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Oral Nifedipine or Intravenous Labetalol for Hypertensive Emergency in Pregnancy: A Randomized Controlled Trial

Shekhar, Shashank MD; Sharma, Chanderdeep MD, DNB; Thakur, Sita MD; Verma, Suresh MD

doi: 10.1097/AOG.0b013e3182a9ea68
Original Research
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OBJECTIVE: To compare the effectiveness of orally administered nifedipine and intravenously administered labetalol for acute blood pressure control in hypertensive emergency of pregnancy.

METHODS: In this double-blind, randomized, controlled trial, pregnant women with sustained increase in systolic blood pressure of 160 mm Hg or higher or diastolic blood pressure of 110 mm Hg or higher were randomized to receive nifedipine (10 mg tablet orally up to five doses) and intravenous placebo saline injection or intravenous labetalol injection in escalating doses of 20, 40, 80, 80, and 80 mg and a placebo tablet every 20 minutes until the target blood pressure of 150 mm Hg systolic and 100 mm Hg diastolic, or lower, was achieved. Crossover treatment was administered if the initial treatment failed. The primary endpoint of the study was time necessary to achieve target blood pressure. Secondary endpoints were number of dosages required, adverse maternal and neonatal effects, side effect profile, and perinatal outcome.

RESULTS: From October 2012 to April 2013, we enrolled 60 patients. The median time taken to achieve target blood pressure was 40 minutes (interquartile range, 20–60 minutes) compared with 60 minutes (interquartile range 40–85 minutes) for nifedipine and labetalol, respectively (P=.008). The median dose required was two (interquartile range 1–3) compared with three (interquartile range 2–4.25) for nifedipine and labetalol, respectively (P=.008). No serious adverse maternal or perinatal side effects were witnessed in either group.

CONCLUSION: As administered in this trial, oral nifedipine lowered blood pressure more quickly than did intravenous labetalol during hypertensive emergency in pregnancy.

CLINICAL TRIAL REGISTRATION: Clinical Trials Registry—India, www.ctri.nic.in, CTRI/2013/02/003350.

LEVEL OF EVIDENCE: I

Because of its effectiveness and comparable side effect profile, oral nifedipine is a reasonable alternative to intravenous labetalol in the management of hypertensive emergency in pregnancy.

Departments of Obstetrics and Gynecology, AIIMS Jodhpur, Rajasthan, and Dr. Rajendra Prasad Government Medical College, Tanda, Kangra HP, India.

Corresponding author: Chanderdeep Sharma, MD, DNB, Set No. 112, Vivekanand Hostel, Dr. Rajendra Prasad Government Medical College, Tanda, Kangra, HP, India; e-mail: cdsharma2006@gmail.com.

The authors thank the resident doctors as well as the nursing staff of the Department of Obstetrics and Gynecology of Dr. Rajendra Prasad Government Medical College, Tanda, Kangra, for their help in recruiting patients for the trial and patient care.

Financial Disclosure The authors did not report any potential conflicts of interest.

© 2013 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.