Pilot Study of the Addition of Osmotic Dilators to Preparation Prior to Labor Induction Abortion - Full Text View

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

This study is not yet open for participant recruitment.

Verified by Boston University, March 2009

First Received: March 2, 2009 Last Updated: March 3, 2009 History of Changes

Sponsored by:	Boston University
Information provided by:	Boston University
ClinicalTrials.gov Identifier:	NCT00855842

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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 induction time [ Time Frame: hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
osmotic dilator: Experimental osmotic dilator	Device: osmotic dilator insertion osmotic dilators are placed in the cervix to cause cervical dilation

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

Contacts

Contact: Lynn Borgatta, MD, MPH	617-414-3440	lynn.borgatta@bmc.org
Contact: Karen Lifford, MD, ScD	617-414-5185	karen.lifford@bmc.org

Locations

United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

Boston University

More Information

No publications provided

Responsible Party:	Boston University ( Lynn Borgatta )
Study ID Numbers:	DAIS
Study First Received:	March 2, 2009
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00855842 History of Changes
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 06, 2009