Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2007-04-30
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Oral Misoprostol 1
Oral misoprostol 25 micrograms every 4 hours for up to two doses.
Misoprostol
Oral misoprostol
Oral Misoprostol 2
Oral misoprostol 50 micrograms every 4 hours for up to two doses.
Misoprostol
Oral misoprostol
Oral Misoprostol 3
Oral misoprostol 100 micrograms every 4 hours for up to two doses.
Misoprostol
Oral misoprostol
Oral Misoprostol 4
Oral Misoprostol 50 micrograms every 2 hours for up to two doses.
Misoprostol
Oral misoprostol
Oral Misoprostol 5
Oral Misoprostol 75 micrograms every 4 hours for up to two doses.
Misoprostol
Oral misoprostol
Interventions
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Misoprostol
Oral misoprostol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* gestational age of at least 36 weeks
* singleton gestation
* cephalic presentation
* reassuring fetal heart rate
* 4 cm or greater cervical dilation
* ruptured membranes with clear amnionic fluid
* intrauterine pressure catheter in place
* less than 200 MVU's
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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University of Texas Southwestern Medical Center
Principal Investigators
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Kathryn S Villano, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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122006051
Identifier Type: -
Identifier Source: org_study_id
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