Official Title: “A Comparison of Titrated Oral Misoprostol Solution to Intravenous Oxytocin for Labor Augmentation: A Randomized Controlled Trial”

The purpose of this study is to compare the efficacy and safety of titrated oral misoprostol solution with intravenous oxytocin for labor augmentation in women without adequate uterine contractions.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

Numerous labor course necessitate augmentation when uterine contractions are inadequate. When the cervix is favorable, labor augmentation attempts are more likely to be successful.

Augmentation is these women is traditionally undertaken with intravenous oxytocin and amniotomy, either alone or in combination. In our previous trial, it has been proven that the method of titrated oral misoprostol is associated with a lower incidence of uterine hyperstimulation and a lower cesarean delivery rate than vaginal misoprostol for labor induction in patients with unfavorable cervix. Because administering Misoprostol solution is easy and cost saving, it is worth to develop this novel method in labor augmentation.

Intervention(s) in this Clinical Trial

• Drug: Misoprostol
  • Titrated Misoprostol Solution
• Drug: Oxytocin
  • Titrated Intravenous Oxytocin

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Titrated Oral Misoprostol Solution
• Active Comparator: 2
  • Intravenous Oxytocin

Primary Measures

• the percentage of women delivering infants vaginally within 12 hours of augmentation
  • Time Frame: post vaginal delivery
    Safety Issue?: No

Secondary Measures

• uterine hyperstimulation rate
  • Time Frame: post vaginal delivery
    Safety Issue?: Yes

Inclusion Criteria:

• Pregnancy between 36 and 42 weeks of gestation
• Live singleton
• Cephalic presentation
• A reassuring fetal heart rate pattern
• Bishop score greater than 6
• Inadequate uterine contraction (less than or equal to 2 per 10 minutes)

Exclusion Criteria:

• Nonreassuring fetal heart rate pattern
• Parity more than five
• Uterine scar
• Suspected placental abruption with abnormal fetal heart rate
• Vaginal bleeding other than "bloody show"
• Significant maternal cardiac, renal, or hepatic disease
• hypersensitivity to oxytocin, misoprostol or prostaglandin analogues

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: China Medical University Hospital

Overall Clinical Trial Officials and Contacts

Shi-Yann Cheng, MD Study Chair China Medical University Beigang Hospital  

Overall Contact: Ming Ho, MD 886-4-22062121 mi.ho@msa.hinet.net

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00695331

Study ID Number: CMUBH R96007

ClinicalTrials.gov Identifier: NCT00695331

Health Authority: Taiwan: Department of Health

China Medical University Hospital