Oral Immediate-Release Nifedipine Versus Intravenous Hydralazine for Controlling Severe Hypertension in Pregnancy: A Double-Blind Randomised Controlled Trial

Ayodele Obianuju Okwuosa; George Uchenna Eleje; Okechukwu Christian Ikpeze; Emmanuel Onyebuchi  Ugwu; Boniface Chukwuneme Okpala; Golibe Christian Ikpeze; Ifeanyi Ogochukwu Okonkwo; Hillary Ikechukwu Obiagwu; Odigonma Zinobia Ikpeze; Ifeanyichukwu Jude Ofor; Emeka Philip Igbodike; Joseph Odirichukwu Ugboaja; Kingsley Emeka Ekwuazi; Chukwuemeka Chukwubuikem Okoro; Chigozie Geoffrey Okafor; Onyecherelam Monday Ogelle; Chukwunonso Isaiah Enechukwu; Lazarus Ugochukwu Okafor; Osita Samuel Umeononihu; Zebulon Chiawolamoke Okechukwu; Chukwudubem Chinagorom Onyejiaka; Chijioke Ogomegbunam Ezeigwe; Adanna Vivian Egwim; Chukwunwendu Aloysius Okeke; Johnbosco Emmanuel Mamah; Joseph Ifeanyichukwu Ikechebelu; Ahizechukwu Chigoziem Eke

doi:10.55640/ijmsdh-12-01-10

Open Access

Oral Immediate-Release Nifedipine Versus Intravenous Hydralazine for Controlling Severe Hypertension in Pregnancy: A Double-Blind Randomised Controlled Trial

Vol. 12 No. 01 (2026): Volume 12 Issue 01 | Pages: 67-77 | https://doi.org/10.55640/ijmsdh-12-01-10

Authors

Ayodele Obianuju Okwuosa
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.
https://orcid.org/0000-0003-3454-4324

George Uchenna Eleje
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria. / Effective Care Research Unit, Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University, Awka, Nigeria.
https://orcid.org/0000-0002-0390-2152

Okechukwu Christian Ikpeze
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.

Emmanuel Onyebuchi Ugwu
Department of Obstetrics and Gynaecology, College of Medicine, University of Nigeria Ituku-Ozalla, Enugu, Nigeria
https://orcid.org/0000-0002-3342-434X

Boniface Chukwuneme Okpala
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria. /Effective Care Research Unit, Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University, Awka, Nigeria.
https://orcid.org/0000-0003-1693-373X

Golibe Christian Ikpeze
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.
https://orcid.org/0000-0001-5034-9276

Ifeanyi Ogochukwu Okonkwo
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.
https://orcid.org/0000-0003-3004-9959

Hillary Ikechukwu Obiagwu
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.
https://orcid.org/0000-0002-4652-3320

Odigonma Zinobia Ikpeze
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.
https://orcid.org/0000-0003-2351-1076

Ifeanyichukwu Jude Ofor
Department of Obstetrics and Gynaecology, ESUT Teaching Hospital, Enugu, Nigeria.
https://orcid.org/0000-0003-2276-9446

Emeka Philip Igbodike
Department of Obstetrics and Gynaecology, Kelina Hospital, Victoria Island, Lagos, Nigeria.
https://orcid.org/0000-0003-4698-6226

Joseph Odirichukwu Ugboaja
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.

Kingsley Emeka Ekwuazi
Department of Obstetrics and Gynaecology, College of Medicine, University of Nigeria Ituku-Ozalla, Enugu, Nigeria
https://orcid.org/0000-0002-6213-4018

Chukwuemeka Chukwubuikem Okoro
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.
https://orcid.org/0000-0001-5772-661X

Chigozie Geoffrey Okafor
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.
https://orcid.org/0000-0003-4458-8216

Onyecherelam Monday Ogelle
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.
https://orcid.org/0000-0002-8772-3193

Chukwunonso Isaiah Enechukwu
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.
https://orcid.org/0000-0003-4639-5127

Lazarus Ugochukwu Okafor
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.
https://orcid.org/0000-0002-8772-3193

Osita Samuel Umeononihu
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.

Zebulon Chiawolamoke Okechukwu
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.
https://orcid.org/0009-0008-4481-8820

Chukwudubem Chinagorom Onyejiaka
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.
https://orcid.org/0000-0001-6471-2566

Chijioke Ogomegbunam Ezeigwe
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.
https://orcid.org/0000-0002-6795-3063

Adanna Vivian Egwim
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.
https://orcid.org/0000-0001-5015-1999

Chukwunwendu Aloysius Okeke
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria.
https://orcid.org/0000-0002-8305-2978

Johnbosco Emmanuel Mamah
Department of Obstetrics and Gynaecology, Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Nigeria.
https://orcid.org/0000-0002-9039-0238

Joseph Ifeanyichukwu Ikechebelu
Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Anambra State, Nigeria. Effective Care Research Unit, Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University, Awka, Nigeria.
https://orcid.org/0000-0003-2515-8464

Ahizechukwu Chigoziem Eke
Division of Maternal Fetal Medicine, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
https://orcid.org/0000-0002-0070-9840

Views: 98 Downloads: 61
Google Scholar

Published Date: 2026-01-23
Download PDF: pdf

Copyright License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Authors retain the rights to their work published in the International Journal of Medical Science and Dental Health and may republish or reproduce their own work, provided proper citation to the original publication in IJMSDH is included.

How to Cite

Okwuosa, A. O., Eleje, G. U., Ikpeze , O. C., Ugwu, E. O., Okpala, B. C., Ikpeze, G. C., Okonkwo, I. O., Obiagwu, H. I., Ikpeze, O. Z., Ofor, I. J., Igbodike, E. P., Ugboaja , J. O., Ekwuazi, K. E., Okoro, C. C., Okafor, C. G., Ogelle, O. M., Enechukwu, C. I., Okafor, L. U., Umeononihu, O. S., … Eke, A. C. (2026). Oral Immediate-Release Nifedipine Versus Intravenous Hydralazine for Controlling Severe Hypertension in Pregnancy: A Double-Blind Randomised Controlled Trial. International Journal of Medical Science and Dental Health, 12(01), 67-77. https://doi.org/10.55640/ijmsdh-12-01-10

More Citation Formats

Download Citation

Downloads

Download data is not yet available.

Abstract

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 20^th June 2019 to 20^th 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: 19^th June, 2019.

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 countries

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.

International Journal of Medical Science and Dental Health

eISSN : 2454-4191

Open Access

Oral Immediate-Release Nifedipine Versus Intravenous Hydralazine for Controlling Severe Hypertension in Pregnancy: A Double-Blind Randomised Controlled Trial

Authors

Ayodele Obianuju Okwuosa

George Uchenna Eleje

Okechukwu Christian Ikpeze

Emmanuel Onyebuchi Ugwu

Boniface Chukwuneme Okpala

Golibe Christian Ikpeze

Ifeanyi Ogochukwu Okonkwo

Hillary Ikechukwu Obiagwu

Odigonma Zinobia Ikpeze

Ifeanyichukwu Jude Ofor

Emeka Philip Igbodike

Joseph Odirichukwu Ugboaja

Kingsley Emeka Ekwuazi

Chukwuemeka Chukwubuikem Okoro

Chigozie Geoffrey Okafor

Onyecherelam Monday Ogelle

Chukwunonso Isaiah Enechukwu

Lazarus Ugochukwu Okafor

Osita Samuel Umeononihu

Zebulon Chiawolamoke Okechukwu

Chukwudubem Chinagorom Onyejiaka

Chijioke Ogomegbunam Ezeigwe

Adanna Vivian Egwim

Chukwunwendu Aloysius Okeke

Johnbosco Emmanuel Mamah

Joseph Ifeanyichukwu Ikechebelu

Ahizechukwu Chigoziem Eke

Copyright License

How to Cite

Downloads

Abstract

Keywords:

References

Similar Articles