Ulipristal Acetate for Cervical Preparation (NCT03802149) | Clinical Trial Compass
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 range18 Years
SexFEMALE
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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