Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia: It's All About Timing
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence of neonatal hypoglycemia
研究概览
简要总结
A single "supraphysiological" course of exogenous corticosteroids is recommended between 24-34 weeks' gestation to minimize the adverse sequelae associated with prematurity. The 24-hour profile of endogenous corticosteroids normally follows a diurnal rhythm with the highest serum level occurs between 5am-11am and nadir over 12 hours.
详细描述
A retrospective study from January 2010 to December 2017. Eligible for analysis are: singleton pregnancies between 24 - 34 weeks' gestation who were given a single course of intramuscular betamethasone. Single course comprised of two separate doses of 12 mg given 24 hours apart. Each woman was allocated into one of the four pre-defined groups based on the time the intramuscular betamethasone was administered; Group 1 (5am-11am), group 2 (11am-5pm), group 3 (5pm-11pm) and group 4 (11pm-5am). The investigators hypothesized that exogenous corticosteroids given during the nadir state of endogenous corticosteroids activity could alter maternal and fetal glucose homeostasis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women between 24 - 34 weeks' gestation who were admitted and given a single course of intramuscular betamethasone for threatened preterm labor in our institution
排除标准
- •higher order multiple pregnancies
- •women who were given more than one course of betamethasone during the course of the current pregnancy
- •known major congenital anomalies.
研究组 & 干预措施
Betamethasone group 1
Betamethasone Group 1 (5am-11am)
干预措施: Betamethasone (Drug)
Betamethasone Group 2
Betamethasone Group 2 (11am-5pm)
干预措施: Betamethasone (Drug)
Betamethasone Group 3
Betamethasone Group 3 (5pm-11pm)
干预措施: Betamethasone (Drug)
Betamethasone Group 4
Betamethasone Group 4 (11pm-5am).
干预措施: Betamethasone (Drug)
结局指标
主要结局
Incidence of neonatal hypoglycemia
时间窗: 7 years
Incidence of neonatal hypoglycemia, glucose ˂ 40 mg/dL at any time
次要结局
未报告次要终点
研究者
Yaniv Zipori MD
Principal Investigator
Rambam Health Care Campus