The Effects of Glyceryl Trinitrate Patch on the Treatment of Preterm Labor: A Single-blind Randomized Clinical Trial

Nankali, Anisodowleh; Kord Jamshidi, Parnian; Rezaei, Mansour

The Effects of Glyceryl Trinitrate Patch on the Treatment of Preterm Labor: A Single-blind Randomized Clinical Trial

Authors

Anisodowleh Nankali ¹

Parnian Kord Jamshidi ¹

Mansour Rezaei ²

¹ Imam Reza Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran

² Biostatistics and Epidemiology Department, Social Development and Health Promotion Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran

Abstract

Background: Preterm labor (PTL) is one of the main causes of neonatal mortality and morbidity. PTL leads to serious complications especially in the gestational age prior to 24-26 weeks. The aim of this study was to investigate the effect of glyceryl trinitrate (GTN) patch on the treatment and complications of PTL. Methods: In this clinical trial, 84 singleton pregnant women with gestational age of 27-35 weeks were surveyed. PTL was clinically diagnosed and the patients were randomly divided into two groups who were treated with GTN or placebo for 48 hr. The consequences, complications and changes in some parameters in both groups were compared. Data were analyzed with chi square test, paired and unpaired t tests by SPSS software and p < 0.05 was considered significant. Results: No significant difference was observed between two groups in terms of successful tocolysis, receiving full dose of corticosteroids and the mean prolongation of the pregnancy. However, delivery times in patients who delivered during the hospitalization were 31±4.4 and 18.3±2.2 hr (p=0.01), respectively. Headache was more severe in control group (p=0.007). The systolic and mean arterial blood pressure decrease (p < 0.001) and maternal heart rate increase (p=0.01) were significant in GTN group. The changes of vital signs were not significant in placebo group. Conclusion: The effect of GTN in the treatment of PTL is similar to the placebo without any serious complication. However, GTN delays the delivery time in delivery during the primary hospitalization. Thus, further studies with larger sample size are needed to evaluate the exact effects of GTN on PTL.

Keywords

Glyceryl trinitrate patch

Obstetric labor

Premature

Tocolysis

James D, Steer P, Weiner C, Gonik B, Crowther C, Robson S. High risk pregnancy management option. 4th ed. Philadelphia: Elsevier Saunders; 2011. p. 457-69.

Cunningham F, Leveno K, Bloom S, Hauth J, Rouse D, Spong C. Williams Obstetrics. 23rd ed. New York: McGraw Hill; 2009. p. 804-32.

Smith GN, Walker MC, Ohlsson A, O'Brien K, Windrim R. Randomized double-blind placebo controlled trial of transdermal nitroglycerin for preterm labor. Am J Obstet Gynecol. 2007;196(1):37.

Children’s Health [Internet]. US National library of medicine, NIH; 2007. Nitroglycerin patch show promise for premature labor; 2011 Jan 27 [cited 2013 Nov 11]; [about 3 screens]. Available from: http://health.Usnews.com/usnews/health/jri_articles/070201/1health.earlylabor.htm.

Leszczynska-Gorzelak B, Laskowska M, Marciniak B, Oleszczuk J. Nitric oxide for treatment of threatened preterm labor. Int J Gynaecol Obstet. 2001;73(3):201-6.

Smith GN, Guo Y, Wen SW, Walker MC. Secondary analysis of the use of transdermal nitroglycerin for preterm labor. Am J Obstet Gynecol. 2010;203(6):565.

Perveen S, Araainuddin J, Naz S. Short term tocolytic efficacy of transdermal nitrogelycerine. Med Channel. 2010;16(1):152-4.

Schleussner E, Moller A, Gross W, Kahler C, Moller U, Richter S, et al. Maternal and fetal side effects of tocolysis using transdermal nitroglycerin or intravenous fenoterol combined with magnesium sulfate. Eur J Obstet Gynecol Reprod Biol. 2003;106(1):14-9.

Geneva foundation for medical education and research [Internet]. Cairo: Geneva Foundation for Medical Education and Research; 2006. Transdermal nitroglycerine patch for tocolysis - An experience; 2011 Feb 9 [cited 2013 Nov 11]; [about 11 screens]. Available from: http://www.gfmer.ch/IAMANEH_ESMANEH_Cairo_2006/pdf/Transdermal_nitroglycerine_Rai_2006.pdf

Lees C, Campbell S, Jauniaux E, Brown R, Ramsay B, Gibb D, et al. Arrest of preterm labour and prolongation of gestation with glyceryl trinitrate, a nitric oxide donor. Lancet. 1994;343(8909):1325-6.

Katzung B. Basic & clinical pharmacology: Lange Medical Books. 11th ed. London: McGraw Hill; 2001. p. 93-6.

Nitroglycerin Transdermal [Internet]. US FDA; 2011. Nitroglycerin Transdermal; 2011 Feb 9 [cited 2013 Nov 11]; [about 7 screens]. Available from: http://www.drugs.com/pro/nitroglycerin-transdermal.html

Gyetvai K, Hannah ME, Hodnett ED, Ohlsson A. Tocolytics for preterm labor: a systemic review. Obstet Gynecol. 1999;94(5 pt 2):869-77.

Bisits A, Madsen G, Knox M, Gill A, Smith R, Yeo G, et al. The Randomized Nitric Oxide Tocolysis Trial (RNOTT) for the treatment of preterm labor. Am J Obstet Gynecol. 2004;191(3):683-90.

Lees CC, Lojacono A, Thompson C, Danti L, Black RS, Tanzi P, et al. Glyceryl trinitrate and ritodrine in tocolysis: an international multicenter randomized study. Obstet Gynecol. 1999;94(3):403-8.

Schleussner E, Richter S, Gross W, Kahler C, Moller A, Moller U, Seewald HJ. [Nitroglycerin patch for tocolysis--a prospective randomized comparison with fenoterol by infusion]. Z Geburtshilfe Neonatol. 2001;205(5):189-94. German.

Duckitt K, Thornton S. Nitric oxide donors for the treatment of preterm labour. Cochrane Database Syst Rev. 2002;(3):CD002860.