Clinical trial NCT05510518: Late Gestational Diabetes Mellitus Diagnosis in Obese Women
Official title: Late Gestational Diabetes Mellitus Diagnosis in Obese Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2022-08-22
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of obese women that will be diagnosed with late GDM diagnosis by the OGTT
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: neonatal macrosomia rate
timeFrame: From admission to discharge, up to 1 week
measure: neonatal hypoglycemia rate
timeFrame: From neonatal admission to discharge, up to 1 week
measure: neonatal hospitalization in intensive care rate
timeFrame: From neonatal admission to discharge, up to 4 week
Other outcomes:
Locations:
city: Nahariyya
country: Israel
facility: Galil Medical Center
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.