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Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks (MIMI11-15)

This study has been terminated.
(Poor subject enrollment)
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01636063
First received: July 3, 2012
Last updated: April 10, 2017
Last verified: April 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 ]
    Initial cervical dilation as measured in French units by a Pratt cervical dilator prior to surgical abortion. The dilation was measured in French units with each French unit being equivalent to 0.33 mm.


Enrollment: 42
Actual Study Start Date: June 2012
Study Completion Date: May 2014
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
Other Name: RU-486
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Locations
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Society of Family Planning
Investigators
Principal Investigator: Primary Investigator Boston University
  More Information

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01636063     History of Changes
Other Study ID Numbers: SFPRF12-16
Study First Received: July 3, 2012
Results First Received: February 23, 2017
Last Updated: April 10, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Boston University:
Induced Abortion
Abortion Techniques
Mifepristone
Misoprostol
Initial Cervical Dilation

Additional relevant MeSH terms:
Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
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

ClinicalTrials.gov processed this record on July 27, 2017