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.
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
- Are there results?
- None posted in the registry
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
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.
- Conditions
- Hyperlipidemia, Pregnancy
- 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 group | Role | What they receive |
|---|---|---|
| LGA neonates | Researchers will compare lipid levels in large for gestational age (LGA) and non-LGA neonates. Receives: Diagnostic Test: Lipid panel | |
| non-LGA neonates | Researchers 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.
Neonatal birthweight
Neonatal birthweight will be classified as large for gestational age (LGA) or non-LGA
Measured: at birth, day 1
Secondary outcomes (14)
Number of participants with preeclampsia
Measured: at birth, day 1
Number of participants with gestational diabetes
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
- First posted10 Sep 2022
- Study start29 Jul 2022
- Primary completion5 Aug 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samsiya Ona, Icahn School of Medicine at Mount Sinai
- Investigators
- Samsiya Ona, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid Profiles as Predictor of Adverse Maternal and Neonatal Outcomes: A Pilot Study
- ClinicalTrials.gov ID
- NCT05535660
- Acronym / sponsor ID
- STUDY-21-01936-MOD002
- Conditions
- Hyperlipidemia, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LGA neonates | – | Diagnostic Test: Lipid panelResearchers will compare lipid levels in large for gestational age (LGA) and non-LGA neonates. |
| non-LGA neonates | – | Diagnostic Test: Lipid panelResearchers will compare lipid levels in large for gestational age (LGA) and non-LGA neonates. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant individuals without preexisting hyperlipidemia
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipid panelfasting blood draw to examine concentrations of lipids in maternal blood during pregnancy | Diagnostic test | LGA neonates, non-LGA neonates |
Primary outcome
Neonatal birthweight
Time frame: at birth, day 1
Neonatal birthweight will be classified as large for gestational age (LGA) or non-LGA
14 secondary outcomes
Number of participants with preeclampsia
Time frame: at birth, day 1
Number of participants with gestational diabetes
Time frame: at birth, day 1
Total Cholesterol
Time frame: at 24-28 weeks gestation
Total Cholesterol
Time frame: at 36 weeks gestation
High-Density Lipoprotein Cholesterol (HDL)
Time frame: at 24-28 weeks gestation
High-Density Lipoprotein Cholesterol (HDL)
Time frame: at 36 weeks gestation
Triglycerides
Time frame: at 24-28 weeks gestation
Triglycerides
Time frame: at 36 weeks gestation
Low-Density Lipoprotein Cholesterol (LDL)
Time frame: at 24-26 weeks gestation
Low-Density Lipoprotein Cholesterol (LDL)
Time frame: at 36 weeks gestation
Very-low-density Lipoprotein Cholesterol (VLDL)
Time frame: at 24-26 weeks gestation
Very-low-density Lipoprotein Cholesterol (VLDL)
Time frame: at 36 weeks gestation
Total Cholesterol/HDL Ratio
Time frame: at 24-26 weeks gestation
Total Cholesterol/HDL Ratio
Time frame: at 36 weeks gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No. This is a pilot study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samsiya Ona, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipidemia and Pregnancy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal birthweight (time frame: at birth, day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.