Cervical Ripening in Obese Women: Efficacy of 25 mcg Versus 50 mcg of Misoprostol
NCT ID: NCT03748147
Last Updated: 2018-11-20
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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UNKNOWN
NA
300 participants
INTERVENTIONAL
2018-12-10
2021-03-01
Brief Summary
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Detailed Description
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Obese women (delivery BMI 30 or more) who agree to participation will be randomly designated to receive either 25 mcg po q 4 hour (control) misoprosol versus 50 mcg po q 4 hours. Our primary outcome will be the rate of successful induction. Secondary outcomes will include ability to achieve a Bishop score greater than 7, time to active labor, and safety data including rate of tachysystole, non-reassuring fetal status, NICU admission.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Control
Standard of care, misoprostol 25 mcg po every four hours
Misoprostol
prostaglandin e1
Intervention
Misoprostol 50 mcg po every four hours
Misoprostol
prostaglandin e1
Interventions
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Misoprostol
prostaglandin e1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
FEMALE
No
Sponsors
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University of Cincinnati
OTHER
Responsible Party
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Carri Warshak
Associate Clinical Professor
Central Contacts
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Other Identifiers
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2016-4435
Identifier Type: -
Identifier Source: org_study_id
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