Gestational diabetes mellitus Pregnancy and Childbirth Diabetes mellitus arising in pregnancy
Conditions
Interventions
Current interventions as of 21/11/2017:
The participants will be randomized to two groups according to the ID number they get when they visit the hospital. According to this method, one group will con
myo-inositol, oral, 2g, two times per day
folic
acid, oral, 200 micrograms, two times per day
2. Control group: Folic acid from 11 – 13+6 weeks of gestation until the time of gestational diabetes diagnosis (26 – 28 weeks of gestation)
folic acid, oral, 400 micrograms, one time per day
At the time of study entry (11-13+6 weeks of gestation), measurements of fasting blood glucose and glycated hemoglobin will be performed for all pa
Sponsors
Alexandra Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 21/11/2017: 1. Female 2. Age over 18 years 3. Singleton pregnancies 4. Absence of pre-existing impaired glucose tolerance Previous inclusion criteria: 1. Female 2. Age over 18 years 3. Singleton pregnancies 4. Diagnosis of diet-treated gestational diabetes (24 - 28 weeks of gestation)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 21/11/2017: 1. Age under 18 years 2. Multiple pregnancy 3. Pre-existing diabetes mellitus 4. Consumption of steroids 5. Hypertensive disorders 6. Hypothyroidism 7. Pre-existing renal or hepatic impairment 8. Beta thalassaemia carriers 9. Vaginal bleeding (e.g. placental abruption) 10. Special diets (e.g. lactose intolerance) 11. Inadequate monitoring during pregnancy Previous exclusion criteria: 1. Age under 18 years 2. Multiple pregnancy 3. Diagnosed diabetes mellitus before 24 - 28 weeks of gestation 4. Requirement of insulin therapy during the period of myo-inositol supplementation 5. Chronic hypertension 6. Preeclampsia, eclampsia 7. Hypothyroidism 8. Pre-existing renal or hepatic impairment 9. Other chronic diseases (e.g. valvular heart disease) 10. Vaginal bleeding (e.g. placental abruption) 11. Special diets (e.g. lactose intolerance) 12. Inadequate monitoring during pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures: Gestational diabetes incidence rate, evaluated by the results of a 75 g oral glucose tolerance test at 26 - 28 weeks of gestation Previous primary outcome measures: Insulin resistance level, evaluated by homeostasis model assessment of insulin resistance (HOMA-IR) - measured at baseline (24-28 weeks of gestation) and after 6 weeks (after intervention) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 21/11/2017: 1. Fasting blood glucose levels, measured by blood test at 26-28 weeks of gestation (after intervention) 2. Glycated hemoglobin levels, measured by blood test at 26-28 weeks of gestation (after intervention) 3. Insulin resistance level, evaluated by homeostasis model assessment of insulin resistance (HOMA-IR) and Matsuda Index at 26-28 weeks of gestation (after intervention) 4. Incidence rate of diet-treated gestational diabetes and diabetes requiring insulin therapy, evaluated at 26-28 weeks of gestation (after intervention) Previous secondary outcome measures: 1. Blood glucose at 0-60 mins, measured by blood test at baseline (24-28 weeks of gestation) and after 6 weeks (after intervention) 2. Glycated hemoglobin, measured by blood test at baseline (24-28 weeks of gestation) and after 6 weeks (after intervention) 3. Fasting insulin, measured by blood test at baseline (24-28 weeks of gestation) and after 6 weeks (after intervention) 4. Fetal biometry at third trimester, measured using ultrasound measurements (biparietal diameter [BPD], head circumference [HC], abdominal circumference [AC], femur length [FL]), measured at 32 - 34 weeks of gestation 5. Requiring insulin therapy, estimated during 6 weeks of intervention 6. Delivery data (gestational age at delivery, birth weight, mode of delivery, indication of labor induction or caesarean section, Apgar score measured using the Apgar Scoring System), estimated from the end of the 6 week intervention till delivery time 7. Adverse obstetric outcome, estimated from the end of the 6 week intervention till delivery time: 7.1. Macrosomia - birth weight greater than 4500g 7.2. Intrauterine growth restriction, estimated using the Fetal Growth Charts - fetal weight below the 10th percentile for the gestational age 7.3. Preeclampsia - systolic blood pressure (SBP) greater than or equal to 140 mm Hg or a diastolic blood pressure (DBP) greater than or equal to 90 mm Hg or | — |
Countries
Greece
Contacts
Public ContactGeorgios Asimakopoulos
Outcome results
None listed