Clinical trial NCT04990141: Molecular Screening Method for Preeclampsia (PREMOM)
Official title: Prospective Clinical Study for the Early Detection of Preeclampsia Based on the Molecular Screening At the First Trimester of Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: Preeclampsia
Early onset Preeclampsia (EOPE)
Late onset Peeclampsia (LOPE)
First trimester
Early screening
Circulating RNA (C-RNA)
Molecular profile
Blood
Lead sponsor: iPremom
Sponsor class: INDUSTRY
First posted: 2021-08-04
Enrollment: 9586
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women over the age of 18 recruited between 9 and 14 gestational weeks who attend the participating referral centers for their regular gynecological-obstetric follow-up, as well as their childbirth care.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily 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 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, in the opinion of the investigator may interfere with the patient's participation in the study or the evaluation of the results of the study.
* Other circumstances or difficulties that, in the investigator's opinion, may suppose a risk to the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study.

Primary outcomes:
measure: Diagnostic precision of EOPE at molecular level
timeFrame: 33 weeks
Secondary outcomes:
measure: Diagnostic precision of LOPE and other pregnancy complications at molecular level
timeFrame: 33 weeks
measure: Characterization of molecular profile in maternal blood
timeFrame: 33 weeks
Other outcomes:
measure: Identification of candidate biomarkers in the maternal blood for therapy studies.
timeFrame: 33 weeks
Locations:
city: Torrejón De Ardoz
country: Spain
facility: Hospital Universitario de Torrejón
state: Madrid
city: Cartagena
country: Spain
facility: Hospital General Universitario Santa Lucía
state: Murcia
city: Baracaldo
country: Spain
facility: Hospital Universitario Cruces
state: Vizcaya
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario Insular Materno Infantil
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Castellón De La Plana
country: Spain
facility: Hospital General de Castellón
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Murcia
country: Spain
facility: Hospital Clinico Universitario Virgen de la Arrixaca
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
city: Valladolid
country: Spain
facility: Hospital del Río Hortega
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: iPremom (Igenomix Preeclampsia SLU)
name: Tamara Garrido, PhD
role: PRINCIPAL_INVESTIGATOR
References: