Atosiban Versus Placebo in the Treatment of Late Threatened Preterm Birth
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 760
- 试验地点
- 1
- 主要终点
- Adverse neonatal outcome
研究概览
简要总结
The aim of this study is to investigate if tocolysis with atosiban in late preterm birth (30 to 34 weeks) is (cost-) effective compared with placebo in improving neonatal morbidity and mortality.
详细描述
Research question Does tocolysis with atosiban reduce neonatal mortality and mortality in women with threatened preterm birth between 30 and 34 weeks when compared to placebo?
Study design Multicenter, double blinded, placebo controlled RCT
Study population Women with threatened preterm birth between 30 and 34 weeks of gestation are eligible for the trial. More than 20 hospitals (including all 10 perinatal centres) in the Netherlands will participate in this trial, as well as 15 hospitals in the UK and 1 in Dublin, Ireland.
Threatened preterm birth is defined as listed below in the inclusion criteria. Our previous APOSTEL III study showed that half of the women with these criteria deliver within seven days, validating this definition of women at high risk for preterm birth.
Inclusion criteria
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded
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
- •Women ≥ 18 years
- •Singleton or twin pregnancy
- •Gestational age between 30 0/7 and 33 6/7 weeks
- •Threatened preterm birth defined by regular uterine contractions, AND one of the following:
- •Cervical length of < 15 mm OR
- •Cervical length of 15-30 mm and a positive Fibronectine test (≥ 50 ng/mL) OR
- •In case of absence of cervical length measurement in local protocol a positive Fibronectin test or Partus test OR
- •Ruptured amniotic membranes
排除标准
- •Previous treatment for threatened preterm birth with corticosteroids in current pregnancy
- •Contra indication for tocolysis
- •Signs of fetal distress
- •Signs of intra uterine infection
研究组 & 干预措施
atosiban
Atosiban: bolus injection of 6.75 mg/0.9 ml atosiban in one minute followed by a continuous infusion of 18 mg/hour (=24ml/hour) for 3 hours followed by a continuous infusion of 6 mg/hour (=8 ml/hour) for the remaining 45 hours.
干预措施: Atosiban (Drug)
placebo
Placebo: injection of 0.9 ml saline in one minute followed by a saline infusion for 3 hours (24 ml/hour) followed by a continuous infusion (8 ml/hour) for the remaining 45 hours.
干预措施: Atosiban (Drug)
结局指标
主要结局
Adverse neonatal outcome
时间窗: Up to 3 months corrected age
Combination perinatal mortality and severe neonatal morbidity (BPD, NEC, ROP, IVH, PVL, sepsis,
次要结局
- Birth within 48 hours(48 hours)
- Birth weight(At birth)
- NICU(Up to 3 months corrected age)
- Mechanical ventilation(Up to 3 months corrected age)
- Time to delivery(Not applicible)
- Gestational age at delivery(At birth)
- Convulsions(Up to 3 months corrected age)
- Asphyxia(Up to 3 months corrected age)
- Meningitis(Up to 3 months corrected age)
- Pneumothorax(Up to 3 months corrected age)
- Maternal infection(Up to 3 months corrected age)
- Maternal side effects(Up to 3 months corrected age)
研究者
Martijn A. Oudijk, MD, PhD
Prof. Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)