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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Hyperlipidemia
• Intervention / Treatment: Diagnostic test: Lipid panel

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.

• Study Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai OBGYN Faculty Practice Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Pregnant individuals without preexisting hyperlipidemia

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LGA neonates; Researchers will compare lipid levels in large for gestational age (LGA) and non-LGA neonates.	Diagnostic test: Lipid panel; fasting blood draw to examine concentrations of lipids in maternal blood during pregnancy
non-LGA neonates; Researchers will compare lipid levels in large for gestational age (LGA) and non-LGA neonates.	Diagnostic test: Lipid panel; fasting blood draw to examine concentrations of lipids in maternal blood during pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal birthweight	Neonatal birthweight will be classified as large for gestational age (LGA) or non-LGA	at birth, day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with preeclampsia		at birth, day 1
Number of participants with gestational diabetes		at birth, day 1
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.	at 24-28 weeks gestation
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.	at 36 weeks gestation
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	at 24-28 weeks gestation
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	at 36 weeks gestation
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.	at 24-28 weeks gestation
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.	at 36 weeks gestation
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.	at 24-26 weeks gestation
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.	at 36 weeks gestation
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.	at 24-26 weeks gestation
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.	at 36 weeks gestation
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.	at 24-26 weeks gestation
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.	at 36 weeks gestation

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Samsiya Ona, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2022
• Primary Completion (Actual): August 5, 2024
• Study Completion (Actual): August 5, 2024

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Hyperlipidemias
• Other Study ID Numbers: STUDY-21-01936-MOD002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No