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临床试验/NCT03576950
NCT03576950Unknown不适用

Uterine Rupture in Pregnancy: the URIDA (Uterine Rupture International Data Acquisition) Study

Università degli Studi dell'Insubria0 个研究点目标入组 100 人开始时间: 2021年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Uterine rupture

研究概览

简要总结

Uterine rupture represents an uncommon event: it is is a life-threatening obstetric complication with high maternal and perinatal morbidity and mortality. Indeed, uterine rupture may cause catastrophic maternal and fetal complications (uterine hemorrhage, hysterectomy with consequent fertility loss, maternal and fetal death or cerebral palsy) which are hardly acceptable within the context of a natural event such as birth.

Uterine rupture can occur during pregnancy, early in labor or following a prolonged labor, most frequently near or at term and, rarely, during early to mid-pregnancy. Its prevalence ranges between 0.006% for women without previous cesarean section (CS) in the western countries, to 25% for women with obstructed labor in African countries.

Pregnancy after myomectomy or CS, vaginal delivery after cesarean sections (VBACs) and vaginal delivery after myomectomy are potentially "at risk" of uterine rupture.

Despite uterine rupture is widely considered a life-threatening condition, so far most of published data refer to case reports or very small case series. In this scenario, the "Uterine Rupture International Data Acquisition" study group would like to collect a large number of events, in order to identify the potential risk factors among different populations through a multivariate analysis.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Women with uterine rupture occurred during pregnancy.

排除标准

  • 未提供

结局指标

主要结局

Uterine rupture

时间窗: A retrospective analysis of 10 years.

Women with uterine rupture occurred during pregnancy.

次要结局

  • Gestational age at uterine rupture(A retrospective analysis of 10 years.)
  • Parity(A retrospective analysis of 10 years.)
  • Body Mass Index(A retrospective analysis of 10 years.)
  • Presence of myomas(A retrospective analysis of 10 years.)
  • Hysterectomy(A retrospective analysis of 10 years.)
  • Hospital stay(A retrospective analysis of 10 years.)
  • Neonatal complications(A retrospective analysis of 10 years.)

研究者

发起方
Università degli Studi dell'Insubria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Simone Laganà

Medical Doctor

Università degli Studi dell'Insubria

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