This study is a prospective randomized controlled trial. Subjects with newly diagnosed gestational diabetes will be randomized to either standard of care diabetes education versus standard of care plus an interactive educational application.
Gestational diabetes is a condition diagnosed during pregnancy that causes blood sugars to rise. Diet and exercise can effectively control blood sugar levels in 70-85% of women diagnosed with gestational diabetes according to the American Diabetes Association. At the investigator's institution, only 50-54% of women with this diagnosis effectively reach the target blood sugar levels with diet and exercise alone. This has become a more commonly seen problem throughout the US. Those that fail to achieve target blood sugar levels require medication and have higher risks of poor maternal and neonatal outcomes. Studies have shown that an increase in education can increase compliance to diet and education. Specifically, media based education that are interactive may more effectively lead to changes in a person's behavior.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
199
Three cartoon illustrated educational videos with information on gestational diabetes will be provided to the patient in addition to standard of care.
Columbia University Irving Medical Center
New York, New York, United States
Total number of women who failed management with diet alone
This is defined as a patient who is unable to adequately control blood sugars with diet alone and requires medical intervention. This information will be collected until the time of delivery which could be up to 42 weeks of gestation.
Time frame: Up to 42 weeks
A1C Level
A1C level will be measured at the 24-28 weeks and at approximately 37 weeks or time of delivery (up to 42 weeks).
Time frame: Up to 42 weeks
Average fasting blood sugar level
Fasting blood sugar level will be measured at first week of entry and at approximately 37 weeks or time of delivery (up to 42 weeks of gestation).
Time frame: Up to 42 weeks
Average 2 hour post-prandial blood sugar level
The 2-hour post-prandial blood sugar level (after breakfast, lunch, and dinner) will be measured at first week of entry and at approximately 37 weeks or at the time of delivery (up to 42 weeks of gestation).
Time frame: Up to 42 weeks
Total insulin requirement
Average insulin required will be measured at first week of entry and at approximately 37 weeks or at the time of delivery (up to 42 weeks of gestation).
Time frame: Up to 42 weeks
Total metformin requirement
Average metformin required will be measured at first week of entry and at delivery (up to 42 weeks of gestation).
Time frame: Up to 42 weeks
Total number of women who develop gestational hypertension
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Gestational hypertension is defined as blood pressures captured after 20 weeks of gestation that are either 140 systolic or 90 diastolic on 2 occasions at least 4 hours apart. This will be collected until delivery which may be up to 42 weeks of gestation.
Time frame: Up to 42 weeks
Total number of women who develop pre-eclampsia
Pre-eclampsia is defined as blood pressures of 140 systolic or 90 diastolic on 2 occasions at least 4 hours apart during the gestation plus either neurologic/hepatic/or end organ dysfunction or proteinuria defined as protein:creatinine ratio of \>0.3 or 24 hr urine protein of over 300 mg/24 hours. This will be collected until delivery which may be up to 42 weeks of gestation.
Time frame: Up to 42 weeks
C-section rate
Total number of women who have a c-section of the total number of deliveries. This will be collected until delivery which may be up to 42 weeks of gestation.
Time frame: Up to 42 weeks
Difference in weight
Weight difference from the time of diagnosis compared to weight at delivery will be measured. This will be collected until delivery which may be up to 42 weeks of gestation.
Time frame: Up to 42 weeks
Total number of neonates with shoulder dystocia
Complication during delivery when an infants shoulder's get lodged in the mother's pelvis, requiring special maneuvers in order to dislodge the shoulder. This will be collected until delivery which may be up to 42 weeks of gestation.
Time frame: Up to 42 weeks
Total number of neonates with a NICU admission
Measures admission to the neonatal intensive care unit within 2 weeks of birth. This information will be collected until postpartum day 7.
Time frame: Up to postpartum day 7
Total number of neonates with neonatal hypoglycemia
Measures plasma glucose level of less than 30 mg/dL (1.65 mmol/L) in the first 24 hours of life and less than 45 mg/dL (2.5 mmol/L) thereafter
Time frame: Up to postpartum day 7
Total number of neonates with neonatal respiratory distress syndrome
Clinical diagnosis made by neonatologist/pediatrician: Symptoms and signs of RDS include rapid, labored, grunting respirations appearing immediately or within a few hours after delivery, with suprasternal and substernal retractions and flaring of the nasal alae. As atelectasis and respiratory failure progress, symptoms worsen, with cyanosis, lethargy, irregular breathing, and apnea. Diagnosis of RDS is by clinical presentation, including recognition of risk factors; ABGs showing hypoxemia and hypercapnia; and chest x-ray. Chest x-ray shows diffuse atelectasis classically described as having a ground-glass appearance with visible air bronchograms; appearance correlates loosely with clinical severity.
Time frame: Up to postpartum day 7
Total number of neonates with jaundice
The total number of neonates needing phototherapy to treat jaundice will be measured.
Time frame: Up to postpartum day 7
Total number of neonates with an Apgar score <7
The total number of neonates with an Apgar score of \<7 at 5 minutes from birth will be measured. This information will be collected until delivery which may be up to 42 weeks of gestation.
Time frame: Up to 42 weeks
Total number of neonates with a preterm birth
The total number of neonates with birth with a gestational period of less than 37 weeks (iatrogenic and spontaneous) will be measured.
Time frame: Up to 36 weeks and 6 days of gestation