Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location
Status:
Completed
Trial end date:
2019-08-19
Target enrollment:
Participant gender:
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
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