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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
  Purpose

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.


Condition Intervention Phase
Labor Induction
 Drug: misoprostol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research

Resource links provided by NLM:

Drug Information available for: Misoprostol
U.S. FDA Resources

Further study details as provided by China Medical University Hospital:

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

Enrollment: 220
Study Start Date: June 2005
Study Completion Date: March 2007
Arms Assigned Interventions
Experimental: 1
Titrated oral misoprostol
 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
Active Comparator: 2
Vaginal misoprostol
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529295

Locations
Taiwan
China Medical University Beigang Hospital
Yun Lin, Taiwan, 651
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Shi-Yann Cheng, M.D. Chinal Medical University Beigang Hospital
  More Information

Additional Information:
China Medical University Hospital  This link exits the ClinicalTrials.gov site
China Medical University Beigang Hospital  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00529295     History of Changes
Other Study ID Numbers: DMR95-IRB-116
Study First Received: September 13, 2007
Last Updated: September 13, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
misoprostol
labor induction

Additional relevant MeSH terms:
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
 Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on June 17, 2013