None listed
Conditions
Interventions
Medical Device : For pregnant women who are newly diagnosed gestational diabetes during gestational age of 24 - 28 week, we design a prospective, randomized controlled study to evaluate the difference
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Newly diagnosed gestational diabetes patients who meet "Two-step" approach (Carpenter and Coustan createria) for gestational diabetes. These tests are done in gestational age of 24-28 week. 1) Step 1 (fasting not required): Measure serum glucose 1 hour after a 50g OGTT. 2) Step 2 (fasting required): Measure 100g OGTT on a separate day in women whose glucose level = 140 mg/dL in previous 50g OGTT. 3) Diagnosis of GDM if at least two of the following plasma glucose values are found: - Fasting: = 95 mg/dL - 1 hour : = 180 mg/dL post oral glucose - 2 hour : = 155 mg/dL post oral glucose - 3 hour : = 140 mg/dL post oral glucose
Exclusion criteria
Exclusion criteria: 1) Known diabetic patient before pregnancy 2) Fasting glucose level= 92 mg/dL, in the first trimester period 3) Patients who don't want regular follow up at Samsung Medical center OBGY and endocrinology clinic 4) Multi-gestation 5) Previously diagnosed diabetes due to other medical problems or by the complication of pregnancy 6) Congenital deformity in fetus 7) History of epilepsy 8) Chronic medical conditions such as malignant hypertension(or systolic blood pressure = 160 mmHg or diastolic blood pressure = 110 mmHg on screening phase) and renal disease (or serum creatinine = twice of upper normal limit on screening phase, renal failure requiring renal replacement therapy) 9) Severe cardiac disase, asthma, miagraine, liver dysfunction, liver disease, liver mass, cholestatic jaundice (screening AST of ALT or bilirubin = 2-fold of normal value) 10) Undiagnosed irregular genital bleeding 11) History or suspicion of breast cancer, cervical caner, or other genital organ malignancy, malignancy history in previous 5 years 12) History or suspicion of thrombogenic disase (thrombogenic vasculitis, cerebrovascular disease, pulmonary embolism, retinal embolism) 13) History of herpes gestationis 14) Porphyria 15) Major depression 16) Heavy smoker, alcohol abuser 17) Participants of other clinical trials whithin 3 months of screening, especially when clinical trial medications are used (Participants who are involved in non-interventional observation studies are not excluded in this study.) 18) Reserchers' dicision of inappropriateness for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite maternal and neonatal outcome;1)pregnancy-induced preeclampsia 2)preterm delivery 3)macrosomia, large for gestational age, small for gestational age 4) Obstetric trauma | — |
Secondary
| Measure | Time frame |
|---|---|
| Cesarean delivery;Eclampsia, Gestational hypertension;Intrauterine fetal death;Gestational age at delivery;Birth weight, Birth weight percentile;Neonatal hypoglycemia;Hyperbilirubinemia;Respiratory distress syndrome in neonates | — |
Countries
Korea, Republic of
Contacts
Public ContactJae Kim
Samsung Medical Center
Outcome results
None listed