The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol
1 other identifier
interventional
64
1 country
1
Brief Summary
The purpose of this study is to compare the efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2009
CompletedFirst Posted
Study publicly available on registry
April 23, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJuly 14, 2010
July 1, 2010
7 months
April 22, 2009
July 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
success rate of cervical ripening in labor induction
12 hours after intervention
Secondary Outcomes (1)
number of vaginal delivery
24 hours
Study Arms (2)
conventional oral misoprostol
ACTIVE COMPARATORmisoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 centimeters
titrated oral misoprostol
EXPERIMENTALmisoprostol 20 micrograms oral every hour until cervical dilatation 3 centimeters
Interventions
misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 cm
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700, Thailand
Related Publications (1)
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.
PMID: 21959071DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kusol Russameecharoen, MD
Siriraj Hospital, Mahidol University Bangkok, Bangkok, Thailand
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 22, 2009
First Posted
April 23, 2009
Study Start
May 1, 2009
Primary Completion
December 1, 2009
Study Completion
March 1, 2010
Last Updated
July 14, 2010
Record last verified: 2010-07