What is the effect of nicardipine on the pregnant woman with severe hypertension and how is nicardipine excreted?

Conditions: 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
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2012-005330-10-NL

Lead Sponsor: Erasmus University Medical Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Eclampsia

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.