In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort before mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
200 mg po 20-24 hours prior to the procedure
osmotic dilators placed in the cervix 20-24 hours prior to the procedure
Boston University
Boston, Massachusetts, United States
Length of Procedure
Interval from speculum insertion to speculum removal
Time frame: Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.
Operative Time
Interval from initiation of vacuum aspiration to speculum removal
Time frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
Subject Discomfort Before the Abortion
Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe
Time frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
Pain Medication (Fentanyl) During the Abortion
Amount of pain medication used during the procedure: reported as micrograms of fentanyl
Time frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
Pain Medication (Midazolam) During the Abortion
Amount of pain medication used during the procedure: reported as milligrams of midazolam
Time frame: Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.
Cervical Dilation Achieved
Cervical dilation at start of procedure
Time frame: At time of abortion
Acceptability to Patient
Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was "yes" is being reported.
Time frame: After procedure completion
Difficulty of Procedure
Outcome measure is the number and percentage of participants where the provider rated the procedure as "difficult or very difficult". Provider assessment of difficulty of procedure categories were: "very easy", "easy", "moderate", "difficult", or "very difficult."
Time frame: After completion of procedure
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