Nicardipine might decrease adverse maternal and neonatal outcome due to its pharmacokinetics and fewer side-effects.
ID
Bron
Verkorte titel
Aandoening
Pregnancy induced hypertension, preeclampsia, anti-hypertensive treatment, labetalol, nicardipine.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Nicardipine might decrease adverse maternal and neonatal outcome due to its pharmacokinetics and fewer side-effects.
Onderzoeksopzet
Inclusion will take place during pregnancy. Neonatal and maternal data of the admission will be collected.
Onderzoeksproduct en/of interventie
Labetalol iv or nicardipine iv in acute hypertension of pregnancy ≥160/110mmHg.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7339 |
| NTR-old | NTR7554 |
| Ander register | 60462 : ABR |