A randomized controlled trial of vaginal misoprostol tablet and intracervical dinoprostone gel in labor induction of women with prolonged pregnancies

Apurba Mandal, Shibram Chattopadhyay, Snehamoy Choudhuri, Samaresh Malo, Kajal Patra, Sharmistha Ganguly, Debmalya Maiti


Background: Objective of the study was to compare the efficacy of vaginal misoprostol and intracervical dinoprostone gel for induction of labor in women with unfavorable cervix beyond 41 weeks (287 days) of gestation.

Methods: This randomized controlled trial was performed at a teaching hospital between January 2011 and December 2012. 192 women with singleton uncomplicated pregnancy with no previous uterine scar not going into spontaneous labor at 288th days of gestation .Misoprostol(25 mcg tablet)in the posterior vaginal fornix, four hourly, maximum six doses or Dinoprostone (0.5 mg gel) intracervical instillation ,six hourly, maximum three doses were given.Oxytocin was administered if needed. Primary outcome: Induction delivery interval (IDI) with incidence of delivery within 12 hours and 24 hours; mode of delivery: vaginal or caesarean section. Secondary outcome: maternal side effects, neonatal outcome. For statistical analysis chi-square test, student t- test and P-value determination were done.

Results: The mean IDI was shorter in the misoprostol group compared to the dinoprostone group (p<0.001) with more delivery within <12 hours (p<0.001) and within <24 hours (p<0.05). Caesarean section rate was lower in misoprostol group compared to dinoprostone group (12.76% versus 23.07%) but this difference was not statistically significant (p>0.05). Adverse neonatal outcome (5-minutes Apgar score<7) with NICU admission was more in misoprostol group compared to dinoprostone group (0.04%versus0.01%) but this difference was also not statistically significant(p>0.05).

Conclusions: Vaginal misoprostol tablet is a safe and more effective method of induction of labour when compared with intracervical dinoprostone gel in prolonged pregnancies.



Prolonged pregnancies, Induction of labour, Misoprostol, Dinoprostone, Apgar score

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De Ribes C. De l’ Accouchement Provoque, Dilatation du canal Genital a l’Aide de Ballons Introduits dans la Cavite Uterine Pendant La Grossesse. Paris, Steinheil. 1988.

Prolonged and post-term pregnancies. Guidelines for clinical practice from CNGOF. Vayssiere C, Haumonte JB, Chantry A, et al. Eur J Obstet Gynecol Reprod Biol. 2013 Feb 20.

WHO Global Survey on Maternal and Perinatal Health. Induction of labour data. Geneva, World Health Organization. 2010. (available at: http:// _ survey).

Hilder L, Costeloe K, Thilaganathan B. Prolonged preganancy: Evaluating gestation specific risks of fetal and infant mortality. Br J Obstet Gynecol. 1998;105:169-73.

Cotzias CS, Paterson- Brown S, Fisk NM. Prospective risk of unexplained stillbirth in singleton pregnancies at term: population based analysis. BMJ. 1999;319:287-98.

Rand L, Robinson JN, Economy KE, Norwitz ER. Post term induction of labour revisited. Obstet Gynecol. 2000;96:779-83.

Hannah ME, Hannah WJ, Hellmann J, Hewson S, Milner R, Willan A. Induction of labour as compared with serial antenatal monitoring in post term pregnancy- A randomized controlled trial. The Canadian Multicenter Post-term Pregnancy Trial Group. N Engl J Med. 1992;326:1587-92.

Crowley P. Interventions for preventing or improving the outcome of delivery at or beyond term. Cochrane Database Syst Rev. 2000:CD 000170.

Karim SMM, Trussele RR, Patel RC, Hillier K. Response of pregnant human uterus to prostaglandin F2 alpha, Induction of labour. BMJ. 1968;4:621-3.

Keirse MJNC. Prostaglandins in preinduction cervical ripening. Meta analysis of world- wide clinical experience. J Reprod Med. 1993;38:69-98.

Sanchez-Ramos L, Kaunitz AM, Delvalle GO. Labor induction with the prostaglandin E 1 methyl analogue misoprostol versus oxytocin: a randomized trial.Obstet Gynecol. 1993;81:332-6.

Hofmeyr GJ, Gulmezoglu AM. Vaginal misoprostol for cervical ripening and labour induction in late pregnancy (Cochrane review).The Cochrane Library Issue 3&4 Oxford: Cochrane update software. 2000 &2002.

Le Roux PA, Olarogun JO, Penny J, Anthony J. Oral and vaginal misoprostol compared with dinoprostone for induction of labour. a randomized controlled trial. Obstet Gynecol. 2002;99:201-5.

kolderup L, McLean L, Grullon K, Safford K, Kilpatrick S: Misoprostol is more efficacious for labour induction than prostaglandin E2, but is it associated with more risk? Am J Obstet Gynecol. 1999;180:1543-50.

Buser D, More G, Arias F. A randomized comparison between misoprostol and dinoprostone for cervical ripening and labour induction in patients with unfavourable cervices.Obstet Gynecol. 1997;89:581-5.

Alexander JM, McIntire DD, Leveno KJ. prolonged pregnancy:induction of labour and caesarean births. Obstet Gynecol. 2001,97:911-5 .

American College of Obstetricians and Gynecologists: Fetal heart rate patterns; monitoring, interpretation and management. ACOG practice Bulletin no.207 Washington DC: ACOG. 1995.

Rayburn WF, Zhang J. Rising rates of labour induction: present concern and future strategies. Obsteet Gynecol. 2002;100:164-7.

Yahn BP, Wollan P, McKeon K, Field CS. Temporal changes in rates and reasons for medical induction of term labour. Am J Obstet Gynecol. 2001;184:611-9.

Sanchez-Ramos L, Kaunitz AM, Wears RL, Delke I, Gaudier FL. misoprostol for cervical ripening and labour induction : a meta analysis.Obstet Gynecol. 1997;89:633-42.

Blanchard K ,Clark S, Winikoff B, Gaines G, Kabani G, Shannon C. Misoprostol for women’s health: A Review .Obstet Gynecol. 2002;99:316-22.

Shivarudraiah G, Palaksha MA. A randomized controlled trial comparing low dose vaginal misoprostol and dinoprostone gel for labour induction. J Obstet Gynecol Ind. 2011:61(2):153-60.