Ulipristal Acetate for Cervical Preparation (U-Prep)

Cervical Preparation Using Ulipristal Acetate for Second Trimester Surgical Abortion

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.

Study Overview

• Status: Completed
• Conditions: Termination of Pregnancy
• Intervention / Treatment: Drug: Ulipristal Acetate

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequacy of cervical dilation	Ease of dilation, measured by visual analog score (0-100mm, 0 being "very easy" and 100 being "very difficult"	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for additional mechanical dilation	Number of dilator increments in French required to dilate the internal os	Intraoperative: start of dilation to completion of dilation
Total procedure time	Minutes	Intraoperative: from speculum placement to speculum removal
Total operative time	Minutes	Intraoperative: insertion of the first instrument to removal of the last instrument from the uterus
Complications	Number of cervical lacerations, uterine perforation, hemorrhage and need for transfer to high level of care	Intraoperative and postoperative through 8-weeks
Overall Pain Experienced	0-100mm on visual analog scale	20-minutes postoperative
Number of procedures completed as scheduled		Time from enrollment to completion of procedure

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• Peterson SF, Lerma K, Shaw KA, Blumenthal PD. Cervical Preparation Using Ulipristal Acetate With Adjunct Misoprostol in Second-Trimester Surgical Abortions. Obstet Gynecol. 2022 May 1;139(5):907-909. doi: 10.1097/AOG.0000000000004754. Epub 2022 Apr 5.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2019
• Primary Completion (Actual): April 2, 2020
• Study Completion (Actual): April 2, 2020

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Dilation and Evacuation; Cervical Preparation; Abortion; Ulipristal Acetate
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Ulipristal acetate
• Other Study ID Numbers: IRB-48756

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Will assess IPD sharing upon request.

Drug and device information, study documents

• 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