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临床试验/NCT06164015
NCT06164015尚未招募不适用

Association of Acquired Uterine Abnormalities With Recurrent Miscarriage

University Hospitals of Derby and Burton NHS Foundation Trust0 个研究点目标入组 400 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
400
主要终点
Prevalence of Acquired Uterine Anomalies

研究概览

简要总结

This observational study aims to compare the prevalence of acquired abnormalities of the uterus (fibroids, polyps, intrauterine adhesions, adenomyosis) in women who have recurrent miscarriages with the fertile population.

详细描述

High-quality studies including several meta-analyses have proven the association between congenital uterine anomalies and recurrent miscarriages. Nevertheless, there are limited studies evaluating the impact of acquired uterine anomalies on recurrent miscarriages.

This prospective observational study will aim to compare the prevalence of acquired uterine anomalies between the study group and the control group. The secondary aim will be to compare the Endometrial morphological features like endometrial volume, endometrial and sub-endometrial vascularity between the two groups

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between the age group of 18-40 years
  • Women who have had 2 or more pregnancy losses before 24 weeks of gestation - Study group.
  • Women who can provide documented informed consent
  • Women with proven fertility with at least one child - Control group

排除标准

  • Women with previous history of miscarriage/ extreme preterm delivery (before 28 weeks of gestation) will be excluded from the Control group.

结局指标

主要结局

Prevalence of Acquired Uterine Anomalies

时间窗: 24 months

Primary outcome will be to compare the prevalence of acquired uterine anomalies (estimated as the proportion of anomalies diagnosed on 3D pelvic ultrasound) between study group and control group

次要结局

  • Endometrial thickness(24 months)
  • Endometrial blood flow indices (vascularisation index, flow index and vascularisation flow index)(24 months)
  • Endometrial volume(24 months)

研究者

申办方类型
Other
责任方
Sponsor

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3D Ultrasound to Assess in Recurrent Miscarriage | 临床试验