Prolene Versus Ethibond for Cervical Cerclage
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
- 是
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
Meike Schuster
Assistant Professor
Rutgers University
