Penn Fertility Care
Philadelphia, Pennsylvania, 19103, United States
Location status: Recruiting
NCT Number: NCT07469605
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 typically do not wait for results to return before proceeding with necessary treatment. Instead, all patients will have a serum bHCG drawn on post-operative day 1, and those with a <50% decrease compared to pre-procedural values will undergo treatment with methotrexate therapy per institutional protocol.
The findings from this pilot study will inform future research comparing hysteroscopic vs. D&C for management of PUL. If hysteroscopic targeted biopsy is more accurate than D&C in detecting an abnormal IUP, this technique could reduce unnecessary methotrexate exposure in patients with abnormal IUPs. If adapted to the office setting, hysteroscopic biopsy could also shorten time to diagnosis and definitive treatment. In addition, targeted treatment in the office setting could lower the rate of intrauterine adhesions, and may improve overall the patient experience.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Philadelphia, Pennsylvania, 19103, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients in this trial will have a diagnostic hysteroscopy performed prior to a dilation and curettage in the treatment of their pregnancy of unknown location
Time frame: From enrollment to 1 week post-operatively
Intra-operative photographs will be taken of the participants uterine cavities at five standardized locations (left cornua, right cornua, anterior uterine wall, posterior uterine wall, and entire uterine cavity at level of internal os). The presence or absence of abnormal tissue will be documented, and findings qualitatively compared between the cavities of participants with the final diagnosis of non-viable intrauterine pregnancy and an ectopic pregnancy.
Time frame: From enrollment to 1 week post-operatively
Sensitivity, specificity, and positive and negative predictive values of hysteroscopic biopsy as a diagnostic test will be compared to that of D&C. Statistical significance will be determined with the use of Fisher exact test analysis with Stata software, with a probability value of <0.05 considered statistically significant
Time frame: From enrollment to 1 week post-operatively
Specificity of hysteroscopic biopsy as a diagnostic test will be compared to that of D&C. Statistical significance will be determined with the use of Fisher exact test analysis with Stata software, with a probability value of <0.05 considered statistically significant
Time frame: From enrollment to 1 week post-operatively
Positive predictive value of hysteroscopic biopsy as a diagnostic test will be compared to that of D&C. Statistical significance will be determined with the use of Fisher exact test analysis with Stata software, with a probability value of <0.05 considered statistically significant
Time frame: From enrollment to 1 week post-operatively
Negative predictive value of hysteroscopic biopsy as a diagnostic test will be compared to that of D&C. Statistical significance will be determined with the use of Fisher exact test analysis with Stata software, with a probability value of <0.05 considered statistically significant
Contact information is provided by the study sponsor or research team.
University of Pennsylvania
Other
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