An observational study in Gestational Diabetes Mellitus in Pregnancy, Macrosomia, Fetal and Dystocia, Shoulder, sponsored by Western Galilee Hospital-Nahariya. Status unknown at 1 site in Israel. Open to female participants. Per ClinicalTrials.gov, last updated 2022-08-22.
Sponsored by Western Galilee Hospital-Nahariya · Observational
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.
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:
Exclusion criteria:
Research objectives:
Primary endpoints:
The percentage of obese women with late GDM diagnosis will be divided into two groups according to BMI:
Secondary endpoints:
Research procedure, interpretation of results, and patient follow-up:
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).
32 studies on the registry are indexed under Fetal Macrosomia; 6 are open to participants now.
This study's planned enrollment of 150 is below the median of 239 across 17 observational studies indexed under Fetal Macrosomia.
Browse Fetal Macrosomia studies →Western Galilee Hospital-Nahariya is the lead sponsor of 89 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Singleton pregnant women with normal OGTT at 24-28 weeks of gestation and BMI \>30 kg/m2
Diagnostic Test: oral glucose tolerance test (OGTT)
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.
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
Time frame: through study completion, an average of 1 year
neonatal macrosomia rate
Time frame: From admission to discharge, up to 1 week
neonatal hypoglycemia rate
Time frame: From neonatal admission to discharge, up to 1 week
neonatal hospitalization in intensive care rate
Time frame: From neonatal admission to discharge, up to 4 week
Plan to share: Undecided
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Western Galilee Hospital-Nahariya