临床试验/NCT01739543

NCT01739543已完成不适用

A Reduction in C-section Rates Using the Hem-Avert Perianal Stabilizer

Stetrix, Inc.1 个研究点分布在 1 个国家目标入组 102 人开始时间: 2012年4月1日最近更新: 2013年3月18日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Stetrix, Inc.
入组人数: 102
试验地点: 1
主要终点: Reduce C-section Rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.

详细描述

This study is being conducted to evaluate an existing FDA approved device called the HEM-AVERT® Perianal Stabilizer for its efficacy in reducing Cesarean births and/or reducing the second stage of labor.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Subject is scheduled for vaginal delivery.
•Subject is willing and able to comply with the study plan as indicated by understanding and signing the Subject Informed Consent Form.
•Subjects' pre-natal examination indicates that this is to be a single birth delivery.

排除标准

•Subject's scheduled for vaginal delivery with anticipated complications.
•Subject is unable to understand and sign the informed consent form.
•Subject does not deliver at study facility (hospital).

研究组 & 干预措施

Investigational

Experimental

Subject receives Hem-Avert Device.

干预措施: Hem-Avert (Device)

Control

No Intervention

Subject does not receive Hem-Avert Device.

结局指标

主要结局

Reduce C-section Rate

时间窗: 24 hours

The primary objective (purpose) of this study is to evaluate the success rate of the HEM-AVERT® device as a method of reducing C-section rates

次要结局

Reduce duration of 2nd stage of labor.(24 hours)

研究者

发起方

Stetrix, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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