A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased "total" time as two sets of dilators.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
200mg Mifepristone orally
Dilapan-S osmostic cervical dilators inserted through the internal os
400mcg buccal misoprostol 90 minutes pre-op
1mg digoxin administered intra-amniotically \~24 hours pre-op
Santa Clara Valley Medical Center
San Jose, California, United States
Stanford University Medical Center
Stanford, California, United States
Procedure Time
Measured as time from speculum insertion to removal
Time frame: Intraoperative Time
Total Procedure Time
Time frame: Measured at clinic visits and on OR day, over a 3 day period
Maximum Cervical Dilation
Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.
Time frame: Measured intra-operatively
Adverse Events (EBL)
One adverse event: Estimated Blood Loss
Time frame: Intraoperatively
Ease of Procedure by Blinded Surgeon
Used a Visual Analogue Scale to determine the ease of procedure by blinded surgeon. The VAS ranges from 0-100. 0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon.
Time frame: Measured Immediately after procedure
Pain Perceived by Patient
Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively). The VAS ranges from 0-100. 0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient.
Time frame: Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)
Overall Patient Experience
Used a Visual Analogue Scale to determine the patient's overall satisfaction with her experience. The VAS ranges from 0-100. 0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience.
Time frame: Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge
Adverse Events
uterine perforation, uterine injury, etc.
Time frame: Intraoperatively and 2 weeks post operatively
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