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

Phase 4

• Conditions: Labor
• Interventions: Drug: Misoprostol; Drug: Oxytocin

• Registration Number: NCT00695331
• Lead Sponsor: China Medical University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-06-08
• Study First Submitted QC: 2008-06-08
• Study First Posted: 2008-06-11
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-08
• Last Update Posted: 2008-07-10
• Primary Completion: 2008-12
• Study Completion: 2009-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 143

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Misoprostol	Titrated Oral Misoprostol Solution
2	Oxytocin	Intravenous Oxytocin

Primary Outcome Measures

Name	Time	Method
the percentage of women delivering infants vaginally within 12 hours of augmentation	post vaginal delivery

Secondary Outcome Measures

Name	Time	Method
uterine hyperstimulation rate	post vaginal delivery

Trial Locations

Locations (1)

Labor Unit, Department of Obstetric and Gynecology, China Medical Univertiy Hospital; 🇨🇳 Taichung, Taiwan