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

Phase 3

Recruiting

• Conditions: hypertension in pregnancy; 10026908

• Registration Number: NL-OMON47595
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 472

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

- 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 or labetalol (asthma, bradycardia, heart blocks, acute chronic heart failure or severe aortic stenosis).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>Maternal morbidity and mortality</p><br>