Status:
COMPLETED
Ulipristal Acetate for Cervical Preparation
Lead Sponsor:
Stanford University
Conditions:
Termination of Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
EARLY_PHASE1
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 ...
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), ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03802149
Start Date
April 16 2019
End Date
April 2 2020
Last Update
July 1 2020
Active Locations (1)
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1
Stanford Health Care
Stanford, California, United States, 94305