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: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
62
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.
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.
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
Number of Participants With a Macrosomic Baby
Fetal macrosomia has been defined birth weight greater than 4500 gm
Time frame: 24 hours after delivery
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
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