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The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.
The current study was conducted at Ain Shams university maternity hospital during the period between June 2016 to December 2016.
All patients were subjected to:
History taking:
General and Abdominal Examination:
With particular emphasis on :
Insulin and metformin doses :
Insulin dose:
0.7 IU/Kg (at the second trimester of pregnancy). 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.
Metformin dose :
Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.
If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.
Investigations:
Fasting and two hours postprandial blood glucose levels were measured in two groups of pregnant women:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral metformin and insulin | Active Comparator | Intervention 'Insulin Mixtard' and Intervention 'metformin' had included |
|
| insulin therapy only | Active Comparator | Intervention 'Insulin Mixtard' had included |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Mixtard | Drug | Insulin dose:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation | Fasting and two-hours postprandial blood glucose every 48 hours, till reaching the target blood glucose concentrations: 60 - 95 mg/dl and < 120 mg/dl (for fasting and two-hour postprandial status, respectively) If patient reached blood glucose concentrations, she considered as controlled Diabetes Mellitus If patient did not reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus | from 20 weeks to 36 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Macrosomic Baby | Fetal macrosomia has been defined birth weight greater than 4500 gm | 24 hours after delivery |
| Number of Participants With Neonates Who Were Hypoglycemic |
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Inclusion Criteria:
Exclusion Criteria:
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The current study was conducted at Ain Shams university maternity hospital during the period between June 2016 to December 2016.
Sixty two pregnant women were recruited from Ain Shams university maternity hospital who fulfilled the inclusion criteria. They were counseled and after consenting were included into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Metformin and Insulin | Intervention 'Insulin Mixtard' and Intervention 'metformin' had included Insulin Mixtard: Insulin dose:
Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin. If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day. |
| FG001 | Insulin Therapy Only | Intervention 'Insulin Mixtard' had included Insulin Mixtard: Insulin dose:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Metformin and Insulin | Intervention 'Insulin Mixtard' and Intervention 'metformin' had included Insulin Mixtard: Insulin dose:
Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin. If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation | Fasting and two-hours postprandial blood glucose every 48 hours, till reaching the target blood glucose concentrations: 60 - 95 mg/dl and < 120 mg/dl (for fasting and two-hour postprandial status, respectively) If patient reached blood glucose concentrations, she considered as controlled Diabetes Mellitus If patient did not reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus | Posted | Count of Participants | Participants | from 20 weeks to 36 weeks gestation |
|
7 months from June 2016 to December 2016
Adverse Events of oral metformin and insulin were assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Metformin and Insulin | Intervention 'Insulin Mixtard' and Intervention 'metformin' had included Insulin Mixtard: Insulin dose:
Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin. If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Rehab Mohamed Abdelrahman | Ain Shams University | +201004992772 | rehababdulrahman.rm@gmail.com |
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| ID | Term |
|---|---|
| C557578 | insulin, pork; isophane insulin, pork drug combination 30:70 |
| D061265 | Biphasic Insulins |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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Group I: pregnant women who received oral metformin in addition to insulin therapy.
Group II: pregnant women who received insulin therapy only.
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Sixty-two opaque envelopes were numbered serially and in each envelope the corresponding letter which detect allocated group were put according to randomization then all envelops were closed and put in one box .When the first patient arrives , the first envelope were opened and the patient were allocated according to the letter inside .
|
| Metformin | Drug | Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin. If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day. |
|
|
Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery
| 24 hours after delivery |
| BG001 | Insulin Therapy Only | Intervention 'Insulin Mixtard' had included Insulin Mixtard: Insulin dose:
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Insulin Therapy Only | Intervention 'Insulin Mixtard' had included Insulin Mixtard: Insulin dose:
|
|
|
| Secondary | Number of Participants With a Macrosomic Baby | Fetal macrosomia has been defined birth weight greater than 4500 gm | Posted | Count of Participants | Participants | 24 hours after delivery |
|
|
|
| Secondary | Number of Participants With Neonates Who Were Hypoglycemic | Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery | Posted | Count of Participants | Participants | 24 hours after delivery |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Insulin Therapy Only | Intervention 'Insulin Mixtard' had included Insulin Mixtard: Insulin dose:
| 0 | 31 | 0 | 31 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |