Impact of Late Gestational Diabetes Detection and Treatment on Cesarean Delivery Rates After Negative Initial Screening
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 主要终点
- Rate of cesarean delivery
研究概览
简要总结
The goal of this randomized trial is determine if re-testing for gestational diabetes in the third trimester after an ultrasound measurement of estimated fetal weight (EFW) or abdominal circumference greater than 90%ile decreases cesarean delivery rate, and to evaluate the optimal method of re-testing. The main question it aims to answer is:
Does repeat testing for gestational diabetes and management of hyperglycemia decrease the cesarean delivery rate in fetuses measuring >90%ile by estimated fetal weight (EFW) or abdominal circumference (AC) on ultrasound in the third trimester.
Participants will be randomized into two groups: Group 1 will undergo a repeat glucose tolerance test (GTT) with blinded continuous glucose monitor (CGM) and group 2 will have no intervention. Participants in group 1 will receive nutrition counseling as this would be standard in patients at high risk for gestational diabetes.
详细描述
This will be a prospective randomized control trial to determine if re-testing for gestational diabetes in the third trimester after an ultrasound measurement of estimated fetal weight (EFW) or abdominal circumference greater than 90%ile decreases cesarean delivery rate, and to evaluate the optimal method of re-testing. Pregnant women will be recruited with gestational age between 30 weeks and 36 weeks gestation with an ultrasound that demonstrates a fetus with either estimated fetal weight (EFW) >90%, abdominal circumference (AC)>90% or both. They will be randomized into two groups: Group 1 will undergo a repeat glucose tolerance test (GTT) with blinded continuous glucose monitor (CGM) and group 2 will have no intervention. Participants in group 1 will receive nutrition counseling as this would be standard in patients at high risk for gestational diabetes.
The primary outcome is cesarean delivery. Labor course, complications, and delivery/neonatal data will be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Gestational age 30 weeks 0 days and 36 weeks 6 days
- •Ultrasound with estimated fetal weight or abdominal circumference greater than 90th%ile
- •Age 18-50 years old.
排除标准
- •Previously diagnosed gestational diabetes or pre-gestational diabetes
- •Multiple gestation
- •Previous cesarean delivery
- •Any condition precluding vaginal delivery (placenta previa/placenta accreta spectrum disorders, vasa previa, prior uterine surgery with contraindication to vaginal delivery)
- •Suboptimal dating (based on US >22wk gestation)
- •Contraindication to glucose tolerance test
结局指标
主要结局
Rate of cesarean delivery
时间窗: From enrollment until delivery
次要结局
未报告次要终点
研究者
Shauna F. Williams, MD
Principal investigator
Rutgers, The State University of New Jersey