Study of Pregnancy And Neonatal Health (SPAN)

NCT05515744 | Terminated DMC

• 2 other identifiers: 10000737000737-CH
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 8

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.

Conditions

Gestational Diabetes Mellitus

Keywords

Gestational Diabetes Mellitus; Delivery Timing

Outcome Measures

Primary Outcomes (13)

• 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)

  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)

  Delivery through Newborn Discharge

• Occurrence of Pneumonia (Component of primary outcome)

  Confirmed by X-ray or positive blood culture

  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

  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.

  Delivery through Newborn Discharge

• Occurrence of Neonatal encephalopathy (Component of primary outcome)

  Defined by Shankaran et al. 2005

  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

  Delivery through Newborn Discharge

• Occurrence of Seizures (Component of primary outcome)

  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

  Delivery through Newborn Discharge

• 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

  NICU stay \> 1 day (24 hours)

  Delivery through Newborn Discharge

Secondary Outcomes (43)

• Incidence of respiratory support less than moderate

  Delivery through Newborn Discharge

• 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

Study Arms (7)

Intervention Arm 1

EXPERIMENTAL

Intervention Arm 1 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 0-2 days.

Procedure: Childbirth

Intervention Arm 2

EXPERIMENTAL

Intervention Arm 2 Experimental Initiation of Delivery by induction or planned cesarean at 37 weeks 3-5 days.

Procedure: Childbirth

Intervention Arm 3

EXPERIMENTAL

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

Intervention Arm 4 Experimental Initiation of Delivery by induction or planned cesarean at 38 weeks 2-4 days.

Procedure: Childbirth

Intervention Arm 5

EXPERIMENTAL

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

Intervention Arm 6 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 1-3 days.

Procedure: Childbirth

Intervention Arm 7

EXPERIMENTAL

Intervention Arm 7 Experimental Initiation of Delivery by induction or planned cesarean at 39 weeks 4-6 days.

Procedure: Childbirth

Interventions

Childbirth PROCEDURE

Induction or planned cesarean

Intervention Arm 1; Intervention Arm 2; Intervention Arm 3; Intervention Arm 4; Intervention Arm 5; Intervention Arm 6; Intervention Arm 7

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Pennsylvania: collaborator
• Intermountain Health Care, Inc.: collaborator
• Duke University: collaborator
• Inova Fairfax Hospital: collaborator
• University of Utah: collaborator
• University of Alabama at Birmingham: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Technical Resources International, Inc.: collaborator
• Ochsner Health System: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Ochsner Baptist

New Orleans, Louisiana, 70115, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Perinatal Research Center

Durham, North Carolina, 27705, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Intermountain Healthcare

Murray, Utah, 84107, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

INOVA Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Parturition

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Katherine L Grantz, MD, MS

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 25, 2022
• Study Start: January 20, 2023
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: December 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared before publication or at the time of publication or shortly thereafter.
• Access Criteria: Access to the anonymised information stored in NIH archives like DASH and dbGaP will only be accepted via applications from appropriately qualified researchers who sign a legally-binding Data Access Agreement in which they commit to use the data only for research purposes; protect the data confidentiality; provide appropriate data security; not attempt to identify individual participants from whom data were obtained; and not redistribute the data or any subset or derivative that could be used to identify the research participant.

Locations

US (8)