Fetal Metabolic Consequences of Late Preterm Steroid Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Umbilical Cord Blood C-peptide
研究概览
简要总结
Annually in the U.S 300,000 neonates are born late preterm, defined as 34 weeks 0 days - 36 weeks 6 days. The Antenatal Late Preterm Steroids (ALPS) Trial demonstrated that maternal treatment with betamethasone in the late preterm period significantly reduces neonatal respiratory complications, but also increases neonatal hypoglycemia, compared to placebo.
This research study will attempt to answer the following primary question: Does a management protocol aimed at maintaining maternal euglycemia after ALPS decrease fetal hyperinsulinemia, compared to usual antepartum care?
详细描述
Euglycemia after Antenatal Late Preterm Steroids, the E-ALPS Study:
There is a fundamental gap in understanding the adverse metabolic effects of antenatal late preterm steroids (ALPS). In 2016, an important randomized clinical trial of 2827 late preterm pregnancies showed that antenatal betamethasone (BMZ) significantly reduced neonatal respiratory complications compared with placebo. However, those neonates exposed to BMZ were also more likely to have hypoglycemia at birth. This unexpected adverse outcome raised concern among both obstetricians and neonatologists and remains an important knowledge gap to be filled. The rationale for the proposed research is that steroid-induced maternal hyperglycemia leads to transient fetal hyperinsulinemia, which causes hypoglycemia in neonates that are delivered during this time-period. Thus, the fetal metabolic consequences and subsequent neonatal hypoglycemia observed after exposure to BMZ in utero can be prevented by achieving maternal euglycemia prior to delivery.
This protocol describes a randomized clinical trial to evaluate whether screening for and treatment of steroid-induced hyperglycemia in non-diabetic women treated with BMZ in the late preterm period can decrease the rate of fetal hyperinsulinemia, thus reducing neonatal hypoglycemia and improving short-term neonatal outcomes.
This study was formerly approved as Institutional Review Board #16-3200.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton gestation with no known major fetal anomalies
- •Gestational age at randomization between 34 weeks 0 days and 36 weeks 5 days
- •Receiving antenatal betamethasone due to high probability of delivery in late preterm period
排除标准
- •Pre-gestational or gestational diabetes mellitus
- •Maternal contraindication to insulin
- •Planned outpatient treatment with antenatal betamethasone
- •Participation in clinical trial that could affect primary outcome or participation in this trial in a previous pregnancy
研究组 & 干预措施
Intervention
Women will undergo regular maternal blood glucose screening and treatment of hyperglycemia following BMZ administration to achieve maternal glycemic control until delivery or hospital discharge, for a maximum of 5 days.
干预措施: Maternal glycemic control (Other)
Usual Care
Routine antenatal care will be performed without any maternal blood glucose screening nor treatment as is usual care at each of the study sites.
结局指标
主要结局
Umbilical Cord Blood C-peptide
时间窗: At delivery
C-peptide level (ng/mL) as measure of fetal hyperinsulinemia
次要结局
- Neonatal Mortality(After birth, during hospital admission, assessed up to 28 days)
- Umbilical Insulin-Like Growth Factor 1(At delivery)
- Neonatal Hypoglycemia(After birth, up to 48 hours of life)
- Maternal Hyperglycemia(For five days after first dose of betamethasone administration)
- Maternal Insulin Treatment(For five days after first dose of betamethasone administration)
- Umbilical Cord Blood Cortisol(At delivery)
- Neonatal Intensive Care Unit Admission(Date of delivery to date of discharge from hospital, assessed up to 28 days)
- Timing of Neonatal Blood Glucose Nadir(After birth, during hospital admission, assessed up to 28 days)
- Neonatal Seizures(After birth, during hospital admission, assessed up to 28 days)
- Maternal Hypoglycemia(For five days after first dose of betamethasone administration)
- Umbilical Cord Blood Leptin(At delivery)
- Neonatal Intensive Care Unit Length of Stay(From neonatal intensive care unit admission to discharge, assessed up to 28 days)
- Neonatal Hypoglycemia Treatment(After birth, during hospital admission, assessed up to 28 days)
- Neonatal Glucose Nadir(After birth, during hospital admission, assessed up to 28 days)