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Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks

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ClinicalTrials.gov Identifier: NCT02679092
Recruitment Status : Withdrawn (Funding changes.)
First Posted : February 10, 2016
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date  ICMJE February 3, 2016
First Posted Date  ICMJE February 10, 2016
Last Update Posted Date September 19, 2019
Estimated Study Start Date  ICMJE April 2016
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2016)
Procedure Time [ Time Frame: Intraoperative ]
Measured as time from speculum insertion to removal.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2016)
  • Cervical Dilation [ Time Frame: Baseline ]
    Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure
  • Total Procedure Time [ Time Frame: 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 [ Time Frame: Measured within 5 minutes after procedure ]
    Using Visual Analogue Scale (VAS)
  • Complications/Adverse Events [ Time Frame: Intraoperatively ]
    Estimated blood loss, uterine injury, infection, retained products of conception
  • Pain Perceived by Patient [ Time Frame: Intraoperatively "Measured during dilator placement" ]
    Using Visual Analogue Scale (VAS)
  • Overall Patient Experience [ Time Frame: Measured post-operatively (30 minutes prior to discharge) ]
    Using Visual Analogue Scale (VAS)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks
Official Title  ICMJE Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Legally Induced Abortion Without Mention of Complication
Intervention  ICMJE
  • Drug: Misoprostol
    400 mcg buccal 60-90 minutes prior to procedure
    Other Name: Cytotec
  • Drug: Mifepristone
    200 mg PO on the day prior to D&E
    Other Names:
    • Danco
    • Mifeprex
  • Device: Hygroscopic cervical dilators
    osmotic cervical dilators inserted through the internal os
    Other Name: Dilapan-S
Study Arms  ICMJE
  • Active Comparator: Dilapan (14wks 0days-15wks, 6days)
    The clinician will place 1 to 2 osmotic cervical dilators (Dilapan-S) (4mm x 65mm) the day before the participant's procedure.
    Intervention: Device: Hygroscopic cervical dilators
  • Active Comparator: Dilapan (16wks 0days-18wks, 6days)
    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.
    Interventions:
    • Drug: Misoprostol
    • Device: Hygroscopic cervical dilators
  • Experimental: Mifepristone (14wks 0days-15wks, 6days)
    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.
    Interventions:
    • Drug: Misoprostol
    • Drug: Mifepristone
  • Experimental: Mifepristone (16wks 0days-18wks, 6days)
    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.
    Interventions:
    • Drug: Misoprostol
    • Drug: Mifepristone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 17, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2016)
100
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • >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

Exclusion Criteria:

  • Allergy to study drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02679092
Other Study ID Numbers  ICMJE IRB-36302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Principal Investigator Stanford University
PRS Account Stanford University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP