Oral Immediate-Release Nifedipine Versus Intravenous Hydralazine for Controlling Severe Hypertension in Pregnancy: A Double-Blind Randomised Controlled Trial
Keywords:
Severe hypertension in pregnancy, Oral immediate-release nifedipine, Intravenous hydralazine, Randomised controlled trial, Hypertensive disorders of pregnancy, Maternal and fetal outcomes, Acute blood pressure control, Low- and middle-income countriesAbstract
Background: A significant gap exists in understanding the efficacy and safety of oral immediate-release nifedipine and intravenous hydralazine in the control of severe hypertension in pregnancy within the context of randomised control trials.
Objectives: To compare the efficacy and safety of oral immediate-release nifedipine and intravenous hydralazine for controlling severe hypertension in pregnancy.
Methods: Randomised, double-blind, 2-arm, single center non-inferiority trial in pregnant women with confirmed severe hypertension in pregnancy who were randomised in a 1:1 ratio to receive oral immediate-release Nifedipine (n=35) or intravenous hydralazine (n=35) was done from 20th June 2019 to 20th December, 2019. The primary outcome was the mean time required to achieve target blood pressure. Secondary outcomes included the mean number of anti-hypertensive doses needed, proportions requiring crossover or rescue therapy, frequency of maternal side effects, fetal heart rate abnormalities, maternal complications, neonatal birth asphyxia, and mode of delivery.
Results: The baseline socio-demographic parameters were similar between the two groups. The mean durations taken to reach the target blood pressure for patients that received oral immediate-release nifedipine versus intravenous hydralazine were 48.29min±31.95 and 41.20min±26.98 respectively (P=0.320). The mean dose used before target blood pressure was reached, the proportion of participants that crossed over to another treatment allocation, and the proportion that required a rescue anti-hypertensive (labetalol) to achieve the target blood pressure were similar between the two groups (P >0.05). None of the participants that received oral immediate-release nifedipine had maternal or neonatal side effect while one participant (2.9%) that received intravenous hydralazine had nausea and vomiting.
Conclusion: Oral immediate-release nifedipine is as effective as intravenous hydralazine in controlling severe hypertension in pregnancy. Both have remarkable materno-fetal safety profile and its non-invasive nature makes it an appealing modality especially in resource poor countries. More robust studies are encouraged to increase the evidence for its use as first line anti-hypertensives, especially in low and middle-income countries.
Trial Registration: Pan African Clinical Trial registry, PACTR201906662822573, registration date: 19th June, 2019.
References
Kaur T, Kumari K, Rai P, Gupta V, Pandey S, Vineeta, et al. Comparative study of oral nifedipine versus intravenous labetalol for acute hypertension management in pregnancy: Evaluation of feto-maternal outcomes in a hospital-based randomized controlled trial. Int J MCH AIDS. 2024;13. doi: 10.25259/IJMA_660.;
Yenet A, Nibret G, Tegegne BA. Challenges to the Availability and Affordability of Essential Medicines in African Countries: A Scoping Review. Clinicoecon Outcomes Res. 2023 Jun 13;15:443-458. doi: 10.2147/CEOR.S413546.
Gudeta TA, Regassa TM. Pregnancy Induced Hypertension and Associated Factors among Women Attending Delivery Service at Mizan-Tepi University Teaching Hospital, Tepi General Hospital and Gebretsadik Shawo Hospital, Southwest, Ethiopia. Ethiop J Health Sci. 2019 Jan;29(1):831-840. doi: 10.4314/ejhs.v29i1.4.
S D, Novri DA, Hamidy Y, Savira M. Effectiveness of nifedipine, labetalol, and hydralazine as emergency antihypertension in severe preeclampsia: a randomized control trial. F1000Res. 2023 Apr 27;11:1287. doi: 10.12688/f1000research.125944.2.
Braunthal S, Brateanu A. Hypertension in pregnancy: Pathophysiology and treatment. SAGE Open Med. 2019 Apr 10;7:2050312119843700. doi: 10.1177/2050312119843700.
Magee LA, Smith GN, Bloch C, Côté AM, Jain V, Nerenberg K, et al. Guideline No. 426: Hypertensive Disorders of Pregnancy: Diagnosis, Prediction, Prevention, and Management. J Obstet Gynaecol Can. 2022 May;44(5):547-571.e1. doi: 10.1016/j.jogc.2022.03.002.
Nyame S, Boateng D, Heeres P, Gyamfi J, Gafane-Matemane LF, Amoah J, et al. Community-Based Strategies to Improve Health-Related Outcomes in People Living With Hypertension in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis. Glob Heart. 2024 Jun 12;19(1):51. doi: 10.5334/gh.1329.
Alavifard S, Chase R, Janoudi G, Chaumont A, Lanes A, Walker M, Gaudet L. First-line antihypertensive treatment for severe hypertension in pregnancy: A systematic review and network meta-analysis. Pregnancy Hypertens. 2019 Oct;18:179-187. doi: 10.1016/j.preghy.2019.09.019.
Duley L, Meher S, Jones L. Drugs for treatment of very high blood pressure during pregnancy. Cochrane Database Syst Rev. 2013 Jul 31;2013(7):CD001449. doi: 10.1002/14651858.CD001449.pub3.
Ehikioya E, Okobi OE, Beeko MAE, Abanga R, Abah NNI, Briggs L, et al. Comparing Intravenous Labetalol and Intravenous Hydralazine for Managing Severe Gestational Hypertension. Cureus. 2023 Jul 23;15(7):e42332. doi: 10.7759/cureus.42332.
Patel P, Koli D, Maitra N, Sheth T, Vaishnav P. Comparison of Efficacy and Safety of Intravenous Labetalol Versus Hydralazine for Management of Severe Hypertension in Pregnancy. J Obstet Gynaecol India. 2018 Oct;68(5):376-381. doi: 10.1007/s13224-017-1053-9.
Easterling T, Mundle S, Bracken H, Parvekar S, Mool S, Magee LA, et al. Oral antihypertensive regimens (nifedipine retard, labetalol, and methyldopa) for management of severe hypertension in pregnancy: an open-label, randomised controlled trial. Lancet. 2019 Sep 21;394(10203):1011-1021. doi: 10.1016/S0140-6736(19)31282-6.
Kausar M, Husain S, Hussain R. Comparison of efficacy of intravenous labetalol and intravenous hydralazine for management of pre-eclampsia in pregnant women. Afri Health Sci. 2023;23(1):320-5. https://dx.doi.org/10.4314/ahs.v23i1.34.
Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian journal of psychological medicine. 2013;35(2):121. doi:10.4103/0253-7176.116232.
Rezaei Z, Sharbaf FR, Pourmojieb M, Youefzadeh-Fard Y, Motevalian M, Khazaeipour Z, et al. Comparison of the efficacy of nifedipine and hydralazine in hypertensive crisis in pregnancy. Acta Medica Iranica. 2011;49(11):701. PMID:22131238.
Sabir S, Yasmin S, Abbas G. Comparison of oral nifedipine with intravenous hydralazine for acute hypertensive emergencies of pregnancy. Journal of Postgraduate Medical Institute (Peshawar-Pakistan). 2016;30(4). https://jpmi.org.pk/index.php/jpmj/articlr/view/1902.
Firoz T, Magee L, MacDonell K, Payne B, Gordon R, Vidler M, et al. Oral antihypertensive therapy for severe hypertension in pregnancy and postpartum: a systematic review. BJOG: An International Journal of Obstetrics &Gynaecology. 2014;121(10):1210-8.
Kwawukume E, Ghosh T. Oral nifedipine therapy in the management of severe preeclampsia. International Journal of Gynecology & Obstetrics. 1995;49(3): 265-9. doi: 10.1016/0020-7292(95)02372-j
Liu Q, Yu Y, Gong S, Huang L. Clinical efficacy and perinatal outcome of nifedipine for severe preeclampsia: meta-analysis. Zhonghua fu chan ke za zhi. 2012;47(8):592-7. doi:10.3760/cma.j.issn.0529-567x.2012.08.008.
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