Pregnancy reLated Acute hyperTension INtervention Action: a randomized trial comparing labetalol and nicardipine in women with acute hypertension in pregnancy (Platina-trial)
- Conditions
- To asses optimal treatment of hypertension of hypertensive disorders in pregnancyTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2015-005811-34-NL
- Lead Sponsor
- VU Medical Center, Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 472
In order to be eligible to participate in this study, a subject must meet the following criteria:
-Pregnant women
->18 years of age
-pregnant women with 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 472
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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%.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method