NCT06716242 Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters
| NCT ID | NCT06716242 |
| Status | Recruiting |
| Phase | — |
| Sponsor | iPremom |
| Condition | Preeclampsia (PE) |
| Study Type | OBSERVATIONAL |
| Enrollment | 7,473 participants |
| Start Date | 2024-12-02 |
| Primary Completion | 2027-02 |
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 7,473 participants in total. It began in 2024-12-02 with a primary completion date of 2027-02.
⚠ 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 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.
Eligibility 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.
Contact & Investigator
Carlos Simón, MD, PhD
PRINCIPAL INVESTIGATOR
Carlos Simon Foundation
Frequently Asked Questions
Who can join the NCT06716242 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preeclampsia (PE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06716242 currently recruiting?
Yes, NCT06716242 is actively recruiting participants. Contact the research team at clinicalstudies@ipremom.com for enrollment information.
Where is the NCT06716242 trial being conducted?
This trial is being conducted at Alicante, Spain, Barcelona, Spain, Vinaròs, Spain, Cadiz, Spain and 7 additional locations.
Who is sponsoring the NCT06716242 clinical trial?
NCT06716242 is sponsored by iPremom. The principal investigator is Carlos Simón, MD, PhD at Carlos Simon Foundation. The trial plans to enroll 7,473 participants.