A comparative randomized controlled parallel group study of efficacy and tolerability of labetalol versus methyldopa in the treatment of mild preeclampsia.

ABSTRACT

Background: The objective of the current study was to compare the efficacy and tolerability of labetalol versus methyldopa in the treatment of mild preeclampsia. Methods: We carried out a prospective randomized controlled parallel group study on 100 outpatients of Obstetrics and Gynaecology Department of Government Medical College, Patiala, a tertiary care teaching hospital. Pregnant patients (20-40 weeks gestational age) newly diagnosed with blood pressure (BP) of ≥140/90 mm Hg were included in the study. All patients with systolic BP (SBP) ≥160 mm Hg and diastolic BP (DBP) ≥110 mm Hg after 20 weeks of gestation, history of hypertension, renal diseases, diabetes mellitus, epilepsy, and thyroid diseases were excluded from the study. After taking the informed consent, 50 patients each were randomized to either of the two treatment arm-oral labetalol or oral methyldopa. Difference in the BP measurements at the time of admission and at the time of delivery were analyzed by applying paired t-test. For intergroup analysis, we applied independent t-test using SPSS version 16. A p<0.05 was regarded as significant. Results: Both methyldopa and labetalol cause significant fall in SBP, DBP and mean arterial pressure (MAP) in their groups (p<0.001). However, when we compared both groups it was labetalol, which causes significant fall in MAP as compared to methyldopa (p<0.001). The incidence of adverse effects like hypotension, headache, and sedation were also less in labetalol group. Conclusion: Labetalol has an upper edge over methyldopa in control of BP during pregnancy with minimal adverse effects.