RCT for Women With a Persisting Pregnancy of Unknown Location
Status:
Terminated
Trial end date:
2013-12-01
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, and 3) Expectant management. Randomization will be
2:2:1 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. Secondary outcome measures: re-interventions, treatment
complications, health-related quality of life, financial costs, future fertility, and
patient's preferences.