Condition: Pregnancy of Unknown Location · Sponsor: University of Pennsylvania
Infertility patients have a higher baseline risk of ectopic pregnancy compared to the general population. If an early pregnancy is not visible by ultrasound, patients with a pregnancy of unknown location (PUL) will undergo uterine aspiration (D\&C) in order to diagnose an ectopic pregnancy and/or treat an abnormal intrauterine pregnancy destined for miscarriage. If the pathologic specimen obtained after D\&C does not contain chorionic villi, the presumptive diagnosis of ectopic pregnancy is made and methotrexate therapy is typically recommended. In many institutions, a D\&C must be scheduled in the operating room so that it may be performed under anesthesia, potentially delaying the urgent treatment of ectopic pregnancy. Office hysteroscopy is a safe and well-tolerated means of evaluating the uterine cavity, though little literature exists supporting its use in the evaluation of PUL. The objective of this study is to compare hysteroscopic biopsy to the gold standard D\&C for the diagnosis and treatment of PUL. The investigators propose a prospective study including patients undergoing care at the University of Pennsylvania. Patients will be included if they have at least three bHCG values demonstrating a \<50% increase in over 48 hours. A hysteroscopy with possible biopsy followed by uterine aspiration will be performed, and the final pathology results will be compared. Although pathology results from the procedure are considered the gold standard of diagnosis, physicians ty…
This description comes directly from the study's public registry record.
Margaret A Rush, MD · 267-624-4249 · margaret.rush@pennmedicine.upenn.edu
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| Penn Fertility Care | Philadelphia, Pennsylvania, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07469605