Late Gestational Diabetes Mellitus Diagnosis in Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of obese women that will be diagnosed with late GDM diagnosis by the OGTT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with normal OGTT at weeks 24-28
- •Women with BMI >30 kg/m2
排除标准
- •Multiple pregnancy
- •Fetal defects
- •Women who received steroids within the preceding week
结局指标
主要结局
Number of obese women that will be diagnosed with late GDM diagnosis by the OGTT
时间窗: through study completion, an average of 1 year
The percentage of obese women with late GDM diagnosis will be analyzed per BMI group: * BMI 30-35 kg/m2 * BMI \>35 kg/m2
次要结局
- 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)
研究者
Dr. Maya Wolf
Director of the Maternal and Fetal Medicine Unit
Western Galilee Hospital-Nahariya