An interventional study of Childbirth in Gestational Diabetes Mellitus, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Terminated at 8 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Not applicable, Interventional, and Treatment
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.
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.
842 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.
This study's enrollment of 304 is above the median of 110 across 549 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 416 studies on the registry; 25 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Aim 3 (GDM randomized trial, TIME) inclusion criteria:
Women inclusion criteria:
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)
EXCLUSION CRITERIA:
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%.110.
Intervention Arm 1 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 0-2 days.
Procedure: Childbirth
Intervention Arm 2 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 3-5 days.
Procedure: Childbirth
Initiation of Delivery by induction or planned cesarean at 37 weeks 6 days to 38 weeks and 1 day.
Procedure: Childbirth
Intervention Arm 4 Experimental Initiation of Delivery by induction or planned cesarean at 38 weeks 2-4 days.
Procedure: Childbirth
Initiation of Delivery by induction or planned cesarean at 38 weeks 5 days to 39 weeks and 0 days.
Procedure: Childbirth
Intervention Arm 6 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 1-3 days.
Procedure: Childbirth
Intervention Arm 7 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 4-6 days.
Procedure: Childbirth
Induction or planned cesarean
Composite of Neonatal Morbidity and Perinatal Mortality
Time frame: Hospital discharge
Occurrence of Antepartum, intrapartum or neonatal death (Component of primary outcome)
Time frame: Antepartum pregnancy period through Newborn Discharge
Incidence of moderate or higher neonatal respiratory support within 72 hours after birth (Component of primary outcome)
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)
Time frame: Delivery through Newborn Discharge
Occurrence of Pneumonia (Component of primary outcome)
Confirmed by X-ray or positive blood culture
Time frame: Delivery through Newborn Discharge
Occurrence of Meconium aspiration syndrome (Component of primary outcome)
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
Time frame: Delivery through Newborn Discharge
Occurrence of Sepsis (Component of primary outcome)
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.
Time frame: Delivery through Newborn Discharge
Occurrence of Neonatal encephalopathy (Component of primary outcome)
Defined by Shankaran et al. 2005
Time frame: Delivery through Newborn Discharge
Occurrence of Intracranial hemorrhage (Component of primary outcome)
Intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma
Time frame: Delivery through Newborn Discharge
Occurrence of Seizures (Component of primary outcome)
Time frame: Delivery through Newborn Discharge
Occurrence of Birth trauma (Component of primary outcome)
Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy
Time frame: Delivery through Newborn Discharge
Occurrence of Hypotension requiring pressor support (Component of primary outcome)
Time frame: Delivery through Newborn Discharge
Occurrence of hypertrophic cardiomyopathy (Component of primary outcome)
Time frame: Delivery through Newborn Discharge
Incidence of neonatal intensive care unit (NICU) > 1 day (24 hours) stay
NICU stay \> 1 day (24 hours)
Time frame: Delivery through Newborn Discharge
Incidence of respiratory support less than moderate
Hood oxygen and Nasal cannula \<2 LPM (liters per minute); Other than room air (No support)
Time frame: Delivery through Newborn Discharge
Duration of any respiratory support
Time frame: Delivery through Newborn Discharge
Duration of moderate respiratory support
Time frame: Delivery through Newborn Discharge
Occurrence of Transient tachypnea of the newborn
Time frame: Delivery through Newborn Discharge
Occurrence of Respiratory distress syndrome in Neonates
Both a clinical diagnosis and whether required surfactant
Time frame: Delivery through Newborn Discharge
Occurrence of Hypoglycemia in neonates
Glucose \< 35 mg/dl) and whether required IV therapy
Time frame: Delivery through Newborn Discharge
Occurrence of Hyperbilirubinemia in Neonates
Requiring phototherapy or exchange transfusion in Neonates
Time frame: Delivery through Newborn Discharge
Occurrence of Polycythemia in Neonates
Both a clinical diagnosis and whether required partial exchange transfusion
Time frame: Delivery through Newborn Discharge
Incidence of Therapeutic hypothermia
Head or body cooling
Time frame: Delivery through Newborn Discharge
Incidence of Transfusion of blood products or blood in neonates
Time frame: Delivery through Newborn Discharge
Occurrence of neonatal intensive care unit (NICU) or intermediate care unit admission
Time frame: Delivery through Newborn Discharge
Duration of Neonatal hospital stay
Measured in days
Time frame: Delivery through Newborn Discharge
Birthweight
Time frame: Delivery through Newborn Discharge
Incidence of small for gestational age
Defined as \< 10th percentile using the Duryea reference
Time frame: Delivery through Newborn Discharge
Incidence of large for gestational age and macrosomia
LGA defined as \> 90th percentile using the Duryea reference and macrosomia defined as birthweight \> 4500 g
Time frame: Delivery through Newborn Discharge
Composite of Maternal Morbidity and Mortality
Maternal death, HELLP syndrome, Eclampsia, Pulmonary edema, placental abruption, blood transfusion
Time frame: Pregnancy through Discharge
Occurrence of maternal death
Time frame: Pregnancy through Discharge
Occurrence of HELLP syndrome
As defined by American College of Obstetricians and Gynecologists (ACOG)
Time frame: Pregnancy through Discharge
Occurrence of Eclampsia
As defined by American College of Obstetricians and Gynecologists (ACOG)
Time frame: Pregnancy through Discharge
Occurrence of Maternal Pulmonary edema
Chest x-ray confirmed
Time frame: Pregnancy through Discharge
Occurrence of Placental abruption
Time frame: Pregnancy through Delivery
Incidence of Maternal Blood transfusion
Time frame: Pregnancy through Discharge
Incidence of spontaneous labor
Time frame: Pregnancy through Delivery
Incidence of induced labor
Time frame: Pregnancy through Delivery
Incidence of planned cesarean
Time frame: Pregnancy through Delivery
Indication for delivery including cesarean for suspected macrosomia
Defined as estimated fetal weight \> 4500 grams
Time frame: Pregnancy through Delivery
Occurrence of Spontaneous vaginal delivery
Time frame: Pregnancy through Delivery
Occurrence of Operative vaginal delivery
Vacuum or forceps
Time frame: Pregnancy through Delivery
Occurrence of Cesarean delivery
Time frame: Pregnancy through Delivery
Indications for operative vaginal delivery
Time frame: Pregnancy through Delivery
Indication for cesarean
Time frame: Pregnancy through Delivery
Incidence of Shoulder dystocia
Time frame: Delivery through Newborn Discharge
Occurrence of Maternal lacerations
1st, 2nd, 3rd or 4th degree perineal; sulcus, vaginal wall; labial, periurethral, clitoral, abrasion, other
Time frame: Delivery through Discharge
Occurrence of Postpartum hemorrhage
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
Time frame: Delivery through Discharge
Occurrence of Maternal ICU Admission
Time frame: Delivery through Discharge
Incidence of Maternal venous thromboembolism
Deep venous thrombosis or pulmonary embolism
Time frame: Delivery through Discharge
Incidence of Chorioamnionitis
Defined as a clinical diagnosis before delivery
Time frame: Delivery through Discharge
Maternal postpartum infection
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
Time frame: Delivery through Discharge
Maternal hypertension
Mild and Severe (systolic and diastolic) defined by ACOG
Time frame: Delivery through Discharge
Incidence of Preeclampsia, with or without severe features
Defined by ACOG
Time frame: Delivery through Discharge
Use of antihypertensive drugs
Includes oral antihypertensive, intravenous antihypertensive, or intravenous anticonvulsant
Time frame: Delivery through Discharge
Number of hours in labor and delivery unit
Time frame: Delivery through Discharge
Duration of maternal hospital stay
Measured in Days.
Time frame: Pregnancy through Newborn Discharge
Plan to share: Yes — Anonymized phenotypic data and the SNP genotype, DNA methylation, and RNA sequence data generated from the study will be deposited into scientific databases that are maintained by the National Institutes of Health.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)