Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Glucometer Use - A Randomized Control Trial (START1)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 430
- 试验地点
- 2
- 主要终点
- Neonatal Composite Outcome
研究概览
简要总结
The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a strict and permissive threshold. The strict threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated), whereas the permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values).
详细描述
Pregnancy is a state of insulin resistance to ensure that the growing fetus has ample nutrition. Gestational Diabetes (GDM) develops in pregnant patients with pancreatic dysfunction that leads to impairment of glucose tolerance.
Various studies have examined the benefit of treatment for GDM, including the 2005 Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) and the 2009 Landon et al randomized controlled trials. These studies found that treatment was associated with a significant reduction in newborn complications of perinatal death, shoulder dystocia, large for gestational age infants, cesarean delivery, and birth trauma. The specific threshold value for initiation and up-titration of medical therapy is unknown. Lack of evidence leads to a wide variation in clinical practice of pharmacological initiation and titration for GDM. A systematic review and meta-analysis by Caissutti in 2019 analyzed criteria for initiating pharmacotherapy for GDM and noted the following: 12 of 15 trials initiated pharmacotherapy after 1-2 abnormal values over 1-2 weeks, 2 studies initiated pharmacotherapy after 50% of overall values were abnormal, and 1 study initiated pharmacotherapy after 30% of overall values were abnormal. However, there have been no randomized controlled trials of head-to-head comparison of different thresholds.
The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes. Our goal is to compare a strict and relaxed threshold. The strict threshold is defined as two abnormal values or more over a one week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated), whereas the relaxed threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Live, non-anomalous fetus
- •Literacy in English, Spanish, Mandarin, or Arabic
- •Patients are also required to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.
排除标准
- •<18 years at EDD
- •pre-existing diabetes or diagnosis of GDM before 24 weeks
- •multi-fetal gestation
- •known major fetal anomaly
- •known allergy to insulin
- •chronic maternal corticosteroid use
- •diagnosis of GDM based on finger sticks alone
- •patients who have contraindication to oral glucose tolerance test
- •a primary language other than English, Spanish, Mandarin, or Arabic
研究组 & 干预措施
Strict Arm
The strict threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated)
干预措施: Insulin (Drug)
Permissive
The permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values).
干预措施: Insulin (Drug)
结局指标
主要结局
Neonatal Composite Outcome
时间窗: First 28 days of birth
neonatal composite including the following measures: large for gestational age (LGA) of neonate defined as birth weight \>90th percentile for gestational age using the Fenton growth chart, hypoglycemia o defined as glucose \<40 mg/dL \<48 hours after birth or glucose, hyperbilirubinemia, stillbirth or neonatal death, birth trauma
次要结局
- Neonatal Outcome: Gestational Age of Birth(Delivery Time)
- Maternal Outcomes: Postpartum hemorrhage(Within 24 hours of delivery)
- Neonatal Outcome: Birthweight(Delivery Time)
- Maternal Outcomes: Maternal hypoglycemia(Initiation of insulin to delivery)
- Maternal Outcomes: Shoulder Dystocia(At Delivery)
- Neonatal Outcome: APGAR Score(At 1 minute of life and at 5 min of life)
- Maternal Outcomes: Obstetric anal sphincter injury (OASIS)(At Delivery)
- Maternal Outcomes: Operative Delivery(At Delivery)
- Neonatal Outcome: Brachial Plexus Injury(Delivery Time)
- Neonatal Outcome: Respiratory distress(Within first 24 hours after delivery)
- Neonatal Outcome: Admission to Neonatal intensive Care Unit(From delivery to discharge from NICU)
- Maternal Outcomes: Cesarean Delivery(At Delivery)
- Maternal Outcomes: Hypertensive Disorders of Pregnancy(From gestational age of 20 weeks during pregnancy to 6 weeks postpartum)