Informations générales (source: ClinicalTrials.gov)
Treatment of Severe Hypertension During Pre-Eclampsia.A Preliminary Equivalence Study Between URAPIDIL and NICARDIPINE
Interventional
Phase 3
University Hospital, Strasbourg, France (Voir sur ClinicalTrials)
juin 2007
août 2010
29 juin 2024
The aim of this study is to confirm that URAPIDIL is as efficient and as safe as
NICARDIPINE to correct severe hypertension in pre-eclamptic patients.
- efficacy endpoint : mean arterial blood pressure corrected to 105-125 mmHg after 120
min of study drug administration.
- safety endpoints : clinical, biological and ultrasound observation for any side
effect.All infants will be observed in the neonatology unit (during 48h).
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hôpital Saint-Jacques, CHU de Besançon - 25000 - BESANçON - France | Myriam KRAUSZ-GRIGNARD, MD | Contact (sur clinicalTrials) | |||
| Maternité A. PINARD - 54042 - Nancy - France | HERVE BOUAZIZ, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg - 67098 - Strasbourg - France | Pierre Auguste DIEMUNSCH, MD | Contact (sur clinicalTrials) | |||
| Sihcus-Cmco - 67303 - Schiltigheim - France | Rita VIZITIU, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion criteria:
- patients 'written informed consent dated and signed by investigator and patient
- affiliation to a social security system
- single pregnancy
- arterial hypertension (PAS ≥140 and/or PAD≥90) in the context of severe
pre-eclampsia
- patients 'written informed consent dated and signed by investigator and patient
- affiliation to a social security system
- single pregnancy
- arterial hypertension (PAS ≥140 and/or PAD≥90) in the context of severe
pre-eclampsia
- patient under 18 year old or unable to give informed consent
- protocol rejected by patient-impossibility to use non invasive blood pressure
monitoring
- antihypertensive treatments within 24h before inclusion
- allergy to or contraindication for one of the study drugs-pre
- eclampsia that does not require an antihypertensive treatment
- acute eclampsia-requirement for other drugs with potential dangerous interactions
with study drugs
- participation to a therapeutic protocol within 6 months prior to the start of study