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Pilot Study of the Addition of Osmotic Dilators to Preparation Prior to Labor Induction Abortion (DAIS)

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ClinicalTrials.gov Identifier: NCT00855842
Recruitment Status : Terminated (inadequate enrollment)
First Posted : March 4, 2009
Results First Posted : July 8, 2011
Last Update Posted : July 8, 2011
Sponsor:
Information provided by:
Boston University

Study Description
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Brief Summary:
One the day prior to medical abortion (labor induction) in the second trimester, insertion of osmotic dilators is added to the routine procedures. The study is to see whether the addition of dilators decreases the abortion time (time for the pregnancy to be expelled)

Condition or disease Intervention/treatment Phase
Abortion, Induced Device: osmotic dilator insertion Not Applicable

Detailed Description:
This is a pilot study and is an uncontrolled, non-randomized series. Women having a medical abortion in second trimester undergo several procedures the day before the medication to cause contractions occurs. On the day before admission, they take mifepristone orally, and have a feticidal injection. to this would be added the insertion of cervical osmotic dilators (the intervention). On the day of induction, the dilators would be removed and misoprostol started to cause contractions. We are hoping the median abortion time will drop from the present 9-10 hours to 4-6 hours. women who do not abort in 6 hours will have option of surgical completion of the abortion (dilation and evacuation) if medically appropriate.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Addition of Osmotic Dilators to Preparation Prior to Labor Induction Abortion
Study Start Date : March 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: osmotic dilator
osmotic dilator
 Device: osmotic dilator insertion
osmotic dilators are placed in the cervix to cause cervical dilation
Other Names:
  • laminaria
  • Dilapan


Outcome Measures
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Primary Outcome Measures :
  1. Length of Medical Abortion [ Time Frame: hours since the start of medical abortion ]
    This is the time elapsed from the first dose of misoprostol (the agent to induce abortion) and expulsion of the fetus


Eligibility Criteria
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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:

  • Requesting abortion 19-23 weeks
  • No contraindication to induction abortion

Exclusion Criteria:

  • Fetal demise
  • Ruptured membranes
  • Evidence of pelvic infection
  • Inability to give informed consent
Contacts and Locations
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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): NCT00855842


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
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Principal Investigator: Lynn Borgatta, MD, MPH Boston University
More Information
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Responsible Party: Lynn Borgatta MD, Boston University
ClinicalTrials.gov Identifier: NCT00855842    
Other Study ID Numbers: DAIS
First Posted: March 4, 2009    Key Record Dates
Results First Posted: July 8, 2011
Last Update Posted: July 8, 2011
Last Verified: June 2011
Keywords provided by Boston University:
second trimester abortion
labor induction abortion
second trimester medical abortion
pregnancy