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The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00886860
First received: April 22, 2009
Last updated: July 12, 2010
Last verified: July 2010

April 22, 2009
July 12, 2010
May 2009
December 2009   (final data collection date for primary outcome measure)
success rate of cervical ripening in labor induction [ Time Frame: 12 hours after intervention ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00886860 on ClinicalTrials.gov Archive Site
number of vaginal delivery [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol
The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol

The purpose of this study is to compare the efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Cervical Ripening
  • Labor Induction
  • Drug: misoprostol
    misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 cm
    Other Name: cytotec
  • Drug: misoprostol
    misoprostol 20 micrograms oral every hours until cervical dilatation 3 cm
    Other Name: cytotec
  • Active Comparator: conventional oral misoprostol
    misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 centimeters
    Intervention: Drug: misoprostol
  • Experimental: titrated oral misoprostol
    misoprostol 20 micrograms oral every hour until cervical dilatation 3 centimeters
    Intervention: Drug: misoprostol
Thaisomboon A, Russameecharoen K, Wanitpongpan P, Phattanachindakun B, Changnoi A. Comparison of the efficacy and safety of titrated oral misoprostol and a conventional oral regimen for cervical ripening and labor induction. Int J Gynaecol Obstet. 2012 Jan;116(1):13-6. doi: 10.1016/j.ijgo.2011.07.027. Epub 2011 Sep 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
March 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 18 years old or more
  • singleton pregnancy at 37 weeks gestation or more
  • cephalic presentation
  • reassuring fetal heart rate pattern
  • admission for labor induction due to medical or obstetrical conditions
  • bishop score less than 6
  • giving consent and having signed the consent form for this study

Exclusion Criteria:

  • parity more than 3
  • estimated fetal weight more than 3,500 grams
  • non-reassuring fetal heart rate pattern
  • having contraindication for vaginal delivery
  • previous uterine scar
  • suspected abruptio placenta with non-reassuring fetal heart rate pattern
  • abnormal bleeding per vagina, except bloody show
  • PROM
  • having underlying cardiac, hepatic, or renal diseases
  • having history of allergy to misoprostol or prostaglandin analogues
  • cervical dilatation 3 centimeters or more
  • uterine contraction 3 times or more in 10 minute
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00886860
091/2552(EC2)
Yes
Kusol Russameecharoen, MD., Faculty of Medicine Siriraj Hospital, Mahidol University
Mahidol University
Not Provided
Study Director: Kusol Russameecharoen, MD Siriraj Hospital, Mahidol University Bangkok, Bangkok, Thailand
Mahidol University
July 2010

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