A clinical trial to study the comparative efficacy of two drugs, intravenous labetalol and oral nifedipine in pregnant patients with severely high blood pressure
Not Applicable
- Conditions
- Health Condition 1: null- Severe hypertension during pregnancy
- Registration Number
- CTRI/2013/02/003350
- Lead Sponsor
- Institutional
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
•Age 18 â?? 45 years
•Period of gestation >= 24 weeks
•Blood pressure : Systolic >= 160 mm of Hg or Diastolic >= 110 mm Hg
•Maternal heart rate >=60 bpm and <= 120 bpm
•Reassuring fetal heart rate
Exclusion Criteria
•History of heart rhythm abnormality
•History of heart failure
•History of bronchial asthma
•History of allergy to either nifedipine or labetalol
•Non pregnancy related hypertension
•Any hypertensive treatment in preceding 24 hours
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time taken to achieve the target systolic BP of â?¤ 150 mm of Hg and diastolic BP of â?¤ 100 mm of Hg ( both targets have to be fulfilled)Timepoint: Minutes
- Secondary Outcome Measures
Name Time Method â?¢Total number of antihypertensive dosages required to achieve the target systolic BP of â?¤ 150 mm of Hg and diastolic BP of â?¤ 100 mm of Hg ( both targets have to be fulfilled) <br/ ><br>â?¢Maternal heart rate profile during the first 80 minutes <br/ ><br>â?¢Maternal hypotension (BP 90/60 mm of Hg) <br/ ><br>â?¢Side effects profile <br/ ><br>â?¢Perinatal outcomeTimepoint: Number of dosages ( 1-5)