Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks

• Status: Terminated
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boston University
• Collaborator: Society of Family Planning
• Treatments: Mifepristone; Misoprostol

Criteria

Inclusion Criteria:

• Age greater or equal to 18 years

• Fluency in English or Spanish

• Intrauterine pregnancy between 11 0/7 and 15 0/7 on the day of the abortion procedure

• Desire for pregnancy termination

• Ability to return for abortion procedure 24-48 hours after the preoperative visit

Exclusion Criteria:

• Allergy or contraindication to study agents

• Requirement of general anesthesia to perform the abortion

• Diagnosis of missed abortion, spontaneous abortion, incomplete abortion, or threatened abortion at time of initial preoperative evaluation