Predicting progression from gestational hypertension to preeclampsia in pregnant women
Exploratory Study. Endothelial Function and Vascular-tropic Biomarkers: Predictive Indicators of the Progression of Hypertensive Disorders in Pregnancy to Pre-eclampsia?
This study is trying to find out if certain blood vessel markers can help predict if pregnant women with gestational hypertension will develop preeclampsia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Bobigny, Seine Saint Denis and 2 other locations) |
| Trial ID | NCT04520048 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to identify vascular biomarkers that can predict the progression of gestational hypertension to preeclampsia in pregnant women. It involves measuring urinary endothelial microparticles, aortic central pressure, carotid-femoral pulse wave velocity, and vascular biomarker assays. The study focuses on women between 18 and 40 years old who are experiencing gestational hypertension or preeclampsia between the 20th and 26th weeks of pregnancy. By understanding the underlying mechanisms and biomarkers, the study seeks to improve management and outcomes for affected pregnancies.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 to 40 with gestational hypertension or preeclampsia between the 20th and 26th weeks of pregnancy.
Not a fit: Patients with significant pre-existing vascular conditions or other serious health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prediction and management of preeclampsia, potentially reducing maternal and fetal complications.
How similar studies have performed: Other studies have explored vascular biomarkers in pregnancy-related hypertension, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Bobigny, Seine Saint Denis and 2 other locations
- AP-HP Avicenne Hospital, Department of internal medicine — Bobigny, Seine Saint Denis, France (Recruiting)
- AP-HP Jean Verdier Hospital, Gynecology and Obstetrics Department — Bondy, Seine Saint Denis, France (Recruiting)
- AP-HP Laribosière Hospital, Gynecology and Obstetrics Department — Paris, France (Recruiting)
Study contacts
- Principal investigator: Marilucy LOPEZ-SUBLET, MD — AP-HP Avicenne Hospital, Department of Internal Medicine, ESH Hypertension European Excellence Centre
- Study coordinator: Marilucy LOPEZ-SUBLET, MD
- Email: marilucy.lopez-sublet@aphp.fr
- Phone: +33 (0)148955391
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.