Molecular Screening Method for Preeclampsia (PREMOM)
- Conditions
- Preeclampsia
- Interventions
- Procedure: Peripheral blood collection in control groupProcedure: Peripheral blood collection in cases group
- Registration Number
- NCT04990141
- Lead Sponsor
- iPremom
- 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麓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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 9586
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control group Peripheral blood collection in control group Women recruited between 9 and 14 gestational weeks without diagnosis of preeclampsia or other complication at the end of the pregnancy Cases group Peripheral blood collection in cases group Women recruited between 9 and 14 gestational weeks diagnosed with preeclampsia or other complication at the end of pregnancy
- Primary Outcome Measures
Name Time Method Diagnostic precision of EOPE at molecular level 33 weeks Sensitivity, specificity, positive and negative predictive value using the clinical outcome of pregnancy as a "gold standard" parameter
- Secondary Outcome Measures
Name Time Method Characterization of molecular profile in maternal blood 33 weeks Molecular profile (DNA/RNA/proteins/metabolites) associated to gestational age, epidemiological and clinical variables
Diagnostic precision of LOPE and other pregnancy complications at molecular level 33 weeks Sensitivity, specificity, positive and negative predictive value using the clinical outcome of pregnancy as a "gold standard" parameter
Trial Locations
- Locations (15)
Hospital Clinico Universitario Virgen de la Arrixaca
馃嚜馃嚫Murcia, Spain
Hospital Universitario de Canarias
馃嚜馃嚫Santa Cruz De Tenerife, Spain
Hospital Universitario Miguel Servet
馃嚜馃嚫Zaragoza, Spain
Complejo Hospitalario Universitario de Albacete
馃嚜馃嚫Albacete, Spain
Hospital Universitario de Torrej贸n
馃嚜馃嚫Torrej贸n De Ardoz, Madrid, Spain
Hospital General de Castell贸n
馃嚜馃嚫Castell贸n De La Plana, Spain
Hospital Universitario Reina Sof铆a
馃嚜馃嚫C贸rdoba, Spain
Hospital Universitario y Polit茅cnico La Fe
馃嚜馃嚫Valencia, Spain
Hospital Universitario Cruces
馃嚜馃嚫Baracaldo, Vizcaya, Spain
Hospital General de Alicante
馃嚜馃嚫Alicante, Spain
Hospital Universitario Puerta de Hierro Majadahonda
馃嚜馃嚫Madrid, Spain
Complejo Hospitalario Universitario Insular Materno Infantil
馃嚜馃嚫Albacete, Spain
Hospital del R铆o Hortega
馃嚜馃嚫Valladolid, Spain
Hospital Cl铆nico Universitario Lozano Blesa
馃嚜馃嚫Zaragoza, Spain
Hospital General Universitario Santa Luc铆a
馃嚜馃嚫Cartagena, Murcia, Spain