Cervical Pessary in Women With Arrested Preterm Labor and Short Cervix
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Spontaneous preterm birth (SPTB)
研究概览
简要总结
Preterm birth (PTB), defined as birth between 20 and 36 6/7 weeks, is responsible for the majority of the neonatal morbidity and mortality in the United States, and 35% of all U.S. healthcare spending on infants. Globally, about 28% of the 4 million annual neonatal deaths are directly attributable to PTB.
Preterm labor (PTL) is the final pathway for about 50% of all PTB. Tocolytic agents are drugs that can slow or stop labor contractions in the attempt to delay births preceded by PTL. Primary tocolysis is defined as tocolysis given on initial presentation of women with PTL. In most of these women, PTL stops, but as their risk of PTB remains high, some have advocated use of maintenance tocolysis, i.e. tocolysis after arrested PTL. So far, no maintenance tocolytic agent has been shown to be beneficial in preventing PTB.
The aim of this study is to evaluate the efficacy of maintenance tocolysis with Arabin pessary compared to standard care in singleton gestations with arrested PTL and with short transvaginal ultrasound (TVU) cervical length (CL) <25mm
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
- 否
入选标准
- •18-50 ages
- •Singleton pregnancy
- •24(0) - 34(6) weeks of gestation
- •Arrested preterm labor after primary tocolysis
- •Transvaginal ultrasound cervical length less than 25mm at admission
- •Agreement to regular follow-up and provision of written informed consent
排除标准
- •pessary and no cerclage in situ
- •vaginal bleeding
- •placeta previa/accreta
- •multiple gestations
- •<24(0) or >24(6) weeks of gestation
- •Cervical dilatation greater than 3 cm
- •Chorioamnionitis
- •Major fetal abnormalities
- •Abruptio placentae
- •Polyhydramnios or oligohydramnios
- •IUGR/FGR with or without Doppler abnormalities
- •Preeclampsia or pregnancy-related hypertension
研究组 & 干预措施
Cervical pessary
Arabin cervical pessary
干预措施: Arabin cervical pessary (Device)
Standard care
No treatment
结局指标
主要结局
Spontaneous preterm birth (SPTB)
时间窗: Less than 34 weeks gestation
次要结局
- Admission to neonatal intensive care unit(Delivery (at birth))
- Spontaneous preterm birth (SPTB)(Less than 37,35,32,28 and 24 weeks gestation)
- Gestational age at delivery(Delivery (at birth))
- intraventricular hemorrhage(Between birth and 28 days of age)
- Latency(Delivery (at birth))
- Birth weight(Delivery (at birth))
- respiratory distress syndrome(Delivery (at birth))
- low birth weight(Delivery (at birth))
- neonatal mortality(Between birth and 28 days of age)
研究者
Gabriele Saccone
MD
Federico II University