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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05535660
• Other study ID #: STUDY-21-01936-MOD002
• Status: Active, not recruiting
• Start date: July 29, 2022
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Pregnancy

Locations

Country	Name	City	State
United States	Mount Sinai OBGYN Faculty Practice Associates	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal birthweight	Neonatal birthweight will be classified as large for gestational age (LGA) or non-LGA	at birth, day 1
Secondary	Number of participants with preeclampsia		at birth, day 1
Secondary	Number of participants with gestational diabetes		at birth, day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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