Identification of Genes of Interest for Severe Forms of Preeclampsia (PRE-OMIQUES)

Identification of Genes of Interest for Severe Forms of Preeclampsia in a Cohort of Pregnant Women With a Precise Phenotype

Preeclampsia is a pregnancy complication characterized by high blood pressure associated with damage to various organs, especially the kidneys. It happens in about 1 to 5% of pregnant women and can cause serious problems for both the mother and the baby.

Several multi-omics studies have already been conducted on preeclampsia, with promising results. However, this is preliminary data that requires further studies. The molecular markers identified in this type of study could potentially be used, first of all, for the early screening of this condition, which is not yet reliably achievable. In addition, the knowledge gained from this research would help us better understand the pathophysiology of preeclampsia. Therefore, the investigators' goal is to carry out a multi-omics analysis of preeclampsia to uncover the genetic and molecular mechanisms involved in this condition.

Study Overview

• Status: Not yet recruiting
• Conditions: Preeclampsia; Severe Preeclampsia

Detailed Description

This study is a cross-sectional, prospective, comparative, and single-center study. It compares a group of 50 pregnant women with severe preeclampsia to a control group of 50 pregnant women without any pathology.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Mme STOERKEL Johanne; Phone Number: 03 88 12 74 55; Email: johanne.stoerkel@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

100 pregnant women recruited at a single center. Participants will be divided into two groups: 50 pregnant women diagnosed with severe preeclampsia and 50 healthy pregnant women without any pregnancy-related pathology serving as the control group. Biological samples and clinical data will be collected at enrollment to identify genetic and molecular markers associated with severe preeclampsia.

Description

Inclusion Criteria:

Inclusion criteria for patients in the experimental group P:

- Pregnant women between 18 and 45 years old, between 24 and 41 weeks of amenorrhea (WA), with severe preeclampsia defined according to the criteria of the joint expert recommendations of the French National College of Gynecologists and Obstetricians (CNGOF) and the French Society of Anesthesia and Intensive Care (SFAR) from 2020 "Management of the patient with severe preeclampsia." These criteria are: gestational hypertension with systolic ≥ 140 mmHg and/or diastolic ≥ 90 mmHg, and proteinuria ≥ 0.3g/24h, plus at least one of the following severity criteria:

• Severe hypertension (SBP ≥ 160 mmHg and/or DBP ≥ 110 mmHg) or uncontrolled.
• Proteinuria > 3g/24h.
• Creatinine ≥ 90 μmol/L.
• Oliguria ≤ 500 mL/24h or ≤ 25 mL/h.
• Thrombocytopenia < 100,000/mm3
• Liver enzyme elevation with AST/ALT >2x normal.
• Epigastric abdominal pain and/or persistent or severe right upper quadrant pain "like a band."
• Chest pain, shortness of breath, acute pulmonary edema.
• Neurological signs: severe headaches not responding to treatment, persistent visual or auditory disturbances, hyperactive, widespread, and polykinetic tendon reflexes.
• Patient's free and informed consent regarding the collection of maternal blood and urine.
• Consent from both legal guardians regarding the collection of cord blood, placenta samples, and newborn data.

Inclusion criteria for patients in the control group:

• Pregnant women between 18 and 45 years old and between 24 and 41 weeks of gestation, with a pregnancy without any complications
• Free and informed consent from the patient regarding the collection of maternal blood and urine
• Consent from both holders of parental authority regarding the collection of cord blood, placental fragments, and newborn data

Exclusion Criteria:

EXCLUSION CRITERIA: for all patients

• Diabetes prior to pregnancy
• Multiple pregnancy
• Long-term medication treatment (except usual pregnancy supplements)
• Smoking, alcohol, or drug use during pregnancy
• Pre-existing liver, kidney, or heart failure
• History of bariatric surgery
• Neonatal acidosis with arterial cord pH below 7.0 (rare event)
• Genetic or chromosomal abnormality of the mother and/or newborn diagnosed prenatally
• Fetal malformation diagnosed prenatally
• Refusal to participate in the study
• Person unable to consent or under protection (guardianship, curatorship)
• Minor
• Inability to participate in the entire study

Exclusion criteria for patients in the control group T: For women in the control group, any obstetric condition (apart from delivery complications).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Experimental group P; a group of 50 pregnant women with severe preeclampsia
Control group T; a control group of 50 pregnant women without any medical conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identifying genetic and molecular markers associated with severe forms of preeclampsia	Identify, from blood, urine, and placental samples, the changes in genetic and molecular signatures as well as in cell composition associated with severe forms of preeclampsia, by comparing the expression levels of the signatures and the relative abundance of different cell populations between patients with severe preeclampsia and control patients.	At enrollment

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: 9262; 2024-A01653-44 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No