Randomised controlled trial to compare safety and efficacy of vaginal versus oral route of misoprostol for induction of labour in term pregnancy with unfavourable cervix
Keywords:Vaginal misoprostol, Oral misoprostol, Induction of labour
Background: The objective of the study was to compare safety and efficacy of vaginal versus oral route of misoprostol for induction of labour in term pregnancy.
Methods: A total of 100 pregnant women with clinical indication for labour induction and poor bishops score were randomly assigned to receive vaginal or oral misoprostol. Group A received 25 μg of misoprostol vaginally (maximum up to 3 doses 4 hourly interval) and group B received 25 μg of misoprostol orally (up to 5 doses 2 hourly interval) in solution form. Maternal and fetal outcomes were compared in both groups to assess the safety and efficacy of vaginal versus oral route.
Results: Fifty women received vaginal and 50 women received oral misoprostol. Average interval from induction to active stage was shorter in oral misoprostol (7.42±4.2 hours versus 10.30±5.1 hours) (p=0.006). There was no significant difference (p=0.272) in the average interval from induction to delivery between the vaginal group (14.42±5.01hrs) and oral group (13.14±5.5 hrs). No significant difference in caesarean section rates (p=0.42). Incidence of hyperstimulation was significantly higher (p=0.025) in vaginal group as compared to oral group (18 % vs 4 %). Incidence of nausea, vomiting, vaginal or cervical tears and postpartum hemorrhage were comparable in both the groups. There were no statistically significant differences in neonatal outcomes.Conclusions: Oral misoprostol has a better safety profile than vaginal route as the incidence of hyperstimulation and tachysystole was significantly more in vaginal group, although there were no significant differences in the maternal and neonatal outcomes.
Cunningham FG, Leveno KJ, Bloom SL, Hauth JC, Gilstrp LC, Wanstrom KD. Williams Obstetrics. 22nded. New York: McGraw Hill Medical Publishing Division. 2005;535-42.
Danielsson KG, Marions L, Rodriguez A, Spur BW, Wong PY, Bygdeman M. Comparison between oral and vaginal administration of misoprostol on uterine contractility. Obstet Gynecol 1999;93:278-80.
Prysak M, Castronova FC. Elective induction versus spontaneous labour: a case-control analysis of safety and efficacy. Obstet Gynecol. 1998;92:47-52.
Seyb ST, Berka RJ, Socal ML, Dooley SL. Risk of cesarean delivery with elective induction of labour at term in nulliparous women. Obstet Gynecol. 1999;94:600-7.
Colón I, Clawson K, Hunter K, Druzin ML, Taslimi MM. Prospective randomized clinical trial of inpatient cervical ripening with stepwise oral misoprostol versus vaginal misoprostol. Am J Obstet Gynecol. 2005;192:747-52.
Induction of labor. NICE guidelines July 2008. Available at http://www.nice.org.uk/nicemedia/live/12012/41256/41256.pdf. Accessed on 2 Nov, 2011.
ACOG committee opinion. New US Food and drug administration labeling of cytotec (misoprostol) use in pregnancy. Int J Gynecol Obstet. 2003;82:137-8.
WHO recommendations for induction of labour 2011, Available at http://whqlibdoc.who.int/publications/2011/9789241501156_eng.pdf. Accessed on 2 Nov, 2011.
Weeks A, Alfirevic Z. Oral misoprostol administration for labor induction. Clin Obstet Gynecol. 2006;49:658-71.
Cheng SY, Ming H, Lee JC. Titrated oral compared with vaginal misoprostol for labor induction: a randomized controlled trial. Obstet Gynecol. 2008;111:119-25.
How HY, Leaseburge L, Khoury JC, Siddiqi TA, Spinnato JA, Sibai BM. A comparison of various routes and dosages of misoprostol for cervical ripening and the induction of labour. Am J Obstet Gynecol. 2001;185:911-5.
Mehrotra S, Singh U, Gupta HP. A prospective double blind study using oral versus vaginal misoprostol for labour induction. J Obstet Gynecol. 2010;30:461-4.
Ayaz A, Saeed S, Farooq M, Ahmad I, Ali Bahoo M, Saeed M. Labour induction with randomized comparison of oral and intravaginal misoprostol in post date multigravida Women. Malaysian Journal of Medical Sciences. 2009;16:34-8.
Tang OS, Gemzell-Daielsson K. Int J Obstet Gynecol. 2007:99:160-7.
Jindal P, Avasthi K, Kaur M. A comparison of vaginal vs oral misoprostol for induction of labor–double blind randomized trial. The Journal of Obstetrics and Gynecology of India. 2011;6:538-42.