Effect of Antenatal Corticosteroids in Late Preterm
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 主要终点
- neonate respiratory distress syndrome
研究概览
简要总结
To test the effect on premature infants of a one-time course of betamethasone administered in weeks 34-36 of gestation.
详细描述
Protocol version 3, 1/7/2012
Research Goal To test the effect on premature infants of a one-time course of betamethasone administered in weeks 34-36 of gestation.
Inclusion criteria
-
Pregnant woman in weeks 34-36 of gestation who did not receive a betamethasone course to enhance fetal lung maturity during pregnancy
-
Clinical, sonographic or laboratory suspicion of premature labor
-
Singleton or twin pregnancy Exclusion criteria
-
Premature rupture of membranes 2. Fetus with known defects 3. Suspicion of fetal distress 4. Betamethasone administered during pregnancy for any reason Research protocol Study group 100 women in weeks 34-36 of gestation with clinical, sonographic or laboratory suspicion of early labor will be recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant woman in weeks 34-36 of gestation who did not receive a betamethasone course to enhance fetal lung maturity during pregnancy
- •Clinical, sonographic or laboratory suspicion of premature labor
- •Singleton or twin pregnancy
排除标准
- •Premature rupture of membranes
- •Fetus with known defects
- •Suspicion of fetal distress
- •Betamethasone administered during pregnancy for any reason
研究组 & 干预措施
betamethasoneb, 34-36 weeks, preterm labor
betamethasone 12 mg 2 injections will be given 24-hours apart.
干预措施: betamethasone (Drug)
结局指标
主要结局
neonate respiratory distress syndrome
时间窗: 1 year
次要结局
- 1 and 5 minute Apgar scores, and complications during the first week of life, including hypoglycemia, seizures, intubation or medications(1 week)