EUCTR2012-005330-10-NL
Active, Not Recruiting
N/A
Maternal pharmacokinetics and pharmacodynamics of nicardipine (iv) during treatment of severe hypertension in pregnancy.
Erasmus University Medical Centre0 sitesMarch 13, 2013
DrugsCardene IV
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus University Medical Centre
- Status
- Active, Not Recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Not specified
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