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Ulipristal Acetate for Cervical Preparation (U-Prep)

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: NCT03802149
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
This is a prospective cohort study exploring a broadened use of ulipristal acetate as a cervical preparation agent for second trimester surgical abortion. Specifically, this pilot study will test the feasibility of using ulipristal as a pharmacologic cervical preparation with adjunct misoprostol prior to surgical abortion.

Condition or disease Intervention/treatment Phase
Termination of Pregnancy Drug: Ulipristal Acetate Early Phase 1

Detailed Description:
Second trimester abortion comprises <10% of all induced abortions in the United States but there is still an important need to provide this service to women. Prior to dilation and evacuation (D&E), adequate preparation of the uterine cervix is an important part of preventing complications of the procedure. Commonly, this is done using osmotic dilators that are placed into the uterine cervix but cervical preparation can also be achieved using medications alone. Mifepristone is commonly used for this purpose but its use is regulated and often restricted due to the REMS (Risk Evaluation and Mitigation Strategy) program. The objective of this pilot study is to test the feasibility of using ulipristal, an oral medication similar to Mifepristone, as a medical form of cervical preparation prior to surgical abortion.This is a prospective cohort study investigating the use of ulipristal acetate (UPA) for pharmacologic cervical preparation with adjunct misoprostol prior to second trimester surgical abortion among women who are 16 to 18 6/7 weeks gestational age. Due the mechanism of action of UPA as a selective progesterone receptor modulator (SPRM) being similar to that of mifepristone, a medication known to be effective for cervical preparation, the investigators seek to describe the use of another SPRM for this same purpose. The investigators will conduct a pilot study assessing the feasibility of using UPA for cervical priming and report descriptive measures of its use. Per clinic protocols, patients over 16-weeks gestation attend a consult and cervical preparation appointment the day prior to their procedure. Eligible patients will be offered enrollment. Subjects will receive UPA 90mg one day prior to their procedure and no osmotic dilators. All subjects will receive pre-procedure misoprostol (600mcg 90 minutes prior to procedure). The investigators will observe patients through their planned procedure and report descriptive measures of its use.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Cervical Preparation Using Ulipristal Acetate for Second Trimester Surgical Abortion
Actual Study Start Date : April 16, 2019
Actual Primary Completion Date : April 2, 2020
Actual Study Completion Date : April 2, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ulipristal Acetate
Participants will be administered a one time dose of 90mg ulipristal acetate 18-24-hours prior to dilation and evacuation (surgical abortion) for cervical preparation.
Drug: Ulipristal Acetate
90mg Ulipristal Acetate 18-24-hours prior to dilation and evacuation




Primary Outcome Measures :
  1. Adequacy of cervical dilation [ Time Frame: Intraoperative ]
    Ease of dilation, measured by visual analog score (0-100mm, 0 being "very easy" and 100 being "very difficult"


Secondary Outcome Measures :
  1. Need for additional mechanical dilation [ Time Frame: Intraoperative: start of dilation to completion of dilation ]
    Number of dilator increments in French required to dilate the internal os

  2. Total procedure time [ Time Frame: Intraoperative: from speculum placement to speculum removal ]
    Minutes

  3. Total operative time [ Time Frame: Intraoperative: insertion of the first instrument to removal of the last instrument from the uterus ]
    Minutes

  4. Complications [ Time Frame: Intraoperative and postoperative through 8-weeks ]
    Number of cervical lacerations, uterine perforation, hemorrhage and need for transfer to high level of care

  5. Overall Pain Experienced [ Time Frame: 20-minutes postoperative ]
    0-100mm on visual analog scale

  6. Number of procedures completed as scheduled [ Time Frame: Time from enrollment to completion of procedure ]


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:

  • Female, aged 18 years or older
  • Singleton, viable intrauterine pregnancy between 16 to 18 6/7 weeks of gestation (by ultrasound dating performed prior to or same day of enrollment visit)
  • Consented for an induced, elective abortion
  • English-speaking
  • Able to consent for research project
  • Willingness to comply with study procedures

Exclusion Criteria:

  • Inability to give informed consent
  • Contraindications to surgical abortion under moderate sedation
  • Allergy or previous unacceptable side effect from study medications
  • Multiple gestation
  • Intrauterine fetal demise or spontaneous abortion
  • Rupture of membranes
  • Current cervical insufficiency
  • History of liver disease
  • Taken a CYP3A4 inhibitor within 5 elimination half-lives of the drug from the procedure
  • Pre-dosing abnormal liver function tests
  • Patients at increased risk of hepatitis based on a history of any of the following:
  • Any history of underlying liver disorder, including hepatitis
  • A family history of hepatitis or currently living with a person who has been given a diagnosis of hepatitis
  • A history of or currently working as a sex worker
  • A history of or currently using IV drugs
  • A self-reported history of alcoholic dependency or abuse

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): NCT03802149


Locations
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United States, California
Stanford Health Care
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Principal Investigator, MD Stanford University
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT03802149    
Other Study ID Numbers: IRB-48756
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will assess IPD sharing upon request.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Stanford University:
Ulipristal Acetate
Abortion
Cervical Preparation
Dilation and Evacuation
Additional relevant MeSH terms:
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Ulipristal acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs