Universal Hemoglobin A1c Versus Risk-based Screening for Early Gestational Diabetes Mellitus (EARLY GDM): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 770
- 主要终点
- Large-for-gestational age
研究概览
简要总结
The goal of this randomized controlled trial is to compare the rate of large-for-gestational-age neonates between universal screening with glycated hemoglobin (A1C) and early risk-based screening with a glucose tolerance test (GTT) among pregnancies that present to prenatal care at <16 weeks 6 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presenting to prenatal care ≤16 6/7 weeks of gestation
- •Intend to deliver at TJUH
排除标准
- •Multifetal gestation
- •Pre-pregnancy diagnosis of diabetes mellitus
- •History of malabsorptive gastric bypass surgery
- •Hemoglobinopathy
研究组 & 干预措施
Universal hemoglobin A1c
Patients at <16 weeks will have a hemoglobin A1c obtained
干预措施: Hemoglobin A1c (Diagnostic Test)
Risk-based screening by ACOG with two-step GTT
Patients at <16 weeks will be assessed for risk factors for diabetes as described by ACOG. If patients meet criteria, they will be screened with two-step screening for gestational diabetes. If patients do not meet criteria, they will not be screened until the routine timing of screening for gestational diabetes.
干预措施: Risk-based screening by ACOG with two-step GTT (Diagnostic Test)
结局指标
主要结局
Large-for-gestational age
时间窗: At time of delivery
Birthweight ≥90th percentile
次要结局
- Neonatal hypoglycemia(From 0 to 24 hours after birth)
- Rate of hypertensive disorders of pregnancy(At time of delivery)
- Stillbirth(At time of delivery)
- Rate of patients requiring medication(At time of delivery)
- Preterm birth(At time of delivery)
- Shoulder dystocia(At time of delivery)
- Birth injury(At time of delivery)
- Neonatal death(28 days after birth)
- Rate of early GDM diagnosis(At time of delivery)
- Rate of pregestational diabetes(At time of delivery)
- Rate of GDM diagnosis after 24 weeks(At time of delivery)
研究者
Rodney McLaren, Jr.
Assistant Professor, Obstetrics and Gynecology, Director of MFM Outpatient Care
Thomas Jefferson University