Clinical trial NCT01634854: A Study Comparing Vaginal Misoprostol and Intravenous Oxytocin for Induction of Labor
Official title: Randomized Comparison of Vaginal Misoprostol and Intravenous Oxytocin for Labor Induction in Multiparous Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induction of Labor in Multiparous Women
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2012-07-06
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the effectiveness of vaginal misoprostol (Cytotec) and intravenous oxytocin (Pitocin) in multiparous women who present at term for labor induction.

Detailed description: Both oxytocin and misoprostol have been demonstrated to be safe and effective methods for induction of labor. A direct comparison of efficacy and time to delivery in multiparas has not been specifically investigated. Additionally, the study will look at costs of the two drugs.Oxytocin is administered through an IV so requires more direct patient care time from the Registered Nurse, IV pump, and tubing, whereas misoprostol is a tablet, administered only once, per vagina or orally, every 4 hours. Misoprostol is also very inexpensive comparatively; if equally or more efficacious than oxytocin, this could demonstrate quite a cost and time savings to Vanderbilt University Medical Center and other institutions. Safety of either drug is not in question.

Eligibility criteria: Inclusion Criteria:

* Clinical candidate for labor induction utilizing either misoprostol or oxytocin
* Greater than or equal to 18 years of age
* Multiparous
* Singleton gestation;
* Greater than 37 weeks gestation;
* Cephalic presentation

Exclusion Criteria:

* Any clinical contraindication to misoprostol as induction drug
* Age less than 18 years
* Contraindication to vaginal birth
* Nonreassuring fetal heart rate tracing
* Prior uterine surgery
* Active labor
* Active maternal bleeding
* Chorioamnionitis (infection)

Primary outcomes:
measure: Time From Induction to Vaginal Delivery
timeFrame: Time to delivery in minutes from initiation of medication, up to 24 hours
Secondary outcomes:
measure: Neonatal APGAR Scores
timeFrame: At 1 minute and 5 minutes after delivery
measure: Neonatal Weight at Delivery
timeFrame: Immediately following delivery
measure: Maternal Delivery Outcomes
timeFrame: Through discharge from hospital
measure: Maternal Satisfaction With Labor
timeFrame: 6 weeks post-partum
measure: Number of Participants With Excessive Uterine Activity Necessitating Treatment
timeFrame: Measured from initiation of medication until delivery time
measure: NICU Admission and APGAR Less Than 7 at 5 Minutes
timeFrame: Through discharge from hospital
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University
name: Angela Wilson-Liverman, MSN, CNM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chaudhuri S, Mitra SN, Banerjee PK, Biswas PK, Bhattacharyya S. Comparison of vaginal misoprostol tablets and prostaglandin E2 gel for the induction of labor in premature rupture of membranes at term: a randomized comparative trial. J Obstet Gynaecol Res. 2011 Nov;37(11):1564-71. doi: 10.1111/j.1447-0756.2011.01575.x. Epub 2011 Jun 16.
citation: Olagbuji BN, Ezeanochie MC, Kubeyinje W, Dunsin T, Ande AB. Pregnancy outcome following induction of labor with intravaginal misoprostol for decreased fetal movements at term. J Matern Fetal Neonatal Med. 2011 Oct;24(10):1225-7. doi: 10.3109/14767058.2011.572309. Epub 2011 Apr 20.
citation: Saeed GA, Fakhar S, Nisar N, Alam AY. Misoprostol for term labor induction: a randomized controlled trial. Taiwan J Obstet Gynecol. 2011 Mar;50(1):15-9. doi: 10.1016/j.tjog.2009.08.001.
citation: Shakya R, Shrestha J, Thapa P. Safety and efficacy of misoprostol and dinoprostone as cervical ripening agents. JNMA J Nepal Med Assoc. 2010 Jan-Mar;49(177):33-7.
citation: Hofmeyr GJ, Gulmezoglu AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD000941. doi: 10.1002/14651858.CD000941.pub2.
citation: Crane JM, Butler B, Young DC, Hannah ME. Misoprostol compared with prostaglandin E2 for labour induction in women at term with intact membranes and unfavourable cervix: a systematic review. BJOG. 2006 Dec;113(12):1366-76. doi: 10.1111/j.1471-0528.2006.01111.x.
citation: Lin MG, Nuthalapaty FS, Carver AR, Case AS, Ramsey PS. Misoprostol for labor induction in women with term premature rupture of membranes: a meta-analysis. Obstet Gynecol. 2005 Sep;106(3):593-601. doi: 10.1097/01.AOG.0000172425.56840.57.
citation: Li XM, Wan J, Xu CF, Zhang Y, Fang L, Shi ZJ, Li K. Misoprostol in labour induction of term pregnancy: a meta-analysis. Chin Med J (Engl). 2004 Mar;117(3):449-52.