Use of Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 主要终点
- Gestational age at delivery
研究概览
简要总结
The purpose of this study is to determine if the use of routine transvaginal cervical length ultrasound can be used to prevent preterm deliveries in twin gestations.
详细描述
This is a randomized controlled trial to determine whether there is a difference in the rate of preterm birth among women with twin pregnancies whose clinicians are aware of transvaginal ultrasound cervical length measurements compared to those managed without this information. The study group had transvaginal cervical length ultrasound monthly from 16-28 weeks and were managed with a standard algorithm for activity restriction and cerclage depending on the cervical length. The control group had digital cervical exams and routine transvaginal cervical length ultrasound was not utilized. The primary outcome was the mean length of gestation. Secondary outcomes included percentage of deliveries < 35 weeks, maternal and neonatal outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Twin pregnancy
- •Gestational age < 20 weeks
排除标准
- •History of incompetent cervix with plans to place a cerclage
- •History of possible cervical incompetence with preexisting plans to monitor cervical length
- •Prior preterm birth at < 28 weeks gestational age
- •Plans to leave the area before delivery
- •Known major fetal anomaly
- •Known diagnosis of twin-twin transfusion syndrome
- •Age < 18
- •Monoamniotic twins
结局指标
主要结局
Gestational age at delivery
时间窗: Immediately at the time of delivery
Gestational age reported as completed weeks of gestation
次要结局
- Administration of steroids(Immediately at the time of delivery)
- Birth weight(Immediately at the time of delivery)
- Length of stay in the neonatal intensive care unit(Newborns will be followed throughout their hospital stay for an anticipated average of 2 weeks)
- Severe neonatal morbidity(Newborns will be followed throughout their hospital stay for an anticipated average of 2 weeks)
- Use of tocolytic medications(Immediately at the time of delivery)
- Preterm birth at < 35 completed weeks of gestation(Immediately at the time of delivery)
- Number of days of maternal bed rest(Immediately at the time of delivery)
- Number of maternal days in the hospital(Immediately at the time of delivery)
研究者
William H. Barth, Jr., M.D., Col(ret), USAF, MC
William H. Barth, Jr., M.D., Col(ret), USAF, MC
59th Medical Wing