Pilot Study of the Addition of Osmotic Dilators to Preparation Prior to Labor Induction Abortion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Boston University
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Length of Medical Abortion
Study Overview
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)
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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
osmotic dilator
osmotic dilator
Intervention: osmotic dilator insertion (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported