Status:
RECRUITING
Vascular Biomarkers Predictive of the Progression From Hypertensive Disorders in Pregnancy to Preeclampsia in Pregnant Women
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hypertension Disorders in Pregnancy
Gestational Hypertension
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
Hypertension during pregnancy remains a leading cause of maternal and fetal morbidity and mortality. The frequency (5 to 10% of pregnancies) and potential severity of these diseases, both for the moth...
Detailed Description
Hypertension in pregnancy is defined by PAS ≥140 mmHg and/or PAD ≥ 90 mmHg, mild to moderate hypertension by PAS = 140-159 mmHg and/or PAD = 90-109 mmHg and severe hypertension by PAS ≥ 160 mmHg and/o...
Eligibility Criteria
Inclusion
- Patients with a hypertension disorder in pregnancy and/or preeclampsia from the 20th amenorrhea week until the 26th ± 2 amenorrhea week.
- Age between 18 and 40 years old.
- Having given written consent.
- Patients affiliated to a social security scheme.
Exclusion
- Presence of pathologies interfering in a major way with vascular parameters: known multicomplicated diabetes treated before pregnancy, hypercholesterolemia known (or LDL\>130 mg/dl), multicomplicated connectivitis, proven cardiovascular disease (ischemic heart disease, stroke, arteriopathy of the lower limbs, heart failure), pre-existing known renal failure (serum creatinine \>125 µmol/L) and/or pre-existing proteinuria ≥ 300 mg/24h).
- Cardiac arrhythmia.
- Hepatitis C, HIV infection (assay performed within 6 months prior to diagnosis of pre-eclampsia).
- Recent history of venous (pulmonary embolism, phlebitis) or arterial (myocardial infarction, unstable angina, stroke, transient ischemic attack), thrombotic event ≤ 3 months.
- Patient already engaged in a therapeutic protocol.
- Patients under legal protective measures.
- Patients receiving State Medical Assistance.
Key Trial Info
Start Date :
August 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04520048
Start Date
August 11 2023
End Date
December 1 2026
Last Update
September 12 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
AP-HP Avicenne Hospital, Department of internal medicine
Bobigny, Seine Saint Denis, France, 93000
2
AP-HP Jean Verdier Hospital, Gynecology and Obstetrics Department
Bondy, Seine Saint Denis, France, 93140
3
AP-HP Laribosière Hospital, Gynecology and Obstetrics Department
Paris, France, 75010