Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks
- Conditions
- Legally Induced Abortion Without Mention of Complication
- Interventions
- Registration Number
- NCT02679092
- Lead Sponsor
- Stanford University
- Brief Summary
Dilation and evacuation (D\&E) is a common surgical procedure in the U.S. Adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. Traditionally, the uterine cervix is prepared for the procedure using water-attracting dilators, which are placed via a speculum exam and cause discomfort for many women. The objective of this study is to investigate the comparative effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for D\&E.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- >18 Years Old
- Viable, Singleton pregnancy
- Voluntarily seeking abortion between 14-19 weeks gestation
- Able to give informed consent and comply with study protocol
- Fluent in English or Spanish
- Allergy to study drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dilapan (14wks 0days-15wks, 6days) Hygroscopic cervical dilators The clinician will place 1 to 2 osmotic cervical dilators (Dilapan-S) (4mm x 65mm) the day before the participant's procedure. Dilapan (16wks 0days-18wks, 6days) Hygroscopic cervical dilators The clinician will place 3 to 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. Dilapan (16wks 0days-18wks, 6days) Misoprostol The clinician will place 3 to 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. Mifepristone (14wks 0days-15wks, 6days) Misoprostol The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. Mifepristone (14wks 0days-15wks, 6days) Mifepristone The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. Mifepristone (16wks 0days-18wks, 6days) Mifepristone The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. Mifepristone (16wks 0days-18wks, 6days) Misoprostol The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
- Primary Outcome Measures
Name Time Method Procedure Time Intraoperative Measured as time from speculum insertion to removal.
- Secondary Outcome Measures
Name Time Method Cervical Dilation Baseline Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure
Total Procedure Time Measured at clinic visit and on OR day, over 2 day period All time required by patient (time in clinic for cervical preparation procedures)
Difficulty of Procedure, as reported by clinician Measured within 5 minutes after procedure Using Visual Analogue Scale (VAS)
Complications/Adverse Events Intraoperatively Estimated blood loss, uterine injury, infection, retained products of conception
Pain Perceived by Patient Intraoperatively "Measured during dilator placement" Using Visual Analogue Scale (VAS)
Overall Patient Experience Measured post-operatively (30 minutes prior to discharge) Using Visual Analogue Scale (VAS)
Trial Locations
- Locations (1)
Planned Parenthood Mar Monte
🇺🇸San Jose, California, United States