NCT04990141

Molecular Screening Method for Preeclampsia (PREMOM)

Prospective Clinical Study for the Early Detection of Preeclampsia Based on the Molecular Screening At the First Trimester of Pregnancy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9,586 (actual)
• Sponsor: iPremom · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Preeclampsia (PE) is a major obstetric complication with short- and long-term consequences for the mother and the fetus. Early screening tools to reduce its mortality and morbidity, as well as to prevent the life-threatening consequences are needed. Thus, the detection of women at risk of suffering PE is key to apply preventive and treatment strategies. Recently, the maternal contribution to PE based on defective decidualization has been evidenced and new technical approaches developed to detect circulating biomolecules in blood such as RNA fragments. The main objective of this study is to evaluate the diagnostic precision of the molecular profile from the maternal blood analysed for the early screening of early onset preeclampsia (EOPE).

Detailed description

The hypothesis is that there is a unique molecular profile in peripheral blood specific to women who develop EOPE that allow an early assess woman´s risk of developing this pregnancy complication. The purposed study is a biomedical, prospective, multicentre, case-control aimed to determine the predictive value and diagnostic precision of the maternal blood molecular profile for the early screening of EOPE. Late-onset preeclampsia (LOPE) and other pregnancy complications (such as preterm birth, intrauterine growth restriction, gestational diabetes, placenta previa, placental abruption, placenta accreta, premature rupture of preterm membranes, antepartum fetal death, uterine rupture and previous vasa, among others) could be analysed as a secondary outcome. Subjects will be 9585 pregnant women recruited between 9 and 14 gestational weeks. Participants will provide peripheral blood sample at three different times during pregnancy to be characterised at molecular level in the iPremom laboratories (Igenomix Preeclampsia SLU) after their obstetric outcome was known. Once the 50% of the total enrolment is achieved, an interim analysis will be conducted by an independent external committee. Data will be registered in an electronic Case Report Form (eCRF) specifically designed for this study. Monitoring activities and data verification will be performed during the whole study to ensure data quality, integrity and transparency. The total estimated duration of the study is 30 months, of which the first 18 months will correspond to the recruitment period of the participants.

Conditions

• Preeclampsia

Interventions

Type	Name	Description
PROCEDURE	Peripheral blood collection in cases group	Maternal peripheral blood will be collected 3 times during pregnancy (1st, 2nd and 3rd trimester) and clinical data compiled in cases group
PROCEDURE	Peripheral blood collection in control group	Maternal peripheral blood will be collected 3 times during pregnancy (1st, 2nd and 3rd trimester) and clinical data compiled in control group

Timeline

• Start date: 2021-09-23
• Primary completion: 2024-03-27
• Completion: 2024-03-27
• First posted: 2021-08-04
• Last updated: 2025-03-25

Locations

15 sites across 1 country: Spain