Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location


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Trial ID: NCT02152696


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.

Official Title

Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location - a Randomized Clinical Trial of Women at Risk for an Ectopic Pregnancy: Active Treatment Versus No Treatment


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


drug: Methotrexate

procedure: Uterine Evacuation

other: Expectant Management


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Oshra Sedan, PhD