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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01636063
Other study ID # SFPRF12-16
Secondary ID
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. completion date
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


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
See also
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