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.

Study Type: Interventional

Study Design: Health Services Research, Randomized, Single Blind (Subject), Parallel Assignment

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.

Intervention(s) in this Clinical Trial

• Drug: misoprostol
  • 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Titrated oral misoprostol
• Active Comparator: 2
  • Vaginal misoprostol

Primary Measures

• 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.
  • Time Frame: within the first week after delivery
    

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: China Medical University Hospital

Overall Clinical Trial Officials and Contacts

Shi-Yann Cheng, M.D. Principal Investigator Chinal Medical University Beigang Hospital  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00529295

Study ID Number: DMR95-IRB-116

ClinicalTrials.gov Identifier: NCT00529295

Health Authority: Taiwan: Department of Health

China Medical University Hospital

China Medical University Beigang Hospital