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Clinical Trials/NCT05535660
NCT05535660
Completed
Not Applicable

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

Icahn School of Medicine at Mount Sinai1 site in 1 country111 target enrollmentJuly 29, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hyperlipidemia
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
111
Locations
1
Primary Endpoint
Neonatal birthweight
Status
Completed
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 29, 2022
End Date
August 5, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Samsiya Ona

Assistant Professor

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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
  • Prenatal care or delivery outside of Mount Sinai Health System

Outcomes

Primary Outcomes

Neonatal birthweight

Time Frame: at birth, day 1

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

Secondary Outcomes

  • Total Cholesterol(at 36 weeks gestation)
  • Triglycerides(at 36 weeks gestation)
  • Total Cholesterol/HDL Ratio(at 36 weeks gestation)
  • Very-low-density Lipoprotein Cholesterol (VLDL)(at 36 weeks gestation)
  • Number of participants with preeclampsia(at birth, day 1)
  • Number of participants with gestational diabetes(at birth, day 1)
  • High-Density Lipoprotein Cholesterol (HDL)(at 36 weeks gestation)
  • Low-Density Lipoprotein Cholesterol (LDL)(at 36 weeks gestation)

Study Sites (1)

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