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

Study Overview
=================
Brief Summary
-----------------
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).

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

Conditions
-----------------
Hypertension During Pre-Eclampsia

Intervention / Treatment
-----------------
* Drug: URAPIDIL (EUPRESSYL*)
* Drug: NICARDIPINE


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 51 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Urapidil<br> | Drug: URAPIDIL (EUPRESSYL*)<br>* 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.<br>|
| Active Comparator: Nicardipine<br> | Drug: NICARDIPINE<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PRE-ECLAMPSIA-URAPIDIL-NICARDIPINE