跳至主要内容
临床试验/NCT03046654
NCT03046654终止不适用

Cervical Cerclage Position Throughout Pregnancy, it's Distance From the Inner and Outer Cervical os', and Implications of the Position on Pregnancy Outcomes.

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2017年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
7
试验地点
1
主要终点
Gestational age at the time of delivery

研究概览

简要总结

Cervical cerclage is an obstetric intervention used in women with poor obstetric histories. After recruiting the participant, Trans vaginal sonography will be used to examine cervical length and funneling. In addition vaginal examination will be performed to evaluate the cervix. After placing the cerclage, the participant will be invited every 4 weeks for a follow up evaluation session in order to examine the cervix and cerclage position. .

详细描述

Cervical cerclage is an obstetric intervention used in women with poor obstetric histories due to late abortions, premature deliveries and painless dilatation. These 3 situations are usually due to cervical incompetence though can be caused by infection and other factors.

The cerclage is usually placed from 12-24 weeks of gestation depending on the indication and medical follow up during pregnancy. There are 2 methods for cerclage performance-McDonald and Shirodkar that have the same efficacy.

After recruiting the participant, Trans vaginal sonography will be used to examine cervical length and funneling. In addition vaginal examination will be performed to evaluate the cervix. After placing the cerclage, the participant will be invited every 4 weeks for a follow up evaluation session in order to examine the cervix and cerclage position. Each follow up will include a vaginal examination and trans vaginal sonography. The trans vaginal sonography will examine total cervical length, funneling, and the cerclage's distance from the inner and outer os' of the cervix.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women that have a cervical cerclage placed during pregnancy at the investigator's medical center.

排除标准

  • Women that do not require cervical cerclage.
  • Women that had a cervical cerclage placed at a different medical center.

结局指标

主要结局

Gestational age at the time of delivery

时间窗: Up to 9 months

Gestational age at the time of delivery

次要结局

  • Gestational age at the time of the removal of the cervical cerclage(Up to 9 months)

研究者

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

ROY LAUTERBACH MD

Principal Investigator

Rambam Health Care Campus

研究点 (1)

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