Late Gestational Diabetes Mellitus Diagnosis in Obese Women

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Polycythemia; Obesity, Morbid; Gestational Diabetes Mellitus in Pregnancy; Neonatal Jaundice; Macrosomia, Fetal; Hypoglycemia Neonatal; Dystocia, Shoulder
• Intervention / Treatment: Diagnostic test: oral glucose tolerance test (OGTT)

Detailed Description

Methods

Study design:

A prospective study that will evaluate the rate of diagnosis of late GDM and clinical effect of performing a repeat OGTT beyond week 32 in women with obesity (BMI >30 kg/m2) and morbid obesity (BMI >35 kg/m2) for whom loading sugar was normal in the second trimester. The study will be carried out in the Mother and Fetus Unit at the Galilee Medical Center in Nahariya, Israel.

Study population:

Target 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.

Inclusion criteria:

1. Women with normal OGTT at weeks 24-28
2. Women with BMI >30 kg/m2

Exclusion criteria:

1. Twins
2. Fetal abnormalities
3. Women who received steroids within the preceding week We will invite women who meet the enrollment criteria to participate in the study, and perform an OGTT.

Research objectives:

1. Primary endpoints:

   The percentage of obese women with late GDM diagnosis will be divided into two groups according to BMI:

   • BMI 30-35 kg/m2
   • BMI >35 kg/m2

2. Secondary endpoints:

   • Differences in the following obstetric outcomes between women diagnosed or not diagnosed with GDM: percentage of macrosomia, delivery method, shoulder dystocia, grade 3-4 tear
   • Differences in the following newborn outcomes between women diagnosed or not diagnosed with GDM: hypoglycemia, jaundice, need for phototherapy, polycythemia, hospitalization in neonatal intensive care, Apgar score, and newborn pH

Research procedure, interpretation of results, and patient follow-up:

• 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.
• Interpretation of the OGTT result is performed according to Carpenter-Coustan criteria [6]
• Women who are not diagnosed with GDM will be discharged for continued follow-up for regular prenatal care and the reason for her hospitalization.
• Per standard of care (regardless of research involvement) women diagnosed with GDM will receive counseling by a dietitian and other key department staff and undergo a complete glucose curve (seven tests per day: fasting, before each of three meals, and two hours after each meal).
• If more than 30% of glucose tests are abnormal, the patient will receive standard drug treatment.
• Follow-up is usually performed for 1-2 days in the hospital ward, after which women are discharged to ambulatory follow-up at the Mother and Fetus Clinic of the medical center.

Statistical analysis:

The sample size was calculated using the chi square formula for comparing two groups.

In a previous study in which repeat OGTT was performed beyond week 32 after initially normal results at week 24-28, the diagnosis rate of GDM for the total sample was 10%. An effect size of 20% was considered significant between obese and morbidly obese women with alpha=0.05, power 80%. The calculated sample size was 124 (at least 62 obese and 62 morbidly obese women).

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Maya Wolf, MD; Phone Number: +972-2-9107186; Email: MayaW@gmc.gov.il
• Study Contact Backup: Name: Osnat Sharon, CRC; Phone Number: +972-52-3980209; Email: OsnatS2@gmc.gov.il

Study Locations

• Israel
  • Nahariyya, Israel
    • Galil Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

1. Women with normal OGTT at weeks 24-28
2. Women with BMI >30 kg/m2

Exclusion Criteria:

1. Multiple pregnancy
2. Fetal defects
3. Women who received steroids within the preceding week

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); • 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 >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); • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya

Publications and helpful links

General Publications

• 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.
• 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.
• 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. 2022 Mar 28. doi: 10.1007/s00404-022-06520-5. Online ahead of print.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): February 1, 2025

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (ACTUAL): August 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: gestational diabetes mellitus; maternal obesity; fetal macrosomia; shoulder dystocia; maternal morbid obesity
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hematologic Diseases; Infant, Newborn, Diseases; Diabetes Complications; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Fetal Diseases; Pregnancy Complications; Obstetric Labor Complications; Skin Manifestations; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Birth Weight; Diabetes Mellitus; Obesity; Hypoglycemia; Obesity, Morbid; Dystocia; Diabetes, Gestational; Pregnancy in Diabetics; Polycythemia; Jaundice; Shoulder Dystocia; Jaundice, Neonatal; Fetal Macrosomia
• Other Study ID Numbers: 0115-22-NHR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No