Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks

This study has been completed.
Sponsor:
Collaborator:
Santa Clara Valley Medical Center
Information provided by (Responsible Party):
Kate Ayers Shaw, Stanford University
ClinicalTrials.gov Identifier:
NCT01615731
First received: May 30, 2012
Last updated: April 4, 2014
Last verified: April 2014

May 30, 2012
April 4, 2014
May 2012
June 2013   (final data collection date for primary outcome measure)
Procedure Time [ Time Frame: Intraoperative Time ] [ Designated as safety issue: No ]
Measured as time from speculum insertion to removal
Same as current
Complete list of historical versions of study NCT01615731 on ClinicalTrials.gov Archive Site
  • Total Procedure Time [ Time Frame: Measured at clinic visits and on OR day, over a 3 day period ] [ Designated as safety issue: No ]
    All time required by patient (time in clinic for cervical preparation procedures)
  • Maximum cervical dilation [ Time Frame: Measured intra-operatively ] [ Designated as safety issue: No ]
    Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.
  • Adverse Events [ Time Frame: Intraoperatively and 2 weeks post operatively ] [ Designated as safety issue: Yes ]
    estimated blood loss, uterine injury, infection, retained products of conception
  • Ease of Procedure by Blinded Surgeon [ Time Frame: Measured Immediately after procedure ] [ Designated as safety issue: No ]
    Using Visual Analogue Scale
  • Pain perceived by patient [ Time Frame: Measured during dilator placement ] [ Designated as safety issue: No ]
    Using Visual Analogue Scale- baseline, after speculum placement, after paracervical block, after dilator placement
  • Overall patient experience [ Time Frame: Measured post operatively (at least 30 minutes) prior to discharge ] [ Designated as safety issue: No ]
    Using visual analogue scale
Same as current
Not Provided
Not Provided
 
Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks
Value of Mifepristone in Eliminating the Need for a Second Set of Osmotic Dilators Prior to Dilation and Evacuation Between 19-24 Weeks: A Randomized Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Abortion, Induced
  • Drug: Mifepristone
    200mg Mifepristone orally
    Other Name: Danco, Mifeprex
  • Other: Hygroscopic cervical dilators
    Dilapan-S osmostic cervical dilators inserted through the internal os
    Other Name: Dilapan-S
  • Drug: Misoprostol
    400mcg buccal misoprostol 90 minutes pre-op
  • Drug: Intra-amniotic digoxin
    1mg digoxin administered intra-amniotically ~24 hours pre-op
  • Active Comparator: Two sets of dilators
    Two sets of osmotic dilators inserted 1 and 2 days pre-op
    Interventions:
    • Other: Hygroscopic cervical dilators
    • Drug: Misoprostol
    • Drug: Intra-amniotic digoxin
  • Experimental: Mifepristone plus one set of dilators
    One set of dilators plus mifepristone
    Interventions:
    • Drug: Mifepristone
    • Other: Hygroscopic cervical dilators
    • Drug: Misoprostol
    • Drug: Intra-amniotic digoxin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • >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

Exclusion Criteria:

  • Allergy to misoprostol or mifepristone
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01615731
SU-05302012-10088
No
Kate Ayers Shaw, Stanford University
Stanford University
Santa Clara Valley Medical Center
Principal Investigator: Kate A Shaw, MD Stanford University
Stanford University
April 2014

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