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

NCT06716242 | Recruiting

• 1 other identifier: IPR-IPR-TG-24-01
• Study Type: observational
• Target: 7,473
• Locations: 1 country
• Sites: 11

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.

Conditions

Preeclampsia (PE)

Keywords

Early Screening; First Trimester Diagnostic; Cell-Free RNA (cfRNA); Molecular Profile; Blood Biomarkers

Outcome Measures

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.

  From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.

Secondary Outcomes (2)

• Validation of second-trimester screening (15-26 weeks) for EOPE

  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

  From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.

Other Outcomes (4)

• Exploratory outcome: Validation of first-trimester screening (9-14 weeks) for LOPE

  From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.

• Exploratory outcome: Validation of first and second trimester screening for other pregnancy complications

  From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.

• Exploratory outcome: Molecular characterization of cfRNA and other biomarkers across gestation

  From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.

Study Arms (1)

Pregnant patients aged 18 years or older

Pregnant patients aged 18 years or older recruited between 9 and 14 weeks' gestation during routine obstetrical follow-ups at referral hospitals.

Procedure: Peripheral blood collection

Interventions

Peripheral blood collection PROCEDURE

Maternal peripheral blood will be collected 3 times during pregnancy (1st, 2nd and 3rd trimester) and clinical data will also be compiled.

Pregnant patients aged 18 years or older

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• iPremom: lead

Study Sites (11)

Hospital General Universitario Dr. Balmis

Alicante, Alicante, 03010, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

NOT YET RECRUITING

Hospital Comarcal de Vinaròs

Vinaròs, Castellón, 12500, Spain

RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, Cádiz, 11009, Spain

RECRUITING

Hospital Universitario A Coruña

A Coruña, La Coruña, 15006, Spain

RECRUITING

Hospital Universitario de Torrejón

Torrejón de Ardoz, Madrid, 28850, Spain

RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

RECRUITING

Hospital Universitario de Canarias

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

RECRUITING

Hospital de Manises

Manises, Valencia, 46940, Spain

RECRUITING

Hospital Universitario Doctor Peset

Valencia, Valencia, 46017, Spain

RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples with cfRNA/DNA and other biomolecules. Maternal peripheral blood samples analyzed for C-RNA, cfRNA, DNA, and other markers linked to preeclampsia and obstetric outcomes.

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Carlos Simón, MD, PhD

  Carlos Simon Foundation

  PRINCIPAL INVESTIGATOR

• Tamara Garrido, PhD

  iPremom

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Studies Department

CONTACT

+34 636 260 481; clinicalstudies@ipremom.com

Érika Ortiz Domingo

CONTACT

+34 636 260 481; erika.ortiz@mshareservices.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 4, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

ES (11)