Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks
Information source: Boston University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Induced Abortion; Abortion Techniques; Mifepristone; Misoprostol
Intervention: Mifepristone (Drug); Misoprostol (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Boston University Official(s) and/or principal investigator(s): Primary Investigator, Principal Investigator, Affiliation: Boston University
Overall contact: Principal Investigator, Phone: 617-414-7310, Email: fpresearch@bmc.org
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.
Clinical Details
Official title: Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Initial cervical dilation at the time of surgical abortion
Secondary outcome: Additional cervical dilation required to complete abortion procedureTime to conduct procedure Percentage of patients who report nausea, vomiting, diarrhea, and vaginal bleeding Preoperative, intraoperative, and postoperative pain score Surgeon's difficulty rating of procedure Complications of procedure
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Principal Investigator, Phone: 617-414-7310, Email: fpresearch@bmc.org
Boston University Medical Center, Boston, Massachusetts 02118, United States; Recruiting Primary Investigator, Phone: 617-414-7310, Email: fpresearch@bmc.org Primary Investigator, Principal Investigator
Additional Information
Starting date: June 2012
Last updated: July 5, 2012
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