Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00529295
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : September 14, 2007
Information provided by:
China Medical University Hospital

September 13, 2007
September 14, 2007
September 14, 2007
June 2005
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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
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Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term
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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.
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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Identifier (NCT Number) in Medline.
Same as current
March 2007
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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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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China Medical University Hospital
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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