Maternal pharmacokinetics and pharmacodynamics of nicardipine (iv) during treatment of severe hypertension in pregnancy.

Erasmus University Medical Centre0 个研究点开始时间: 2013年3月13日最近更新: 2013年3月25日

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•Pregnant patients with preeclampsia (hypertension and protein/creatinine ratio = 30mg/mmol or = 300mg protein/24hours) complicated with severe hypertension (systolic bloodpressure = 160mmHg and/or diastolic blood pressure = 110mmHg)
•gestational age = 20 weeks
•working knowledge of Dutch language
•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 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Fetal indication for immediate delivery, ie. signs of fetal distress: spontaneous repeated persistent unprovoked decelerations on CTG
•Fetal death or major fetal congenital anomalies or estimated fetal weight below 500 grams
•Placental abruption
•Concomitant medication: nifedipine, cimetidine, labetalol
•Clinically relevant pulmonary edema, defined as clinically relevant respiratory failure or severe respiratory distress requiring oxygen supplementation (more than 10 litres), with rales and/or pulse oximetry of <94% on room air
•Suspicion of (sub)capsular liverhematoma on physical examination
•Renal failure (creatinine clearance < 40 mL/min)
•Suspicion of cerebro-vascular incident on physical examination
•Suspicion of trombo-embolism on physical examination
•Other severe maternal complications
•Maternal age <16 years
•Mentally incapacitated patient
•Impossible to place an intra-arterial catheter.

发起方

Erasmus University Medical Centre