Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications).
Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications). The study was performed as a randomized controlled trial in one center, Turku University hospital using the non-inferiority design in June 2006 - December 2010. The final study population consisted of altogether 217 women, of whom 110 received metformin and 107 insulin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
221
Birth Weight Per Arm
birth weight adjusted for gestational weeks expressed as standard deviation units using data from Finnish fetal growth charts in normal pregnancies
Time frame: delivery
Pregnancy Induced Hypertension Per Arm
Participants with pregnancy induced hypertension defined as blood pressure over 140/90 mmHg or increase in systolic blood pressure \> 30 mmHg or diastolic blood pressure \> 15 mmHg
Time frame: up to on the average 40 weeks of gestation
Maternal Weight Gain Per Arm
Time frame: up to on the average 40 weeks of gestation
Pre-eclampsia Per Arm
Time frame: up to on the average 40 weeks of gestation
Mode of Delivery Per Arm
Time frame: delivery
Gestational Weeks at Delivery Per Arm
Time frame: delivery
Induction of Delivery Per Arm
Time frame: delivery
Shoulder Dystocia Per Arm
Time frame: delivery
Neonatal Hypoglycemia Per Arm
Time frame: 0-24 h after delivery
Neonatal Hyperbilirubinemia Per Arm
Time frame: 0-3 days after delivery
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Apgar Score at 5 Min After Delivery Per Arm
Apgar score 0-10. 0-2 points from heart rate; 0-2 points for respiratory effort; 0-2 points for skin colour; 0-2 points for muscle tone; 0-2 points for reflex response. For all items the higher the value, the better the outcome
Time frame: 5 minutes after delivery
Neonate Transfer to Intensive Care Unit Per Arm
Time frame: 0-5 days after delivery
Child Outcome at 2 Years Per Arm
neuropsychological and motor skills testing
Time frame: 2 years after birth