Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location

• Status: Completed
• Trial end date: 2019-08-19
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: Augusta University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Penn State University; University of California, San Francisco; University of North Carolina; University of Oklahoma; University of Pennsylvania
• Treatments: Methotrexate

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