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NCT Number: NCT06463990

Influence of TyG Index and TG/HDL-C Ratio on Fetal Macrosomia

Metabolic disorders that can occur during pregnancy, in particular disorders of lipid metabolism and insulin resistance, can have a detrimental effect on pregnancy and the fetus.

The triglyceride level and other lipids increase slightly during pregnancy. This increase has a positive effect on the development of the fetus. However, an excessive increase in lipid levels can cause some metabolic disorders such as gestational diabetes and increase feto-maternal morbidity/mortality.

While some existing studies have shown that elevated triglyceride levels can cause fetal macrosomia, others have found no correlation between these two variables. The ratio of triglycerides to HDL is a widely used marker for lipid disorders. In addition, the triglyceride-glucose index is also an index used to detect insulin resistance.

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Key information

Conditions

Fetal Macrosomatia Birth Weight Body Weight Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Complications Diabetes Mellitus Diabetes, Gestational Dyslipidemias Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Macrosomia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy in Diabetics Signs and Symptoms Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

About this study

In this study, the investigators aimed to investigate whether the ratio of triglycerides to high-density lipoprotein cholesterol and the triglyceride glucose index are associated with fetal macrosomia in low-risk nulliparous pregnant women.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Screening for fetal macrosomia was based on the term defined according to the standards of the American College of Obstetricians and Gynecologists (ACOG).
  • Low-risk nulliparous singleton pregnant women.
  • Age between 18 and 40 years old

Exclusion criteria

  • Post-term pregnancies
  • Hospitalized for preterm labor or preterm premature rupture of membranes.
  • Gestational diabetes mellitus, diabetes mellitus type I - type II.
  • Pregnant women with fetal growth restriction, hypertensive pregnancy disorders, familial hypercholesterolemia and hyperlipidemia.
  • Multiparous pregnant women
  • Multiple pregnancies
  • Pregnant women with chronic diseases.
  • Pregnant women with impaired liver function;
  • Pregnant women with body mass index <25 and >40 kg/m2.

Treatment and study plan

TyG index

Other

association between TyG index and triglyceride to high-density lipoprotein cholesterol ratio with fetal macrosomia

Other names: Triglyceride to high-density lipoprotein cholesterol ratio

Primary outcomes

  1. The TyG index

    Time frame: between 28 and 40 weeks of pregnancy

    The triglyceride-glucose index was determined using the formula Ln [fasting triglycerides (mg/dL) × fasting plasma glucose (mg (dL)/2], with blood samples taken from pregnant women in the third trimester.

  2. The triglyceride to high density lipoprotein cholesterol ratio

    Time frame: between 28 and 40 weeks of pregnancy

    The triglyceride to high density lipoprotein cholesterol ratio was calculated from the blood samples taken from pregnant women in the third trimester.

Secondary outcomes

  1. HOMA-IR

    Time frame: between 28 and 40 weeks of pregnancy

    HOMA-IR was calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5 with blood samples taken from pregnant women in the third trimester.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

Association Between the Triglyceride-glucose Index and the Ratio of Triglyceride to High-density Lipoprotein Cholesterol With Fetal Macrosomia in Low-risk Nulliparous Pregnant Women

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2024
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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