Transdermal nitroglycerin as a tocolytic in the treatment of preterm labour : a randamised placebo controlled clinical study.

Abstract

The aim of this randomised single blind, controlled clinical trial is to determine, at the end of 48 hours, whether Transdermal Nitroglycerin is more effective than placebo in the treatment of preterm labour. Maternal and foetal side effect profile of the active agent was assessed by monitoring changes in the maternal pulse, blood pressure and foetal heart rate over this time period, and comparing to placebo for significant difference. Forty women in preterm labour, between 20 and 34 weeks of gestation were recruited. Initial assessment and monitoring were done according to a pre-decided protocol. The active agent used was Transdermal Nitroglycerin (10 mg/24 Hrs), placed over the abdomen. The same patch, without removing its protective backing, was used as placebo. In those women with increase in uterine activity, rescue tocolysis using a different agent was initiated after removal of study patch. *15/20 (75 percentage) of women belonging to the drug arm, and 16/20(80 percentage) of women the placebo arm remained undelivered at 48 hours. The mean contraction/10 minutes had decreased to0.41 (SD 0.25), and 0.50(SD 0.82) in the drug and placebo groups respectively. On applying t-test for significance