NCT06463990

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2024

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

1.6 years

First QC Date

June 8, 2024

Last Update Submit

August 30, 2024

Conditions

Keywords

Fetal macrosomiaNulliparousTriglycerideTyG index

Outcome Measures

Primary Outcomes (2)

  • The TyG index

    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.

    between 28 and 40 weeks of pregnancy

  • The triglyceride to high density lipoprotein cholesterol ratio

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

    between 28 and 40 weeks of pregnancy

Secondary Outcomes (1)

  • HOMA-IR

    between 28 and 40 weeks of pregnancy

Study Arms (2)

Study group

women with macrosomic newborns

Other: TyG index

Control group

women with non-macrosomic newborns

Other: TyG index

Interventions

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

Also known as: Triglyceride to high-density lipoprotein cholesterol ratio
Control groupStudy group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The singleton pregnant women who delivered a macrosomic newborn were included in the study group (Group I) and the singleton pregnant women who delivered a non-macrosomic fetus were included in the control group (Group II). For each pregnant woman who met the inclusion and exclusion criteria and was eligible for Group I, the first patient in the ranking order of the files who met the criteria previously mentioned in the Materials and Methods section was selected for Group II.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Location

Related Publications (5)

  • Macrosomia: ACOG Practice Bulletin, Number 216. Obstet Gynecol. 2020 Jan;135(1):e18-e35. doi: 10.1097/AOG.0000000000003606.

  • Poveda NE, Garces MF, Darghan AE, Jaimes SAB, Sanchez EP, Diaz-Cruz LA, Garzon-Olivares CD, Parra-Pineda MO, Bautista-Charry AA, Muller EA, Alzate HFS, Acosta LMM, Sanchez E, Ruiz-Parra AI, Caminos JE. Triglycerides/Glucose and Triglyceride/High-Density Lipoprotein Cholesterol Indices in Normal and Preeclamptic Pregnancies: A Longitudinal Study. Int J Endocrinol. 2018 Aug 6;2018:8956404. doi: 10.1155/2018/8956404. eCollection 2018.

  • Babic N, Valjevac A, Zaciragic A, Avdagic N, Zukic S, Hasic S. The Triglyceride/HDL Ratio and Triglyceride Glucose Index as Predictors of Glycemic Control in Patients with Diabetes Mellitus Type 2. Med Arch. 2019 Jun;73(3):163-168. doi: 10.5455/medarh.2019.73.163-168.

  • Barat S, Ghanbarpour A, Bouzari Z, Batebi Z. Triglyceride to HDL cholesterol ratio and risk for gestational diabetes and birth of a large-for-gestational-age newborn. Caspian J Intern Med. 2018 Fall;9(4):368-375. doi: 10.22088/cjim.9.4.368.

  • Firatligil FB, Tuncdemir S, Sucu S, Reis YA, Ozkan S, Dereli ML, Sucu ST, Engin-Ustun Y. Association of the triglyceride-glucose index and the ratio of triglyceride to high-density lipoprotein cholesterol with fetal macrosomia in nulliparous pregnant women: a prospective case-control study. BMC Pregnancy Childbirth. 2025 Feb 17;25(1):175. doi: 10.1186/s12884-025-07317-5.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Singleton nulliparous pregnant women who had performed an oral glucose challenge test (OGCT) between 24 and 28 weeks' gestation with a result of less than 140 mg/dL had blood samples taken at 8:00 am on the first visit to the outpatient clinic in the third trimester after an 8-hour fasting state

MeSH Terms

Conditions

Lipid Metabolism DisordersHyperlipidemiasFetal Macrosomia

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasDiabetes, GestationalPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesPregnancy in DiabeticsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesBirth WeightBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yaprak Engin-Ustun, Prof

    Etlik Zubeyde Hanim Women's Health Education and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist doctor in obstetrics and gynecology and Fellow student in Perinatology

Study Record Dates

First Submitted

June 8, 2024

First Posted

June 18, 2024

Study Start

January 1, 2023

Primary Completion

July 30, 2024

Study Completion

August 25, 2024

Last Updated

September 3, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

Data are available on request only due to ethical, legal or commercial reasons

Shared Documents
ANALYTIC CODE
Time Frame
one or two months

Locations