Lipid Profile as Predictor of Adverse Maternal and Neonatal Outcomes: A Pilot Study
- Conditions
- PregnancyHyperlipidemia
- Interventions
- Diagnostic Test: Lipid panel
- Registration Number
- NCT05535660
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 111
- 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
- Multiple gestations
- Preexisting hyperlipidemia
- Preexisting diabetes
- Delayed presentation to prenatal care after the 2nd trimester 5. Prenatal care or delivery outside of Mount Sinai Health System
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description LGA neonates Lipid panel Researchers will compare lipid levels in large for gestational age (LGA) and non-LGA neonates. non-LGA neonates Lipid panel Researchers will compare lipid levels in large for gestational age (LGA) and non-LGA neonates.
- Primary Outcome Measures
Name Time Method Neonatal birthweight at birth, day 1 Neonatal birthweight will be classified as large for gestational age (LGA) or non-LGA
- Secondary Outcome Measures
Name Time Method Total Cholesterol at 36 weeks gestation Total Cholesterol obtained while fasting at 36 weeks gestation. Different blood tests can be done to measure each type of cholesterol. Total cholesterol level measures all types of cholesterol in the blood.
Triglycerides at 36 weeks gestation Triglycerides obtained while fasting at 36 weeks gestation. Triglycerides interact with HDL cholesterol in such a way that HDL levels fall as triglyceride levels rise. High triglyceride levels are also associated with the inflammatory response -- the harmful effect of an overactive immune system that can cause considerable damage to cells and tissues, including the arteries.
Total Cholesterol/HDL Ratio at 36 weeks gestation Total Cholesterol/HDL Ratio obtained while fasting at 36 weeks gestation. The total cholesterol /HDL ratio is the proportion of one type of cholesterol to all the other cholesterol in the blood. Total cholesterol includes three substances HDL, LDL, and VLDL. Higher ratios indicate greater risk of heart coronary heart disease.
Very-low-density Lipoprotein Cholesterol (VLDL) at 36 weeks gestation Very-low-density Lipoprotein Cholesterol (VLDL) obtained while fasting at 36 weeks gestation. VLDL is one of the three main types of lipoproteins. Lipoproteins are made up of cholesterol, triglycerides, and proteins. They move cholesterol, triglycerides, and other lipids (fats) around the body.
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 High-Density Lipoprotein Cholesterol (HDL) obtained while fasting at 36 weeks. HDL helps keep arteries open and reduces the risk for heart attack. High levels of HDL may be nearly as protective for the heart as low levels of LDL
Low-Density Lipoprotein Cholesterol (LDL) at 36 weeks gestation Low-Density Lipoprotein Cholesterol (LDL) obtained while fasting at 36 weeks gestation. Low-density lipoprotein (LDL) transports about 75% of the blood's cholesterol to the body's cells. Heart disease is least likely to occur among people with the lowest LDL levels. Lowering LDL is the primary goal of cholesterol drug and lifestyle therapy.
Trial Locations
- Locations (1)
Mount Sinai OBGYN Faculty Practice Associates
🇺🇸New York, New York, United States