Study of Pregnancy And Neonatal Health (SPAN)
- Conditions
- Gestational Diabetes Mellitus
- Interventions
- Procedure: Childbirth
- Registration Number
- NCT05515744
- Lead Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 6450
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Arm 5 Childbirth Initiation of Delivery by induction or planned cesarean at 38 weeks 5 days to 39 weeks and 0 days. Intervention Arm 7 Childbirth Intervention Arm 7 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 4-6 days. Intervention Arm 4 Childbirth Intervention Arm 4 Experimental Initiation of Delivery by induction or planned cesarean at 38 weeks 2-4 days. Intervention Arm 3 Childbirth Initiation of Delivery by induction or planned cesarean at 37 weeks 6 days to 38 weeks and 1 day. Intervention Arm 2 Childbirth Intervention Arm 2 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 3-5 days. Intervention Arm 1 Childbirth Intervention Arm 1 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 0-2 days. Intervention Arm 6 Childbirth Intervention Arm 6 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 1-3 days.
- Primary Outcome Measures
Name Time Method 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 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 Hypotension requiring pressor support (Component of primary outcome) Delivery through Newborn Discharge 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 Pneumonia (Component of primary outcome) Delivery through Newborn Discharge Confirmed by X-ray or positive blood culture
Occurrence of hypertrophic cardiomyopathy (Component of primary outcome) Delivery through Newborn Discharge 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
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 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 Seizures (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 Outcome Measures
Name Time Method Incidence of Therapeutic hypothermia Delivery through Newborn Discharge Head or body cooling
Birthweight Delivery through Newborn Discharge Occurrence of Cesarean delivery Pregnancy through Delivery Occurrence of HELLP syndrome Pregnancy through Discharge As defined by American College of Obstetricians and Gynecologists (ACOG)
Duration of maternal hospital stay Pregnancy through Newborn Discharge Measured in Days.
Incidence of spontaneous labor Pregnancy through Delivery Incidence of planned cesarean Pregnancy through Delivery 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 Defined as estimated fetal weight \> 4500 grams
Occurrence of Operative vaginal delivery Pregnancy through Delivery Vacuum or forceps
Incidence of Chorioamnionitis Delivery through Discharge Defined as a clinical diagnosis before delivery
Duration of any respiratory support Delivery through Newborn Discharge 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 Transfusion of blood products or blood in neonates Delivery through Newborn Discharge Occurrence of Spontaneous vaginal delivery Pregnancy through Delivery 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
Incidence of Maternal venous thromboembolism Delivery through Discharge Deep venous thrombosis or pulmonary embolism
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
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)
Occurrence of Respiratory distress syndrome in Neonates Delivery through Newborn Discharge Both a clinical diagnosis and whether required surfactant
Composite of Maternal Morbidity and Mortality Pregnancy through Discharge Maternal death, HELLP syndrome, Eclampsia, Pulmonary edema, placental abruption, blood transfusion
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 Measured in days
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
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 Occurrence of Maternal lacerations Delivery through Discharge 1st, 2nd, 3rd or 4th degree perineal; sulcus, vaginal wall; labial, periurethral, clitoral, abrasion, other
Occurrence of Maternal ICU Admission Delivery through Discharge Duration of moderate respiratory support Delivery through Newborn Discharge Incidence of small for gestational age Delivery through Newborn Discharge Defined as \< 10th percentile using the Duryea reference
Incidence of induced labor Pregnancy through Delivery Incidence of Shoulder dystocia Delivery through Newborn Discharge 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
Trial Locations
- Locations (8)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Ochsner Baptist
🇺🇸New Orleans, Louisiana, United States
University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Duke University Perinatal Research Center
🇺🇸Durham, North Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Intermountain Healthcare
🇺🇸Murray, Utah, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
INOVA Fairfax Hospital
🇺🇸Falls Church, Virginia, United States