Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters
ConditionPreeclampsia (PE)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsoriPremom
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Active neoplasm.
History of organ or bone marrow transplantation.
Maternal transfusion within 8 weeks before sample collection.
Evidence of early pregnancy loss at consent.
Trial population
Pregnant patients aged 18 years or older, recruited between 9 and 14 weeks' gestation during routine obstetrical follow-ups at referral hospitals.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Peripheral blood collection
Procedure/SurgeryMaternal peripheral blood will be collected 3 times during pregnancy (1st, 2nd and 3rd trimester) and clinical data will also be compiled.
Treatment groups
7,473 Participants
are divided into 1 treatment groupGroup A: Pregnant patients aged 18 years or older1 intervention
Trial outcomes
Primary outcomes
1
Validation of the MaiRa Preeclampsia Test for first-trimester screening (9-14 weeks) of EOPE
Sensitivity, specificity, accuracy, F1-score, positive/negative predictive values, false discovery rate, AUC.
Time frame
From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.Secondary outcomes
1
Validation of second-trimester screening (15-26 weeks) for EOPE
Sensitivity, specificity, accuracy, F1-score, positive/negative predictive values, false discovery rate, AUC.
Time frame
From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.2
Validation of second-trimester screening (15-26 weeks) for LOPE
Sensitivity, specificity, accuracy, F1-score, positive/negative predictive values, false discovery rate, AUC.
Time frame
From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.Other outcomes
1
Exploratory outcome: Validation of first-trimester screening (9-14 weeks) for LOPE
Sensitivity, specificity, accuracy, F1-score, positive/negative predictive values, false discovery rate, AUC.
Time frame
From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.2
Exploratory outcome: Validation of first and second trimester screening for other pregnancy complications
Other pregnancy complications such as preterm labour, intrauterine growth restriction, gestational diabetes and placenta previa among others. Sensitivity, specificity, accuracy, F1-score, positive/negative predictive values, false discovery rate, AUC.
Time frame
From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.3
Exploratory outcome: Molecular characterization of cfRNA and other biomarkers across gestation
DNA/RNA/proteins/metabolites associated with gestational age and clinical outcomes.
Time frame
From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.4
Exploratory outcome: Identification of candidate biomarkers in maternal blood for therapeutic interventions
Molecular characterization (DNA/RNA/proteins/metabolites).
Time frame
From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks. Source ClinicalTrials.gov