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

Last updated: May 13, 2026
Sponsor: iPremom
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Peripheral blood collection

Clinical Study ID

NCT06716242
IPR-IPR-TG-24-01
  • Ages > 18
  • Female

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.

Eligibility Criteria

Inclusion

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 9and 14 weeks' gestation.

Exclusion

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 dataquality.

Study Design

Total Participants: 7473
Treatment Group(s): 1
Primary Treatment: Peripheral blood collection
Phase:
Study Start date:
December 02, 2024
Estimated Completion Date:
February 28, 2027

Study Description

This multicentre, prospective observational study aims to validate the MaiRa Preeclampsia Test, a molecular screening tool for predicting early-onset preeclampsia (EOPE) and late-onset preeclampsia (LOPE) in the first and second trimesters of pregnancy. The study will evaluate its diagnostic accuracy, including sensitivity, specificity, predictive values, and area under the curve (AUC).

Study Design:

Duration: 40 months

  • Recruitment and Sample Collection: 28 months

  • Sample Analysis: 32 months

  • Follow-Up: 8 months

  • Statistical Analysis and Publication: 6 months Participants: 7,473 pregnant women from 12 tertiary hospitals in Spain.

Visits:

  • Visit 1 (T1): 9-14 weeks' gestation (first blood sample)

  • Visit 2 (T2): 15-26 weeks' gestation (second blood sample)

  • Visit 3 (T3): ≥27 weeks' gestation (third blood sample)

Blood samples will be analyzed using the MaiRa Preeclampsia Test, with results correlated against obstetric outcomes as the gold standard. Data will be documented in an electronic Case Report Form (eCRF). Quality assurance will be maintained via continuous data monitoring and verification.

Connect with a study center

  • Hospital General Universitario Dr. Balmis

    Alicante, Alicante 03010
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona 08025
    Spain

    Active - Recruiting

  • Hospital Comarcal de Vinaròs

    Vinaroz, Castellón 12500
    Spain

    Site Not Available

  • Hospital Comarcal de Vinaròs

    Vinaròs, Castellón 12500
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta del Mar

    Cadiz, Cádiz 11009
    Spain

    Active - Recruiting

  • Hospital Universitario A Coruña

    A Coruña, La Coruña 15006
    Spain

    Active - Recruiting

  • Hospital Universitario de Torrejón

    Torrejón de Ardoz, Madrid 28850
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia 30120
    Spain

    Active - Recruiting

  • Hospital Universitario de Canarias

    La Laguna, Santa Cruz de Tenerife 38320
    Spain

    Site Not Available

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa Cruz de Tenerife 38320
    Spain

    Active - Recruiting

  • Hospital de Manises

    Manises, Valencia 46940
    Spain

    Active - Recruiting

  • Hospital Universitario Doctor Peset

    Valencia, Valencia 46017
    Spain

    Active - Recruiting

  • Hospital Universitario y Politécnico La Fe

    Valencia, Valencia 46026
    Spain

    Active - Recruiting

  • Hospital Universitario de Cruces

    Bilbao, Vizcaya 48903
    Spain

    Site Not Available

  • Hospital Universitario Puerta del Mar

    Cádiz, 11009
    Spain

    Site Not Available

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