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临床试验/NCT03133104
NCT03133104已完成不适用

Retrospective Review of Repeat Antenatal Corticosteroids in Preterm Premature Rupture of Membranes

St. Louis University1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2017年1月5日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cara Buskmiller, MD

Principal Investigator

St. Louis University

研究点 (1)

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