Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06716242

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Preeclampsia (PE) Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital General Universitario Dr. Balmis, Alicante, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

    Sensitivity, specificity, accuracy, F1-score, positive/negative predictive values, false discovery rate, AUC.

Secondary outcomes

  1. 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.

    Sensitivity, specificity, accuracy, F1-score, positive/negative predictive values, false discovery rate, AUC.

  2. 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.

    Sensitivity, specificity, accuracy, F1-score, positive/negative predictive values, false discovery rate, AUC.

Other outcomes

  1. Exploratory outcome: Validation of first-trimester screening (9-14 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.

    Sensitivity, specificity, accuracy, F1-score, positive/negative predictive values, false discovery rate, AUC.

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

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

    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.

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

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

    DNA/RNA/proteins/metabolites associated with gestational age and clinical outcomes.

  4. Exploratory outcome: Identification of candidate biomarkers in maternal blood for therapeutic interventions

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

    Molecular characterization (DNA/RNA/proteins/metabolites).

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Studies Department

CONTACT

[email protected]

+34 636 260 481

Érika Ortiz Domingo

CONTACT

[email protected]

+34 636 260 481

Sponsors and collaborators

Lead sponsor

iPremom

Industry

Registry information

Official study title

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

Acronym: iPregnostic

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 4, 2024
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.