Efficacy and Safety Study of Titrated Oral Misoprostol Solution for Labor Augmentation

Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00695331
• Other study ID #: CMUBH R96007
• Secondary ID: DMR96-IRB-176
• Status: Recruiting
• Phase: Phase 4
• First received: June 8, 2008
• Last updated: July 8, 2008
• Start date: February 2008
• Est. completion date: January 2009

Study information

• Verified date: July 2008
• Source: China Medical University Hospital
• Contact: Ming Ho, MD
• Phone: 886-4-22062121
• Email: mi.ho[@]msa.hinet.net
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 143
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor

Intervention

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

Locations

Country	Name	City	State
Taiwan	Labor Unit, Department of Obstetric and Gynecology, China Medical Univertiy Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Cheng SY, Ming H, Lee JC. Titrated oral compared with vaginal misoprostol for labor induction: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):119-25. doi: 10.1097/01.AOG.0000297313.68644.71. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of women delivering infants vaginally within 12 hours of augmentation		post vaginal delivery	No
Secondary	uterine hyperstimulation rate		post vaginal delivery	Yes

External Links

•   China Medical University Hospital