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
  Purpose

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 Intervention
Abortion, Induced
Drug: Mifepristone
Other: Hygroscopic cervical dilators
Drug: Misoprostol
Drug: Intra-amniotic digoxin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Procedure Time [ Time Frame: Intraoperative Time ] [ Designated as safety issue: No ]
    Measured as time from speculum insertion to removal


Secondary Outcome Measures:
  • 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 (EBL) [ Time Frame: Intraoperatively ] [ Designated as safety issue: Yes ]
    One adverse event: Estimated Blood Loss

  • Ease of Procedure by Blinded Surgeon [ Time Frame: Measured Immediately after procedure ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge ] [ Designated as safety issue: No ]
    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 [ Time Frame: Intraoperatively and 2 weeks post operatively ] [ Designated as safety issue: Yes ]
    uterine perforation, uterine injury, etc.


Enrollment: 50
Study Start Date: May 2012
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 30, 2012
Results First Received: December 19, 2014
Last Updated: January 26, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Mifepristone
Abortifacient Agents
Abortifacient Agents, Steroidal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital
Contraceptives, Postcoital, Synthetic
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on March 26, 2015