Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of Participants With a Positive Gestational Diabetes Mellitus (GDM) Screen (>= 140 mg/dL) on the 1 Hour 50-g Oral Glucose Tolerance Test (OGTT)
研究概览
简要总结
Studies suggest that the timing interval between oral intake and the 1-hour gestational diabetes screen may have a significant impact on gestational diabetes screening glucose levels. The investigators plan to conduct a prospective randomized trial comparing a 6-hour fast versus liberal oral intake within 2 hours prior to the glucose tolerance test in pregnancy in order to evaluate the effect of the fasting versus the fed state on routine gestational diabetes screening results.
详细描述
Gestational diabetes (GDM) complicates approximately 400,000 pregnancies in the United States annually and is associated with significant adverse pregnancy outcomes, including increasing the lifetime risk of type 2 diabetes. The American College of Obstetricians and Gynecologists (ACOG) recommends that all pregnant women undergo GDM screening between 24-28 weeks gestation utilizing a 1-hour oral glucose tolerance test that was designed to be administered without regard to the last meal or time of day. However, studies suggest that the timing of one's last meal prior to the 1-hour GDM screen may have a significant impact on GDM screening glucose levels. In addition, providers routinely alter the timing of the 1-hour GDM screen based on patients' self reported oral intake prior to the exam. The investigators plan to conduct a prospective randomized trial comparing a 6-hour fast versus liberal oral intake within 2 hours prior to the glucose tolerance test in pregnancy in order to evaluate the effect of the fasting versus the fed state on routine GDM screening results.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patients 18 years and older
- •Singleton gestation
- •Pregnancy managed at Lucile Packard Children's Hospital (LPCH) Stanford outpatient obstetrics clinic
- •Planned delivery at Lucile Packard Children's Hospital (LPCH) Stanford Labor and Delivery unit
排除标准
- •Pregestational diabetes
- •Gestational diabetes diagnosed in the 1st trimester
- •Less than 18 years of age
- •Planned delivery outside LPCH
- •Diabetes medication use prior to pregnancy
- •Inability to give informed consent
- •Chronic steroid use in pregnancy
- •Less than 24 weeks of gestation at the time of the 1 hour oral glucose tolerance test
- •Prior history of bariatric surgery
- •Multifetal gestation
结局指标
主要结局
Number of Participants With a Positive Gestational Diabetes Mellitus (GDM) Screen (>= 140 mg/dL) on the 1 Hour 50-g Oral Glucose Tolerance Test (OGTT)
时间窗: Day of GDM screen (occurring between 24-28 weeks gestation)
Number of positive GDM screen (\>= 140 mg/dL) on the 1 hour 50-g oral glucose tolerance test conducted between 24-28 weeks gestation This outcome was assessed in pregnant participants.
次要结局
- Number of Participants With Positive GDM Diagnosis Based on the OGTT(Day of GDM screen (occurring between 24-28 weeks gestation))
- Number of Participants With Positive GDM Diagnosis(Day of OGTT (occurring at 24-28 weeks gestation up to 42 weeks gestation))
- Number of Participants Who Delivered Vaginally(At time of delivery (up to 42 weeks' gestation))
- Number of Neonates Considered Large for Gestational Age (LGA)(Day of delivery (Within approximately 2 hours after delivery))
- Number of Neonates Considered Small for Gestational Age (SGA)(Day of delivery (Within approximately 2 hours after delivery))
- Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)(Up to 28 days after delivery)
- Number of Neonates With Hyperbilirubinemia(Up to 28 days after delivery)
- Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge(Up to 28 days after delivery)
- Mean Glucose Level at the OGTT Screen(Day of GDM screen (occurring between 24-28 weeks gestation))
- Mean Gestational Age at Delivery(At time of delivery (Up to 42 weeks' gestation))
- Number of Participants Who Delivered Via a Repeat Cesarean Section(At time of delivery (up to 42 weeks' gestation))
- Number of Participants Complicated by Shoulder Dystocia at Delivery(At time of delivery (up to 42 weeks' gestation))
- Number of Participants With Post-partum Hemorrhage(Up to 6 weeks after delivery)
- Number of Neonates With Hypoglycemia(Up to 28 days after delivery)
- Number of Neonates Diagnosed With Respiratory Distress Syndrome(Up to 28 days after delivery)
- Mean Gestational Age at OGTT Screen(Day of GDM screen (occurring between 24-28 weeks gestation))
- Number of Participants Who Delivered Vaginally After a Prior Cesarean Section(At time of delivery (up to 42 weeks' gestation))
- Number of Participants Complicated by Third or Fourth Degree Perineal Laceration(At time of delivery (up to 42 weeks' gestation))
- Number of Participants Diagnosed With a Hypertensive Disorder of Pregnancy(From time of GDM screen up to 6 weeks after delivery)
- Length of Postnatal Stay From Delivery to Discharge(Up to 1 week after delivery)
- Number of Participants With Type 2 Diabetes Mellitus Diagnosis Post-partum(From time of delivery up to 6 weeks post-partum)
- Mean Neonatal Birthweight(Day of delivery (Within approximately 2 hours after delivery))
- Average Time of Last Oral Intake Prior to the OGTT Screen(Day of GDM screen (occurring between 24-28 weeks gestation))
- Number of Participants Who Delivered Via Operative Vaginal Birth(At time of delivery (up to 42 weeks' gestation))
- Number of Participants Who Delivered Via a Primary Cesarean Section(At time of delivery (up to 42 weeks' gestation))
- Number of Participants Who Had a Postpartum Readmission(From initial hospital discharge up to 6 weeks post-partum)
- Number of Neonates With Birth Weight More Than 4000 Grams(Day of delivery (Within approximately 2 hours after delivery))
研究者
Yair Blumenfeld
Associate Professor
Stanford University