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NCT04990141Completed

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

Source: ClinicalTrials.gov · Last updated 25 Mar 2025

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Observational
Enrollment
9586 (actual)
First submitted
23 Jul 2021
Start date
23 Sept 2021
Primary completion date
27 Mar 2024
Lead sponsor
iPremom
NCT number
NCT04990141

What you commit to

  • Study type: Observational
  • Participants enrolled: 9586
  • From 23 Sept 2021 to the primary completion date, 27 Mar 2024
  • 15 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • Known malignancy
  • History of organ transplant or bone marrow transplant.
  • 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

  • Early gestational loss
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Complejo Hospitalario Universitario de Albacete
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AlbaceteSpainUnknown status
Complejo Hospitalario Universitario Insular Materno Infantil
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AlbaceteSpainUnknown status
Hospital General de Alicante
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AlicanteSpainUnknown status
Hospital Universitario Cruces
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BarakaldoSpainUnknown status
Hospital General Universitario Santa Lucia
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CartagenaSpainUnknown status
Hospital General de Castellon
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CastellonSpainUnknown status
Hospital Universitario Reina Sofia
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CórdobaSpainUnknown status
Hospital Universitario Puerta de Hierro - Majadahonda
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MadridSpainUnknown status
Hospital Clínico Universitario Virgen de la Arrixaca
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MurciaSpainUnknown status
Hospital Universitario de Canarias
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Santa Cruz de TenerifeSpainUnknown status
Hospital Universitario de Torrejon
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Torrejón de ArdozSpainUnknown status
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainUnknown status
Hospital del Río Hortega
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ValladolidSpainUnknown status
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainUnknown status
Hospital Universitario Miguel Servet
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ZaragozaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.