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临床试验/NCT07469605
NCT07469605招募中不适用

Hysteroscopy for the Diagnosis and Treatment of Pregnancy of Unknown Location

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Presence or absence of abnormal tissue within the endometrial cavity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients 18 years of age and older
  • Patients undergoing care with (1) positive serum hcg and (2) abnormal hcg trend, as defined by <50% rise in bHCG over 48h period, repeated across three lab values.
  • Patients with pregnancy via unassisted conception, conception after ovulation induction and/or intrauterine insemination, and/or embryo transfer
  • Well established pregnancy dating, either with known LMP, or dating by IUI or embryo transfer

排除标准

  • Patients with known abnormal cavity (history of fibroids, septum, or uterine anomaly)
  • Patients who are hemodynamically unstable or with an acute abdomen

研究组 & 干预措施

Hysteroscopy prior to Dilation and Curettage

Experimental

All patients in this study will have a diagnostic hysteroscopy with possible biopsy of abnormal pregnancy tissue prior to dilation and curettage

干预措施: Hysteroscopy for diagnosis and treatment of pregnancy of unknown location (Diagnostic Test)

结局指标

主要结局

Presence or absence of abnormal tissue within the endometrial cavity

时间窗: 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.

次要结局

  • Sensitivity of hysteroscopy compared to gold-standard dilation and curettage(From enrollment to 1 week post-operatively)
  • Specificity of hysteroscopy compared to gold-standard dilation and curettage(From enrollment to 1 week post-operatively)
  • Positive predictive value of hysteroscopy compared to gold-standard dilation and curettage(From enrollment to 1 week post-operatively)
  • Negative predictive value of hysteroscopy compared to gold-standard dilation and curettage(From enrollment to 1 week post-operatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Clarisa Gracia

Chief, Division of Reproductive Endocrinology and Infertility

University of Pennsylvania

研究点 (1)

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