Clinical trial NCT06716242: Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters
Official title: Prospective, Observational, Multicentre Study to Confirm the Performance of Molecular Screening for Early Detection of Preeclampsia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preeclampsia (PE)
Keywords: Early Screening
First Trimester Diagnostic
Cell-Free RNA (cfRNA)
Molecular Profile
Blood Biomarkers
Lead sponsor: iPremom
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 7473
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients aged 18 years or older, recruited between 9 and 14 weeks' gestation during routine obstetrical follow-ups at referral hospitals.

Brief 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.

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: 30 months

* Recruitment and Sample Collection: 18 months
* Sample Analysis: 12 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.

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.

Primary outcomes:
measure: Validation of the MaiRa Preeclampsia Test for first-trimester screening (9-14 weeks) of EOPE
timeFrame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.
Secondary outcomes:
measure: Validation of second-trimester screening (15-26 weeks) for EOPE
timeFrame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.
measure: Validation of second-trimester screening (15-26 weeks) for LOPE
timeFrame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.
Other outcomes:
measure: Exploratory outcome: Validation of first-trimester screening (9-14 weeks) for LOPE
timeFrame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.
measure: Exploratory outcome: Validation of first and second trimester screening for other pregnancy complications
timeFrame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.
measure: Exploratory outcome: Molecular characterization of cfRNA and other biomarkers across gestation
timeFrame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.
measure: Exploratory outcome: Identification of candidate biomarkers in maternal blood for therapeutic interventions
timeFrame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.
Locations:
city: Vinaroz
country: Spain
facility: Hospital Comarcal de Vinaròs
state: Castellón
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
state: La Coruña
city: Torrejón de Ardoz
country: Spain
facility: Hospital Universitario de Torrejón
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
state: Murcia
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz de Tenerife
city: Manises
country: Spain
facility: Hospital de Manises
state: Valencia
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
Study officials:
affiliation: Carlos Simon Foundation
name: Carlos Simón, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: iPremom
name: Tamara Garrido, PhD
role: PRINCIPAL_INVESTIGATOR
References: