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
  Purpose

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


Condition Intervention Phase
Cervical Ripening
Labor Induction
Drug: misoprostol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • success rate of cervical ripening in labor induction [ Time Frame: 12 hours after intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • number of vaginal delivery [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: May 2009
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: conventional oral misoprostol
misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 centimeters
Drug: misoprostol
misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 cm
Other Name: cytotec
Experimental: titrated oral misoprostol
misoprostol 20 micrograms oral every hour until cervical dilatation 3 centimeters
Drug: misoprostol
misoprostol 20 micrograms oral every hours until cervical dilatation 3 cm
Other Name: cytotec

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886860

Locations
Thailand
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Study Director: Kusol Russameecharoen, MD Siriraj Hospital, Mahidol University Bangkok, Bangkok, Thailand
  More Information

No publications provided by Mahidol University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kusol Russameecharoen, MD., Faculty of Medicine Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT00886860     History of Changes
Other Study ID Numbers: 091/2552(EC2)
Study First Received: April 22, 2009
Last Updated: July 12, 2010
Health Authority: United States: Institutional Review Board
Thailand: Food and Drug Administration

Keywords provided by Mahidol University:
Efficacy
Cervical ripening/Labor induction
Titrated oral misoprostol/Conventional oral misoprostol
Term pregnancy

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

ClinicalTrials.gov processed this record on September 30, 2014