Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy:A Comparative Effectiveness Randomized Control Trial (PRECISE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,628
- 试验地点
- 2
- 主要终点
- Number of Neonates That Show Composite Adverse Neonatal Outcome
研究概览
简要总结
The purpose of this study is to evaluate whether Continuous glucose monitoring (CGM) for diagnosis of gestational diabetes mellitus (GDM) improves maternal and neonatal outcomes related to GDM and to evaluate whether CGM for GDM diagnosis reduces the health system costs for mother-infant dyads compared to usual care
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
- Single (Outcomes Assessor)
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
- •24-30 weeks gestation undergoing GDM screening
排除标准
- •Known diagnosis of Type I and II DM
- •History of bariatric surgery
- •Major fetal anomalies
- •Unwilling to use CGM for GDM screening
- •Incarcerated subjects
- •History of allergic reaction to any of CGM metals or adhesives in contact with the skin
结局指标
主要结局
Number of Neonates That Show Composite Adverse Neonatal Outcome
时间窗: From birth to about 28 days of life.
Composite adverse neonatal outcome include one or more of the following: * Large for Gestational Age(LGA) is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al) * Shoulder Dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered * Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury * Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy * Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life * Fetal or neonatal death (within 28 days of birth)
Number of Neonates That Show Adverse Neonatal Outcome of Large for Gestational Age(LGA)
时间窗: at time of birth
LGA is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)
Number of Neonates That Show Adverse Neonatal Outcome of Shoulder Dystocia
时间窗: at time of birth
Shoulder dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered
Number of Neonates That Show Adverse Neonatal Outcome of Birth Injury
时间窗: at time of birth
Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury
Number of Neonates That Show Adverse Neonatal Outcome of Neonatal Hypoglycemia
时间窗: from birth to discharge (about 3-15 days)
Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy
Number of Fetal or Neonatal Deaths
时间窗: within 28 days of birth
Number of Neonates That Show Adverse Neonatal Outcome of Respiratory Distress
时间窗: from birth to discharge (about 3-15 days)
Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life
次要结局
- Number of Women That Show Polyhydramnios During Pregnancy Not Related to Known Fetal Anomaly(From enrollment to delivery)
- Number of Women That Experience Pregnancy Induced Hypertension(From enrollment to 6 weeks post partum, on average 21 weeks)
- Number of Women That Experience Eclampsia: Seizures(From enrollment to 6 weeks post partum, on average 21 weeks)
- Number of Women Admitted Due to Poor Glucose Control(From enrollment up to delivery)
- Number of Women With Primary Cesarean Section(at time of birth)
- Number of Women With Postpartum Hemorrhage: Defined as Greater Then 1000ml(From enrollment to 6 weeks post partum, on average 21 weeks)
- Number of Women With Endometritis(From enrollment to 6 weeks post partum, on average 21 weeks)
- Number of Women With Wound Complications(From enrollment to 6 weeks post partum, on average 21 weeks)
- Number of Women With Diagnosis of Type 2 Diabetes During Postpartum(birth to 6 weeks postpartum)
- Number of Women That Have Preterm Birth(at time of birth)
- Number of Women That Undergo Induced Labor(at time of birth)
- Feasibility as Assessed by the Number of Participants Who Complete the CGM Diagnostic Testing(From enrollment to 6 weeks post partum, on average 21 weeks)
- Number of Women That Use Diabetic Medication During Pregnancy(From enrollment to 6 weeks post partum, on average 21 weeks)
- Number of Neonates With Apgar Score Less Than 7(5 minutes after birth)
- Number of Neonates That Are Admitted to the Neonatal Intensive Care Unit (NICU)(birth to time of discharge from NICU (about 15 days))
- NICU Length of Stay(birth to time of discharge from NICU (about 15 days))
- Number of Neonates With Hyperbilirubinemia Requiring Phototherapy(birth to discharge (about 3-15 days))
- Number of Neonates With Need for Intravenous or Oral Administration Glucose Therapy(birth to discharge (about 3-15 days))
- Number of Neonates That Are Small for Gestational Age(at time of birth)
- Number of Participants Who Breastfed Their Babies(from birth to 6 weeks postpartum)
- Number of Participants Who Formula Fed Their Babies(from birth to 6 weeks postpartum)
- Maximum Bilirubin Level - Neonates(birth to discharge (about 3 -15 days))
- Cord Arterial pH(at time of birth)
- Number of Neonates With Polycythemia(birth to discharge (about 3 -15 days))
- Number of Women That Experience Preeclampsia With Severe Features(From enrollment to 6 weeks post partum, on average 21 weeks)
- Number of Women That Experience Super Imposed Preeclampsia(From enrollment to 6 weeks post partum, on average 21 weeks)
- Number of Women With Need for Blood Transfusion(From enrollment to 6 weeks post partum, on average 21 weeks)
- Number of Participants With Ultrasound Diagnosis of Estimated Fetal Weight >90%Ile in the Third Trimester(Third trimester (≥28 weeks gestation through delivery))
- Number of Women That Experience HELLP Syndrome(From enrollment to 6 weeks post partum, on average 21 weeks)
- Cord Venous pH(at time of birth)
- Total Health System Costs for Mothers and Infants(From enrollment to 6 weeks post partum, on average 21 weeks)
研究者
Michal Fishel Bartal
Assistant Professor
The University of Texas Health Science Center, Houston