Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks

Abortion Clinical Trial

— SAMi  

Official title:

Mifepristone vs. Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986921
• Other study ID #: SAMi
• Status: Completed
• Phase: N/A
• First received: September 23, 2009
• Last updated: December 28, 2013
• Start date: October 2009
• Est. completion date: March 2011

Study information

• Verified date: December 2013
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• women aged 18-45 having pregnancy termination at 14-16 weeks

Exclusion Criteria:

• multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion

Intervention

Drug:
• mifepristone 200 mg
mifepristone would be given the day before the procedure

Device:
• osmotic dilator insertion
osmotic dilators (3-6) would be inserted as usual the day before the procedure

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time for Completion of Procedure	Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal)	Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.	No
Secondary	Assessment of Ease of Procedure by Operator	The operator for each procedure rated the ease of procedure on a categorical scale. The categories were collapsed into two: "easy or very easy" and "average or difficult".	It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point.	No
Secondary	Moderate or Severe Pain Overnight	Women wer asked to rank their amount of pain on a catergorical scale. The outcome measure is the number of women experiencing moderate or severe pain overnight (after mifepristone or osmotic dilators, and before the abortions procedure)	Overnight	No