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

This study has been terminated.
(inadequate enrollment)
Sponsor:
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00855842
First received: March 2, 2009
Last updated: June 10, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
Abortion, Induced
 Device: osmotic dilator insertion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of the Addition of Osmotic Dilators to Preparation Prior to Labor Induction Abortion

Further study details as provided by Boston University:

Primary Outcome Measures:
  • Length of Medical Abortion [ Time Frame: hours since the start of medical abortion ] [ Designated as safety issue: No ]
    This is the time elapsed from the first dose of misoprostol (the agent to induce abortion) and expulsion of the fetus


Enrollment: 4
Study Start Date: March 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: osmotic dilator
osmotic dilator
 Device: osmotic dilator insertion
osmotic dilators are placed in the cervix to cause cervical dilation
Other Names:
  • laminaria
  • Dilapan

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855842

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Lynn Borgatta, MD, MPH Boston University
  More Information

No publications provided

Responsible Party: Lynn Borgatta MD, Boston University
ClinicalTrials.gov Identifier: NCT00855842     History of Changes
Other Study ID Numbers: DAIS
Study First Received: March 2, 2009
Results First Received: April 4, 2011
Last Updated: June 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston University:
second trimester abortion
labor induction abortion
second trimester medical abortion
pregnancy

ClinicalTrials.gov processed this record on May 21, 2013