Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters
Recruiting · NCT06716242 · Observational (researchers observe without assigning treatment) · Lead sponsor: iPremom
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Preeclampsia (PE) is a major obstetric complication with severe short- and long-term consequences for both mother and fetus. Early detection is critical to mitigate PE-related morbidity and mortality. Effective screening tools are needed to identify women at risk, enabling timely preventive and therapeutic interventions. Current screening methods primarily target placental biomarkers like sFLT1 and PlGF, which are limited to short-term predictions near symptom onset. Existing first-trimester assessments that incorporate maternal factors and Doppler metrics remain constrained by low sensitivity (\<41%) in compliance with NICE and ACOG guidelines. Recent advancements in cell free RNA (cf-RNA) analysis have revealed potential in first-trimester PE prediction. Findings from the PREMOM study (NCT04990141) established a molecular profile for early-onset preeclampsia (EOPE) and late-onset preeclampsia (LOPE) through cfRNA analysis, culminating in the development of the MaiRa Preeclampsia Test (Maternal Advanced and Innovative Preeclampsia Risk Assessment), which demonstrated high predictive performance for first- and second-trimester screening. The current study hypothesizes that the MaiRa Preeclampsia Test is generalizable, maintaining its predictive accuracy in an independent cohort.
Who can take part
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 it is running
11 locations listed.
- Hospital General Universitario Dr. Balmis - Alicante, Alicante, Spain
- Hospital de la Santa Creu i Sant Pau - Barcelona, Barcelona, Spain
- Hospital Comarcal de Vinaròs - Vinaròs, Castellón, Spain
- Hospital Universitario Puerta del Mar - Cadiz, Cádiz, Spain
- Hospital Universitario A Coruña - A Coruña, La Coruña, Spain
- Hospital Universitario de Torrejón - Torrejón de Ardoz, Madrid, Spain
- Hospital Clínico Universitario Virgen de la Arrixaca - El Palmar, Murcia, Spain
- Hospital Universitario de Canarias - San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
- Hospital de Manises - Manises, Valencia, Spain
- Hospital Universitario Doctor Peset - Valencia, Valencia, Spain
- Hospital Universitario y Politécnico La Fe - Valencia, Valencia, Spain