A RANDOMIZED CONTROLLED TRIAL OF LABETALOL AND HYDRALAZINE IN THE MANAGEMENT OF SEVERE PREECLAMPSIA/ECLAMPSIA AT FEDERAL TEACHING HOSPITAL, ABAKALIKI
Background: Severe preeclampsia and eclampsia are important causes of maternal and perinatal morbidity and mortality. The definitive treatment is delivery of the baby and placenta. An essential component of its management is the control of severe hypertension. Hydralazine, a vasodilator, is the most commonly used agent at the Federal Teaching Hospital, Abakaliki (FETHA), but it is associated with sudden hypotension and tachycardia. Labetalol has only recently been introduced in FETHA for same management.
Objective: This study was designed to evaluate the efficacy and tolerability of intravenous hydralazine versus intravenous labetalol in the management of severe hypertension in patients with severe preeclampsia and eclampsia.
Method: This was a single blind randomized controlled trial on the efficacy of Labetalol and Hydralazine in the management of severe hypertension in preeclampsia and eclampsia at the Federal Teaching Hospital Abakaliki (FETHA). Eighty patients who were admitted with severe pre-eclampsia/ eclampsia and who fulfilled the inclusion criteria were randomized either into Group A (40 patients) or Group B (40 patients) using sequentially numbered opaque sealed envelopes. Finally, 38 patients in Group A (who received intravenous Labetalol in escalating doses of 20,40,80,80 and 80mg every 10 minutes if not effective), and 37 patients in Group B (who received intravenous Hydralazine 10mg slowly and repeated every 30 minutes if not effective), were included in the analysis. The primary end point was minimal number of doses and/or time taken to successfully achieve target blood pressure of diastolic blood pressure ˂110mmHg and/or systolic blood pressure˂160mmHg. The study was conducted from September 2016 to July 2017. Data analysis was done using statistical Package for Social Science (IBM SPSS) software (version 22, Chicago II, USA). Statistical significance was set at a P value of less than 0.05.
Results: The demographic characteristics of the participants in both groups were matched. No significant differences were observed for maternal blood pressure control, number of doses to achieve the desired blood pressure or persistent severe hypertension. However, the Labetalol arm achieved the target blood pressure in a shorter mean interval of 28.84±12.55min compared to Hydralazine, 47.65±18.23min; p <0.0001. Though headache occurred significantly more among the patients treated with Hydralazine, other maternal and neonatal complications and outcome were similar.
Conclusion: This study demonstrates that intravenous labetalol is equally as effective as intravenous hydralazine in controlling severe hypertension. Although the time taken to achieve the target blood pressure control was shorter with labetalol, the risk of having headache was more with hydralazine. Other variables were similar.