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

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ClinicalTrials.gov Identifier: NCT01615731
Recruitment Status : Completed
First Posted : June 11, 2012
Results First Posted : January 26, 2015
Last Update Posted : October 31, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Abortion, Induced Drug: Mifepristone Other: Hygroscopic cervical dilators Drug: Misoprostol Drug: Intra-amniotic digoxin

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2012
Primary Completion Date : June 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Two sets of dilators
Two sets of osmotic dilators inserted 1 and 2 days pre-op
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
Experimental: Mifepristone plus one set of dilators
One set of dilators plus mifepristone
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


Outcome Measures

Primary Outcome Measures :
  1. Procedure Time [ Time Frame: Intraoperative Time ]
    Measured as time from speculum insertion to removal


Secondary Outcome Measures :
  1. Maximum Cervical Dilation [ Time Frame: Measured intra-operatively ]
    Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.

  2. Adverse Events (EBL) [ Time Frame: Intraoperatively ]
    One adverse event: Estimated Blood Loss

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

  4. 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) ]
    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.

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

  6. Adverse Events [ Time Frame: Intraoperatively and 2 weeks post operatively ]
    uterine perforation, uterine injury, etc.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615731


Locations
United States, California
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Santa Clara Valley Medical Center
Investigators
Principal Investigator: Kate A Shaw, MD Stanford University
More Information

Publications:
Responsible Party: Kate Ayers Shaw, Clinical Instructor, Clinical Fellow, Stanford University
ClinicalTrials.gov Identifier: NCT01615731     History of Changes
Other Study ID Numbers: SU-05302012-10088
First Posted: June 11, 2012    Key Record Dates
Results First Posted: January 26, 2015
Last Update Posted: October 31, 2017
Last Verified: September 2017

Keywords provided by Kate Ayers Shaw, Stanford University:
Mifepristone
Induced Abortion
Dilation and Evacuation
Cervical preparation
Osmotic dilators

Additional relevant MeSH terms:
Dilatation, Pathologic
Pathological Conditions, Anatomical
Misoprostol
Mifepristone
Digoxin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents