The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine

Study Overview
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Brief Summary
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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))

Official Title
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The Treatment of Hypertension Associated With Severe Preeclampsia. A Randomize Controlled Trial of Urapidil Versus Nicardipine. The Uranic Trial

Conditions
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Hypertension, Preeclampsia

Intervention / Treatment
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* Drug: Urapidil
* Drug: Nicardipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients Singleton pregnancy Patients with remaining hypertension despite an oral treatment for who an iv antihypertensive treatment is indicated Patient with PE, as defined by : Systolic Blood Pressure (BP) ≥ 140 mmHg and/or Diastolic BP ≥ 90 mmHg, after the 20th week of amenorrhea, without chronic hypertension, AND Proteinuria > 300 mg.day-1 or > 2 crosses(++) on an urinary dipstick, OR Patient with severe Pregnancy Induced Hypertension (PIH), as defined by : Systolic BP ≥ 160 mmHg and/or Diastolic BP ≥110 mmHg, after the 20th week of amenorrhea, without chronic hypertension, Written informed consent signed and dated by both investigator and patient, Valid social security affiliation Exclusion Criteria: Known allergy to study drugs Contra-indication to the study drugs: stenosis of the aortic isthmus, arteriovenous shunt, coarctation of the aorta, unstable angina, compensatory hypertension, myocardial infarction < 8 days. Eclampsia Person with difficulty understanding information Person with diminished responsibility, Ongoing intravenous antihypertensive treatment, No pressure cuff adapted to the morphology of the arms of the patients Concomitant use of 5 phosphodiesterase inhibitors Participation in a clinical trial within 6 months prior to inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urapidil<br>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. | Drug: Urapidil<br>* 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.<br>|
| Active Comparator: Nicardipine<br>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 | Drug: Nicardipine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure at two hours |  | up to 4 days | 

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