Comparing the use of oral labour inducing agent with vaginal agent

Phase 3

Completed

• Conditions: Pregnancy

• Registration Number: CTRI/2014/02/004402
• Lead Sponsor: Christian Medical College and Hospital Vellore

Brief Summary

**Induction of labour is considered beneficial in many circumstances. Cervical status is an important clinical factor which determines the outcome of induction process. More than 15 % of all gravid women require aid in cervical ripening. The main problems during induction of labour range from inability to achieve effective labour to excessively strong uterine contractions. Misoprostol a synthetic prostaglandin E1 analogue has been proposed as an alternative agent to Dinoprostone- agent of choice, for pre-induction cervical ripening. The recommended dose for vaginal route is 25 mcg every 4 hours. Excessive uterine contractions leading to fetal distress with these doses are still a cause of concern. Oral dose is known to be safer than vaginal route (1) probably because of its pharmacokinetics (2). In the WHO recommendation for Induction of labour,(3) the dosage of oral misoprostol was considered a research priority. Dodd et al showed that 25mg of misoprostol was ineffective (4).xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /**

**Oral administration is easier and has greater acceptability among women. Absorption by oral route is rapid and peak serum concentration is reached in 34 minutes with a half-life of 20-40 minutes. Peak serum concentration for vaginal route is 60-80 minutes and effect lasts for 4 hours. Some studies have shown a short induction delivery interval with titrated doses of oral misoprostol (5,6,7).**

**The aim of this randomized controlled trial is to compare the safety and efficacy of titrated oral misoprostol with vaginal misoprostol for labour induction.**

**BIBILOGRAPHY:**

**1.** **Oral Misoprostol for induction of labour. *Zarko Alfirevic, Andrew Weeks. Copyright 2010. The Cochrane Collaboration. Published by John Wiley & Sons, Ltd., .***

**2.** **Zieman M, Fong S, Benowitz N, Darney P. Absorption kinetics of misoprostol with oral or vaginal administration*. Obstet Gynecol 1997;90:88-92***

**3.** **WHO Recommendations for Induction of Labour, 2011**

**4.** **Jodie M Dodd et al. Oral misoprostol for induction of labour at term : randomized controlled trial. BMJ 332:509 Published xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /2nd February, 2006.**

**5.** **Titrated oral misoprostol solution for induction of labour: a multi-centre, randomized trial. G.J.Hofmeyr, Z Alfirevic et al. *British Journal of Obstetrics and Gynaecology, September 2001, Vol.108, pp.952-959***

**6.** **Titrated Oral Compared With Vaginal Misoprostol for Labor Induction. A Randomized Controlled Trial. *Shi-Yann Cheng et al. The American College of Obstetricians and Gynecologists. VOL 111, NO.1, January 2008***

**7.** **Prospective randomized clinical trial of inpatient cervical ripening with stepwise oral misoprostol vs vaginal misoprostol. Iris Colon et al. American Journal of Obstetrics and Gynecology (2005) 192, 747-52**

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-23
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 788

Inclusion Criteria

Pregnancies between 37 to 42 weeks of gestation admitted for labor induction with live, singleton fetus Cephalic presentation Bishop score less than 6 Reassuring fetal heart rate Intact membranes.

Exclusion Criteria

Non-reassuring fetal heart rate Contraindications to vaginal delivery Previous uterine scar Bishops score more than or equal to 7 Ruptured membranes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3. Caesarean section	1. Vaginal delivery not achieved within 24 hours | 2. Uterine hyperstimulation with fetal heart rate (FHR) changes | 3. Caesarean section
1. Vaginal delivery not achieved within 24 hours	1. Vaginal delivery not achieved within 24 hours | 2. Uterine hyperstimulation with fetal heart rate (FHR) changes | 3. Caesarean section
2. Uterine hyperstimulation with fetal heart rate (FHR) changes	1. Vaginal delivery not achieved within 24 hours | 2. Uterine hyperstimulation with fetal heart rate (FHR) changes | 3. Caesarean section

Secondary Outcome Measures

Name	Time	Method
Measures of effectiveness	Cervix Unfavourable unchanged after 12 hours

Trial Locations

Locations (1)

Department of Obstetrics and Gynaecology; 🇮🇳 Vellore, TAMIL NADU, India

Department of Obstetrics and Gynaecology

🇮🇳Vellore, TAMIL NADU, India

Dr Jiji Mathews

Principal investigator

04162283387

coronistrial@yahoo.co.in