario Virgen de la Arrixaca — Murcia, Murcia, Spain (recruiting)
- Hospital Universitario de Canarias — Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain (recruiting)
- Hospital Universitario y Politécnico La Fe — Valencia, Valencia, Spain (recruiting)
FAQ about this NCT record
Is NCT06232668 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06232668?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06232668?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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