THE TREATMENT OF HYPERTENSION ASSOCIATED WITH SEVERE PREECLAMPSIA.A RANDOMIZED CONTROLLED TRIAL OF URAPIDIL VERSUS NICARDIPINE.The URANIC trial. - URANIC

Hôpitaux Universitaires de Strasbourg0 个研究点目标入组 366 人开始时间: 2015年6月26日最近更新: 2020年9月7日

适应症

试验速览

暂无简介。

•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,
•Proteinuria > 300 mg.day-1 or > 2 crosses(++) on an urinary dipstick,
•Patient with severe PIH, as defined by :
•Systolic BP = 160mmHg and/or Diastolic BP =110mmHg, after the 20th week of amenorrhea, without chronic hypertension,
•Written informed consent signed and dated by both investigator and patient
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 366
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Known allergy to the 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.
•Person with difficulty understanding information
•Person with diminished responsiblity,
•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

发起方

Hôpitaux Universitaires de Strasbourg