Retrospective Review of Repeat Antenatal Corticosteroids in Preterm Premature Rupture of Membranes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Infant outcomes
研究概览
简要总结
This study will review records of women who broke their water early who received a repeat course of antenatal steroids.
详细描述
Antenatal corticosteroids (ANCS) administered to a mother at risk of preterm delivery have been shown to decrease morbidity of prematurity if preterm birth occurs. Although early animal studies found that many repeated doses led to growth restriction a single repeat dose was found to benefit human neonates without a significant decrease in birth weight.
Current guidelines recommend two doses of ANCS administered 24 hours apart as a single "course." A repeat course of steroids is administered no less than 1-2 weeks after the first course if the mother remains at risk of preterm delivery. However, the main studies supporting the repeat course of ANCS excluded women with preterm premature rupture of membranes (PPROM). These authors designed exclusion criteria this way because of a theoretical increased risk of chorioamnionitis with administration of a glucocorticoid, which may have immunosuppressant effects. As a result, there is insufficient data to recommend a repeat dose of ANCS in women with PPROM.
One study and its follow up publication did include women with PPROM. It did not find an increased incidence of chorioamnionitis between the treatment and the placebo groups, although women with PPROM were not analyzed separately.
The combination of no increased incidence of chorioamnionitis but no clearly studied populations creates an opportunity for a randomized controlled trial of repeat doses of ANCS including only women with PPROM.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 13 Years 至 55 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women with preterm premature rupture of membranes
排除标准
- •Women who did not have preterm premature rupture of membranes
结局指标
主要结局
Infant outcomes
时间窗: 1 year
infant birth weight
次要结局
未报告次要终点
研究者
Cara Buskmiller, MD
Principal Investigator
St. Louis University
