Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location
Condition: Persistent Pregnancy of Unknown Location; Ectopic Pregnancy
MeSH terms: Pregnancy, Ectopic; Cardiac Complexes, Premature
Intervention: Methotrexate; Uterine Evacuation; Expectant Management
Intervention description: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.; Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation.; Pregnancy will be expectantly managed using serum hcg monitoring
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 255.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized controlled trial to compare three currently available management
      strategies for women with a persisting pregnancy of unknown location (PPUL), which makes them
      at-risk for ectopic pregnancy. We will recruit hemodynamically stable women with a confirmed
      PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed by
      methotrexate (MTX) for some (those that have evidence of a non visualized ectopic pregnancy)
      2) Empiric treatment with MTX for all 3) Expectant management. Randomization will be 1:1:1
      into these three arms. After randomization, they will be followed and treated clinically as
      is indicated by the progression of their condition. Primary outcome measures: uneventful
      decline of hCG to 5 IU/mL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female with a persisting pregnancy of unknown location:

          -  A pregnancy of unknown location is defined as a pregnancy in a woman with a positive
             pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on
             ultrasound imaging. A definitive sign of gestation includes ultrasound visualization
             of a gestational sac with a yolk sac (with or without an embryo) in the uterus or in
             the adnexa. Ultrasound must be performed within 7 days prior to randomization.

          -  Persistence of hCG is defined as at least 2 serial hCG values (over 2-14 days),
             showing < 15% rise per day, or < 50% fall between the first and last value.

          -  Patient is hemodynamically stable, hemoglobin >10 mg/dL

          -  Greater than or 18 years of age

        Exclusion Criteria:

          -  Hemodynamically unstable in need of acute treatment

          -  Most recent hCG > 5000 mIU/mL

          -  Patient obtaining care in relation to a recently completed pregnancy (delivery,
             spontaneous or elective abortion)

          -  Diagnosis of gestational trophoblastic disease

          -  Subject unwilling or unable to comply with study procedures

          -  Known hypersensitivity to MTX

          -  Presence of clinical contraindications for treatment with MTX

          -  Prior medical or surgical management of this gestation

          -  Subject unwilling to accept a blood transfusion