Randomization of Early Versus Standard Diabetes Screening Among Obese Pregnant Women
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Large for gestational age or macrosomia
研究概览
简要总结
This will be a randomization of two groups of obese pregnant women into early screening for diabetes mellitus at the time of their first or subsequent prenatal visits before 20 weeks of gestation versus standard time of screening for diabetes at 24 - 28 weeks as it is done for all pregnant women. The perinatal outcomes between the two groups will be compared to determine whether early screening for diabetes in all obese pregnant women has a clinical merit or significant.
详细描述
As part of normal physiological changes of pregnancy, there is increased insulin resistance, which causes dysregulation of maternal glucose homeostasis. Obesity, which is body mass index greater or equal to 30 kg/m2, is also associated with impaired glucose metabolism. Women with higher body mass index (BMI) usually have higher risk of developing gestational diabetes mellitus (GDM) than normal BMI women. The American Congress of Obstetricians and Gynecologists (ACOG) recommends early screening for gestational diabetes mellitus in certain categories of patients with higher risk factors which includes previous medical history of gestational diabetes mellitus, known impaired glucose metabolism and obesity.
However, there is poor compliance by many clinicians of this ACOG recommendation.. One of the reasons for the poor compliance is that it was based on expert opinion and consensus which is level III evidence. There has not been any robust study to determine the clinical importance of screening obese women early versus screening them at the same time like every pregnant women at 24 - 28 weeks.
The justifications for recommendation for early diabetes screening are:
- It will help diagnose pre-existing type 2 DM unrecognized prior to pregnancy. Uncontrolled pre-gestational type 2 DM in the first trimester has been shown to have the same maternal and perinatal adverse effects as type 1 DM.
- It will help detect women with impaired glucose metabolism, in which early interventions may prevent the development of GDM later on in pregnancy and its associated complications.
- Treatment of type 2 diabetes in the first trimester will minimize adverse maternal and perinatal outcomes such as congenital malformation, hypertension or preeclampsia often associated with poorly controlled diabetes.
However, there is currently no strong evidence to support that early GDM screening in obese pregnant women is cost effective or is beneficial in reducing maternal and perinatal adverse outcomes despites its recommendation by many professional societies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Obese pregnant women with BMI > 30 kg/m2
- •First prenatal visit or subsequent visit prior to 20 weeks of gestation
- •Maternal age > 18 years
- •Willingness to participate in the study and give informed consent
排除标准
- •Pre-existing DM or pre-gestational diabetes mellitus,
- •Gestational age more than 20 weeks at time of enrollment
- •Unknown or inability to determine gestational age even with last menstrual period
- •Previous medical history of gestational diabetes mellitus.
- •Known impaired glucose metabolism
- •HbA1C > 6.5 %
研究组 & 干预措施
Screening for diabetes with 1-hour GCT and HbA1
Participants in this group will do 1-hour GCT before 20 weeks of gestation. Those with positive test will undergo 3-hours OGTT. Diabetes will be diagnosed if they have two or more abnormal values out of the 4 values and they will be treated accordingly based on the institutional protocol. They will also have HbA1C done.
干预措施: Screening for diabetes with 1-hour GCT and HbA1 (Drug)
Early screening with only HbA1C
Participants in this group will only have HbA1C done before 20 weeks but will do the standard diabetes screening at 24 - 28 weeks. Those who have abnormal values will also be treated based on the institutional protocol.
干预措施: Screening for diabetes with 1-hour GCT and HbA1 (Drug)
结局指标
主要结局
Large for gestational age or macrosomia
时间窗: To be assessed within 2 days after delivery.
Birth weight of newborn more than 90 percentile or birth weight of 4000gm or more will be assessed at the completion of that pregnancy.
次要结局
- Maternal medical complications(For 6 months during antepartum and 6 weeks postpartum.)
- Birth injuries(To be assessed within 2 days of delivery.)
- Mode of delivery(To be assessed within 2 days of delivery.)
- Glycemic control(To be assessed during pregnancy and 6 weeks postpartum.)
研究者
Mary Stephenson
Professor of Obstetrics and Gynecology
University of Illinois at Chicago