Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks
This trial is active, not recruiting.
|Condition||legally induced abortion without mention of complication|
|Treatments||misoprostol, mifepristone, hygroscopic cervical dilators|
|Start date||April 2016|
|End date||February 2018|
|Trial size||100 participants|
|Trial identifier||NCT02679092, IRB-36302|
Dilation and evacuation (D&E) is a common surgical procedure in the U.S. Adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. Traditionally, the uterine cervix is prepared for the procedure using water-attracting dilators, which are placed via a speculum exam and cause discomfort for many women. The objective of this study is to investigate the comparative effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for D&E.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: Intraoperative
time frame: Baseline
Total Procedure Time
time frame: Measured at clinic visit and on OR day, over 2 day period
Difficulty of Procedure, as reported by clinician
time frame: Measured within 5 minutes after procedure
time frame: Intraoperatively
Pain Perceived by Patient
time frame: Intraoperatively "Measured during dilator placement"
Overall Patient Experience
time frame: Measured post-operatively (30 minutes prior to discharge)
Female participants at least 18 years old.
Inclusion Criteria: - >18 Years Old - Viable, Singleton pregnancy - Voluntarily seeking abortion between 14-19 weeks gestation - Able to give informed consent and comply with study protocol - Fluent in English or Spanish Exclusion Criteria: - Allergy to study drugs
|Official title||Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks|
|Principal investigator||Principal Investigator|
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