Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks (MIMI 11-15)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Induced Abortion Abortion Techniques Mifepristone Misoprostol |
Drug: Mifepristone Drug: Misoprostol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]Initial cervical dilation as measured by a Pratt cervical dilator prior to surgical abortion
- Additional cervical dilation required to complete abortion procedure [ Time Frame: 24 to 48 hours after enrollment ] [ Designated as safety issue: No ]Additional cervical dilation necessary to complete abortion procedure
- Time to conduct procedure [ Time Frame: 24 to 48 hours after enrollment ] [ Designated as safety issue: No ]
- Percentage of patients who report nausea, vomiting, diarrhea, and vaginal bleeding [ Time Frame: 24 to 48 hours after enrollment ] [ Designated as safety issue: Yes ]
- Preoperative, intraoperative, and postoperative pain score [ Time Frame: 24 to 48 hours after enrollment ] [ Designated as safety issue: No ]
- Surgeon's difficulty rating of procedure [ Time Frame: 24 to 48 hours after enrollment ] [ Designated as safety issue: No ]
- Complications of procedure [ Time Frame: At time of enrollment to 48 hours after enrollment. ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 110 |
| Study Start Date: | June 2012 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Mifepristone
Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion
|
Drug: Mifepristone
Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure
|
|
Active Comparator: Misoprostol
Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.
|
Drug: Misoprostol
Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure
Other Name: Cytotec
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Principal Investigator | 617-414-7310 | fpresearch@bmc.org |
| United States, Massachusetts | |
| Boston University Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Primary Investigator 617-414-7310 fpresearch@bmc.org | |
| Principal Investigator: Primary Investigator | |
| Principal Investigator: | Primary Investigator | Boston University |
More Information
No publications provided
| Responsible Party: | Boston University |
| ClinicalTrials.gov Identifier: | NCT01636063 History of Changes |
| Other Study ID Numbers: | SFPRF12-16 |
| Study First Received: | July 3, 2012 |
| Last Updated: | July 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Boston University:
|
Induced Abortion Abortion Techniques Mifepristone Misoprostol Initial Cervical Dilation |
Additional relevant MeSH terms:
|
Mifepristone Misoprostol Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptives, Postcoital, Synthetic |
Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents Abortifacient Agents, Steroidal Abortifacient Agents Anti-Ulcer Agents Gastrointestinal Agents Oxytocics Abortifacient Agents, Nonsteroidal |
ClinicalTrials.gov processed this record on May 16, 2013