Oral Misoprostol for Labor Augmentation: A Pilot Study
1 other identifier
interventional
46
1 country
1
Brief Summary
A phase I, open-label trial to determine a safe dose of oral misoprostol required to augment labor in nulliparous women diagnosed with arrest of dilation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2007
Typical duration for phase_1
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
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 19, 2009
CompletedFirst Posted
Study publicly available on registry
May 21, 2009
CompletedMay 21, 2009
May 1, 2009
1.4 years
May 19, 2009
May 20, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
uterine hyperstimulation
Secondary Outcomes (6)
adequate uterine activity
need for oxytocin augmentation
time from administration of study drug to delivery
route of delivery and indications
maternal and neonatal infectious morbidity
- +1 more secondary outcomes
Study Arms (5)
Oral Misoprostol 1
EXPERIMENTALOral misoprostol 25 micrograms every 4 hours for up to two doses.
Oral Misoprostol 2
EXPERIMENTALOral misoprostol 50 micrograms every 4 hours for up to two doses.
Oral Misoprostol 3
EXPERIMENTALOral misoprostol 100 micrograms every 4 hours for up to two doses.
Oral Misoprostol 4
EXPERIMENTALOral Misoprostol 50 micrograms every 2 hours for up to two doses.
Oral Misoprostol 5
EXPERIMENTALOral Misoprostol 75 micrograms every 4 hours for up to two doses.
Interventions
Oral misoprostol
Eligibility Criteria
You may qualify if:
- nulliparous
- gestational age of at least 36 weeks
- singleton gestation
- cephalic presentation
- reassuring fetal heart rate
- cm or greater cervical dilation
- ruptured membranes with clear amnionic fluid
- intrauterine pressure catheter in place
- less than 200 MVU's
You may not qualify if:
- non-reassuring fetal heart rate
- meconium-stained amnionic fluid
- previous uterine incision
- maternal fever
- pregnancy-induced hypertension or other pregnancy-related complications
- known fetal anomalies
- placenta previa or unexplained vaginal bleeding
- estimated fetal weight of 4,500 grams or greater
- evidence of cephalopelvic disproportion
- any moderate or severe preexisting disease
- contraindication to the use of prostaglandins
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn S Villano, M.D.
University of Texas Southwestern Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 19, 2009
First Posted
May 21, 2009
Study Start
April 1, 2007
Primary Completion
September 1, 2008
Study Completion
May 1, 2009
Last Updated
May 21, 2009
Record last verified: 2009-05