Clinical Trial Details
| Trial ID: | L3956 |
| Source ID: | NCT05479214 |
| Associated Drug: | Metformin |
| Title: | Effect of Adding Metformin to Insulin in Uncontrolled Diabetic Patients During the 3rd Trimester of Pregnancy |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus Pregnancy |
| Interventions: | DRUG: Metformin|DRUG: Insulin |
| Outcome Measures: | Primary: Maternal glycemic control 3 months., blood glucose levels, 3 months|Maternal insulin requirements, Daily Insulin doses requirements, 3 months|Maternal Blood glucose readings, fasting and 2 hours post prandial blood sugar., 3 months | Secondary: Maternal weight gain, measured by kilograms, 3 months|weekly fetal weight gain, measured by ultrasound in grams, 3 months|increase of attacks of maternal hypoglycemia., maternal hypoglycemia defined by plasma glucose level below 65 mg/dl, 3 months|fetal outcomes, intra uterine fetal death (IUFD), 3 months|Neonatal outcomes, RDS, 1 week |
| Sponsor/Collaborators: | Sponsor: Cairo University |
| Gender: | FEMALE |
| Age: | ADULT |
| Phases: | PHASE4 |
| Enrollment: | 150 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2022-07-29 |
| Completion Date: | 2023-02-10 |
| Results First Posted: | |
| Last Update Posted: | 2023-02-21 |
| Locations: | Cairo University, Cairo, Egypt |
| URL: | https://clinicaltrials.gov/show/NCT05479214 |
