Status:
COMPLETED
Ulipristal Acetate for Use in Early Pregnancy Loss
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
North Carolina Translational and Clinical Sciences Institute
Conditions:
Missed Abortion
Anembryonic Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The investigators will study the feasibility of using 90mg ulipristal acetate, a selective progesterone receptor agonist, as an adjunct to 800mcg vaginal misoprostol for the medical management of earl...
Detailed Description
Study Background: Early pregnancy loss affects approximately 10% of women throughout their reproductive lives and many women desire medical management of early pregnancy loss. Data from two large rand...
Eligibility Criteria
Inclusion
- Female, age 18 years or older
- English- or Spanish-speaking
- Ultrasound examination showing a non-viable intrauterine pregnancy between 5- and 12-weeks' gestation or anembryonic gestation
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Provision of signed and dated informed consent form
Exclusion
- Desire for non-medical management of early pregnancy loss (either expectant management or surgical management)
- Hemodynamically unstable
- Evidence of incomplete or inevitable abortion (due to high efficacy of misoprostol alone)
- Contraindication or allergy to ulipristal acetate or misoprostol (glaucoma, mitral stenosis, sickle cell anemia, chronic glucocorticoid use)
- Evidence of a viable intrauterine pregnancy, ectopic pregnancy, or pregnancy with intrauterine device in place
- Evidence of pelvic infection
- Hemoglobin \<9.5g/dL
- Known cardiovascular disease (arrhythmia, cardiac failure, valvular disease, angina)
- Known clotting or bleeding disorder, or on anticoagulation therapy
- Use of the following medications that may influence metabolization of the study medications: barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate
- Use of CYP3A4 inhibitors within five elimination half-lives of ulipristal acetate or other strong CYP3A4 inhibitors
- Chronic adrenal failure (risk of acute renal insufficiency)
- Concurrent long-term corticosteroid therapy (risk of acute renal insufficiency)
- Any history of underlying liver disorder, including hepatitis
- Elevation of any or all liver enzymes (alanine aminotransferase, aspartate aminotransferase, total bilirubin) above the upper limit of normal (ULN) at baseline testing prior to enrollment
- 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 intravenous (IV) drugs
- A self-reported history of alcohol dependency or abuse
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05216952
Start Date
May 11 2022
End Date
April 30 2023
Last Update
June 28 2023
Active Locations (4)
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1
University of North Carolina, Chapel Hill - Same Day OBGYN Clinic
Chapel Hill, North Carolina, United States, 27514
2
University of North Carolina, Chapel Hill - Vilcom Center
Chapel Hill, North Carolina, United States, 27514
3
University of North Carolina, Chapel Hill - Weaver Crossing
Chapel Hill, North Carolina, United States, 27514
4
University of North Carolina, Chapel Hill - Hillsborough Medical Office Building
Hillsborough, North Carolina, United States, 27278