Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term

Study Overview
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Brief Summary
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The purpose of this study was to estimate the safety and efficacy of titrated oral misoprostol compared with vaginal route for labor induction at term.

Detailed Description
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Oral misoprostol absorption is more rapid and possible more predictable, with a peak serum concentration following oral administration of 34 minutes and a half-life of 20-40 minutes. Peak serum concentration for vaginal administration is 60-80 minutes, this level being sustained for up to four hours. Although the direct local effect of vaginal administration on cervical ripening may be advantageous, the shorter half-life of oral delivery may be beneficial in the event of uterine hyperstimulation.In order to avoid uterine hyperstimulation, it appears reasonable to suggest that oral misoprostol should be administered in small, frequent doses, titrated against the uterine response.

Conditions
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Labor Induction

Intervention / Treatment
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* Drug: misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 34 to 42 weeks of gestation live singleton Bishop score < or = 6 reassuring fetal heart beat pattern Exclusion Criteria: nonreassuring fetal heart beat pattern parity ovr five any contraindication to labor and/or vaginal delivery uterine scar suspected placental abruption with abnormal FHR pattern vaginal bleeding other than bloody show cervical dilatation of > or = 4 cm uterine contractions > or = 3 in 10 minutes significant maternal cardiac, renal or hepatic disease hypersensitivity to misoprostol or prostaglandin analogs

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Titrated oral misoprostol | Drug: misoprostol<br>* Titrated oral misoprostol: one tablet of 200 microgram was dissolved in water 200 ml, and 20 ml P.O. per one hour for 4 doses, then titrated against uterine response; Vaginal misoprostol: 25 microgram per vagina<br>|
| Active Comparator: 2<br>Vaginal misoprostol | Drug: misoprostol<br>* Titrated oral misoprostol: one tablet of 200 microgram was dissolved in water 200 ml, and 20 ml P.O. per one hour for 4 doses, then titrated against uterine response; Vaginal misoprostol: 25 microgram per vagina<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes. |  | within the first week after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dosage of misoprostol and the rate of women given oxytocin, cesarean section and induction failure. |  | The days during induction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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misoprostol, labor induction