Download fulltext HTML
Nasrolahei, S., Hoseini, S. A., Hosseini, S. A., Hosseini, S. N. K., Hosseini, S. S., & Lotfi, P. M. (2023). Effect of nifedipine with and without sildenafil citrate for the management of preterm labor in pregnant women: A randomized clinical trial. International Journal of Reproductive BioMedicine (IJRM), 21(5), 379–386. https://doi.org/10.18502/ijrm.v21i5.13471

https://doi.org/10.18502/ijrm.v21i5.13471

statistics

  • 136 Abstract Views
  • 77 PDF Views
  • 0 HTML Views
  • Cited by 1 article

authors

  • Shahla Nasrolahei

    Shahla Nasrolahei

    Department of Obstetrics and Gynecology, School of Medicine Endometrium and Endometriosis Research Center, Fatemieh Hospital, Hamadan University of Medical Sciences, Hamadan, Iran.
  • Seyedeh Arezoo Hoseini

    Seyedeh Arezoo Hoseini

    Department of Obstetrics and Gynecology, Zanjan University of Medical Sciences, Zanjan, Iran.
  • Seyedeh Azadeh Hosseini

    Seyedeh Azadeh Hosseini

    Iran University of Medical Sciences, Tehran, Iran.
  • Seyedeh Narjes Khatoon Hosseini

    Seyedeh Narjes Khatoon Hosseini

    Bahçeşehir Medical University Istanbul Turkey, Istanbul, Turkey.
  • Seyedeh Sahar Hosseini

    Seyedeh Sahar Hosseini

    Bahçeşehir Medical University Istanbul Turkey, Istanbul, Turkey.
  • Parsa Moradian Lotfi

    Parsa Moradian Lotfi

    Hamadan University of Medical Sciences, Hamadan, Iran.

Published Date

  • Jun 10, 2023

Effect of nifedipine with and without sildenafil citrate for the management of preterm labor in pregnant women: A randomized clinical trial

International Journal of Reproductive BioMedicine (IJRM) / International Journal of Reproductive BioMedicine (IJRM): Volume 21, Issue No. 5 / Pages 379–386

Abstract

Background: Preterm labor is one of the main causes of neonatal mortality and its treatment is still challenging.


Objective: The study aimed to compare the effectiveness of nifedipine (Nif) with and without sildenafil citrate (SC) for the treatment of preterm labor in pregnant women.


Materials and Methods: In this clinical trial study, 126 pregnant women referred to the Fatemieh hospital, Hamadan, Iran with a complaint of preterm labor were evaluated. Participants were randomly divided into 2 groups of Nif 20 mg orally (single dose), then 10 mg every 6-hr, and at the same time vaginal SC 25 mg every 8 hr (Nif + SC) or Nif alone. Treatment was continued for 48-72 hr if uterine contractions did not resolve in both groups. Delivery rates at the time of hospitalization and neonatal outcome were compared between the 2 groups.


Results: No statistically significant difference was observed between the 2 study groups in terms of mean age, gestational age, body mass index, and parity. 76.2% of Nif + SC participants in the first 72 hr of hospitalization and 57.2% of Nif participants remained without delivery (p = 0.02). The neonatal hospitalization rate of the Nif + SC group in the neonatal intensive care unit was 25.4% and in the Nif group was 42.9% (p = 0.03).


Conclusion: Nif with SC is superior to Nif alone in women at risk of preterm labor due to increasing gestational age and better neonatal outcomes.


Key words: Nifedipine, preterm labor, Sildenafil citrate, Randomized trial.

References
[1] Suff N, Story L, Shennan A. The prediction of preterm delivery: What is new? Semin Fetal Neonatal Med 2019; 24: 27–32.

[2] Jacobsson B, Pettersson K, Modzelewska D, Abrahamsson T, Bergman L, Hakansson S. [Preterm delivery: An overview on epidemiology, pathophysiology and consequences for the individual and the society]. Lakartidningen 2019; 116: FR6F. (in Swedish)

[3] Fritz T, Kallen K, Marsal K, Jacobsson B. Outcome of extremely preterm infants after iatrogenic or spontaneous birth. Acta Obstet Gynecol Scand 2018; 97: 1388–1395.

[4] Sebastian E, Bykersma C, Eggleston A, Eddy KE, Chim ST, Zahroh RI, et al. Cost-effectiveness of antenatal corticosteroids and tocolytic agents in the management of preterm birth: A systematic review. EClinicalMedicine 2022; 49: 101496.

[5] Patel SS, Ludmir J. Drugs for the treatment and prevention of preterm labor. Clin Perinatol 2019; 46: 159–172.

[6] Lamont RF, Jorgensen JS. Safety and efficacy of tocolytics for the treatment of spontaneous preterm labour. Curr Pharm Des 2019; 25: 577–592.

[7] Ferreira RS, Negrini R, Bernardo WM, Simoes R, Piato S. The effects of sildenafil in maternal and fetal outcomes in pregnancy: A systematic review and meta-analysis. PLoS One 2019; 14: e0219732.

[8] Ala M, MohammadJafari R, Dehpour AR. Sildenafil beyond erectile dysfunction and pulmonary arterial hypertension: Thinking about new indications. Fundam Clin Pharmacol 2021; 35: 235–259.

[9] Mohammadi E, Noei Teymoordash S, Norouzi AR, Norouzi F, Norouzi HR. Comparison of the effect of nifedipine alone and the combination of nifedipine and sildenafil in delaying preterm labor: A randomized clinical trial. J Family Reprod Health 2021; 15: 112–117.

[10] Mokhtari G, Hamidi Madani A, Kazemnezhad Leyli E, Jafari A. Sildenafil citrate effects on seminal parameters in male participants with idiopathic infertility; A randomized, double-blind, controlled cross-over clinical trial study. Urol Sci 2022; 33: 93–98.

[11] Hanley M, Sayres L, Reiff ES, Wood A, Grotegut CA, Kuller JA. Tocolysis: A review of the literature. Obstet Gynecol Surv 2019; 74: 50–55.

[12] Kashanian M, Shirvani Sh, Sheikhansari N, Javanmanesh F. A comparative study on the efficacy of nifedipine and indomethacin for prevention of preterm birth as monotherapy and combination therapy: A randomized clinical trial. J Matern Fetal Neonatal Med 2020; 33: 3215–3220.

[13] Ibrahim MH, Elfaki T, Elhassan EM, Abdelrahiem SK, Adam I. The effectiveness of nifedipine/indomethacin combination therapy and nifedipine monotherapy for postponing preterm birth (25–34 weeks of gestation) in Sudanese women: A randomized clinical trial study protocol. BMC Pregnancy Childbirth 2021; 21: 457.

[14] van Winden TMS, Nijman TAJ, Kleinrouweler CE, Salim R, Kashanian M, Al-Omari WR, et al. Tocolysis with nifedipine versus atosiban and perinatal outcome: An individual participant data meta-analysis. BMC Pregnancy Childbirth 2022; 22: 567.

[15] Conde-Agudelo A, Romero R, Kusanovic JP. Nifedipine in the management of preterm labor: A systematic review and metaanalysis. Am J Obstet Gynecol 2011; 204: 134. e1–20.

[16] Lotfalizadeh M, Teymoori M. [Comparison of nifedipine and magnesium sulfate in the treatment of Preterm]. Iran J Obstet Gynecol Infertil 2010; 13: 7–12. (In Persian)

[17] Nikbakht R, Taheri Moghadam M, Ghane’ee H. Nifedipine compared to magnesium sulfate for treating preterm labor: A randomized clinical trial. Iran J Reprod Med 2014; 12: 145–150.

[18] Abd El-Ghader AN, Ali AE-N, Abdallah KhM, Abdelhamid A. Sildenafil citrate versus nifedipine and dydrogesreone in prevention of preterm labor with short cervix. J Obstet Gynecol Reprod Sci 2018; 2.

[19] Turner J, Dunn L, Tarnow-Mordi W, Flatley C, Flenady V, Kumar S. Safety and efficacy of sildenafil citrate to reduce operative birth for intrapartum fetal compromise at term: A phase 2 randomized controlled trial. Am J Obstet Gynecol 2020; 222: 401–414.

[20] Chiossi G, Costantine MM, Betancourt A, Hankins GDV, Longo M, Saade GR, et al. Does sildenafil citrate affect myometrial contractile response to nifedipine in vitro? Am J Obstet Gynecol 2010; 203: 252. e1–5.

[21] Khan RN, Hamoud H, Warren A, Wong LF, Arulkumaran S. Relaxant action of sildenafil citrate (Viagra) on human myometrium of pregnancy. Am J Obstet Gynecol 2004; 191: 315–321.