Clinical trial NCT00409253: Treatment of Severe Hypertension During Pre-Eclampsia: A Preliminary Equivalence Study Between Urapidil and Nicardipine
Official title: Treatment of Severe Hypertension During Pre-Eclampsia.A Preliminary Equivalence Study Between URAPIDIL and NICARDIPINE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertension During Pre-Eclampsia
Keywords: PRE-ECLAMPSIA-URAPIDIL-NICARDIPINE
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2006-12-08
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: 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.
timeFrame: 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 outcomes:
measure: -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
timeFrame: During the first 48hour of life
Other outcomes:
Locations:
city: BESANçON
country: France
facility: Hôpital Saint-Jacques, CHU de Besançon
city: Nancy
country: France
facility: Maternité A. PINARD
city: Schiltigheim
country: France
facility: Sihcus-Cmco
city: Strasbourg
country: France
facility: Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Pierre Auguste DIEMUNSCH, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diemunsch P, Garcia V, Lyons G, Pottecher J, Emmanuel S. Urapidil versus nicardipine in preeclamptic toxaemia: A randomised feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):822-3. doi: 10.1097/EJA.0000000000000303. No abstract available.