Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks (MIMI11-15)
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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 ]Initial cervical dilation as measured in French units by a Pratt cervical dilator prior to surgical abortion. The dilation was measured in French units with each French unit being equivalent to 0.33 mm.
|Actual Study Start Date:||June 2012|
|Study Completion Date:||May 2014|
|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
Other Name: RU-486
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01636063
|United States, Massachusetts|
|Boston University Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Primary Investigator||Boston University|