Treatment of Severe Hypertension During Pre-Eclampsia: A Preliminary Equivalence Study Between Urapidil and Nicardipine

Trial Overview

Status	Condition	Sponsor/Collaborator(s)	First Received	Last Changed	Verification Date
Recruiting	Hypertension During Pre-Eclampsia	University Hospital, Strasbourg, France Other	December 7, 2006	February 24, 2009	February 2009

Study Type	Study Design	Phase	Enrollment	Start Date	End Date
Interventional	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment	Phase 3	72	June 2007	-

Facility	Address	Contact	Phone	Email	Status
Hôpital Saint-Jacques, CHU de Besançon	BESANçON 25000 France	Myriam KRAUSZ-GRIGNARD, MD	-	mgrignardkrausz@chu-besancon.fr	Recruiting
Maternité A. PINARD	Nancy 54042 France	HERVE BOUAZIZ, MD	-	h.bouaziz@chu-nancy.fr	Recruiting
Sihcus-Cmco	Schiltigheim 67303 France	Rita VIZITIU, MD	-	rita.vizitiu@chru-strasbourg.fr	Recruiting
Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Strasbourg 67098 France	Pierre Auguste DIEMUNSCH, MD	-	Pierre.Diemunsch@chru-strasbourg.fr	Recruiting

Type	Intervention	Description
Drug	URAPIDIL (EUPRESSYL*)	Urapidil (Eupressyl*) :IV (PSE) 1 microg/kg/min° until reduction PAM 15 %. Reduction ¼ of the posology to obtain PAM between 105 and 125 mmHg with adjustment 0.25 microg/kg/min/15 min. Maximal dose = 30mg/h.
Drug	NICARDIPINE	Nicardipine : IV 6.25 mg bolus until PAD >105 mm/Hg. Perfusion (PSE) 4 mg/h to obtain PAM between 105 and 125 mm/Hg with adjustment 2mg/h/5 min without overshoot 20 mg/h Maximal treatment duration : 7 days

Type	Measure	Time Frame	Safety Issue
Primary	Systolic, diastolic, mean blood pressure and pulse rate :-every 5 min during the titration phase-every 15 min up to the second hour treatment-every hour up to the 6th hour and every 3 hour during the rest of the treatment period.	Systolic, diastolic, mean blood pressure and pulse rate :-every 5 min during the titration phase-every 15 min up to the second hour treatment-every hour up to the 6th hour and every 3 hour during the rest of the treatment period	Yes
Secondary	-maternal and foetal ultrasonography, biology and clinical assessment-type of delivery-post-partum bleeding-neo-natal evaluation by neonatologist during the first 48 hours of life	During the first 48hour of life	Yes

Treatment of Severe Hypertension During Pre-Eclampsia.A Preliminary Equivalence Study Between URAPIDIL and NICARDIPINE

Gender	Minimum Age	Maximum Age	Healthy Volunteers
Female	-	51 Years	No

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

Exclusion criteria:

- 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