Gestational Diabetes Mellitus in Pregnancy
Conditions
Brief summary
The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.
Detailed description
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: 1. History taking: 2. General and Abdominal Examination: With particular emphasis on : * Body mass index * Blood pressure. * Fundal height . * Estimated fetal weight . 3. 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. 4. Investigations: Fasting and two hours postprandial blood glucose levels were measured in two groups of pregnant women: 1. Group I: pregnant women who received oral metformin in addition to insulin therapy. 2. Group II: pregnant women who received insulin therapy only.
Interventions
DRUGInsulin Mixtard
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.
DRUGMetformin
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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 .
Intervention model description
Group I: pregnant women who received oral metformin in addition to insulin therapy. Group II: pregnant women who received insulin therapy only.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 20 - 35 years. 2. Gestational age: 20- 36 weeks gestation. 3. Singleton pregnancy. 4. Women with pregestational or gestational diabetes mellitus
Exclusion criteria
1. Pregnant women with secondary diabetes (e.g. those on chronic steroid therapy). 2. Hypertensive patients. 3. Women with impaired liver or renal function 4. Non-compliant patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Macrosomic Baby | 24 hours after delivery | Fetal macrosomia has been defined birth weight greater than 4500 gm |
| Number of Participants With Neonates Who Were Hypoglycemic | 24 hours after delivery | Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Oral Metformin and Insulin Intervention 'Insulin Mixtard' and Intervention 'metformin' had included
Insulin Mixtard: 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: 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. | 31 |
| Insulin Therapy Only Intervention 'Insulin Mixtard' had included
Insulin Mixtard: 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. | 31 |
| Total | 62 |
Baseline characteristics
| Characteristic | Insulin Therapy Only | Oral Metformin and Insulin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 31 Participants | 62 Participants |
| Age, Continuous | 29.7 years STANDARD_DEVIATION 3.5 | 28.9 years STANDARD_DEVIATION 3.9 | 29.3 years STANDARD_DEVIATION 3.7 |
| Region of Enrollment Egypt | 31 Participants | 31 Participants | 62 Participants |
| Sex: Female, Male Female | 31 Participants | 31 Participants | 62 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 |
Outcome results
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
Time frame: from 20 weeks to 36 weeks gestation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Metformin and Insulin | Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation | 24 Participants |
| Insulin Therapy Only | Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation | 27 Participants |
Secondary
Number of Participants With a Macrosomic Baby
Fetal macrosomia has been defined birth weight greater than 4500 gm
Time frame: 24 hours after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Metformin and Insulin | Number of Participants With a Macrosomic Baby | 5 Participants |
| Insulin Therapy Only | Number of Participants With a Macrosomic Baby | 12 Participants |
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
Time frame: 24 hours after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oral Metformin and Insulin | Number of Participants With Neonates Who Were Hypoglycemic | 5 Participants |
| Insulin Therapy Only | Number of Participants With Neonates Who Were Hypoglycemic | 6 Participants |