No registrations found.
ID
Source
Brief title
Health condition
Pregnancy induced hypertension, preeclampsia, anti-hypertensive treatment, labetalol, nicardipine.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
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.
Background summary
Compare women with severe hypertension in pregnancy the two most promising drugs: labetalol for its international antihypertensive agent of choice and lack of reflex tachycardia or increased intracranial pressure and nicardipine for its pharmacokinetics with the shortest half-life of antihypertensive drugs and minimal side effects.
Study objective
Nicardipine might decrease adverse maternal and neonatal outcome due to its pharmacokinetics and fewer side-effects.
Study design
Inclusion will take place during pregnancy. Neonatal and maternal data of the admission will be collected.
Intervention
Labetalol iv or nicardipine iv in acute hypertension of pregnancy ≥160/110mmHg.
Inclusion criteria
- Pregnant women.
- ≥18 years of age.
- Severe pregnancy induced hypertension (PIH) or severe preeclampsia (PE) at any gestational age. Pre-eclampsia is defined as hypertension with proteinuria ≥0.3g/24hrs.
Exclusion criteria
- Maternal age at eligibility <18 years.
- Fetal abnormalities.
- Multiple pregnancy in current pregnancy.
- Clinically relevant pulmonary edema, defined as pulmonary failure or distress requiring oxygen supplementation (more than 10 liters) and/or pulse oximetry of <94%.
- An allergy to (a substrate of) nicardipine or labetalol.
- A contraindication for the usage of nicardipine (severe aortic stenosis) or labetalol (asthma, bradycardia, heart blocks, acute chronic heart failure).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7339 |
| NTR-old | NTR7554 |
| Other | 60462 : ABR |