Study of Pregnancy And Neonatal Health (SPAN)
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
🗓️ Study Start (Actual) 20 January 2023
🗓️ Primary Completion (Estimated) 31 December 2027
✅ Study Completion (Estimated) 31 December 2027
👥 Enrollment (Estimated) 6450
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Birmingham, Alabama, United States
📍 New Orleans, Louisiana, United States
📍 Chapel Hill, North Carolina, United States
📍 Durham, North Carolina, United States
📍 Philadelphia, Pennsylvania, United States
📍 Murray, Utah, United States
📍 Salt Lake City, Utah, United States
📍 Falls Church, Virginia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

      Inclusion Criteria:

        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:

        • 1. 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.
        • 2. Previous stillbirth defined as fetal demise ≥ 20 weeks of gestation
        • 3. Self-reported history of alcohol dependency disorder and/or other drug/substance dependency in the past year
        • 4. Teratogen exposure (e.g. cyclophosphamide, valproic acid, warfarin)
        • 5. Known infectious diseases associated with neonatal morbidity (e.g. malaria, cytomegalovirus, rubella, toxoplasmosis, syphilis or Zika virus)
        • 6. Genetic disorders, aneuploidy and known major fetal anomalies
        • 7. Fetal demise
        • 8. Pregnancies with concurrent conditions and other indications for earlier delivery will also be excluded.
        • 9. Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 August 2022
  • First Submitted that Met QC Criteria 24 August 2022
  • First Posted 25 August 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 September 2023
  • Last Update Posted 28 September 2023
  • Last Verified September 2023