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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia (PE)
• Intervention / Treatment: Procedure: Peripheral blood collection

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.

• Study Type: Observational
• Enrollment (Estimated): 7473

Contacts and Locations

• Study Contact: Name: Clinical Studies Department; Phone Number: +34 636 260 481; Email: clinicalstudies@ipremom.com
• Study Contact Backup: Name: Érika Ortiz Domingo; Phone Number: +34 636 260 481; Email: erika.ortiz@mshareservices.es

Study Locations

• Spain
  • Alicante
    • Alicante, Alicante, Spain, 03010
      • Recruiting
      • Hospital General Universitario Dr. Balmis
      • Contact: Ana Palacios Marqués; Phone Number: +34 965 93 34 60; Email: ana.palacios.marques@gmail.com
      • Principal Investigator: Ana Palacios Marqués
  • Barcelona
    • Barcelona, Barcelona, Spain, 08025
      • Recruiting
      • Hospital De La Santa Creu I Sant Pau
      • Contact: Elisa Llurba Olivé; Phone Number: +34 932 91 90 00; Email: ellurba@santpau.cat
      • Principal Investigator: Elisa Llurba Olivé
  • Castellón
    • Vinaròs, Castellón, Spain, 12500
      • Recruiting
      • Hospital Comarcal de Vinaròs
      • Contact: Liliana Salazar González; Phone Number: +34 964 47 70 00; Email: lili.salazar87@gmail.com
      • Contact: Laura Román Juan; Phone Number: +34 964 47 70 00; Email: laura.romanjuan@gmail.com
      • Principal Investigator: Liliana Salazar González
      • Principal Investigator: Laura Román Juan
  • Cádiz
    • Cadiz, Cádiz, Spain, 11009
      • Recruiting
      • Hospital Universitario Puerta del Mar
      • Contact: José Román Broullón Molanes; Phone Number: +34 964 47 70 00; Email: joseroman.broullon@uca.es
      • Principal Investigator: José Román Broullón Molanes
  • La Coruña
    • A Coruña, La Coruña, Spain, 15006
      • Recruiting
      • Hospital Universitario A Coruña
      • Contact: Nuria Valiño Calviño; Phone Number: +34 981 57 77 17; Email: nuvalino@gmail.com
      • Principal Investigator: Nuria Valiño Calviño
  • Madrid
    • Torrejón de Ardoz, Madrid, Spain, 28850
      • Recruiting
      • Hospital Universitario De Torrejon
      • Contact: Maria del Mar Gil Mira; Phone Number: Ext 7197 +34 916 26 26 00; Email: mmar1984@gmail.com
      • Principal Investigator: María del Mar Gil Mira
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Recruiting
      • Hospital Clinico Universitario Virgen de la Arrixaca
      • Contact: Juan Luis Delgado Marín; Phone Number: +34 968 36 96 74; Email: juanluisdelgado@tokos.org
      • Principal Investigator: Juan Luis Delgado Marín
  • Santa Cruz de Tenerife
    • San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain, 38320
      • Recruiting
      • Hospital Universitario de Canarias
      • Contact: Erika Padrón Pérez; Phone Number: +34 922 67 85 76; Email: erikapadronperez@gmail.com
      • Principal Investigator: Erika Padrón Pérez
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Recruiting
      • Hospital de Manises
      • Contact: Fernando Gil Raga; Phone Number: +34 922 67 85 76; Email: gil_ferrag@gva.es
      • Principal Investigator: Fernando Gil Raga
    • Valencia, Valencia, Spain, 46026
      • Recruiting
      • Hospital Universitario y Politécnico La Fe
      • Contact: Rogelio Monfort Ortiz; Phone Number: +34 961 24 40 00; Email: monfort_isaort@gva.es
      • Contact: Beatriz Marcos Puig; Phone Number: +34 961 24 40 00; Email: marcos_bea@gva.es
      • Principal Investigator: Rogelio Monfort Ortiz
      • Principal Investigator: Beatriz Marcos Puig
    • Valencia, Valencia, Spain, 46017
      • Recruiting
      • Hospital Universitario Doctor Peset
      • Contact: Belén Aparicio Navarro; Phone Number: +34 963 18 87 99; Email: aparicio_rosnav@gva.es
      • Contact: Reyes Balanzá Chancosa; Phone Number: +34 963 18 87 99; Email: balanza_rey@gva.es
      • Principal Investigator: Belén Aparicio Navarro
      • Principal Investigator: Reyes Balanzá Chancosa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of second-trimester screening (15-26 weeks) for 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.
Validation of second-trimester screening (15-26 weeks) for LOPE	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	DNA/RNA/proteins/metabolites associated with gestational age and clinical outcomes.	From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.
Exploratory outcome: Identification of candidate biomarkers in maternal blood for therapeutic interventions	Molecular characterization (DNA/RNA/proteins/metabolites).	From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.

Collaborators and Investigators

• Sponsor: iPremom
• Investigators: Principal Investigator: Carlos Simón, MD, PhD, Carlos Simon Foundation; Principal Investigator: Tamara Garrido, PhD, iPremom

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Blood Biomarkers; Molecular Profile; Early Screening; First Trimester Diagnostic; Cell-Free RNA (cfRNA)
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: IPR-IPR-TG-24-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No