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Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location -- a Randomized Clinical Trial of Women at Risk for an Ectopic Pregnancy
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Greenville Hospital System University Medical Center
Greenville, South Carolina, United States
Start Date
February 1, 2013
Primary Completion Date
December 1, 2013
Completion Date
December 1, 2013
Last Updated
December 29, 2017
2
ACTUAL participants
Methotrexate
DRUG
Uterine Evacuation
PROCEDURE
Expectant Management
OTHER
Lead Sponsor
University of Pennsylvania
NCT07431411
NCT06721403
NCT05446012
Data Source & Attribution
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