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临床试验/NCT07048587
NCT07048587已完成不适用

Evaluating the Diagnostic Efficacy of β-hCG Levels in Uterine Cavity Lavage: A Potential Tool for Identifying Pregnancies of Unknown Location (PUL) and Ectopic Pregnancies

Zeynep Kamil Maternity and Pediatric Research and Training Hospital2 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2020年6月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
121
试验地点
2
主要终点
Comparison of beta-hCG levels in simultaneously collected uterine lavage and venous blood with pathology results

研究概览

简要总结

The goal of this interventional study is to investigate the role of beta-hCG levels in uterine cavity lavage for differentiating between ectopic pregnancy and early pregnancy loss in female patients aged 18-45 years. The main questions it aims to answer are as follows:

  1. Can beta-hCG levels in uterine cavity lavage provide a decisive cut-off value for distinguishing between ectopic pregnancy and intrauterine pregnancy (early pregnancy loss)?
  2. How do beta-hCG levels in uterine cavity lavage compare with venous blood beta-hCG levels and pathological results, final diagnoses?

Researchers will compare beta-hCG levels in uterine cavity lavage to pathological results and final diagnoses to determine whether this method can provide a quick and accurate differentiation between ectopic pregnancy and early pregnancy loss.

Participants will:

  • Undergo uterine cavity lavage with 5 cc of saline solution before anesthesia and probe curettage
  • Have 3 cc of aspirated liquid collected in a gel tube for beta-hCG level measurement
  • Proceed with the scheduled probe curettage procedure

The study focuses on patients with positive serum beta-hCG values, serum beta-hCG levels below the differential level (<1500-2000 mIU/mL), abnormal beta-hCG progression in consecutive measurements, and inconclusive transvaginal ultrasound results for differential diagnosis.

详细描述

This study aims to investigate the potential of using beta-hCG levels in uterine cavity lavage as a diagnostic tool for differentiating between ectopic pregnancy and early pregnancy loss. The research focuses on female patients aged 18-45 years who present with positive serum beta-hCG values but inconclusive clinical findings and transvaginal ultrasound results.

The study will specifically target patients with serum beta-hCG levels below the differential level (typically <1500-2000 mIU/mL) and abnormal beta-hCG progression in consecutive measurements. These patients, who are scheduled for probe curettage (P/C), will undergo uterine cavity lavage prior to the procedure.

The lavage process involves administering 5 cc of saline solution into the uterine cavity before anesthesia and the P/C procedure. Subsequently, 3 cc of the aspirated liquid will be collected in a gel tube for beta-hCG level measurement.

The primary objective is to determine if there is a decisive cut-off value in the beta-hCG levels of the lavage fluid that can accurately differentiate between ectopic pregnancy and early pregnancy loss. This approach aims to provide a quick and minimally invasive diagnostic method, potentially reducing the need for more invasive procedures or operations.

The results of the beta-hCG measurements from the lavage fluid will be compared with the pathology results from the P/C and the final diagnosis. This comparison will help evaluate the accuracy and reliability of this novel diagnostic approach.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between 18 and 45
  • Beta-HCG positivity
  • Hemodynamically stable
  • Consecutive beta-hCG measurements do not show a normal pregnancy,
  • Beta-hCG is below the differential level (<1500-2000 mIU / mL) and TV-USG examination is insufficient for differential diagnosis

排除标准

  • Hemodynamic instability
  • Confirmed intrauterine pregnancy

结局指标

主要结局

Comparison of beta-hCG levels in simultaneously collected uterine lavage and venous blood with pathology results

时间窗: The time frame from patient enrollment in the intervention to the receipt of pathology results and comparison with intrauterine lavage results was an average of three weeks.

Primary outcome include diagnostic accuracy, correlation between lavage fluid and venous blood beta-hCG levels and final diagnoses.

次要结局

未报告次要终点

研究者

发起方
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Reyyan Gokcen Iscan

Consultant gynecologist and obstetrician, MD

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

研究点 (2)

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