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Mifepristone Versus Osmostic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks (SaMi2)

This study is currently recruiting participants.
Verified October 2011 by Boston University
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01436279
First received: September 15, 2011
Last updated: October 13, 2011
Last verified: October 2011
History of Changes
  Purpose

In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort after mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.


Condition Intervention Phase
Cervical Preparation
 Drug: Mifepristone
Device: osmotic dilators
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mifepristone Versus Osmostic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston University:

Primary Outcome Measures:
  • Length of procedure [ Time Frame: Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days. ] [ Designated as safety issue: No ]
    Interval from speculum insertion to speculum removal


Secondary Outcome Measures:
  • Operative time [ Time Frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. ] [ Designated as safety issue: No ]
    Interval from initiation of vacuum aspiration to speculum removal

  • Cervical dilation at the start of the procedure [ Time Frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. ] [ Designated as safety issue: No ]
  • Patient opinions about the process [ Time Frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. ] [ Designated as safety issue: No ]
  • Provider assessment of the procedure [ Time Frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. ] [ Designated as safety issue: No ]
  • Subject discomfort during the abortion [ Time Frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. ] [ Designated as safety issue: No ]
  • Subject discomfort after the abortion [ Time Frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. ] [ Designated as safety issue: No ]
  • Subject discomfort before the abortion [ Time Frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mifepristone + misoprostol
Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
 Drug: Mifepristone
200 mg po 20-24 hours prior to the procedure
Other Names:
  • Mifeprex
  • RU-486
  • Mifegyne
Active Comparator: Osmotic dilators
Placed 20-24 hours prior to procedure
 Device: osmotic dilators
osmotic dilators placed in the cervix 20-24 hours prior to the procedure
Other Names:
  • Laminaria
  • Dilapan-S
  • Dilapan

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women 18-50 years of age undergoing surgical termination of pregnancy
  • English or Spanish speaking
  • Gestational age between 15 and 18 weeks gestation on day of abortion (inclusive), by ultrasound dating
  • Eligible for a dilation and evacuation abortion with local anesthesia and sedation
  • Ultrasound for dating purposes done within the last two weeks

Exclusion Criteria:

  • Intrauterine infection
  • Fetal demise
  • Ruptured membranes
  • Multiple gestation
  • Uterine anomaly or significant distortion of the uterus with fibroids
  • BMI greater than 45
  • Inability to place osmotic dilators
  • Active substance abuse or intoxication
  • Adrenal failure, chronic corticosteroid use, anticoagulant usage
  • Severe cervicitis, until treated and resolved
  • Prior Cesarean section
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436279

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

Locations
United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Boston University
Society of Family Planning
Investigators
Principal Investigator: Principal Investigator Boston University
  More Information

No publications provided

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01436279     History of Changes
Other Study ID Numbers: H-31032, AU 6003109
Study First Received: September 15, 2011
Last Updated: October 13, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mifepristone
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

ClinicalTrials.gov processed this record on June 17, 2013