The Effect of Early Screening and Intervention for Gestational Diabetes Mellitus on Pregnancy Outcomes: the TESGO Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 967
- 试验地点
- 2
- 主要终点
- TESGO composite outcome
研究概览
简要总结
Context: Women with gestational diabetes have excessive fetus growth weeks earlier than the screening period recommended currently, suggesting that earlier screening and intervention may improve pregnancy outcomes and the health of the offspring.
Objective: To determine if early screening and intervention could alter pregnancy outcomes, the incidence of maternal diabetes after delivery, and growth and development of the offspring, compared to the standard group.
Design, Setting, Participants: We will conduct a multi-center open-label randomized controlled trial in 2068 pregnant women, who deliver a singleton and who have not been diagnosed with overt diabetes mellitus at National Taiwan University Hospital (NTUH) and NTUH Hsinchu Branch from 2018 to 2020.
Interventions: Gestational diabetes mellitus (GDM) is diagnosed by a 75g 2-hour OGTT at 18-20 weeks of GA for the early-screening group and at 24-28 weeks for the standard-screening group. The diagnostic cutoffs are according to the IADPSG criteria. GDM is diagnosed if one of the plasma glucose levels at fasting, 1-hour, and 2-hour during OGTT is above 92 mg/dL, 180 mg/dL, or 153 mg/dL respectively. Subjects who are diagnosed with GDM receive lifestyle intervention and self-monitoring of blood glucose. Pharmacological therapies are given when the target of glycemic control is not achieved within 4-6 weeks.
Main Outcome Measure: The primary outcome is a composite measure of pregnancy outcomes, including primary CS, birth weight >90th percentile, neonatal hypoglycemia, cord serum C-peptide >90th percentile, pregnancy-induced hypertension, preeclampsia, and birth trauma. The primary outcome is measured within the entire period of perinatal and neonatal intensive-care units (NICU) stay for infants and the entire period of gestation for pregnant women after randomization.
Conclusion: This study will test our hypothesis that early screening and intervention of GDM improves pregnancy outcomes as compared to standard practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 20 years old
- •First prenatal visit before 14 weeks of GA
- •Deliver a singleton at medical centers, including National Taiwan University Hospital (NTUH), and NTUH, Hsinchu Branch.
排除标准
- •Diagnosed with preexisting diabetes
- •Twin or multiple births pregnancy
- •Current exposure to steroids
- •Cannot tolerate an OGTT
研究组 & 干预措施
Early-screen Group
The early screening group will be screened by a 75g 2-hour oral glucose tolerance test (OGTT) at 18-20 weeks of gestational age (GA). The time of early screening and intervention will be 6-8 weeks earlier than that of standard screening and intervention.
干预措施: early screening and intervention (Other)
Standard-screen Group
The standard screening group will be screened by a 75g 2-hour oral glucose tolerance test (OGTT) at 24-28 weeks of gestational age (GA). The time of standard screening and intervention will be 6-8 weeks later than that of early screening and intervention.
干预措施: standard screening and intervention (Other)
结局指标
主要结局
TESGO composite outcome
时间窗: The primary outcome is measured within the entire period of perinatal and NICU stay for infants and the entire period of gestation for pregnant women after randomization, an average of 10 months
the occurrence rate of any of the following adverse outcome, including primary cesarean section (CS), birth weight \>90th percentile, cord serum C-peptide ≥90th percentile, neonatal hypoglycemia, pregnancy-induced hypertension, preeclampsia, birth trauma, hypoglycemia, cord serum C-peptide \>90th percentile, gestational hypertension, preeclampsia and birth trauma
次要结局
- Preterm delivery(This secondary outcome is measured within the entire period of gestation for pregnant women after randomization, an average of 10 months)
- Jaundice(This secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks)
- Fetal growth during pregnancy(The secondary outcome is measured within the entire period of gestation for pregnant women after randomization, an average of 10 months)
- Neonatal adiposity(The secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks)
- Maternal incident diabetes(This secondary outcome is measured during 3 years after delivery for eligible women)
- Admission to NICU(This secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks)
- Fetal death or stillbirth(This secondary outcome is measured within the entire period of perinatal and NICU stay for infants and the entire period of gestation for pregnant women after randomization, an average of 10 months)
- The growth and development of the offspring(This secondary outcome is measured during 3 years after delivery for eligible infants)