Lipid Profiles as Predictor of Adverse Maternal and Neonatal Outcomes: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Neonatal birthweight
研究概览
简要总结
The purpose of this study is to ascertain lipid profiles during pregnancy, specifically during the 24-28 week gestation and again near term at 36 weeks gestation. The research team are investigating whether lipid profiles can predict adverse maternal and neonatal outcomes.
详细描述
The purpose of this research is to investigate whether lipids profiles during pregnancy impact LGA and other adverse outcomes in pregnancy. Participants will have blood drawn twice; the first blood work is a fasting blood draw (separate blood draw) on the same day but preceding the standard glucose test. The second blood draw is drawn at the time of routine clinical care (third trimester blood work).
Patients will be approached at the time of the anatomy ultrasound for participation. If they consent to participate they will have a FASTING lipid panel drawn at the time of their 24-28w GCT and again at the time of their 36w third trimester labs. Patients will receive a reminder call prior to scheduled 24-28 week appointment for fasting instructions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy
- •Ages 18-45
- •Presentation to prenatal care by the 2nd trimester
- •Prenatal care at Mount Sinai Hospital
- •Anticipated delivery at Mount Sinai Hospital
排除标准
- •Multiple gestations
- •Preexisting hyperlipidemia
- •Preexisting diabetes
- •Delayed presentation to prenatal care after the 2nd trimester
- •Prenatal care or delivery outside of Mount Sinai Health System
结局指标
主要结局
Neonatal birthweight
时间窗: at birth, day 1
Neonatal birthweight will be classified as large for gestational age (LGA) or non-LGA
次要结局
- Total Cholesterol(at 36 weeks gestation)
- Triglycerides(at 36 weeks gestation)
- Total Cholesterol/HDL Ratio(at 36 weeks gestation)
- Very-low-density Lipoprotein Cholesterol (VLDL)(at 36 weeks gestation)
- Number of participants with preeclampsia(at birth, day 1)
- Number of participants with gestational diabetes(at birth, day 1)
- High-Density Lipoprotein Cholesterol (HDL)(at 36 weeks gestation)
- Low-Density Lipoprotein Cholesterol (LDL)(at 36 weeks gestation)
研究者
Samsiya Ona
Assistant Professor
Icahn School of Medicine at Mount Sinai