Pregnancy related Acute hyperTension Intervention Action: a randomized trial comparing labetalol and nicardipine in women with acute hypertension in pregnancy (Platina-trial)

Pregnancy related Acute hyperTension Intervention Action: a randomized trial comparing labetalol and nicardipine in women with acute hypertension in pregnancy (Platina-trial) - Platina-trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47595

Enrollment

472

Registered

2018-03-28

Start date

2018-08-13

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

hypertension in pregnancy

Interventions

INTERVENTIONS: Intravenous administration of labetalol iv vs. oral nifedipine

hypertension

labetalol

nicardipine

pregnancy

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Pregnant women; - >=18 years of age; - Severe pregnancy induced hypertension (PIH) or severe pre-eclampsia (PE) at any gestational age. Preeclampsia is defined as hypertension with proteinuria >= 0.3 g/24 hrs.

Exclusion criteria

Exclusion criteria: - Maternal age at eligibility

Design outcomes

Primary

Measure	Time frame
PRIMARY OUTCOME MEASURES: Composite poor maternal and neonatal outcome (mortality and morbidity). POWER/DATA ANALYSIS: Analysis will be intention-to-treat. To detect a difference of 15% in neonatal and maternal outcome with 90% power and alpha 0.05 we will include 472 women (236 per arm).	—

Secondary

Measure	Time frame
Maternal morbidity and mortality	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)