Clinical trial NCT00695331: Efficacy and Safety Study of Titrated Oral Misoprostol Solution for Labor Augmentation
Official title: A Comparison of Titrated Oral Misoprostol Solution to Intravenous Oxytocin for Labor Augmentation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Labor
Keywords: Labor Augmentation
Misoprostol
Oxytocin
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2008-06-11
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: the percentage of women delivering infants vaginally within 12 hours of augmentation
timeFrame: post vaginal delivery
Secondary outcomes:
measure: uterine hyperstimulation rate
timeFrame: post vaginal delivery
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Labor Unit, Department of Obstetric and Gynecology, China Medical Univertiy Hospital
Study officials:
affiliation: China Medical University Beigang Hospital
name: Shi-Yann Cheng, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Ho M, Cheng SY, Li TC. Titrated oral misoprostol solution compared with intravenous oxytocin for labor augmentation: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):612-618. doi: 10.1097/AOG.0b013e3181ed36cc.