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

NCT05535660 | Completed

• 1 other identifier: STUDY-21-01936-MOD002
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperlipidemia; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Neonatal birthweight

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

  at birth, day 1

Secondary Outcomes (14)

• Number of participants with preeclampsia

  at birth, day 1

• Number of participants with gestational diabetes

  at birth, day 1

• Total Cholesterol

  at 24-28 weeks gestation

• Total Cholesterol

  at 36 weeks gestation

• High-Density Lipoprotein Cholesterol (HDL)

  at 24-28 weeks gestation

Study Arms (2)

LGA neonates

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

Diagnostic Test: Lipid panel

non-LGA neonates

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

Diagnostic Test: Lipid panel

Interventions

Lipid panel DIAGNOSTIC_TEST

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

LGA neonates; non-LGA neonates

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant individuals without preexisting hyperlipidemia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai OBGYN Faculty Practice Associates

New York, New York, 10029, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Samsiya Ona, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: September 10, 2022
• Study Start: July 29, 2022
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)