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

Abortion, Induced Clinical Trial

— DAIS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00855842
• Other study ID #: DAIS
• Status: Terminated
• Phase: N/A
• First received: March 2, 2009
• Last updated: June 10, 2011
• Start date: March 2009
• Est. completion date: January 2010

Study information

• Verified date: June 2011
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Induced

Intervention

Device:
• osmotic dilator insertion
osmotic dilators are placed in the cervix to cause cervical dilation

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Medical Abortion	This is the time elapsed from the first dose of misoprostol (the agent to induce abortion) and expulsion of the fetus	hours since the start of medical abortion	No