Columbia University Irving Medical Center
New York, 10032, United States
NCT Number: NCT03947073
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.
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Notify Me18 year–60 year
Female
Interventional
Not applicable
New York, 10032, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Three cartoon illustrated educational videos with information on gestational diabetes will be provided to the patient in addition to standard of care.
Time frame: Up to 42 weeks
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 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
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
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
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
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
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
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
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
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
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 postpartum day 7
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
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
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
The total number of neonates needing phototherapy to treat jaundice will be measured.
Time frame: Up to 42 weeks
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 36 weeks and 6 days of gestation
The total number of neonates with birth with a gestational period of less than 37 weeks (iatrogenic and spontaneous) will be measured.
Columbia University
Other
Gestation Diabetes N'Teractive Media-based Education (GDnME) Trial
Acronym: GDnME
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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