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临床试验/NCT03096691
NCT03096691Unknown不适用

Use of Pessary in Case of Cervical Insufficiency and Short Cervix

Zeynep Kamil Maternity and Pediatric Research and Training Hospital2 个研究点 分布在 2 个国家目标入组 2 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2
试验地点
2
主要终点
Preterm delivery

研究概览

简要总结

Prematurity is the most important cause of obstetric morbidity and mortality. Health centers and obstetricians are trying to reduce the preterm birth rate by taking into account the permanent effects of premature birth on human life in the early and long term.

The most effective solution of preterm delivery is to determine the patients entering the risk group and to prevent preterm labor by putting the correct diagnosis at the right time. Recently, there have been studies on the efficacy of pessary practice in preventing preterm birth, but with the positive results of these studies, there has been hope for early birth prevention as well as other treatments.

The aim of this study is; To assess the effectiveness of pessary use in patients with high risk for preterm labor and prophylactic cervical length less than 25 mm below 25 weeks and with a history of cervical insufficiency.

详细描述

The aim of this study is; To assess the effectiveness of pessary use in patients with high risk for preterm labor and prophylactic cervical length less than 25 mm below 25 weeks and with a history of cervical insufficiency.

100 pregnant women with a preterm delivery history and / or a cervical length of less than 25 mm will be included among the pregnancies between 16 and 24 weeks of gestation referred to obstetric and perinatology clinics. Information will be given about the success of treatment in the prevention of early birth of the pessary and the use of the disease pessary. Urine culture and cervical culture samples will be taken from both groups of patients. In the presence of infection, the patient's treatment will be planned and out of work. If no infection is detected and the patient agrees to use the pessary, the pessary will be used to prevent premature birth.

研究设计

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

入排标准

年龄范围
17 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with a cervical length of 25 mm> and a preterm labor history in the previous pregnancy

排除标准

  • Patients with vaginal bleeding, with congenital anomalies, chorioamnionitis

结局指标

主要结局

Preterm delivery

时间窗: Less than 34 weeks gestation

Spontaneous delivery before 34 completed weeks

次要结局

未报告次要终点

研究者

发起方
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilsad Herkiloglu

Principal Investigator

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

研究点 (2)

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