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
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complejo Hospitalario Universitario de Albacete Coordinator of this site? Confirm its status | Albacete | Spain | Unknown status |
| Complejo Hospitalario Universitario Insular Materno Infantil Coordinator of this site? Confirm its status | Albacete | Spain | Unknown status |
| Hospital General de Alicante Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| Hospital Universitario Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Unknown status |
| Hospital General Universitario Santa Lucia Coordinator of this site? Confirm its status | Cartagena | Spain | Unknown status |
| Hospital General de Castellon Coordinator of this site? Confirm its status | Castellon | Spain | Unknown status |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro - Majadahonda Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Clínico Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
| Hospital Universitario de Canarias Coordinator of this site? Confirm its status | Santa Cruz de Tenerife | Spain | Unknown status |
| Hospital Universitario de Torrejon Coordinator of this site? Confirm its status | Torrejón de Ardoz | Spain | Unknown status |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital del Río Hortega Coordinator of this site? Confirm its status | Valladolid | Spain | Unknown status |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.