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Clinical Trial Details

Trial ID: L6388
Source ID: NCT01240785
Associated Drug: Metformin
Title: Metformin Versus Insulin in Gestational Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01240785/results
Conditions: Gestational Diabetes
Interventions: DRUG: metformin|DRUG: insulin
Outcome Measures: Primary: 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, delivery | Secondary: 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, up to on the average 40 weeks of gestation|Maternal Weight Gain Per Arm, up to on the average 40 weeks of gestation|Pre-eclampsia Per Arm, up to on the average 40 weeks of gestation|Mode of Delivery Per Arm, delivery|Gestational Weeks at Delivery Per Arm, delivery|Induction of Delivery Per Arm, delivery|Shoulder Dystocia Per Arm, delivery|Neonatal Hypoglycemia Per Arm, 0-24 h after delivery|Neonatal Hyperbilirubinemia Per Arm, 0-3 days after delivery|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, 5 minutes after delivery|Neonate Transfer to Intensive Care Unit Per Arm, 0-5 days after delivery|Child Outcome at 2 Years Per Arm, neuropsychological and motor skills testing, 2 years after birth
Sponsor/Collaborators: Sponsor: Turku University Hospital
Gender: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 221
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2006-06
Completion Date: 2012-12
Results First Posted: 2014-11-24
Last Update Posted: 2014-11-24
Locations:
URL: https://clinicaltrials.gov/show/NCT01240785