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临床试验/NCT06262373
NCT06262373已完成不适用

Are Early Pregnancies Implanted Close to the Tubal Ostia at Increased Risk of Miscarriage? A Prospective Observational Study

King's College Hospital NHS Trust1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
236
试验地点
1
主要终点
Primary

研究概览

简要总结

The aim of this study is to establish clinically meaningful ultrasound-based diagnostic criteria for AP. To this end, the investigators will prospectively collect clinical and ultrasound data from early intrauterine pregnancies and correlate this data with pregnancy outcomes (particularly with risk of miscarriage), to establish whether there are any diagnostic criteria that can be used to make the diagnosis, facilitate increased surveillance of at risk pregnancies and reassure those with normally located pregnancies. The collected data will be used to correlate incidence of angular pregnancy and clinical variables such as maternal age, uterine fibroids, assisted conception, multiple pregnancy, ethnicity, previous uterine and adnexal surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Have capacity to understand the study and to provide signed and dated informed consent.
  • Willing to comply with all study procedures and be available for the duration of the study including consenting to follow up of the pregnancy outcome by letter, phone or email according to individual preference.
  • Age 16 years or over
  • Mean gestational sac diameter (GSD) on ultrasound of 2-15mm inclusive
  • GS implantation site within the upper half of the uterine cavity on 2D USS

排除标准

  • Women with pregnancies of unknown location, ectopic pregnancies or larger GSD than specified in the inclusion criteria.
  • Implantation site within the lower half of the endometrial cavity on 2D USS screening.
  • Intention to terminate the pregnancy
  • Women with unicornuate uteri or unicornuate uteri with rudimentary horns
  • Women with uterine fibroids which distort the uterine cavity

结局指标

主要结局

Primary

时间窗: 2 years

To define "angular pregnancy" using ultrasound based criteria.

次要结局

  • Secondary(2 years)

研究者

发起方
King's College Hospital NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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