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Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term

This study has been completed.
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT00529295
First received: September 13, 2007
Last updated: NA
Last verified: September 2006
History: No changes posted

September 13, 2007
September 13, 2007
June 2005
Not Provided
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 ]
Same as current
No Changes Posted
Total dosage of misoprostol and the rate of women given oxytocin, cesarean section and induction failure. [ Time Frame: The days during induction ]
Same as current
Not Provided
Not Provided
 
Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term
Not Provided

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Labor Induction
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
  • Experimental: 1
    Titrated oral misoprostol
    Intervention: Drug: misoprostol
  • Active Comparator: 2
    Vaginal misoprostol
    Intervention: Drug: misoprostol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
March 2007
Not Provided

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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00529295
DMR95-IRB-116
No
Not Provided
China Medical University Hospital
Not Provided
Principal Investigator: Shi-Yann Cheng, M.D. Chinal Medical University Beigang Hospital
China Medical University Hospital
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP