Study of Pregnancy And Neonatal Health (SPAN): TIMing of dElivery (TIME) Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 304
- 试验地点
- 16
- 主要终点
- Composite of Neonatal Morbidity and Perinatal Mortality
研究概览
简要总结
This study will conduct a randomized trial among women with gestational diabetes (GDM). Study of Pregnancy And Neonatal health (SPAN), TIMing of dElivery (TIME) is a randomized trial that will recruit up to 3,450 pregnant women with uncontrolled GDM and randomize the timing of their delivery. Women with GDM who are approached for the trial and are found eligible but do not consent to participating in randomization for delivery will be asked to consent for chart review only (estimated additional n=3,000). The primary objective is to determine the best time to initiate delivery for GDM-complicated deliveries (defined as the time when risk of illness and death for the newborn is the lowest) between 37-39 weeks.
详细描述
This is a randomized clinical trial under an adaptive design nested in a larger observational study, among women who are diagnosed with uncontrolled gestational diabetes mellitus (GDM). Women from multiple clinical sites around the United States will be recruited into the study (n=3,450). Women with GDM who are approached for the trial and are found eligible but do not consent to participating to randomization for delivery will be asked to consent for chart review only (estimated additional n=3,000). The primary objective is to determine the optimal time to initiate delivery for GDM complicated deliveries (defined as the time when neonatal morbidity and perinatal mortality risk is the lowest) between 37-39 weeks (n=3,450 women). Newborn developmental and behavior outcomes, and anthropometric measures will also be assessed as secondary outcomes, as well as an exploratory analysis to investigate whether there are clinical, non-clinical or biochemical factors such as glucose measures that will further assist in refining the interval for optimizing time of GDM complicated deliveries relative to neonatal morbidity and perinatal mortality.
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
- •Aim 3 (GDM randomized trial, TIME) inclusion criteria:
- •Women inclusion criteria:
- •Age ≥ 18 Years
- •Verified diagnosis of Gestational Diabetes Mellitus (GDM) with abnormal glucose levels*** or meeting other criteria for poor control, specifically any one of the following: Estimated fetal weight ≥90th percentile (LGA), Polyhydramnios, and or Demonstrate noncompliance or nonadherence as defined clinically, including missing visits, not keeping accurate log, etc.
- •***One or more elevated fasting blood glucoses OR three or more elevated post-prandial blood glucoses after receiving education about appropriate diet and lifestyle modification (e.g. physical activity)
- •Accurate gestational age as verified by ultrasound
- •Singleton gestation
- •English or Spanish speaker
- •Plans to deliver at the study site hospital
- •Ability to provide informed consent to be randomized to initiation of delivery
排除标准
- •Aim 3 (GDM randomized trial, TIME) exclusion criteria:
- •Pre-gestational diabetes*
- •*will be defined as diabetes diagnosis before pregnancy OR before 13 weeks of gestation with a documented fasting plasma glucose ≥ 126 mg/dL, random plasma glucose ≥ 200 mg/dL, 2 hour post glucose ≥ 200 mg/dL during an oral glucose tolerance test (75 g glucose load), or hemoglobin A1c ≥ 6.5%.
- •Previous stillbirth defined as fetal demise ≥ 20 weeks of gestation
- •Self-reported history of alcohol dependency disorder and/or other drug/substance dependency in the past year
- •Teratogen exposure (e.g. cyclophosphamide, valproic acid, warfarin)
- •Known infectious diseases associated with neonatal morbidity (e.g. malaria, cytomegalovirus, rubella, toxoplasmosis, syphilis or Zika virus)
- •Genetic disorders, aneuploidy and known major fetal anomalies
- •Fetal demise
- •Pregnancies with concurrent conditions and other indications for earlier delivery will also be excluded.
- •Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality
结局指标
主要结局
Composite of Neonatal Morbidity and Perinatal Mortality
时间窗: Hospital discharge
Occurrence of Antepartum, intrapartum or neonatal death (Component of primary outcome)
时间窗: Antepartum pregnancy period through Newborn Discharge
Occurrence of Sepsis (Component of primary outcome)
时间窗: Delivery through Newborn Discharge
The diagnosis of sepsis will require the presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, CSF, or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal X-ray confirming infection.
Occurrence of Hypotension requiring pressor support (Component of primary outcome)
时间窗: Delivery through Newborn Discharge
Occurrence of Meconium aspiration syndrome (Component of primary outcome)
时间窗: Delivery through Newborn Discharge
Respiratory distress in an infant born through meconium-stained amniotic fluid with X-ray findings consistent with meconium aspiration syndrome, and whose symptoms could not be otherwise explained
Occurrence of Pneumonia (Component of primary outcome)
时间窗: Delivery through Newborn Discharge
Confirmed by X-ray or positive blood culture
Occurrence of hypertrophic cardiomyopathy (Component of primary outcome)
时间窗: Delivery through Newborn Discharge
Occurrence of Birth trauma (Component of primary outcome)
时间窗: Delivery through Newborn Discharge
Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy
Incidence of moderate or higher neonatal respiratory support within 72 hours after birth (Component of primary outcome)
时间窗: Delivery through Newborn Discharge
Including any of the following: Nasal cannula \>/= 2 LPM (liters per minute), Nasal continuous positive airway pressure (NCPAP), NIPPV; (non-invasive intermittent positive pressure ventilation; Note that NIPPV is more general than Bilevel positive airway pressure (BiPAP) i.e. BiPAP is a form of NIPPV, as is non-invasive NAVA, synchronized NIPPV, non-synchronized NIPPV, some ventilators can do nasal IMV in certain situations, etc.), Mechanical ventilation, High frequency ventilation, and ECMO/ECLS (extracorporeal mechanical support/extracorporeal life support)
Occurrence of Neonatal encephalopathy (Component of primary outcome)
时间窗: Delivery through Newborn Discharge
Defined by Shankaran et al. 2005
Occurrence of Intracranial hemorrhage (Component of primary outcome)
时间窗: Delivery through Newborn Discharge
Intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma
Occurrence of Seizures (Component of primary outcome)
时间窗: Delivery through Newborn Discharge
Incidence of neonatal intensive care unit (NICU) > 1 day (24 hours) stay
时间窗: Delivery through Newborn Discharge
NICU stay \> 1 day (24 hours)
次要结局
- Duration of maternal hospital stay(Pregnancy through Newborn Discharge)
- Occurrence of maternal death(Pregnancy through Discharge)
- Incidence of Maternal Blood transfusion(Pregnancy through Discharge)
- Indication for delivery including cesarean for suspected macrosomia(Pregnancy through Delivery)
- Occurrence of Operative vaginal delivery(Pregnancy through Delivery)
- Incidence of Chorioamnionitis(Delivery through Discharge)
- Duration of any respiratory support(Delivery through Newborn Discharge)
- Occurrence of Hypoglycemia in neonates(Delivery through Newborn Discharge)
- Occurrence of Hyperbilirubinemia in Neonates(Delivery through Newborn Discharge)
- Occurrence of Polycythemia in Neonates(Delivery through Newborn Discharge)
- Incidence of Transfusion of blood products or blood in neonates(Delivery through Newborn Discharge)
- Occurrence of HELLP syndrome(Pregnancy through Discharge)
- Incidence of spontaneous labor(Pregnancy through Delivery)
- Incidence of planned cesarean(Pregnancy through Delivery)
- Occurrence of Spontaneous vaginal delivery(Pregnancy through Delivery)
- Occurrence of Cesarean delivery(Pregnancy through Delivery)
- Occurrence of Postpartum hemorrhage(Delivery through Discharge)
- Incidence of Maternal venous thromboembolism(Delivery through Discharge)
- Maternal postpartum infection(Delivery through Discharge)
- Incidence of respiratory support less than moderate(Delivery through Newborn Discharge)
- Occurrence of Respiratory distress syndrome in Neonates(Delivery through Newborn Discharge)
- Incidence of Therapeutic hypothermia(Delivery through Newborn Discharge)
- Composite of Maternal Morbidity and Mortality(Pregnancy through Discharge)
- Indications for operative vaginal delivery(Pregnancy through Delivery)
- Indication for cesarean(Pregnancy through Delivery)
- Occurrence of Transient tachypnea of the newborn(Delivery through Newborn Discharge)
- Occurrence of neonatal intensive care unit (NICU) or intermediate care unit admission(Delivery through Newborn Discharge)
- Duration of Neonatal hospital stay(Delivery through Newborn Discharge)
- Incidence of large for gestational age and macrosomia(Delivery through Newborn Discharge)
- Occurrence of Eclampsia(Pregnancy through Discharge)
- Occurrence of Maternal Pulmonary edema(Pregnancy through Discharge)
- Occurrence of Placental abruption(Pregnancy through Delivery)
- Occurrence of Maternal lacerations(Delivery through Discharge)
- Occurrence of Maternal ICU Admission(Delivery through Discharge)
- Duration of moderate respiratory support(Delivery through Newborn Discharge)
- Birthweight(Delivery through Newborn Discharge)
- Incidence of small for gestational age(Delivery through Newborn Discharge)
- Incidence of induced labor(Pregnancy through Delivery)
- Incidence of Shoulder dystocia(Delivery through Newborn Discharge)
- Maternal hypertension(Delivery through Discharge)
- Incidence of Preeclampsia, with or without severe features(Delivery through Discharge)
- Use of antihypertensive drugs(Delivery through Discharge)
- Number of hours in labor and delivery unit(Delivery through Discharge)