A Randomised Parallel-Group Trial For Comparison Of Safety And Efficacy Of Oral Nifedipine Retard Versus Intravenous Labetalol In Management Of Hypertensive Emergencies Of Pregnancy

Abstract

Background: Pre-eclampsia is a complication of pregnancy that is associated with substantial maternal and fetal morbidity and mortality. The disease presents with new-onset hypertension and often proteinuria in the mother, which can progress to multi-organ dysfunction, including hepatic, renal and cerebral disease, if the fetus and placenta are not delivered. Treating of severely increased blood pressure is widely recommended to reduce the risk for maternal complications. Regimens for the acute treatment of severe hypertension typically include intravenous medications. Although effective, these drugs require venous access and careful fetal monitoring and might not be feasible in busy or low resource environments. Aims and objectives: To compare the safety and efficacy of oral Nifedipine retard to intravenous Labetalol in the management of hypertensive emergencies of pregnancy. Methodology: A Randomized parallel group comparative study was conducted in Department of Obstetrics and Gynecology of Shri B.M Patil Medical College And Research Centre, Vijaypura. A total of 104 pregnant women with Hypertensive emergencies attending outpatient department were included and divided into 2 groups with 52 each in group A which was given IV labetalol and group B with oral Nifedipine retard 20mg. IV Labetalol group received 20mg initially followed by escalating doses of 40m and 80mg up to maximum of 5 doses every 15min up to target blood pressure is reached. Group B received Oral Nifedipine retard (Extended release) 20mg initially followed by repeated doses of 20mg every 30 minutes maximum of 5 doses until desired target blood pressure was reached. (SBP <150 mm Hg and DBP between 80-100 mm Hg). During the study, vitals are monitored closely and the maternal blood pressures will be recorded at every 15 minutes to achieve target blood pressure. Then at every 30 minutes for the next 2 hours followed by hourly monitoring and recording any adverse effect of the drugs. Results: The present study showed the maximum age group were in between 18-24 year of age. In this study mean of SBP enrollment of IV Labetalol and Oral Nifedipine retard was 169.42±13.197 and 163.48±5.363 respectively and Mean DBP of IV Labetalol and Oral Nifedipine retard was 112.69±7.440 and 112.60±5.154 respectively. Proteinuria and oedema were more in IV Labetalol than in Oral Nifedipine retard group. Mean dose of IV Labetalol and Oral Nifedipine was 70±42.565 and 33.17±13.137 respectively. A highly significant (p value 0.001) results with mean of total number of doses given in IV Labetalol and Oral Nifedipine was 2.06±.669 and 1.73±.630 were obtained respectively. Mean SBP after 15 min, 30 min, 45 min, 60 min, 75 min and 90 min in group A and group B was 155.10±13.172 and 158.54±5.301, 143.64±12.776 and 149.48±7.883, 141.67±16.967 and 148.47±6.601, 138±16.745 and 140.96±8.126, 136±11.256 and 138.40±6.066 and 132±13.246 and136±7.071 respectively. Results were found to be significant. Mean DBP after 15 min, 30 min, 45 min, 60 min, 75 min and 90 min was in group A and group B was 100.78±7.441 and 107.37±6.630, 92.73±8.174 and 98.63±7.659, 90.83±9.962 and 98.17±6.412, 86±6.783 and 90.56±5.938, 84±8.567 and 88.40±3.209 and 82 ±9.563 and 86±8.960 respectively. Results were found to be significant. Mean target SBP of IV Labetalol and Oral Nifedipine was 139.42±8.498 and 139.12±6.379 respectively. Mean target DBP of IV Labetalol and Oral Nifedipine was 89.42±6.076 and 89.52±4.672 respectively. Most of the patients 35(67.3%) of IV Labetalol and 30(57.5%) of Oral Nifedipine group B did not had any side effects. 7(13.4%) patients had Headache and 2(3.9%) patients had abdominal pain side effect in IV Labetalol and 12(23%) had tachycardia in Oral Nifedipine. Results were found to be significant (P value0.04) when comparing side effect in IV Labetalol and Oral Nifedipine. Conclusion: The blood pressure can be effectively controlled with the use of Labetalol in the dosage used which was observed in cases of moderate to severe pregnancy- induced hypertension. IV labetalol is safe drug and effective drug in management of hypertension in pregnancy.