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| Name | Class |
|---|---|
| Middle-Eastern College of Obstetricians and Gynecologists | OTHER |
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This study aims to compare the maternal, fetal, and neonatal outcomes associated with the use of metformin versus glyburide for managing gestational diabetes.
The objective is to assess the safety and effectiveness profiles of both medications as potential alternatives to initiating insulin therapy.
Primary Outcome: treatment failure is defined as the initiation of insulin due to failure of glycemic control (more than 10% of high values using 4-point glucose checks) or side effects.
Secondary Outcomes:
Maternal:
Fetal and neonatal:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental | Metformin (500 to 2000 mg orally) |
|
| Glyburide | Experimental | Glyburide (2.5 mg to 20 mg orally) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MetFORMIN 500 Mg Oral Tablet | Drug | Metformin (500 to 2000 mg orally) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure | Initiation of insulin due to failure of glycemic control (more than 10% of high values using 4-point glucose checks) or side effects | From 28 weeks till 41 weeks of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of maternal hypoglycemia | Incidence of blood glucose levels below 4 mmol/L during the period of treatment | From 28 weeks till 41 weeks of pregnancy |
| Significant side effects | Incidence of maternal significant side effects requiring cessation of treatment (gastrointestinal side effects) |
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Inclusion Criteria:
Exclusion Criteria:
Patients with pre-gestational diabetes.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sherif Shazly, MSc | Contact | +447554480388 | shazly.sherif2020@gmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35613728 | Background | Ye W, Luo C, Huang J, Li C, Liu Z, Liu F. Gestational diabetes mellitus and adverse pregnancy outcomes: systematic review and meta-analysis. BMJ. 2022 May 25;377:e067946. doi: 10.1136/bmj-2021-067946. | |
| 22505499 | Background | Silva JC, Fachin DR, Coral ML, Bertini AM. Perinatal impact of the use of metformin and glyburide for the treatment of gestational diabetes mellitus. J Perinat Med. 2012 Jan 10;40(3):225-8. doi: 10.1515/jpm-2011-0175. |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D013607 | Tablets |
| D005905 | Glyburide |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004304 |
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| GlyBURIDE 2.5 MG Oral Tablet |
| Drug |
Glyburide (2.5 mg to 20 mg orally) |
|
| From 28 weeks till 41 weeks of pregnancy |
| Fetal macrosomia (large for gestational age) | Incidence of fetuses growing above the 90th percentile on third ultrasound scan using customised growth chart | 32 weeks of gestation to onset of labour |
| 31869430 | Background | Shuster DL, Shireman LM, Ma X, Shen DD, Flood Nichols SK, Ahmed MS, Clark S, Caritis S, Venkataramanan R, Haas DM, Quinney SK, Haneline LS, Tita AT, Manuck TA, Thummel KE, Brown LM, Ren Z, Brown Z, Easterling TR, Hebert MF. Pharmacodynamics of Glyburide, Metformin, and Glyburide/Metformin Combination Therapy in the Treatment of Gestational Diabetes Mellitus. Clin Pharmacol Ther. 2020 Jun;107(6):1362-1372. doi: 10.1002/cpt.1749. Epub 2020 Jan 25. |
| 35195193 | Background | Oliveira MM, Andrade KFO, Lima GHS, Rocha TC. Metformin versus glyburide in treatment and control of gestational diabetes mellitus: a systematic review with meta-analysis. Einstein (Sao Paulo). 2022 Feb 16;20:eRW6155. doi: 10.31744/einstein_journal/2022RW6155. eCollection 2022. |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |