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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
mifepristone would be given the day before the procedure
osmotic dilators (3-6) would be inserted as usual the day before the procedure
Boston Medical Center
Boston, Massachusetts, United States
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)
Time frame: 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.
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".
Time frame: It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point.
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)
Time frame: Overnight
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