Clinical trial NCT05535660: Lipid Profile as Predictor of Adverse Maternal and Neonatal Outcomes: A Pilot Study
Official title: Lipid Profiles as Predictor of Adverse Maternal and Neonatal Outcomes: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlipidemia
Pregnancy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant individuals without preexisting hyperlipidemia

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.

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 5. Prenatal care or delivery outside of Mount Sinai Health System

Primary outcomes:
measure: Neonatal birthweight
timeFrame: at birth, day 1
Secondary outcomes:
measure: Number of participants with preeclampsia
timeFrame: at birth, day 1
measure: Number of participants with gestational diabetes
timeFrame: at birth, day 1
measure: Total Cholesterol
timeFrame: at 24-28 weeks gestation
measure: Total Cholesterol
timeFrame: at 36 weeks gestation
measure: High-Density Lipoprotein Cholesterol (HDL)
timeFrame: at 24-28 weeks gestation
measure: High-Density Lipoprotein Cholesterol (HDL)
timeFrame: at 36 weeks gestation
measure: Triglycerides
timeFrame: at 24-28 weeks gestation
measure: Triglycerides
timeFrame: at 36 weeks gestation
measure: Low-Density Lipoprotein Cholesterol (LDL)
timeFrame: at 24-26 weeks gestation
measure: Low-Density Lipoprotein Cholesterol (LDL)
timeFrame: at 36 weeks gestation
measure: Very-low-density Lipoprotein Cholesterol (VLDL)
timeFrame: at 24-26 weeks gestation
measure: Very-low-density Lipoprotein Cholesterol (VLDL)
timeFrame: at 36 weeks gestation
measure: Total Cholesterol/HDL Ratio
timeFrame: at 24-26 weeks gestation
measure: Total Cholesterol/HDL Ratio
timeFrame: at 36 weeks gestation
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai OBGYN Faculty Practice Associates
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Samsiya Ona, MD
role: PRINCIPAL_INVESTIGATOR
References: