Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term

Phase 3

Completed

• Conditions: Labor Induction
• Interventions: Drug: misoprostol

• Registration Number: NCT00529295
• Lead Sponsor: China Medical University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-06
• Status Verified: 2006-09
• Study Completion: 2007-03
• Study First Submitted: 2007-09-13
• Study First Submitted QC: 2007-09-13
• Last Update Submitted: 2007-09-13
• Study First Posted: 2007-09-14
• Last Update Posted: 2007-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	misoprostol	Titrated oral misoprostol
2	misoprostol	Vaginal misoprostol

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Total dosage of misoprostol and the rate of women given oxytocin, cesarean section and induction failure.	The days during induction

Trial Locations

Locations (1)

China Medical University Beigang Hospital; 🇨🇳 Yun Lin, Taiwan