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

This study is not yet open for participant recruitment.

Verified by Mahidol University, April 2009

First Received: April 22, 2009 No Changes Posted

Sponsored by:	Mahidol University
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00886860

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 IV

Drug Information available for: Misoprostol

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol

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 ]

Estimated Enrollment:	70
Study Start Date:	April 2009
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
conventional oral misoprostol: Active Comparator 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
titrated oral misoprostol: Experimental misoprostol 20 micrograms oral every hour until cervical dilatation 3 centimeters	Drug: misoprostol misoprostol 20 micrograms oral every hours until cervical dilatation 3 cm

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

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

Contacts

Contact: Amporn Thaisomboon, MD.	+66-(0)8-1541-1837	halloweenbee@hotmail.com
Contact: Kusol Russameecharoen, MD.	+66-(0)8-1804-3617	rkusol@yahoo.com

Locations

Thailand
Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700

Sponsors and Collaborators

Mahidol University

More Information

No publications provided

Responsible Party:	Faculty of Medicine Siriraj Hospital, Mahidol University ( Amporn Thaisomboon, MD. )
Study ID Numbers:	091/2552(EC2)
Study First Received:	April 22, 2009
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00886860 History of Changes
Health Authority:	United States: Institutional Review Board; Thailand: Food and Drug Administration

Keywords provided by Mahidol University:

term pregnancy
cervical ripening/labor induction
titrated oral misoprostol
conventional oral misoprostol

efficacy
a randomized trial
misoprostol
full term pregnancy

Study placed in the following topic categories:

Misoprostol

Additional relevant MeSH terms:

Oxytocics
Therapeutic Uses
Anti-Ulcer Agents
Physiological Effects of Drugs
Abortifacient Agents

Misoprostol
Gastrointestinal Agents
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009