Molecular Screening Method for Preeclampsia (PREMOM)

NCT04990141 | Completed

• 1 other identifier: IGX1-PRE-CS-20-11
• Study Type: observational
• Target: 9,586
• Locations: 1 country
• Sites: 15

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).

Conditions

Preeclampsia

Keywords

Preeclampsia; Early onset Preeclampsia (EOPE); Late onset Peeclampsia (LOPE); First trimester; Early screening; Circulating RNA (C-RNA); Molecular profile; Blood

Outcome Measures

Primary Outcomes (1)

• Diagnostic precision of EOPE at molecular level

  Sensitivity, specificity, positive and negative predictive value using the clinical outcome of pregnancy as a "gold standard" parameter

  33 weeks

Secondary Outcomes (2)

• Diagnostic precision of LOPE and other pregnancy complications at molecular level

  33 weeks

• Characterization of molecular profile in maternal blood

  33 weeks

Other Outcomes (1)

• Identification of candidate biomarkers in the maternal blood for therapy studies.

  33 weeks

Study Arms (2)

Cases group

Women recruited between 9 and 14 gestational weeks diagnosed with preeclampsia or other complication at the end of pregnancy

Procedure: Peripheral blood collection in cases group

Control group

Women recruited between 9 and 14 gestational weeks without diagnosis of preeclampsia or other complication at the end of the pregnancy

Procedure: Peripheral blood collection in control group

Interventions

Peripheral blood collection in cases group PROCEDURE

Maternal peripheral blood will be collected 3 times during pregnancy (1st, 2nd and 3rd trimester) and clinical data compiled in cases group

Cases group

Peripheral blood collection in control group PROCEDURE

Maternal peripheral blood will be collected 3 times during pregnancy (1st, 2nd and 3rd trimester) and clinical data compiled in control group

Control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women over 18 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• iPremom: lead

Study Sites (15)

Hospital Universitario de Torrejón

Torrejón de Ardoz, Madrid, Spain

Location

Hospital General Universitario Santa Lucía

Cartagena, Murcia, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain

Location

Hospital Universitario Cruces

Barakaldo, Vizcaya, Spain

Location

Complejo Hospitalario Universitario de Albacete

Albacete, Spain

Location

Complejo Hospitalario Universitario Insular Materno Infantil

Albacete, Spain

Location

Hospital General de Alicante

Alicante, Spain

Location

Hospital General de Castellón

Castellon, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, Spain

Location

Hospital Clinico Universitario Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

Location

Hospital del Río Hortega

Valladolid, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Maternal peripheral blood samples with circulating genetic material (C-RNA/C-DNA) and other biomolecules and cellular component to provide preeclampsia information and other obstetric complications.

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Tamara Garrido, PhD

  iPremom (Igenomix Preeclampsia SLU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 4, 2021
• Study Start: September 23, 2021
• Primary Completion: March 27, 2024
• Study Completion: March 27, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (15)