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Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters

NCT06716242 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 7473

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Preeclampsia (PE)

Interventions

PROCEDURE

Peripheral blood collection

Maternal peripheral blood will be collected 3 times during pregnancy (1st, 2nd and 3rd trimester) and clinical data will also be compiled.

Sponsors & Collaborators

  • iPremom

    lead INDUSTRY

Principal Investigators

  • Carlos Simón, MD, PhD · Carlos Simon Foundation

  • Tamara Garrido, PhD · iPremom

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-02
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06716242 on ClinicalTrials.gov