NL-OMON36863
Not Yet Recruiting
Phase 2
Maternal pharmacokinetics and pharmacodynamics of nicardipine (iv) during treatment of severe hypertension in pregnancy. - Nicardipine PkPd study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- preeclampsia
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 40
- Status
- Not Yet Recruiting
- Last Updated
- 2 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
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.
Outcomes
Primary Outcomes
Not specified
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