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Oxytocin

Pitocin, Syntocinon

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Studies 93
Trials 100
Completed PHASE3 INTERVENTIONAL NCT00529295

Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: misoprostol
Type: DRUG
Description: 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

Primary Outcomes

Measure: 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.
TimeFrame: within the first week after delivery
Description:

Trial Information

NCT ID

NCT00529295

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

China Medical University Hospital

Last Updated

December 15, 2025