Pregnancy Outcomes and Medical Costs According to Gestational Diabetes Mellitus Diagnostic Criteria: Randomized Prospective Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,644
- 试验地点
- 2
- 主要终点
- Large for gestational age
研究概览
简要总结
The aim of the study is to evaluate differences in pregnancy outcomes and medical costs depending on gestational diabetes diagnostic criteria used (one vs two-step approach).
详细描述
Due to Hyperglycemia and Adverse Pregnancy Outcomes study results, a new gestational diabetes mellitus (GDM) diagnostic criteria was defined using a one-step approach (75-g oral glucose tolerance test -OGTT-).
However, not all scientific societies have accepted and have implanted this new diagnostic criteria. The lowest glycemia cut-off of this criteria regarding the two-step approach entails an increase in GDM incidence with discordant studies about its cost-effectivity.
It will be assessed if pregnancy outcomes and medical costs are different depending on diagnostic criteria used.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-50 years
- •No expectation that subject will be moving out of the area of the clinical center during the next year
- •Informed Consent Form signed by the subject
排除标准
- •Preexisting type 1 or 2 diabetes
- •Advanced HIV( on medications that cause hyperglycemia), severe liver disease, gastric bypass surgery or other illness/surgeries that preclude them from drinking the glucose solution.
研究组 & 干预措施
One-step:IADPSG Criteria
Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gr oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL.
干预措施: IADPSG Criteria (Diagnostic Test)
Two-step:NDDG Criteria
Step 1: Perform a 1h 50-g glucose load test (nonfasting. If the plasma glucose level measured 1 h after the load is 140 mg/dL, proceed to a 100-g OGTT.
Step 2: 100-g OGTT. The diagnosis of GDM is made if at least two of the following four plasma glucose levels(measured fasting and 1 h, 2 h, 3 h after the OGTT) are met or exceeded: 105mg/dl, 190mg/dl, 165mg/dl and 145mg/dl respectively
干预措施: NDDG Criteria (Diagnostic Test)
结局指标
主要结局
Large for gestational age
时间窗: At birth of infant
Infant birthweight \>90th centile using customized growth curves
次要结局
- Congenital anomalies(At birth of infant)
- Macrosomia(At birth of infant)
- Small for gestational age(At birth of infant)
- Hypertension in pregnant(First 3 months postpartum)
- Neonatal obstetric trauma(At birth of infant)
- Neonatal hypoglycemia(up to 4 weeks after delivery)
- Neonatal hypocalcemia(up to 4 weeks after delivery)
- Neonatal hyperbilirubinemia(up to 4 weeks after delivery)
- Neonatal polycythemia(up to 4 weeks after delivery)
- Respiratory Distress Syndrome(up to 4 weeks after delivery)
- Infant Outcomes(up to 4 weeks after delivery)
- Hypertrophic cardiomyopathy(up to 4 weeks after delivery)
- Polyhydramnios(At birth of infant)
- Gestational age at delivery(At birth of infant)
- Cesarean section(At birth of infant)
- Perinatal mortality(First 7days postpartum)
- NICU admission(up to 4 weeks after delivery)
- Maternal hospital stay(up to 4 weeks from maternal discharge)
- Neonatal hospital stay(up to 4 weeks from neonatal discharge)
- Evaluation of mediterranean diet adherence(up to 12-14weeks from last menstrual period.)
- Evaluation of health-related physical activity(up to 12-14weeks from last menstrual period.)
- Medical cost(First 3 months postpartum)