drugset / Trial / NCT04435210

Efficacy of Nifedipine Versus Hydralazine in Management of Severe Hypertension in Pregnancy

NCT04435210

Completed 69 enrolled Adebayo Joshua Adeniyi
RandomizedParallel-groupOpen-labelTreatment

Summary

Introduction - Hypertension is the commonest medical complication of pregnancy. When severe, it puts the lives of both the mother and the unborn baby at risk. Therefore, immediate lowering of blood pressure is indicated whenever this is detected. Different anti-hypertensive drugs are being used to that effect, but more commonly these include: hydralazine, labetalol and nifedipine. Nifedipine, despite being cheap, readily available, safe in pregnancy and easy to administer, is hardly utilized for this purpose in our setting. Hydralazine is usually used instead. Objectives - This will be: to determine the efficacy of nifedipine and compare it with that of hydralazine, which is more commonly used, and to compare their maternal and fetal side effect profile. Materials and methods - This will be a prospective randomized controlled open label study of nifedipine versus hydralazine. Patients will be assigned to different arms of the study using computer-generated random numbers. Efficacy and adverse effects of the drugs will be noted on each arm of the study. Data will be collated, tabulated and then statistically analysed using the statistical package for social sciences (SPSS). Conclusion - The outcome of the study will enable recommendation to be made on the use of nifedipine for severe hypertension if found to be effective.

Timeline

Start
2018-08-13
Primary completion
2019-02-09
Completion
2019-02-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydralazine Small molecule 10 mg Intravenous
Subject Nifedipine Other / unclassified 20 mg Oral

Indications