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临床试验/NCT05591599
NCT05591599招募中不适用

Diagnostic Value of Calponin 2 in Identifying Tubal Pregnancies

Mỹ Đức Hospital1 个研究点 分布在 1 个国家目标入组 407 人开始时间: 2022年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
407
试验地点
1
主要终点
The average serum CNN2 level

研究概览

简要总结

Ectopic pregnancy (EP) is the implantation of a fertilized egg outside the main cavity of the uterus. EP is one of the most common gynecologic surgical emergencies , and one of leading causes of maternal mortality in the first trimester of pregnancy. Embryo implantation exerts different pressure on uterine and tubal epithelial and smooth muscle cells, calponin 2 (CNN2) expression at the implantation site would differ between intrauterine pregnancy and tubal pregnancy. The investigators conduct this study to find out the diagnostic value of CNN2 in identifying tubal pregnancies.

详细描述

This is a case-control prospective study. Women age 18-35 years old, come to My Duc, My Duc phu Nhuan Hospital and Ngoc Lan Clinic and have the indication of testing beta human chorionic gonadotropin (hCG) for determining pregnancy status because of 1-14 days period delay with or without abdominal pain, vaginal bleeding or after assisted reproductive technology. Those women will be introduced about the study. If they agree to take part in and write the consent form, they will be taken 5ml of blood more at the same time of testing beta hCG. Blood sample will then be centrifuged and collected serum will then be stored at -80 celsius degree.

Women with negative beta hCG will be excluded. Women with positive beta hCG will be followed-up pregnancy as routine until 12 6/7 weeks of gestational age (GA). At this time, those women will be screened using including and excluding criteria for each group. They then be put group into (1) tubal pregnancy, (2) viable pregnancy and (3) early pregnancy loss.

Stored serum sample will be defrosted and measured CNN2 concentration.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The average serum CNN2 level

时间窗: Up to 12 6/7 weeks of gestational age

The average serum CNN2 level of each group

次要结局

  • The average beta hCG level(Up to 12 6/7 weeks of gestational age)

研究者

发起方
Mỹ Đức Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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