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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-29

Study Completion Date

2024-08-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lipid Metabolism in Gestational Diabetes

NCT00534105

Gestational Diabetes Hyperlipidemia

COMPLETED

Regulation Of Maternal Fuel Supply And Neonatal Adiposity

NCT00826904

Fetal Macrosomia Gestational Diabetes

COMPLETED

The Early and Late Contribution of Fasting and Postprandial Triglycerides on Newborn Subcutaneous and Intrahepatic Fat in Pregnancy

NCT04394806

Pregnancy

RECRUITING

Maternal Lipids and Offspring Adiposity at 5-7 Years

NCT03317522

Adiposity

COMPLETED

Cholesterol and CYP3A4/5 Metabolism Across Pregnancy and Postpartum

NCT05504889

Pregnancy Related

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperlipidemia Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LGA neonates

Researchers will compare lipid levels in large for gestational age (LGA) and non-LGA neonates.

Lipid panel

Intervention Type DIAGNOSTIC_TEST

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.

Lipid panel

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lipid panel

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes