NCT04520048 Vascular Biomarkers Predictive of the Progression From Hypertensive Disorders in Pregnancy to Preeclampsia in Pregnant Women
| NCT ID | NCT04520048 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Hypertension Disorders in Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-08-11 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2023-08-11 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 mother and the child, are reasons for standardizing and optimizing medical practices. The cause of hypertension during pregnancy is quite complex, as it depends on a number of factors. Among the hypertensive disorders in pregnancy (HDP), the pathophysiology of pre-eclampsia (one of the most studied in terms of severity) remains poorly understood. The evolution of international guidelines in recent years has made it possible to distinguish various HDP, but schematically we distinguish two main entities by the existence of proteinuria from and after the 20th week of amenorrhea and by maternal-fetal complications, more serious in pre-eclampsia than in gestational hypertension. Acute placental vasculature and blood flow abnormalities were observed during gestational hypertension and preeclampsia, and maybe due to generalized vascular endothelial activation and vasospasm resulting in systemic hypertension and organ hypoperfusion. Endothelial dysfunction (ED) and abnormal expression of several specific blood biomarkers are now well accepted as characteristics of preeclampsia as a leader. However, the progression of any HDP to preeclampsia is possible, but difficult to predict. By way of example, among between 15 and 40 % of gestational hypertension cases progress to preeclampsia, suggesting that it is the same worsening disease. ED could be pre-existing (chronic, white-coat or masked hypertension) but also at the origin of gestational hypertension (unclassified hypertension, transient pregnancy hypertension), and subsequent development of preeclampsia through an imbalance between pro- and anti-angiogenic factors. An imbalance of pro-angiogenic and anti-angiogenic proteins can testify to ED, as can adequate levels of endothelial microparticles. The main objective of this research is to assess the presence of urinary endothelial microparticles in stable pregnant women with hypertensive disorder of pregnancy as a marker for the occurrence of pre-eclampsia during pregnancy.
Eligibility 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.
Contact & Investigator
Marilucy LOPEZ-SUBLET, MD
PRINCIPAL INVESTIGATOR
AP-HP Avicenne Hospital, Department of Internal Medicine, ESH Hypertension European Excellence Centre
Frequently Asked Questions
Who can join the NCT04520048 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Hypertension Disorders in Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04520048 currently recruiting?
Yes, NCT04520048 is actively recruiting participants. Contact the research team at marilucy.lopez-sublet@aphp.fr for enrollment information.
Where is the NCT04520048 trial being conducted?
This trial is being conducted at Bobigny, France, Bondy, France, Paris, France.
Who is sponsoring the NCT04520048 clinical trial?
NCT04520048 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Marilucy LOPEZ-SUBLET, MD at AP-HP Avicenne Hospital, Department of Internal Medicine, ESH Hypertension European Excellence Centre. The trial plans to enroll 110 participants.