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Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679092
Recruitment Status : Withdrawn (Funding changes.)
First Posted : February 10, 2016
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
Dilation and evacuation (D&E) is a common surgical procedure in the U.S. Adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. Traditionally, the uterine cervix is prepared for the procedure using water-attracting dilators, which are placed via a speculum exam and cause discomfort for many women. The objective of this study is to investigate the comparative effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for D&E.

Condition or disease Intervention/treatment Phase
Legally Induced Abortion Without Mention of Complication Drug: Misoprostol Drug: Mifepristone Device: Hygroscopic cervical dilators Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks
Estimated Study Start Date : April 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dilapan (14wks 0days-15wks, 6days)
The clinician will place 1 to 2 osmotic cervical dilators (Dilapan-S) (4mm x 65mm) the day before the participant's procedure.
Device: Hygroscopic cervical dilators
osmotic cervical dilators inserted through the internal os
Other Name: Dilapan-S

Active Comparator: Dilapan (16wks 0days-18wks, 6days)
The clinician will place 3 to 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
Drug: Misoprostol
400 mcg buccal 60-90 minutes prior to procedure
Other Name: Cytotec

Device: Hygroscopic cervical dilators
osmotic cervical dilators inserted through the internal os
Other Name: Dilapan-S

Experimental: Mifepristone (14wks 0days-15wks, 6days)
The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
Drug: Misoprostol
400 mcg buccal 60-90 minutes prior to procedure
Other Name: Cytotec

Drug: Mifepristone
200 mg PO on the day prior to D&E
Other Names:
  • Danco
  • Mifeprex

Experimental: Mifepristone (16wks 0days-18wks, 6days)
The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure.
Drug: Misoprostol
400 mcg buccal 60-90 minutes prior to procedure
Other Name: Cytotec

Drug: Mifepristone
200 mg PO on the day prior to D&E
Other Names:
  • Danco
  • Mifeprex




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


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

  2. Total Procedure Time [ Time Frame: Measured at clinic visit and on OR day, over 2 day period ]
    All time required by patient (time in clinic for cervical preparation procedures)

  3. Difficulty of Procedure, as reported by clinician [ Time Frame: Measured within 5 minutes after procedure ]
    Using Visual Analogue Scale (VAS)

  4. Complications/Adverse Events [ Time Frame: Intraoperatively ]
    Estimated blood loss, uterine injury, infection, retained products of conception

  5. Pain Perceived by Patient [ Time Frame: Intraoperatively "Measured during dilator placement" ]
    Using Visual Analogue Scale (VAS)

  6. Overall Patient Experience [ Time Frame: Measured post-operatively (30 minutes prior to discharge) ]
    Using Visual Analogue Scale (VAS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >18 Years Old
  • Viable, Singleton pregnancy
  • Voluntarily seeking abortion between 14-19 weeks gestation
  • Able to give informed consent and comply with study protocol
  • Fluent in English or Spanish

Exclusion Criteria:

  • Allergy to study drugs

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): NCT02679092


Locations
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United States, California
Planned Parenthood Mar Monte
San Jose, California, United States, 95126
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Principal Investigator Stanford University
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02679092    
Other Study ID Numbers: IRB-36302
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Keywords provided by Stanford University:
Induced Abortion
Mifepristone
Dilation and Evacuation
Cervical Preparation
Osmotic Dilators
Misoprostol
Additional relevant MeSH terms:
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Misoprostol
Mifepristone
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