Gestational Diabetes Mellitus
Conditions
Keywords
Gestational Diabetes Mellitus, Delivery Timing
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREChildbirth
Induction or planned cesarean
Sponsors
Ochsner Health System
University of Pennsylvania
Intermountain Health Care, Inc.
Duke University
Inova Fairfax Hospital
University of Utah
University of Alabama at Birmingham
University of North Carolina, Chapel Hill
Technical Resources International, Inc.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Aim 3 (GDM randomized trial, TIME) inclusion criteria: Women inclusion criteria: 1. Age ≥ 18 Years 2. 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) 3. Accurate gestational age as verified by ultrasound 4. Singleton gestation 5. English or Spanish speaker 6. Plans to deliver at the study site hospital 7. Ability to provide informed consent to be randomized to initiation of delivery
Exclusion criteria
Aim 3 (GDM randomized trial, TIME)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Seizures (Component of primary outcome) | Delivery through Newborn Discharge | — |
| Composite of Neonatal Morbidity and Perinatal Mortality | Hospital discharge | — |
| Occurrence of Antepartum, intrapartum or neonatal death (Component of primary outcome) | Antepartum pregnancy period through Newborn Discharge | — |
| Incidence of moderate or higher neonatal respiratory support within 72 hours after birth (Component of primary outcome) | 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 Pneumonia (Component of primary outcome) | Delivery through Newborn Discharge | Confirmed by X-ray or positive blood culture |
| Occurrence of Meconium aspiration syndrome (Component of primary outcome) | 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 Sepsis (Component of primary outcome) | 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 Neonatal encephalopathy (Component of primary outcome) | Delivery through Newborn Discharge | Defined by Shankaran et al. 2005 |
| Occurrence of Intracranial hemorrhage (Component of primary outcome) | Delivery through Newborn Discharge | Intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma |
| Occurrence of Birth trauma (Component of primary outcome) | Delivery through Newborn Discharge | Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy |
| Occurrence of Hypotension requiring pressor support (Component of primary outcome) | Delivery through Newborn Discharge | — |
| Occurrence of hypertrophic cardiomyopathy (Component of primary outcome) | Delivery through Newborn Discharge | — |
| Incidence of neonatal intensive care unit (NICU) > 1 day (24 hours) stay | Delivery through Newborn Discharge | NICU stay \> 1 day (24 hours) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of small for gestational age | Delivery through Newborn Discharge | Defined as \< 10th percentile using the Duryea reference |
| Incidence of large for gestational age and macrosomia | Delivery through Newborn Discharge | LGA defined as \> 90th percentile using the Duryea reference and macrosomia defined as birthweight \> 4500 g |
| Composite of Maternal Morbidity and Mortality | Pregnancy through Discharge | Maternal death, HELLP syndrome, Eclampsia, Pulmonary edema, placental abruption, blood transfusion |
| Occurrence of maternal death | Pregnancy through Discharge | — |
| Occurrence of HELLP syndrome | Pregnancy through Discharge | As defined by American College of Obstetricians and Gynecologists (ACOG) |
| Occurrence of Eclampsia | Pregnancy through Discharge | As defined by American College of Obstetricians and Gynecologists (ACOG) |
| Occurrence of Maternal Pulmonary edema | Pregnancy through Discharge | Chest x-ray confirmed |
| Occurrence of Placental abruption | Pregnancy through Delivery | — |
| Incidence of Maternal Blood transfusion | Pregnancy through Discharge | — |
| Incidence of spontaneous labor | Pregnancy through Delivery | — |
| Incidence of induced labor | Pregnancy through Delivery | — |
| Incidence of planned cesarean | Pregnancy through Delivery | — |
| Indication for delivery including cesarean for suspected macrosomia | Pregnancy through Delivery | Defined as estimated fetal weight \> 4500 grams |
| Occurrence of Spontaneous vaginal delivery | Pregnancy through Delivery | — |
| Occurrence of Operative vaginal delivery | Pregnancy through Delivery | Vacuum or forceps |
| Occurrence of Cesarean delivery | Pregnancy through Delivery | — |
| Indications for operative vaginal delivery | Pregnancy through Delivery | — |
| Indication for cesarean | Pregnancy through Delivery | — |
| Incidence of Shoulder dystocia | Delivery through Newborn Discharge | — |
| Occurrence of Maternal lacerations | Delivery through Discharge | 1st, 2nd, 3rd or 4th degree perineal; sulcus, vaginal wall; labial, periurethral, clitoral, abrasion, other |
| Occurrence of Postpartum hemorrhage | Delivery through Discharge | Defined as any of the following: Transfusion, Non-elective hysterectomy, Use of two or more uterotonics other than oxytocin, Other surgical interventions such as uterine compression sutures, uterine artery ligation, embolization, hypogastric ligation, or balloon tamponade, and Curettage |
| Occurrence of Maternal ICU Admission | Delivery through Discharge | — |
| Birthweight | Delivery through Newborn Discharge | — |
| Incidence of Chorioamnionitis | Delivery through Discharge | Defined as a clinical diagnosis before delivery |
| Maternal postpartum infection | Delivery through Discharge | Defined as, Clinical diagnosis of endometritis, Wound reopened for hematoma, seroma, infection or other reasons, Cellulitis requiring antibiotics, Pneumonia, Pyelonephritis, Bacteremia unknown source, and Septic pelvic thrombosis |
| Maternal hypertension | Delivery through Discharge | Mild and Severe (systolic and diastolic) defined by ACOG |
| Incidence of Preeclampsia, with or without severe features | Delivery through Discharge | Defined by ACOG |
| Use of antihypertensive drugs | Delivery through Discharge | Includes oral antihypertensive, intravenous antihypertensive, or intravenous anticonvulsant |
| Number of hours in labor and delivery unit | Delivery through Discharge | — |
| Duration of maternal hospital stay | Pregnancy through Newborn Discharge | Measured in Days. |
| Incidence of Maternal venous thromboembolism | Delivery through Discharge | Deep venous thrombosis or pulmonary embolism |
| Incidence of respiratory support less than moderate | Delivery through Newborn Discharge | Hood oxygen and Nasal cannula \<2 LPM (liters per minute); Other than room air (No support) |
| Duration of any respiratory support | Delivery through Newborn Discharge | — |
| Duration of moderate respiratory support | Delivery through Newborn Discharge | — |
| Occurrence of Transient tachypnea of the newborn | Delivery through Newborn Discharge | — |
| Occurrence of Respiratory distress syndrome in Neonates | Delivery through Newborn Discharge | Both a clinical diagnosis and whether required surfactant |
| Occurrence of Hypoglycemia in neonates | Delivery through Newborn Discharge | Glucose \< 35 mg/dl) and whether required IV therapy |
| Occurrence of Hyperbilirubinemia in Neonates | Delivery through Newborn Discharge | Requiring phototherapy or exchange transfusion in Neonates |
| Occurrence of Polycythemia in Neonates | Delivery through Newborn Discharge | Both a clinical diagnosis and whether required partial exchange transfusion |
| Incidence of Therapeutic hypothermia | Delivery through Newborn Discharge | Head or body cooling |
| Incidence of Transfusion of blood products or blood in neonates | 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 | Measured in days |
Countries
United States
Outcome results
None listed