CompletedEarly Phase 1

Ulipristal Acetate for Cervical Preparation

United States13 participantsStarted 2019-04-16

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adequacy of cervical dilation

Timeframe: Intraoperative

Trial details

NCT IDNCT03802149

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-02

View on ClinicalTrials.gov More Termination of Pregnancy trials