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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01436279
First Posted: September 19, 2011
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Boston University
  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 before 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks

Resource links provided by NLM:


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. ]
    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. ]
    Interval from initiation of vacuum aspiration to speculum removal

  • 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. ]
    Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe

  • Pain Medication (Fentanyl) 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. ]
    Amount of pain medication used during the procedure: reported as micrograms of fentanyl

  • Pain Medication (Midazolam) 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. ]
    Amount of pain medication used during the procedure: reported as milligrams of midazolam

  • Cervical Dilation Achieved [ Time Frame: At time of abortion ]
    Cervical dilation at start of procedure

  • Acceptability to Patient [ Time Frame: After procedure completion ]
    Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was "yes" is being reported.

  • Difficulty of Procedure [ Time Frame: After completion of procedure ]
    Outcome measure is the number and percentage of participants where the provider rated the procedure as "difficult or very difficult". Provider assessment of difficulty of procedure categories were: "very easy", "easy", "moderate", "difficult", or "very difficult."


Enrollment: 50
Study Start Date: July 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436279


Locations
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Boston University
Society of Family Planning
Investigators
Principal Investigator: Sarita Sonalkar, MD Boston Medical Center
  More Information

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01436279     History of Changes
Other Study ID Numbers: H-31032
AU 6003109 ( Other Grant/Funding Number: Society of Family Planning )
First Submitted: September 15, 2011
First Posted: September 19, 2011
Results First Submitted: April 11, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
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