NCT03738293撤回不适用
An Observational Study to Predict Neonatal Hypoglycemia Using Antenatal Continuous Glucose Monitoring Among Late Preterm Parturients Receiving Corticosteroids
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Pediatrix
- 主要终点
- Neonatal Hypoglycemia
研究概览
简要总结
Women undergoing late preterm birth are at high risk of delivering a newborn with neonatal hypoglycemia. The investigators plan to monitor interstitial glucose levels prior to delivery in these women in order to develop a better understanding of the relationship between maternal hyperglycemia and neonatal hypoglycemia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Pregnancy admitted to labor and delivery between 34w0d and 36w5d
- •English speaking women
- •High probability of delivery in late preterm period defined by any of the following:
- •Membrane rupture by 2 criteria (pooling, positive nitrazine, or ferning) OR leaking amniotic fluid from the cervix
- •Preterm labor with intact membrane, defined as at least 6 uterine contractions in 60 minutes and at least: cervical dilation greater than or equal to 3cm dilated OR 80% effaced OR planned delivery by induction of labor or cesarean in no less than 24 hrs and no more than 7 days, for any indication as deemed necessary by the provider
- •Received at least one dose of corticosteroid within twelve hours of enrollment
排除标准
- •Any prior antenatal corticosteroid course in current pregnancy
- •Systemic corticosteroid administration during current pregnancy
- •Fetal demise or known major fetal anomaly, including cardiac anomaly or hydrops
- •Maternal contraindication to betamethasone: hypersensitivity reaction to any component of the medication, idiopathic thrombocytopenic, purpura, systemic fungal infection, or current use of amphotericin B
- •Diabetes, pregestational or gestational
- •Preexisting plan for intrapartum monitoring of maternal glucose levels for any reason
- •Delivery expected within 12 hours of randomization, because of insufficient time for corticosteroids to confer benefit, including:
- •Ruptured membranes with cervical dilation ≥ 3cm or with more than 6 contractions per hour unless Pitocin is deferred for at least 12 hours
- •Chorioamnionitis
- •Cervical dilation ≥ 8cm
- •Evidence of non-reassuring fetal status requiring immediate delivery
- •To ensure that there is an adequate proportion of women presenting at 34 to 35 weeks gestation, enrollment will be restricted so that no more than 50% of the women in the trial present at 36 weeks.
结局指标
主要结局
Neonatal Hypoglycemia
时间窗: 48 hours
Newborn glucose level less than 40mg/dL
次要结局
未报告次要终点
研究者
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