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临床试验/NCT01680731
NCT01680731已完成不适用

3-Dimension Ultrasound Findings in Women Who Have Undergone Vacuum Versus Forceps-Assisted Vaginal Deliveries

University of Rochester1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Levator ani injury on 3D ultrasound

研究概览

简要总结

The purpose of this study is to investigate of the differences in pelvic floor anatomy and function in women who have undergone a vacuum assisted vaginal delivery (VAVD) versus a forceps assisted vaginal delivery (FAVD) using three-dimensional ultrasound imaging. Women within 1-5 years after first delivery who did not have an internal delivery will be included. The total number of subjects is forty. This will include ten primiparous subjects who have undergone vacuum delivery, ten who have undergone forceps delivery, ten who had spontaneous vaginal delivery and ten who have undergone primary elective cesarean section.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Females age >18 and <
  • Primiparous females with singleton pregnancy who have undergone a term vacuum assisted vaginal delivery, forceps assisted vaginal delivery, spontaneous vaginal delivery, or elective primary cesarean section or spontaneous vaginal delivery.
  • Birth weight >2500g and <4500g.
  • Delivery should have occurred more than one year ago, but less than five years ago.
  • Pregestational BMI <35kg40kg/m2.

排除标准

  • Presence of interim delivery.
  • Presence of both vacuum and forceps use during delivery.
  • Presence of pregestational or A2 gestational diabetes mellitus.
  • Presence of neuromuscular disorder (i.e., spinal cord disease, Multiple Sclerosis, Myasthenia Gravis) or connective tissue disorder (i.e., Lupus and Sjogren's disease).

结局指标

主要结局

Levator ani injury on 3D ultrasound

时间窗: 1-5 years after delivery

Assessment of levator ani injury on trasnperineal 3D ultrasound images

次要结局

未报告次要终点

研究者

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

Tulin Ozcan MD

Associate Professor of Obstetrics and Gynecology

University of Rochester

研究点 (1)

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