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

Recruitingn/aAges 18 Years - anyFemaleiPremom
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In plain words

What the trial is, and whether it could suit you

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 pre

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Peripheral blood collection
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Where

11 sites
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Comarcal de Vinaròs
Vinaròs, Spain
Hospital Universitario Puerta del Mar
Cadiz, Spain
Hospital Universitario A Coruña
A Coruña, Spain
Hospital Universitario de Torrejón
Torrejón de Ardoz, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Spain

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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