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

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Mount Sinai Health System

Status

Completed

Conditions

Hyperlipidemia
Pregnancy

Treatments

Diagnostic Test: Lipid panel

Study type

Observational

Funder types

Other

Identifiers

NCT05535660
STUDY-21-01936-MOD002

Details and patient eligibility

About

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.

Full 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.

Enrollment

111 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

111 participants in 2 patient groups

LGA neonates
Description:
Researchers will compare lipid levels in large for gestational age (LGA) and non-LGA neonates.
Treatment:
Diagnostic Test: Lipid panel
non-LGA neonates
Description:
Researchers will compare lipid levels in large for gestational age (LGA) and non-LGA neonates.
Treatment:
Diagnostic Test: Lipid panel

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Nico Tavella

Data sourced from clinicaltrials.gov

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