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Completed

NCT Number: NCT05535660

Lipid Profile as Predictor of Adverse Maternal and Neonatal Outcomes: A Pilot Study

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.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Mount Sinai OBGYN Faculty Practice Associates

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Lipid panel

Diagnostic Test

fasting blood draw to examine concentrations of lipids in maternal blood during pregnancy

Primary outcomes

  1. Neonatal birthweight

    Time frame: at birth, day 1

    Neonatal birthweight will be classified as large for gestational age (LGA) or non-LGA

Secondary outcomes

  1. Number of participants with preeclampsia

    Time frame: at birth, day 1

  2. Number of participants with gestational diabetes

    Time frame: at birth, day 1

  3. Total Cholesterol

    Time frame: at 24-28 weeks gestation

    Total Cholesterol obtained while fasting at 24-28 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.

  4. Total Cholesterol

    Time frame: 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.

  5. High-Density Lipoprotein Cholesterol (HDL)

    Time frame: at 24-28 weeks gestation

    High-Density Lipoprotein Cholesterol (HDL) obtained while fasting at 24-28 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

  6. High-Density Lipoprotein Cholesterol (HDL)

    Time frame: 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

  7. Triglycerides

    Time frame: at 24-28 weeks gestation

    Triglycerides obtained while fasting at 24-28 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.

  8. Triglycerides

    Time frame: 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.

  9. Low-Density Lipoprotein Cholesterol (LDL)

    Time frame: at 24-26 weeks gestation

    Low-Density Lipoprotein Cholesterol (LDL) obtained while fasting at 24-28 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.

  10. Low-Density Lipoprotein Cholesterol (LDL)

    Time frame: 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.

  11. Very-low-density Lipoprotein Cholesterol (VLDL)

    Time frame: at 24-26 weeks gestation

    Very-low-density Lipoprotein Cholesterol (VLDL) obtained while fasting at 24-28 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.

  12. Very-low-density Lipoprotein Cholesterol (VLDL)

    Time frame: 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.

  13. Total Cholesterol/HDL Ratio

    Time frame: at 24-26 weeks gestation

    Total Cholesterol/HDL Ratio obtained while fasting at 24-28 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.

  14. Total Cholesterol/HDL Ratio

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Lipid Profiles as Predictor of Adverse Maternal and Neonatal Outcomes: A Pilot Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 10, 2022
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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