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

Induced Abortion Clinical Trial

— MIMI 11-15  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01636063
• Other study ID #: SFPRF12-16
• Status: Recruiting
• Phase: N/A
• First received: July 3, 2012
• Last updated: July 5, 2012
• Start date: June 2012

Study information

• Verified date: July 2012
• Source: Boston University
• Contact: Principal Investigator
• Phone: 617-414-7310
• Email: fpresearch[@]bmc.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion Techniques
• Induced Abortion
• Mifepristone
• Misoprostol

Intervention

Drug:
• Mifepristone
Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure
• Misoprostol
Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure

Locations

Country	Name	City	State
United States	Boston University Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial cervical dilation at the time of surgical abortion	Initial cervical dilation as measured by a Pratt cervical dilator prior to surgical abortion	24 to 48 hours after enrollment	No
Secondary	Additional cervical dilation required to complete abortion procedure	Additional cervical dilation necessary to complete abortion procedure	24 to 48 hours after enrollment	No
Secondary	Time to conduct procedure		24 to 48 hours after enrollment	No
Secondary	Percentage of patients who report nausea, vomiting, diarrhea, and vaginal bleeding		24 to 48 hours after enrollment	Yes
Secondary	Preoperative, intraoperative, and postoperative pain score		24 to 48 hours after enrollment	No
Secondary	Surgeon's difficulty rating of procedure		24 to 48 hours after enrollment	No
Secondary	Complications of procedure	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.	At time of enrollment to 48 hours after enrollment.	Yes