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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00986921
Other study ID # SAMi
Secondary ID
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


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
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