A Comparative Study of Oral Nifedipine and Intravenous Labetalol for Acute Hypertensive Management in Pregnancy: Assessing Feto-Maternal Outcomes in a Hospital-based Randomized Control Trial.

Abstract

Background and objective: Hypertension is one of the most common medical complications during pregnancy and a leading cause of maternal mortality and morbidity. Severe preeclampsia is defined as blood pressure (BP) >160/110 mmHg with warning signs such as headache, blurring of vision, and epigastric pain. Nifedipine (C₁₇H₁₈N₂O₆), labetalol (C₁₉H₂₄N₂O₃), and hydralazine (C₈H₈N₄) are commonly used drugs, and all are recommended as first-line agents. Hydralazine is associated with a higher incidence of adverse outcomes, so oral nifedipine has been proposed as a first-line alternative to intravenous labetalol. Consequently, this study aims to compare the efficacy and safety of oral nifedipine with that of intravenous labetalol. The objective is to compare the ability/effectiveness of oral nifedipine and intravenous labetalol to normalize acute hypertension in severe preeclampsia and to assess the birth outcome. Relations between different factors were established by appropriate statistical tests. The p-value <0.05 was considered statistically significant.

Methods: The study was conducted on 120 antenatal women with blood pressure ≥160/110 mmHg admitted to our hospital, a tertiary care center, from January 1st, 2020 to June 30th, 2021. Patients were randomized by a single blinding method to receive intravenous labetalol and oral nifedipine. The primary outcome measures were the time taken to control the blood pressure and the number of doses of drugs required. The secondary outcome measures were the birth outcome like a method of delivery, side effect profile, and the number of admissions in the neonatal intensive care unit.

Results: A total of 120 patients were included with 60 patients in each group. The labetalol group took 48.67 ± 17.80 minutes and the nifedipine group took 64.33 ± 9.81 minutes to achieve a target BP of <=140/90 mmHg (p < 0.05). No side effects were seen in 70% of patients in the labetalol group and 71.67% in the nifedipine group (p > 0.05).

Conclusion and global health implications: Intravenous labetalol is faster in restoring blood pressure in pregnant women with preeclampsia than oral nifedipine and may be used as a first-line drug in the acute control of blood pressure in a hypertensive emergency during pregnancy. More studies are needed in order to evaluate the findings from this pilot study in a large sample of patients.