Molecular analysis of the maternal-fetal interface in preeclampsia
Molecular Study of the Maternal-fetal Interface Prospectively to the Onset of Preeclampsia Using Single Cell Technology.
This study is trying to find specific markers in early pregnancy that could help identify women at risk for preeclampsia, using samples from those undergoing routine testing.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2084 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Carlos Simon Foundation Academic / other |
| Locations | 5 sites (Alicante, Alicante and 4 other locations) |
| Trial ID | NCT06232668 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify molecular markers and aberrant cell types at the maternal-fetal interface during early pregnancy in women at risk for preeclampsia. By collecting chorionic villi samples from pregnant women undergoing aneuploidy testing between 9 and 14 weeks of gestation, the study will utilize single-cell sequencing technology to analyze the molecular profiles associated with preeclampsia. The goal is to characterize the early development of preeclampsia and improve early detection and prevention strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over the age of 18 who are between 9 and 14 weeks of gestation and are undergoing chorionic villus biopsy due to a risk of fetal chromosomal abnormalities.
Not a fit: Patients with multiple pregnancies or non-evolving pregnancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early identification and intervention for women at risk of developing preeclampsia, potentially reducing maternal and fetal morbidity and mortality.
How similar studies have performed: While the approach of using single-cell sequencing for early detection of preeclampsia is innovative, similar studies have shown promise in identifying biomarkers for other obstetric complications.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Alicante, Alicante and 4 other locations
- Hospital General Universitario Dr. Balmis — Alicante, Alicante, Spain (Recruiting)
- Hospital Universitario de Torrejón — Madrid, Madrid, Spain (Not_yet_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)
Study contacts
- Principal investigator: Tamara Garrido, PhD — Fundación Carlos Simon para la investigación en salud de la mujer
- Study coordinator: Carla Gómez, BSc, MSc
- Email: cgomez@fundacioncarlossimon.com
- Phone: +34962938210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.