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Clinical Trial Details

Trial ID: L5915
Source ID: NCT03928340
Associated Drug: Metformin
Title: Effect of Adding Metformin to Insulin Therapy on Pregnancy Outcomes in Women With Uncontrolled Type I Diabetes.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type1 Diabetes Mellitus
Interventions: DRUG: Metformin|DRUG: Insulin
Outcome Measures: Primary: HbA1c, the change in level of glycosylated haemoglobin, 12 weeks|capillary glucose, the change in level of glucose in capillary blood, 12 weeks|fasting blood sugar measurement., the change in level of glucose in venous blood after fasting for 8 hours, 12 weeks|2 hours post prandial blood sugar measurement., the change in level of glucose in venous blood 2 hours after meal, 12 weeks | Secondary: Maternal weight gain, the change in mothers' weight in kilograms, 12 weeks|weekly fetal weight gain measured by ultrasound, the change of fetal weight measured by ultrasound, 12 weeks|insulin requirements, the change in dose of insulin taken by patient, 12 weeks|attacks of maternal hypoglycemia, Number of patients with plasma glucose level below 65 mg/dl, 12 weeks|intra uterine fetal death (IUFD), The number of patients with death of fetus after 20 weeks of gestation, 12 weeks|neonatal weight, The change in neonatal weight in kilograms, 12 weeks|preterm birth, The number of patients giving birth berfore 37 completed weeks, 12 weeks|neonatal respiratory distress, the number of neonates with neonatal respiratory distress, 12 weeks|neonatal hypoglycemia, the number of neonates with plasma glucose level below less than 45 mg/dL (2.5 mmol/L), 12 weeks|neonatal Intensive care admission, the number of neonates with neonatal Intensive care admission, 12 weeks
Sponsor/Collaborators: Sponsor: Kasr El Aini Hospital | Collaborators: Amal Kotb Abdallah|Amir Gabr|Mohamed Abdeltawwab Mahmoud
Gender: FEMALE
Age: ADULT
Phases: PHASE4
Enrollment: 80
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-04-29
Completion Date: 2020-03-29
Results First Posted:
Last Update Posted: 2020-05-28
Locations: Beniswef university hospital, Cairo, Egypt
URL: https://clinicaltrials.gov/show/NCT03928340