PreeclampsiaPRE-OMIQUESNCT07703826
Identification of Genes of Interest for Severe Forms of Preeclampsia
An observational study of Preeclampsia and Severe Preeclampsia, run by University Hospital, Strasbourg, France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preeclampsia, Severe Preeclampsia
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Preeclampsia, Severe Preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703826
- Sponsor's protocol ID
- 9262
- Other IDs
- 2024-A01653-44
- Acronym
- PRE-OMIQUES
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Genes of Interest for Severe Forms of Preeclampsia in a Cohort of Pregnant Women With a Precise Phenotype
- ClinicalTrials.gov ID
- NCT07703826
- Acronym / sponsor ID
- PRE-OMIQUES / 9262
- Conditions
- Preeclampsia, Severe Preeclampsia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identifying genetic and molecular markers associated with severe forms of preeclampsia
Time frame: At enrollment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Severe Preeclampsia, run by University Hospital, Strasbourg, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mme STOERKEL Johanne (03 88 12 74 55, johanne.stoerkel@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying genetic and molecular markers associated with severe forms of preeclampsia (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.