Back to resultsOral Misoprostol for Labor Augmentation: A Pilot Study
Primary Purpose
Arrest of Dilation in Labor
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Misoprostol
Sponsored by
About this trial
This is an interventional treatment trial for Arrest of Dilation in Labor focused on measuring oral misoprostol, labor augmentation, arrest of dilation, nulliparous
Eligibility Criteria
Inclusion Criteria:
- nulliparous
- 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:
- 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
Sites / Locations
- University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Oral Misoprostol 1
Oral Misoprostol 2
Oral Misoprostol 3
Oral Misoprostol 4
Oral Misoprostol 5
Arm Description
Oral misoprostol 25 micrograms every 4 hours for up to two doses.
Oral misoprostol 50 micrograms every 4 hours for up to two doses.
Oral misoprostol 100 micrograms every 4 hours for up to two doses.
Oral Misoprostol 50 micrograms every 2 hours for up to two doses.
Oral Misoprostol 75 micrograms every 4 hours for up to two doses.
Outcomes
Primary Outcome Measures
uterine hyperstimulation
Secondary Outcome Measures
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
neonatal outcomes
Full Information
NCT ID
NCT00906126
First Posted
May 19, 2009
Last Updated
May 20, 2009
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00906126
Brief Title
Oral Misoprostol for Labor Augmentation: A Pilot Study
Official Title
Oral Misoprostol for Labor Augmentation: A Dose-Finding Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrest of Dilation in Labor
Keywords
oral misoprostol, labor augmentation, arrest of dilation, nulliparous
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Misoprostol 1
Arm Type
Experimental
Arm Description
Oral misoprostol 25 micrograms every 4 hours for up to two doses.
Arm Title
Oral Misoprostol 2
Arm Type
Experimental
Arm Description
Oral misoprostol 50 micrograms every 4 hours for up to two doses.
Arm Title
Oral Misoprostol 3
Arm Type
Experimental
Arm Description
Oral misoprostol 100 micrograms every 4 hours for up to two doses.
Arm Title
Oral Misoprostol 4
Arm Type
Experimental
Arm Description
Oral Misoprostol 50 micrograms every 2 hours for up to two doses.
Arm Title
Oral Misoprostol 5
Arm Type
Experimental
Arm Description
Oral Misoprostol 75 micrograms every 4 hours for up to two doses.
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Cytotec
Intervention Description
Oral misoprostol
Primary Outcome Measure Information:
Title
uterine hyperstimulation
Secondary Outcome Measure Information:
Title
adequate uterine activity
Title
need for oxytocin augmentation
Title
time from administration of study drug to delivery
Title
route of delivery and indications
Title
maternal and neonatal infectious morbidity
Title
neonatal outcomes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
nulliparous
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn S Villano, M.D.
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Oral Misoprostol for Labor Augmentation: A Pilot Study
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