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临床试验/NCT01487616
NCT01487616Unknown不适用

Prevalence of Congenital Uterine Malformations in Women With a History of Preterm Delivery or Miscarriage

University of Nottingham1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
246
试验地点
1
主要终点
Presence of uterine malformations

研究概览

简要总结

Aims: We plan to investigate how common uterine malformations are in high-risk women (with history of miscarriage or preterm delivery), by analysing different characteristics in these groups. This study will also investigate other ultrasound characteristics detected on these women. This study will point towards the possible mechanism of how uterine malformations may affect pregnancy outcomes.

详细描述

Background: Congenital abnormally shaped wombs (uterine malformations) have long been thought to be more common in women with poor pregnancy outcomes, e.g. miscarriage (Rackow and Arici 2007) and preterm delivery (Tomazevic, Ban-Frangez et al. 2007). However, the true prevalence is difficult to assess as there are no universally agreed classification systems and some of the best investigations are invasive. In addition, previous prevalence studies have not examined the details of subfertility or pregnancy loss, such as duration of subfertility, the gestation of pregnancy loss, or miscarriage pattern.

Aims: We plan to investigate how common uterine malformations are in high-risk women (with history of miscarriage or preterm delivery), by analysing different characteristics in these groups. This study will also investigate other ultrasound characteristics detected on these women. This study will point towards the possible mechanism of how uterine malformations may affect pregnancy outcomes.

Methods: We plan to recruit women who have had miscarriage or preterm delivery into our study. A sample of women who had normal term deliveries will be recruited as comparison. All women will undergo one 3-dimensional ultrasound scan each.

Outcomes: The proportions of women with congenital uterine malformations will be determined. Any ultrasound-detected markers found especially in women with poor pregnancy outcomes may point towards how uterine malformations affect pregnancies.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with a previous miscarriage
  • Age: 18 years old or more
  • Definition of miscarriage: the spontaneous pregnancy loss up until 24 weeks of gestation, where the pregnancy was confirmed histologically or with previous presence of a gestational sac with or without fetal pole and fetal heart activity on ultrasound scanning.
  • At least 8 weeks after the end of last pregnancy
  • Women with preterm birth
  • Age: 18 years old or more
  • Definition of preterm birth: birth at less than 37 weeks of gestation.
  • At least 8 weeks after the end of last pregnancy
  • Control group (women with term birth)
  • Age: 18 years old or more
  • Definition of term birth: birth at 37 or more weeks of gestation
  • At least 8 weeks after the end of last pregnancy

排除标准

  • Pregnant at the date of the 3D TVUS
  • Recent uterine or endometrial surgery
  • Women unable to tolerate 3D TVUS
  • Unable to give informed consent

结局指标

主要结局

Presence of uterine malformations

时间窗: At least 8 weeks after the end of last pregnancy

Presence of uterine malformations in study group compared to control group

次要结局

  • Ultrasound markers on pelvic 3D ultrasound(At least 8 weeks after the end of last pregnancy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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