Ulipristal Acetate for Use in Early Pregnancy Loss
Condition: Missed Abortion; Anembryonic Pregnancy; Non-Viable Pregnancy
MeSH terms: Abortion, Missed; Abortion, Spontaneous
Intervention: Ulipristal Acetate Tablets; Misoprostol Pill
Intervention description: 90mg (three 30mg tablets) administered orally once; 800mcg (four 200mcg pills) administered vaginally once 6-18 hours following ulipristal acetate
Intervention MeSH terms: Misoprostol; Ulipristal acetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Medical management of miscarriage

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 early pregnancy loss. Patients will be followed to assess effective treatment
      of early pregnancy loss, additional interventions needed, side effects, adverse events and
      patient acceptability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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