Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to Foley balloon for induction of the unfavorable cervix.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2009
Shorter than P25 for not_applicable
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
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 7, 2010
CompletedFirst Posted
Study publicly available on registry
June 9, 2010
CompletedResults Posted
Study results publicly available
August 24, 2018
CompletedAugust 24, 2018
August 1, 2018
6 months
June 7, 2010
January 29, 2018
August 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Induction To Delivery
To assess effectiveness of misoprostol used in conjunction with Foley balloon versus the standard oxytocin regimen in regards to induction times
24 hrs
Secondary Outcomes (1)
Delivery Route
24 hrs
Study Arms (2)
Oxytocin
ACTIVE COMPARATORFoley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.
Misoprostol
EXPERIMENTALMisoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
Interventions
Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.
Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
Eligibility Criteria
You may qualify if:
- Participant or surrogate is capable of giving informed consent
- Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy
- Participant is undergoing an indicated induction of labor
- Participant is found to have cervical Bishop score ≤5 on initial cervical exam
- Participant has no medical or obstetrical contraindications to induction of labor
You may not qualify if:
- Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods
- Manufacturer's contraindications to misoprostol or oxytocin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aultman Health Foundation
Canton, Ohio, 44710, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jane Sewell
- Organization
- Aultman Health Foundation
Study Officials
- PRINCIPAL INVESTIGATOR
Erica Downey, MD
Aultman Health Foundation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2010
First Posted
June 9, 2010
Study Start
September 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
August 24, 2018
Results First Posted
August 24, 2018
Record last verified: 2018-08