Study of Pregnancy And Neonatal Health (SPAN)

Ki vehet részt

• 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

Ki nem vehet részt

• Previous stillbirth defined as fetal demise ≥ 20 weeks of gestation
• Pregnancies with concurrent conditions and other indications for earlier delivery will also be excluded
• Self-reported history of alcohol dependency disorder and/or other drug/substance dependency in the past year
• 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
• 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
• Aim 3 (GDM randomized trial, TIME) exclusion criteria:
• Teratogen exposure (e.g. cyclophosphamide, valproic acid, warfarin)
• Fetal demise
• Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality