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A clinical trial to study the comparative efficacy of two drugs, intravenous labetalol and oral nifedipine in pregnant patients with severely high blood pressure

A randomized double blind trial comparing oral nifedipine and intravenous labetalol for acute blood pressure control in hypertensive emergencies of pregnancy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/02/003350
Enrollment
60
Registered
2013-02-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Severe hypertension during pregnancy

Interventions

Intervention1: intravenous labetalol: Intravenous Labetalol 20, 40, 80, 80, 80 at 20 minutes interval with maximum of 300 mg Control Intervention1: Oral Nifedipine: Oral Nifedipine 10 mg at 20 minut

Sponsors

Institutional
Lead Sponsor

Eligibility

Inclusion criteria

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 • Reassuring fetal heart rate

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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) â?¢ Maternal heart rate profile during the first 80 minutes â?¢ Maternal hypotension (BP 90/60 mm of Hg) â?¢ Side effects profile â?¢ Perinatal outcomeTimepoint: Number of dosages ( 1-5)

Countries

India

Contacts

Public ContactDr Shashank Shekhar

Dr RPGMC Tanda

longshanks28@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 22, 2026