Late Gestational Diabetes Mellitus Diagnosis in Obese Women

NCT05510518 | Unknown

• 1 other identifier: 0115-22-NHR
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

In the current work, we aim to perform a prospective study that will investigate the relationship between maternal obesity (BMI \>30 kg/m2) and morbid obesity (BMI \>35 kg/m2) with a late GDM diagnosis (\>32 weeks), with an emphasis on obstetric and neonatal outcomes.

Conditions

Gestational Diabetes Mellitus in Pregnancy; Macrosomia, Fetal; Dystocia, Shoulder; Neonatal Jaundice; Polycythemia; Hypoglycemia Neonatal; Obesity; Obesity, Morbid

Keywords

gestational diabetes mellitus; fetal macrosomia; shoulder dystocia; maternal obesity; maternal morbid obesity

Outcome Measures

Primary Outcomes (1)

• Number of obese women that will be diagnosed with late GDM diagnosis by the OGTT

  The percentage of obese women with late GDM diagnosis will be analyzed per BMI group: * BMI 30-35 kg/m2 * BMI \>35 kg/m2

  through study completion, an average of 1 year

Secondary Outcomes (3)

• neonatal macrosomia rate

  From admission to discharge, up to 1 week

• neonatal hypoglycemia rate

  From neonatal admission to discharge, up to 1 week

• neonatal hospitalization in intensive care rate

  From neonatal admission to discharge, up to 4 week

Study Arms (2)

BMI >30 kg/m2

Singleton pregnant women with normal OGTT at 24-28 weeks of gestation and BMI \>30 kg/m2

Diagnostic Test: oral glucose tolerance test (OGTT)

BMI >35 kg/m2

Singleton pregnant women with normal OGTT at 24-28 weeks of gestation and BMI \>35 kg/m2

Diagnostic Test: oral glucose tolerance test (OGTT)

Interventions

oral glucose tolerance test (OGTT) DIAGNOSTIC_TEST

• The OGTT involves assessing fasting blood glucose, drinking a solution comprising 100 g of glucose, and three glucose tests at one, two, and three hours following glucose load.

BMI >30 kg/m2; BMI >35 kg/m2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women hospitalized in the Mother and Fetus Unit for various reasons, e.g., premature labor, amniotic fluid leakage, reduced fetal movements, following a car accident, etc.

You may qualify if:

• Women with normal OGTT at weeks 24-28
• Women with BMI \>30 kg/m2

You may not qualify if:

• Multiple pregnancy
• Fetal defects
• Women who received steroids within the preceding week

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Galil Medical Center

Nahariya, Israel

Location

Related Publications (7)

• Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. NCHS Data Brief. 2020 Feb;(360):1-8.

  PMID: 32487284 BACKGROUND

• Arabin B, Stupin JH. Overweight and Obesity before, during and after Pregnancy: Part 2: Evidence-based Risk Factors and Interventions. Geburtshilfe Frauenheilkd. 2014 Jul;74(7):646-655. doi: 10.1055/s-0034-1368462.

  PMID: 25100879 BACKGROUND

• Abu Shqara R, Or S, Wiener Y, Lowenstein L, Frank Wolf M. Clinical implications of the 100-g oral glucose tolerance test in the third trimester. Arch Gynecol Obstet. 2023 Feb;307(2):421-429. doi: 10.1007/s00404-022-06520-5. Epub 2022 Mar 28.

  PMID: 35344083 BACKGROUND

• Zilberberg E, Mazaki S, Zilberman N, Mazkereth R, Weisz B, Sivan E, et al. Should late third trimester oral glucose tolerance test be offered for patients with suspected macrosomia or polyhydramnios? Evidence in support of the clinical importance of this policy. Am J Obstet Gynecol. 2012;206(1):S122.

  BACKGROUND

• Kandauda C, Wanasinghe W. Repeat OGTT at 34 - 36 weeks to detect the late occurrence of GDM: A descriptive cross-sectional study conducted at the professorial unit, teaching hospital Peradeniya, Sri Lanka. Adv Reproduct Sci. 2020;8:157-65.

  BACKGROUND

• Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982 Dec 1;144(7):768-73. doi: 10.1016/0002-9378(82)90349-0.

  PMID: 7148898 BACKGROUND

• Harrison RK, Cruz M, Wong A, Davitt C, Palatnik A. The timing of initiation of pharmacotherapy for women with gestational diabetes mellitus. BMC Pregnancy Childbirth. 2020 Dec 11;20(1):773. doi: 10.1186/s12884-020-03449-y.

  PMID: 33308193 BACKGROUND

MeSH Terms

Conditions

Fetal Macrosomia; Shoulder Dystocia; Jaundice, Neonatal; Polycythemia; Obesity; Obesity, Morbid; Diabetes, Gestational; Pregnancy in Obesity

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Pregnancy in Diabetics; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Birth Weight; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dystocia; Obstetric Labor Complications; Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Hyperbilirubinemia; Pathologic Processes; Hematologic Diseases; Hemic and Lymphatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Central Study Contacts

Maya Wolf, MD

CONTACT

+972-2-9107186; MayaW@gmc.gov.il

Osnat Sharon, CRC

CONTACT

+972-52-3980209; OsnatS2@gmc.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Maternal and Fetal Medicine Unit

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 22, 2022
• Study Start: August 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

IL (1)