Trial Search Results
Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location
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.
Stanford is currently accepting patients for this trial.
Collaborator: University of Pennsylvania
- Drug: Methotrexate
- Procedure: Uterine Evacuation
- Other: Expectant Management
- 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
- 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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study