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Gestational diabetic mellitus (GDM) patients randomised to metformin or insulin group.Aim was to achieve blood sugar levels of Blood sugar fasting (BSF) <5.3 mmol/l and 1 hour post meal<7.8mmol/l. Both groups were followed till delivery and outcome studied.
75 gm Oral Glucose Tolerance Test (OGTT) was done in pregnant patients. Blood sugar fasting(BSF) > 5.5 mmol/l & 2 hours postprandial >7.8 mmol/l was labelled as GDM. They were randomised to metformin or insulin group. Those assigned to metformin group were started metformin 500mg twice daily & increased until 2500mg depending on the blood sugar levels. Aim was to achieve blood sugar levels of BSF <5.3 mmol/l and 1 hour post meal<7.8mmol/l. If blood sugar levels were not controlled, insulin was added. The insulin group was given 3 injections of regular insulin & one intermediate acting insulin injection at night subcutaneously. Both groups were followed till delivery and outcome studied
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin | Experimental | Metformin will be given until 2500mg in divided doses till normoglycemia is achieved and will be continued till delivery |
|
| Insulin | Active Comparator | Insulin will be give as 3 regular injection and one intermediate acting injection at bedtime till normoglycemia is achieved and will be continued till delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | metformin 500mg twice daily & increased until 2500mg till normoglycemia was achieved and was continued till delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| maternal glycemic control | Maternal glycemic control was measured by blood sugar levels | From time of randomisation till 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal macrosomia | Birth weight more than 4kg | at birth |
| Apgar score | <7 at 5min | at birth |
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Inclusion Criteria:•
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Services Institute of Medical Sciences | Lahore | Punjab Province | Pakistan |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D007328 | Insulin |
| D000068880 | Isophane Insulin, Human |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D011384 |
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| Insulin | Drug | The insulin group was given 3 S/C injections of regular insulin & one intermediate acting injection at night till normoglycemia was achieved and was continued till delivery |
|
|
| Neonatal intensive care unit (NICU) stay | Admitted to NICU | >24 hours after birth |
| Perinatal death | Fetal or neonatal death within 7 days | 7 days of delivery |
| mode of delivery | Lower segment cesarean section , Spontaneous Vaginal Delivery, Instrumental delivery | at delivery |
| Neonatal hypoglycemia | Neonatal blood sugar was checked at birth and if <2.2mmol/l, was labelled | at birth |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007336 | Insulin, Isophane |
| D049528 | Insulin, Long-Acting |
| D061386 | Insulin, Regular, Human |