Platina-trial: labetalol versus nicardipine in acute hypertension in pregnancy.
Recruiting
- Conditions
- Pregnancy induced hypertension, preeclampsia, anti-hypertensive treatment, labetalol, nicardipine.
- Registration Number
- NL-OMON20888
- Lead Sponsor
- Amsterdam UMC.
- Brief Summary
one.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 472
Inclusion Criteria
Pregnant women.
- ≥18 years of age.
Exclusion Criteria
- Maternal age at eligibility <18 years.
- Fetal abnormalities.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite adverse neonatal outcome (Respiratory Distress Syndrome, Broncho Pulmonary Dysplasia, Intraventricular Haemorrhage grade 3 or 4, Necrotizing Enterocolitis > stadium 1, Periventricular Leukomalacia, Retinopathy of Prematurity and death before discharge for the neonatal intensive care unit).
- Secondary Outcome Measures
Name Time Method Secondary neonatal outcomes are preterm birth rate (<34 and <37 weeks), hospital admission and number of days in neonatal intensive care, and hypotension, asphyxia, hypoglycemia and bradycardia if needed treatment.<br /><br>The main maternal outcome will be defined as a composite of the occurence of eclamptic seizures, cerebral hemorrhage, liver hematoma and rupture, pulmonary edema, admission to the intensive care for ventilation or necessity for intra-arterial monitoring and maternal death. Other outcomes are inadequat control of blood pressure, necessity to use additional or switch to ohter antihypertensive medication, time and dose to blood pressure control.