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临床试验/NCT03703401
NCT03703401已完成不适用

The Role of Hydrosalpinx in Recurrent Miscarriage

University of Birmingham1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2018年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
137
试验地点
1
主要终点
Hydrosalpinx

研究概览

简要总结

Miscarriage affects one in five pregnancies and little progress has been made in understanding and treating this distressing condition. C. trachomatis is the most common sexually transmitted infection in the UK. C. trachomatis infection can have serious health consequences, including fallopian tube damage. Untreated C. trachomatis infection and tubal damage have been associated with miscarriage and adverse pregnancy outcomes such as preterm birth, low birth weight and stillbirth. A cohort study is needed to establish the prevalence of tubal disease in women with recurrent miscarriages. HyCoSy will be performed to identify tubal disease and establish the magnitude of the problem in the recurrent miscarriage population. The prognosis of tubal disease on miscarriage and other obstetric outcomes, and the role of medical interventions such as tubal surgery (to treat hydrosalpinx) on reducing miscarriage and adverse obstetric outcomes will also be studied.

Objectives

  1. Establish the prevalence of hydrosalpinx in the recurrent miscarriage population.
  2. Establish the prognosis of women diagnosed with recurrent miscarriage with concurrent hydrosalpinx.
  3. Explore the role of tubal surgery for improving reproductive outcomes in women with recurrent miscarriage population and hydrosalpinx.

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
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18-45
  • Women diagnosed with recurrent miscarriage i.e. 2 or more miscarriages
  • Ability to give informed consent

排除标准

  • Allergy to contrast media used for Hysterosalpingo-contrast-sonogram
  • Allergy to sonographic gel used for ultrasound scanning
  • Anatomical anomaly meaning transvaginal ultrasound scan not possible
  • Stenosed/occluded cervix meaning contrast media unable to be introduced via cervix
  • Inability to give informed consent
  • Pregnant at the time of recruitment
  • Declined recruitment

结局指标

主要结局

Hydrosalpinx

时间窗: 12 months

The presence or absence of tubal blockage and hydrosalpinx

次要结局

  • Miscarriage(12 months)

研究者

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

Dr Jayasish Ghosh

Principal Investigator

University of Birmingham

研究点 (1)

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