Platina-trial: labetalol versus nicardipine in acute hypertension in pregnancy.

Pregnancy reLated Acute hyperTension INtervention Action: a randomized trial comparing labetalol and nicardipine in women with acute hypertension in pregnancy.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20888

Enrollment

472

Registered

2018-10-11

Start date

2018-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy induced hypertension, preeclampsia, anti-hypertensive treatment, labetalol, nicardipine.

Interventions

Labetalol iv or nicardipine iv in acute hypertension of pregnancy &#8805

160/110mmHg.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)