IV LABETALOL AND ORAL NIFEDIPINE IN ACUTE CONTROL OF SEVERE HYPERTENSION IN PREGNANCY- A RANDOMIZED CONTROLLED TRIAL
Thursday, February 13, 2020
4:15 PM – 4:30 PM
Location: Max Bell Auditorium
Introduction: Hypertension is the most common medical disorder of pregnancy and is undoubtedly responsible for most morbidity. Although previous meta-analysis showed oral nifedipine was associated with less risk of persistent hypertension and as efficacious and safe as intravenous labetalol, the most important limitation was small number of included trials and small number of participants,thererfore the need for an RCT. We also used a double blinded double dummy design to reduce the bias of comparing oral vs IV drug. Our objective is to compare the efficacy of Intravenous Labetalol with Oral Nifedipine in the treatment of severe hypertension in pregnancy.
Methods: DESIGN Prospective double-blinded randomized controlled trial over a period of 2 years in women with severe hypertension of ≥160/110mm Hg. METHODS Labetalol group received 20 mg initially followed by escalating doses of 40 mg, 80 mg, 80 mg and 80 mg (5 doses) every 15 minutes to a maximum of 300mg. Nifedipine group received 10 mg initially followed by repeated doses of 20 mg every 15 minutes (total 5 doses) to a maximum of 90 mg. Statistical analysis was done with SPSS20 (P <0.05 significant). Survival analysis was used to compare the efficacy of treatment regimens. MAIN OUTCOME MEASURE - The time taken and the number of doses required to achieve the target blood pressure (150/100 mmHg).
Results: The mean time taken for intravenous labetalol was higher (36.75 minutes) compared to oral nifedipine (27.25 minutes) [p=0.002]. Nifedipine group required significantly lower doses (1.82±0.83) as compared to labetalol (2.45±1.32) [p=0.002] to reach the target BP. Nifedipine was 1.8 times more likely to achieve target BP (Hazard Ratio=1.8)
Conclusion: Both intravenous Labetalol and oral Nifedipine were effective in controlling blood pressure. Nifedipine reduced BP more rapidly than Labetalol. Oral Nifedipine may be a better alternative because of its ease of oral administration and flat dosing regimen.