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临床试验/NCT02056639
NCT02056639已完成不适用

Prevention of Preterm Birth With a Pessary in Twin Gestations

University of Pennsylvania6 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2014年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
6
主要终点
Number of Participants With Preterm Delivery

研究概览

简要总结

Preterm birth (PTB) is a major health problem and contributes to more than 50% of the overall perinatal mortality. Twins are at increased risk for PTB. The number of twins births has risen substantially due to the increased use of assisted reproductive technology. The rate of twin births in the United States rose from 18.9 to 32.2 per 100 live births between 1980 and 2004. The increased rate of PTB in twins is associated with increased morbidity and mortality rates. Almost one in four very low birth-weight infants (below 1500 g) born in the United States are twins, as are one in six infants who die in the first month of life. Cervical shortening is a risk factor for PTB. Transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of PTB. There is currently no effective treatment to decrease the incidence of PTB in women with twin gestations, but there is some evidence that the use of a cervical pessary in women with a short cervix has promise. If effective this approach would be particularly appealing because of the wide availability of pessaries, ease of use, and low cost. Unfortunately, existing studies are inadequate to confirm effectiveness; a well designed, properly powered, prospective randomized trial is warranted prior to widespread implementation in clinical practice. We propose such a trial to study the effectiveness of the pessary in decreasing the incidence of PTB in an inner city Philadelphia population.

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
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-50 years of age
  • Twin pregnancy (limits the participants to female gender)
  • Short cervical length (less than or equal to 30 mm) on second trimester ultrasound at 18-27 6/7 weeks gestation

排除标准

  • Singleton or higher order than twins multiple gestation
  • Monoamniotic twins
  • Twin twin transfusion syndrome
  • Ruptured membranes
  • Lethal fetal structural anomaly
  • Fetal chromosomal abnormality
  • Cerclage in place (or planned placement)
  • Vaginal bleeding
  • Suspicion of chorioamnionitis
  • Ballooning of membranes outside the cervix into the vagina
  • Painful regular uterine contractions
  • Placenta previa

研究组 & 干预措施

Pessary

Experimental

Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)

干预措施: Bioteque cup pessary (Device)

No pessary

No Intervention

No pessary will be used. Subjects will receive standard obstetrical management

结局指标

主要结局

Number of Participants With Preterm Delivery

时间窗: Less than 34 weeks gestation

次要结局

  • Average Birth Weight of Babies in Each Group(Time of delivery)
  • Number of Participants That Experienced Neonatal Death(Between birth and 28 days of age)
  • Number of Subjects Experiencing Chorioamnionitis(Time of delivery)
  • Spontaneous Preterm Birth Rates(Less than 37 weeks gestation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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