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临床试验/NCT02637739
NCT02637739Unknown不适用

Office Hysteroscopy as a Diagnostic Tool of Pregnancy of Unknown Location

Shin Kong Wu Ho-Su Memorial Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
percentage of women with PUL waived from laparoscopic examination

研究概览

简要总结

About 10% of early pregnancies can not be visualized by transvaginal ultrasound (TVU) on first visit and are classified as pregnancy of unknown location (PUL). The etiology includes ongoing intra-uterine pregnancy, failing pregnancy, or ectopic pregnancy. Early diagnosis of ectopic pregnancy is important because it allows conservative treatment. Serum β-hCG, D&C, and laparoscopy are routinely used as diagnostic methods. The purpose of the study is to evaluate if the less invasive office hysteroscopy (HSC) can help diagnose PUL.

详细描述

If TVU showed no evidence of intra-uterine and extra-uterine pregnancy, a blood test for β-hCG was done. If β-hCG was < 1000 IU/L, the woman was followed with β-hCG 2 days later. Women with β-hCG > 1000 IU/L or abnormal β-hCG trend (increase < 66% or decrease < 15%) were offered HSC. If gestational tissues were visualized, ectopic pregnancy was ruled out. Otherwise, the tentative diagnosis was ectopic pregnancy.

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

性别
Female
接受健康志愿者

入选标准

  • women with PUL

排除标准

  • 未提供

结局指标

主要结局

percentage of women with PUL waived from laparoscopic examination

时间窗: 2 weeks

次要结局

未报告次要终点

研究者

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

Yu-Hung Lin

M.D.

Shin Kong Wu Ho-Su Memorial Hospital

研究点 (2)

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