Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks
- Conditions
- Abortion, Induced
- Interventions
- Registration Number
- NCT01615731
- Lead Sponsor
- Stanford University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
- >18 years old
- Viable, Singleton pregnancy
- Voluntarily seeking abortion between 19 and 24wks gestation
- Able to give informed consent and comply with study protocol
- Fluent in English or Spanish
- Allergy to misoprostol or mifepristone
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Two sets of dilators Misoprostol Two sets of osmotic dilators inserted 1 and 2 days pre-op Two sets of dilators Intra-amniotic digoxin Two sets of osmotic dilators inserted 1 and 2 days pre-op Two sets of dilators Hygroscopic cervical dilators Two sets of osmotic dilators inserted 1 and 2 days pre-op Mifepristone plus one set of dilators Intra-amniotic digoxin One set of dilators plus mifepristone Mifepristone plus one set of dilators Hygroscopic cervical dilators One set of dilators plus mifepristone Mifepristone plus one set of dilators Mifepristone One set of dilators plus mifepristone Mifepristone plus one set of dilators Misoprostol One set of dilators plus mifepristone
- Primary Outcome Measures
Name Time Method Total Procedure Time Measured at clinic visits and on OR day, over a 3 day period Procedure Time Intraoperative Time Measured as time from speculum insertion to removal
- Secondary Outcome Measures
Name Time Method Overall Patient Experience Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge 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.
Adverse Events (EBL) Intraoperatively One adverse event: Estimated Blood Loss
Ease of Procedure by Blinded Surgeon Measured Immediately after procedure 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.
Maximum Cervical Dilation Measured intra-operatively Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.
Pain Perceived by Patient Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively) 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.
Adverse Events Intraoperatively and 2 weeks post operatively uterine perforation, uterine injury, etc.
Trial Locations
- Locations (2)
Santa Clara Valley Medical Center
🇺🇸San Jose, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States