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临床试验/NCT04098289
NCT04098289已完成不适用

Effect of Hysteroscopic Septum Resection on Preterm Birth Rate in Singleton Pregnancies After Primary Infertility Treatment

Università degli Studi dell'Insubria0 个研究点目标入组 420 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
420
主要终点
Preterm delivery rate

研究概览

简要总结

Uterine septum is the most common congenital uterine malformation. It accounts for approximately 35% of all uterine malformations, while the frequency of uterine malformations in the general fertile population is estimated to be between 1% and 4%.

The presence of a uterine septum is associated with subfertility and a high incidence of obstetric complications, such as spontaneous abortion, 3-fold increase in preterm premature rupture of the membranes (PROM), 6-fold increase in preterm delivery, malpresentation at delivery, caesarean section, and increased perinatal morbidity and mortality.

Some studies have found that surgical resection of the uterine septum improves pregnancy outcomes and significantly reduces the risk of preterm delivery. Therefore, the risk for a short-term adverse outcome and long-term sequelae due to preterm delivery such as intraventricular hemorrhage, necrotizing enterocolitis, sepsis, patent ductus arteriosus, retinopathy, deafness, chronic lung disease, cerebral palsy, perinatal death, and impaired mental development in women with uterine septum could be lowered by performing a relatively simple and safe hysteroscopic septum resection (HSR).

However, there are two major concerns regarding HSR: cervical incompetence due to excessive dilatation during hysteroscopy and the rare yet serious complication of uterine rupture in subsequent pregnancy or delivery.

Considering these elements, the aim of this study will be to evaluate the rate of preterm delivery in singleton pregnancy comparing primary infertile women who underwent HSR and who did not undergo the same procedure, with our without in vitro fertilization.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

  • Female primary infertility
  • Singleton pregnancies

排除标准

  • Female secondary infertility
  • Multiple pregnancies

结局指标

主要结局

Preterm delivery rate

时间窗: Through study completion, an average of 5 year

Percentage of delivery that occurs before the start of the 37th week of pregnancy.

次要结局

未报告次要终点

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

Principal Investigator

Università degli Studi dell'Insubria

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