Validation of a blood test for early detection of preeclampsia in pregnant women
Prospective, Observational, Multicentre Study to Confirm the Performance of Molecular Screening for Early Detection of Preeclampsia
This study is testing a new blood test to see if it can help pregnant women find out early if they might develop preeclampsia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 7473 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | iPremom Industry-sponsored |
| Locations | 11 sites (Alicante, Alicante and 10 other locations) |
| Trial ID | NCT06716242 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the MaiRa Preeclampsia Test, a molecular screening tool designed to predict early-onset and late-onset preeclampsia during the first and second trimesters of pregnancy. The study will involve 7,473 pregnant women from 12 tertiary hospitals in Spain, who will provide blood samples at various stages of their pregnancy. The test's diagnostic accuracy will be evaluated by comparing results against obstetric outcomes, with a focus on improving early detection and intervention strategies for preeclampsia.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older with single gestation pregnancies who can provide a blood sample between 9 and 14 weeks of gestation.
Not a fit: Patients with active neoplasms, a history of organ or bone marrow transplantation, or severe uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this test could significantly enhance early detection of preeclampsia, leading to timely interventions that improve maternal and fetal outcomes.
How similar studies have performed: Previous studies, such as the PREMOM study, have shown promise in using cell-free RNA analysis for early prediction of preeclampsia, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent approved by the Ethics Committee. * Women ≥18 years of age at consent. * Single gestation pregnancies with first sample collection (T1) possible between 9 and 14 weeks' gestation. Exclusion Criteria: * Active neoplasm. * History of organ or bone marrow transplantation. * Maternal transfusion within 8 weeks before sample collection. * Evidence of early pregnancy loss at consent. * Severe, uncontrolled infections. * Other investigator-assessed risks that could compromise participation or data quality.
Where this trial is running
Alicante, Alicante and 10 other locations
- Hospital General Universitario Dr. Balmis — Alicante, Alicante, Spain (Recruiting)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Barcelona, Spain (Not_yet_recruiting)
- Hospital Comarcal de Vinaròs — Vinaròs, Castellón, Spain (Recruiting)
- Hospital Universitario Puerta del Mar — Cadiz, Cádiz, Spain (Recruiting)
- Hospital Universitario A Coruña — A Coruña, La Coruña, Spain (Recruiting)
- Hospital Universitario de Torrejón — Torrejón de Ardoz, Madrid, Spain (Recruiting)
- Hospital Clínico Universitario Virgen de la Arrixaca — El Palmar, Murcia, Spain (Recruiting)
- Hospital Universitario de Canarias — San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain (Recruiting)
- Hospital de Manises — Manises, Valencia, Spain (Recruiting)
- Hospital Universitario Doctor Peset — Valencia, Valencia, Spain (Recruiting)
- Hospital Universitario y Politécnico La Fe — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Carlos Simón, MD, PhD — Carlos Simon Foundation
- Study coordinator: Clinical Studies Department
- Email: clinicalstudies@ipremom.com
- Phone: +34 636 260 481
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.