Study of Pregnancy And Neonatal Health (SPAN)

Stopped early · Not applicable

Conditions studied: Gestational Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT05515744

Run by

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

People needed

304

Starts

2023-01-20

Expected to finish

2024-12-16

Last updated by the study team

2025-12-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Aim 3 (GDM randomized trial, TIME) inclusion criteria:
• Women inclusion criteria:
• 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…

• 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.
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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