Trial record 4 of 381 for:    abortion

Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks (MIMI 11-15)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Boston University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01636063
First received: July 3, 2012
Last updated: July 5, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636063

Contacts
Contact: Principal Investigator 617-414-7310 fpresearch@bmc.org

Locations
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         
Sponsors and Collaborators
Boston University
Society of Family Planning
Investigators
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
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on July 31, 2014