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

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Universitario A Coruña
RECRUITING
A Coruña
Hospital General Universitario Dr. Balmis
RECRUITING
Alicante
Hospital de la Santa Creu i Sant Pau
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Puerta del Mar
RECRUITING
Cadiz
Hospital Clínico Universitario Virgen de la Arrixaca
RECRUITING
El Palmar
Hospital de Manises
RECRUITING
Manises
Hospital Universitario de Canarias
RECRUITING
San Cristóbal De La Laguna
Hospital Universitario de Torrejón
RECRUITING
Torrejón De Ardoz
Hospital Universitario Doctor Peset
RECRUITING
Valencia
Hospital Universitario y Politécnico La Fe
RECRUITING
Valencia
Hospital Comarcal de Vinaròs
RECRUITING
Vinaròs
Contact Information
Primary
Clinical Studies Department
clinicalstudies@ipremom.com
+34 636 260 481
Backup
Érika Ortiz Domingo
erika.ortiz@mshareservices.es
+34 636 260 481
Time Frame
Estimated Completion Date: 2027-02
Participants
Target number of participants: 7473
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: iPremom

This content was sourced from clinicaltrials.gov