Ulipristal Acetate for Cervical Preparation

NCT ID: NCT03802149

Last Updated: 2020-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-16
• Study Completion Date: 2020-04-02

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.

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.

Conditions

Termination of Pregnancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ulipristal Acetate

Intervention Type: DRUG

90mg Ulipristal Acetate 18-24-hours prior to dilation and evacuation

Interventions

Ulipristal Acetate

90mg Ulipristal Acetate 18-24-hours prior to dilation and evacuation

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Principal Investigator, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Health Care

Stanford, California, United States

Countries

United States

References

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. No abstract available.

Reference Type: DERIVED

PMID: 35576349 (View on PubMed)

Other Identifiers

IRB-48756

Identifier Type: -

Identifier Source: org_study_id