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Recruiting NCT06716242

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

— Observational Preeclampsia (PE)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peripheral blood collection.
Who it may be relevant to
Registry conditions: Preeclampsia (PE). Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective, Observational, Multicentre Study to Confirm the Performance of Molecular Screening for Early Detection of Preeclampsia

Overview

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.

Detailed 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.

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.

Primary outcome measures

  • Validation of the MaiRa Preeclampsia Test for first-trimester screening (9-14 weeks) of EOPE [Time frame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.]
Secondary outcome measures (2)
  • Validation of second-trimester screening (15-26 weeks) for EOPE [Time frame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.]
  • Validation of second-trimester screening (15-26 weeks) for LOPE [Time frame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 11 centers
  • Hospital General Universitario Dr. Balmis — Alicante
  • Hospital de la Santa Creu i Sant Pau — Barcelona
  • Hospital Comarcal de Vinaròs — Vinaròs
  • Hospital Universitario Puerta del Mar — Cadiz
  • Hospital Universitario A Coruña — A Coruña
  • Hospital Universitario de Torrejón — Torrejón de Ardoz
  • Hospital Clínico Universitario Virgen de la Arrixaca — El Palmar
  • Hospital Universitario de Canarias — San Cristóbal de La Laguna
  • … and 3 more centers

Identifiers

NCT: NCT06716242 · IPR-IPR-TG-24-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗