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HyperlipidemiaNCT05535660

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

An observational study of Hyperlipidemia and Pregnancy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Hyperlipidemia, Pregnancy
What is being tested?
Lipid panel
How many people
111 participants
Where
1 siteUnited States
Study dates
29 Jul 2022to 5 Aug 2024
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Pregnant individuals without preexisting hyperlipidemia

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mount Sinai OBGYN Faculty Practice Associates

    New York, New York, 10029

Other trials in United States

About this study

Official title: Lipid Profiles 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.

Read the 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.

Being tested
Lipid panel
Medical subject headings
Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lipid panelDiagnostic test

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

Study groups in NCT05535660
Study groupRoleWhat they receive
LGA neonatesResearchers will compare lipid levels in large for gestational age (LGA) and non-LGA neonates.
Receives: Diagnostic Test: Lipid panel
non-LGA neonatesResearchers will compare lipid levels in large for gestational age (LGA) and non-LGA neonates.
Receives: Diagnostic Test: Lipid panel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neonatal birthweight

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

    Measured: at birth, day 1

Secondary outcomes (14)

  1. Number of participants with preeclampsia

    Measured: at birth, day 1

  2. Number of participants with gestational diabetes

    Measured: at birth, day 1

  3. Total Cholesterol

    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.

    Measured: at 24-28 weeks gestation

  4. Total Cholesterol

    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.

    Measured: at 36 weeks gestation

  5. High-Density Lipoprotein Cholesterol (HDL)

    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

    Measured: at 24-28 weeks gestation

  6. High-Density Lipoprotein Cholesterol (HDL)

    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

    Measured: at 36 weeks gestation

  7. Triglycerides

    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.

    Measured: at 24-28 weeks gestation

  8. Triglycerides

    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.

    Measured: at 36 weeks gestation

  9. Low-Density Lipoprotein Cholesterol (LDL)

    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.

    Measured: at 24-26 weeks gestation

  10. Low-Density Lipoprotein Cholesterol (LDL)

    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.

    Measured: at 36 weeks gestation

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

    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.

    Measured: at 24-26 weeks gestation

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

    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.

    Measured: at 36 weeks gestation

  13. Total Cholesterol/HDL Ratio

    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.

    Measured: at 24-26 weeks gestation

  14. Total Cholesterol/HDL Ratio

    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.

    Measured: at 36 weeks gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2022
  2. Study start29 Jul 2022
  3. Primary completion5 Aug 2024
  4. Study completion5 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05535660
Sponsor's protocol ID
STUDY-21-01936-MOD002
Status last verified
Nov 2024
First submitted
19 Aug 2022
Last updated
7 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This is a pilot study.

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