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

Primary Purpose

Abortion, Induced

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mifepristone
Hygroscopic cervical dilators
Misoprostol
Intra-amniotic digoxin
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abortion, Induced focused on measuring Mifepristone, Induced Abortion, Dilation and Evacuation, Cervical preparation, Osmotic dilators

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Santa Clara Valley Medical Center
  • Stanford University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Two sets of dilators

Mifepristone plus one set of dilators

Arm Description

Two sets of osmotic dilators inserted 1 and 2 days pre-op

One set of dilators plus mifepristone

Outcomes

Primary Outcome Measures

Procedure Time
Measured as time from speculum insertion to removal
Total Procedure Time

Secondary Outcome Measures

Maximum Cervical Dilation
Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.
Adverse Events (EBL)
One adverse event: Estimated Blood Loss
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.
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.
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.
Adverse Events
uterine perforation, uterine injury, etc.

Full Information

First Posted
May 30, 2012
Last Updated
December 22, 2017
Sponsor
Stanford University
Collaborators
Santa Clara Valley Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01615731
Brief Title
Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Santa Clara Valley Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Induced
Keywords
Mifepristone, Induced Abortion, Dilation and Evacuation, Cervical preparation, Osmotic dilators

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Two sets of dilators
Arm Type
Active Comparator
Arm Description
Two sets of osmotic dilators inserted 1 and 2 days pre-op
Arm Title
Mifepristone plus one set of dilators
Arm Type
Experimental
Arm Description
One set of dilators plus mifepristone
Intervention Type
Drug
Intervention Name(s)
Mifepristone
Other Intervention Name(s)
Danco, Mifeprex
Intervention Description
200mg Mifepristone orally
Intervention Type
Other
Intervention Name(s)
Hygroscopic cervical dilators
Other Intervention Name(s)
Dilapan-S
Intervention Description
Dilapan-S osmostic cervical dilators inserted through the internal os
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
400mcg buccal misoprostol 90 minutes pre-op
Intervention Type
Drug
Intervention Name(s)
Intra-amniotic digoxin
Intervention Description
1mg digoxin administered intra-amniotically ~24 hours pre-op
Primary Outcome Measure Information:
Title
Procedure Time
Description
Measured as time from speculum insertion to removal
Time Frame
Intraoperative Time
Title
Total Procedure Time
Time Frame
Measured at clinic visits and on OR day, over a 3 day period
Secondary Outcome Measure Information:
Title
Maximum Cervical Dilation
Description
Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.
Time Frame
Measured intra-operatively
Title
Adverse Events (EBL)
Description
One adverse event: Estimated Blood Loss
Time Frame
Intraoperatively
Title
Ease of Procedure by Blinded Surgeon
Description
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
Title
Pain Perceived by Patient
Description
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)
Title
Overall Patient Experience
Description
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
Title
Adverse Events
Description
uterine perforation, uterine injury, etc.
Time Frame
Intraoperatively and 2 weeks post operatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate A Shaw, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Clara Valley Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25499589
Citation
Shaw KA, Shaw JG, Hugin M, Velasquez G, Hopkins FW, Blumenthal PD. Adjunct mifepristone for cervical preparation prior to dilation and evacuation: a randomized trial. Contraception. 2015 Apr;91(4):313-9. doi: 10.1016/j.contraception.2014.11.014. Epub 2014 Dec 12.
Results Reference
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Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks

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