Volume 21, Issue 5 (May 2023)                   IJRM 2023, 21(5): 379-386 | Back to browse issues page


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Nasrolahei S, Hosseini S A, Hosseini S A, Hosseini S N K, Hosseini S S, Moradian Lotfi P. Effect of nifedipine with and without sildenafil citrate for the management of preterm labor in pregnant women: A randomized clinical trial. IJRM 2023; 21 (5) :379-386
URL: http://ijrm.ir/article-1-2511-en.html
1- Department of Obstetrics and Gynecology, School of Medicine Endometrium and Endometriosis Research Center, Fatemieh Hospital, Hamadan University of Medical Sciences, Hamadan, Iran.
2- Department of Obstetrics and Gynecology, Zanjan University of Medical Sciences, Zanjan, Iran. , dr.seyedeh_arezoo_hoseini@yhoo.com
3- Iran University of Medical Sciences, Tehran, Iran.
4- Bahçeşehir Medical University Istanbul Turkey, Istanbul, Turkey.
5- Hamadan University of Medical Sciences, Hamadan, Iran.
Abstract:   (729 Views)
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.
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Type of Study: Original Article | Subject: Pregnancy Health

References
1. Suff N, Story L, Shennan A. The prediction of preterm delivery: What is new? Semin Fetal Neonatal Med 2019; 24: 27-32. [DOI:10.1016/j.siny.2018.09.006] [PMID]
2. Jacobsson B, Pettersson K, Modzelewska D, Abrahamsson T, Bergman L, Håkansson 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, Källén K, Maršál K, Jacobsson B. Outcome of extremely preterm infants after iatrogenic or spontaneous birth. Acta Obstet Gynecol Scand 2018; 97: 1388-1395. [DOI:10.1111/aogs.13387] [PMID]
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. [DOI:10.1016/j.eclinm.2022.101496] [PMID] [PMCID]
5. Patel SS, Ludmir J. Drugs for the treatment and prevention of preterm labor. Clin Perinatol 2019; 46: 159-172. [DOI:10.1016/j.clp.2019.02.001] [PMID]
6. Lamont RF, Jørgensen JS. Safety and efficacy of tocolytics for the treatment of spontaneous preterm labour. Curr Pharm Des 2019; 25: 577-592. [DOI:10.2174/1381612825666190329124214] [PMID]
7. Ferreira RS, Negrini R, Bernardo WM, Simões 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. [DOI:10.1371/journal.pone.0219732] [PMID] [PMCID]
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. [DOI:10.1111/fcp.12633] [PMID]
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. [DOI:10.18502/jfrh.v15i2.6452] [PMID] [PMCID]
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. [DOI:10.4103/UROS.UROS_113_21]
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. [DOI:10.1097/OGX.0000000000000635] [PMID]
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. [DOI:10.1080/14767058.2019.1570117] [PMID]
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. [DOI:10.1186/s12884-021-03951-x] [PMID] [PMCID]
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. [DOI:10.1186/s12884-022-04854-1] [PMID] [PMCID]
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. [DOI:10.1016/j.ajog.2010.11.038] [PMID] [PMCID]
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. [DOI:10.31579/2578-8965/009]
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. [DOI:10.1016/j.ajog.2020.01.025] [PMID]
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. [DOI:10.1016/j.ajog.2010.05.007] [PMID]
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. [DOI:10.1016/j.ajog.2003.11.005] [PMID]

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