Ulipristal Acetate for Cervical Preparation

• Status: Completed
• Trial end date: 2020-04-02
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Ulipristal acetate

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