Ulipristal Acetate for Cervical Preparation
Completed · Early Phase 1
Conditions studied: Termination of Pregnancy
In brief
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.
Key facts
- Study ID
- NCT03802149
- Run by
- Stanford University
- People needed
- 13
- Starts
- 2019-04-16
- Expected to finish
- 2020-04-02
- Last updated by the study team
- 2020-07-01
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford Health Care — Stanford, California, United States
Full record on ClinicalTrials.gov
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