Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks (MIMI 11-15)
Recruitment status was Recruiting
Surgical abortion in the late first trimester and early second trimester is usually performed with the aid of a cervical preparing agent, which helps to open up the uterine cervix for the procedure. Routine use of cervical preparants is recommended by several organizations during this period of pregnancy before surgical abortion, especially in younger women or those who have not delivered a baby, because their cervices may be more difficult to dilate without a preparant.
The standard medication used for cervical preparation is misoprostol. Unfortunately, misoprostol may cause uncomfortable uterine cramping and vaginal bleeding in patients who use it. Another medication called mifepristone has been shown to dilate the cervix better than misoprostol in the first trimester, but little information exists about using mifepristone in the late first trimester and early second trimester.
The investigators plan to perform a prospective, double-blind, randomized trial to evaluate if mifepristone is a better cervical preparant than misoprostol. A total of 110 participants who are pregnant women desiring pregnancy termination 11 to 15 weeks gestational age will be recruited. Half will receive mifepristone and the other half misoprostol. The investigators will measure the amount of cervical dilation achieved right before a surgical abortion to determine if mifepristone is significantly different than misoprostol as a cervical preparant at this stage of pregnancy. The investigators expect that mifepristone will work better than misoprostol for this purpose.
The investigators hope to generate information about mifepristone so that women and their health care providers can know more about mifepristone as an option for cervical preparation before surgical abortion.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks|
- Initial cervical dilation at the time of surgical abortion [ Time Frame: 24 to 48 hours after enrollment ] [ Designated as safety issue: No ]Initial cervical dilation as measured by a Pratt cervical dilator prior to surgical abortion
- Additional cervical dilation required to complete abortion procedure [ Time Frame: 24 to 48 hours after enrollment ] [ Designated as safety issue: No ]Additional cervical dilation necessary to complete abortion procedure
- Time to conduct procedure [ Time Frame: 24 to 48 hours after enrollment ] [ Designated as safety issue: No ]
- Percentage of patients who report nausea, vomiting, diarrhea, and vaginal bleeding [ Time Frame: 24 to 48 hours after enrollment ] [ Designated as safety issue: Yes ]
- Preoperative, intraoperative, and postoperative pain score [ Time Frame: 24 to 48 hours after enrollment ] [ Designated as safety issue: No ]
- Surgeon's difficulty rating of procedure [ Time Frame: 24 to 48 hours after enrollment ] [ Designated as safety issue: No ]
- Complications of procedure [ Time Frame: At time of enrollment to 48 hours after enrollment. ] [ Designated as safety issue: Yes ]Complications including expulsion of pregnancy before surgical abortion, uterine perforation, hemorrhage requiring blood transfusion, need for additional surgical procedures, and unplanned admission to the hospital.
|Study Start Date:||June 2012|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion
Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure
Active Comparator: Misoprostol
Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.
Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure
Other Name: Cytotec
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636063
|Contact: Principal Investigatorfirstname.lastname@example.org|
|United States, Massachusetts|
|Boston University Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Primary Investigator 617-414-7310 email@example.com|
|Principal Investigator: Primary Investigator|
|Principal Investigator:||Primary Investigator||Boston University|