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: January 26, 2015
Last verified: January 2015
Results First Received: December 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Abortion, Induced
Interventions: Drug: Mifepristone
Other: Hygroscopic cervical dilators
Drug: Misoprostol
Drug: Intra-amniotic digoxin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Two Sets of Dilators

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

Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os

Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op

Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op

Mifepristone Plus One Set of Dilators

One set of dilators plus mifepristone

Mifepristone: 200mg Mifepristone orally

Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os

Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op

Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op


Participant Flow:   Overall Study
    Two Sets of Dilators     Mifepristone Plus One Set of Dilators  
STARTED     24     26  
COMPLETED     21     24  
NOT COMPLETED     3     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Two Sets of Dilators

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

Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os

Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op

Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op

Mifepristone Plus One Set of Dilators

One set of dilators plus mifepristone

Mifepristone: 200mg Mifepristone orally

Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os

Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op

Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op

Total Total of all reporting groups

Baseline Measures
    Two Sets of Dilators     Mifepristone Plus One Set of Dilators     Total  
Number of Participants  
[units: participants]
  24     26     50  
Age  
[units: years]
Mean (Standard Deviation)
  27.6  (6.5)     27.7  (6.7)     27.7  (6.5)  
Gender  
[units: participants]
     
Female     24     26     50  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     24     26     50  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Procedure Time   [ Time Frame: Intraoperative Time ]

2.  Secondary:   Maximum Cervical Dilation   [ Time Frame: Measured intra-operatively ]

3.  Secondary:   Adverse Events (EBL)   [ Time Frame: Intraoperatively ]

4.  Secondary:   Ease of Procedure by Blinded Surgeon   [ Time Frame: Measured Immediately after procedure ]

5.  Secondary:   Pain Perceived by 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) ]

6.  Secondary:   Overall Patient Experience   [ Time Frame: Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge ]

7.  Secondary:   Adverse Events   [ Time Frame: Intraoperatively and 2 weeks post operatively ]

8.  Secondary:   Total Procedure Time   [ Time Frame: Measured at clinic visits and on OR day, over a 3 day period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Failure of randomization with respect to assigning similar numbers of nulliparous women to both groups; inaccurate method for measurement of pre-operative cervical dilation; small size of cohort.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Kate Shaw
Organization: Stanford University
phone: (650) 725-5986
e-mail: kateshaw@stanford.edu


Publications of Results:

Responsible Party: Kate Ayers Shaw, Stanford University
ClinicalTrials.gov Identifier: NCT01615731     History of Changes
Other Study ID Numbers: SU-05302012-10088
Study First Received: May 30, 2012
Results First Received: December 19, 2014
Last Updated: January 26, 2015
Health Authority: United States: Institutional Review Board