The objective of this study is to demonstrate that urapidil is not inferior to nicardipine for the treatment of hypertension associated with preeclampsia (PE) and that it is better tolerated. * efficacy endpoint : mean arterial blood pressure corrected to 100-120 mmHg after 120 min of study drug administration. * safety endpoints : clinical and biological observation for any side effect. All infants will be observed in the neonatology unit (during 48h). Pharmacokinetic study included to study : * transplacental transfer, * transfer in breast milk, * and neonatal elimination (premature babies of mothers treated with urapidil (less than 33 WG))
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
14
Urapidil (Eupressyl\*) : IV One initial iv bolus of 12.5 mg. One or more bolus of 6.25 mg at intervals of 5 minutes if the diastolic pressure remains above 100 mmHg. The treatment is then continued at 4 mg.h-1 iv via a syringe pump. The maintenance dose needed to maintain MAP between 100 and 120 mmHg is sought by adjustments of ± 2 mg.h-1every 5 minutes. Maximum dose of 30 mg.h-1.
Nicardipine : IV 1 mcg.kg-1.min-1until reduction MAP 15%. Reduction 1/4 of the posology (0.75 mcg.kg -1.min-1). The maintenance dose needed to maintain MAP between 100 and 120 mmHg is then sought by adjustments of ± 0.25 mcg.kg.min-1every 5 minutes. Maximum dose of 6 mg.h-1
Service d'Anesthésie - CMCO
Schiltigheim, France
Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Blood pressure at two hours
Time frame: up to 4 days
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