Molecular Screening Method for Preeclampsia (PREMOM)

Last updated: March 21, 2025
Sponsor: iPremom
Overall Status: Completed

Phase

N/A

Condition

Pregnancy Complications

Preeclampsia

Treatment

Peripheral blood collection in cases group

Peripheral blood collection in control group

Clinical Study ID

NCT04990141
IGX1-PRE-CS-20-11
  • Ages > 18
  • Female

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients whose written informed consent approved by the Ethics Committee (EC) hasbeen obtained, after having been duly informed of the nature of the study andvoluntarily accepted to participate after being fully aware of the potential risks,benefits and any discomfort involved.

  • Women over the age of 18 at the time of signing the informed consent form.

  • Pregnant women with single gestation between weeks 9 and 14 of gestation.

Exclusion

Exclusion Criteria:

  • Known malignancy

  • History of organ transplant or bone marrow transplant.

  • Maternal transfusion in the last 8 weeks prior to taking the sample.

  • Early gestational loss

  • Existence of serious or uncontrolled bacterial, fungal or viral infections that, inthe opinion of the investigator may interfere with the patient's participation inthe study or the evaluation of the results of the study.

  • Other circumstances or difficulties that, in the investigator's opinion, may supposea risk to the subject or reduce the chances of obtaining satisfactory data toachieve the objectives of the study.

Study Design

Total Participants: 9586
Treatment Group(s): 2
Primary Treatment: Peripheral blood collection in cases group
Phase:
Study Start date:
September 23, 2021
Estimated Completion Date:
March 27, 2024

Study 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.

Connect with a study center

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias
    Spain

    Site Not Available

  • Hospital Universitario de Torrejón

    Torrejón De Ardoz, Madrid
    Spain

    Site Not Available

  • Hospital General Universitario Santa Lucía

    Cartagena, Murcia
    Spain

    Site Not Available

  • Hospital Universitario Cruces

    Baracaldo, Vizcaya
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario Insular Materno Infantil

    Albacete,
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Albacete

    Albacete,
    Spain

    Site Not Available

  • Hospital General de Alicante

    Alicante,
    Spain

    Site Not Available

  • Hospital General de Castellón

    Castellón De La Plana,
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofía

    Córdoba,
    Spain

    Site Not Available

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid,
    Spain

    Site Not Available

  • Hospital Clinico Universitario Virgen de la Arrixaca

    Murcia,
    Spain

    Site Not Available

  • Hospital Universitario Regional de Málaga

    Málaga,
    Spain

    Site Not Available

  • Hospital Universitario de Canarias

    Santa Cruz De Tenerife,
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Sevilla,
    Spain

    Site Not Available

  • Hospital Universitario y Politécnico La Fe

    Valencia,
    Spain

    Site Not Available

  • Hospital del Río Hortega

    Valladolid,
    Spain

    Site Not Available

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza,
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza,
    Spain

    Site Not Available

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