Identification of Genes of Interest for Severe Forms of Preeclampsia

NCT07703826 | Not Yet Recruiting

• 2 other identifiers: 92622024-A01653-44
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Preeclampsia; Severe Preeclampsia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• \- 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mme STOERKEL Johanne

CONTACT

03 88 12 74 55; johanne.stoerkel@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): January 1, 2031
• Last Updated: July 14, 2026

Record last verified: 2026-07