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临床试验/NCT03311867
NCT03311867已完成不适用

Prolene Versus Ethibond for Cervical Cerclage

Rutgers University4 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
4
主要终点
Change in Vaginal Microbiome

研究概览

简要总结

The purpose of the proposed study is to examine the relationship between cerclage suture material of Ethibond and Prolene and its effect on the vaginal microbiome in a prospective randomized control trial. Ethibond is another commonly used suture material for performing cervical cerclage that shares some characteristics with previously studied suture materials. It is braided like the Mersilene, but thinner like the monofilament Prolene. The investigators will study whether Ethibond causes the vaginal microbiome to be adversely affected like Mersilene or whether there is a healthy microbiome like Prolene. This study will allow the investigators to determine whether it is advisable to continue to use Ethibond for cervical cerclage in clinical practice, or whether obstetricians should avoid its use as now done with Mersilene.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

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

  • Greater than18 years of age
  • Singleton pregnancy
  • History of preterm delivery between 17 0/7 weeks - 33 4/7 weeks with painless cervical
  • dilation or cervical insufficiency

排除标准

  • younger than 18 years of age
  • multiple gestation
  • iatrogenic preterm delivery
  • pregnancies with fetal anomalies

结局指标

主要结局

Change in Vaginal Microbiome

时间窗: At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)

16S rRNA gene sequencing will be performed

Change in Vaginal Cytokine Expression

时间窗: At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation)

Cytokine analysis will be performed

次要结局

  • Rate of preterm birth(Delivery between 24-26 weeks gestation)

研究者

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

Meike Schuster

Assistant Professor

Rutgers University

研究点 (4)

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Prolene Versus Ethibond for Cervical Cerclage | 临床试验