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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Labor

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Titrated Oral Misoprostol Solution | Drug: Misoprostol<br>* Titrated Misoprostol Solution<br>* Other names: Cytotec;|
| Active Comparator: 2<br>Intravenous Oxytocin | Drug: Oxytocin<br>* Titrated Intravenous Oxytocin<br>* Other names: Piton-S;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of women delivering infants vaginally within 12 hours of augmentation |  | post vaginal delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uterine hyperstimulation rate |  | post vaginal delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor Augmentation, Misoprostol, Oxytocin