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

Boston University

Status: Terminated

Conditions: Abortion, Induced

Treatments: Device: osmotic dilator insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT00855842

DAIS

Details and patient eligibility

About

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)

Full 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.

Enrollment: 4 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

osmotic dilator

Experimental group

Description:

osmotic dilator

Treatment:

Device: osmotic dilator insertion