COMPARISON OF MEAN BIRTH WEIGHT OF NEONATES BORN TO FEMALES HAVING GESTATIONAL DIABETES ON METFORMIN VERSUS INSULIN.
Objective: To compare the mean birth weight of neonates born to women having gestational diabetes treated with oral metformin versus insulin.
Methodology: In this study, 360 females with gestational diabetes (GDM) were selected. The subjects were randomly divided into two equal groups. In group A, during first week of trimester, metformin was administrated in 750 mg once daily dose, two times per day during second week and thrice daily from the third week onwards. In group B, long-acting insulin was used to normalize fasting, and rapid-acting insulin was used to normalize postprandial glucose concentrations. Patients were followed till delivery and birth weight of baby was noted. All this information was recorded on proforma. Data was analyzed using SPSS-17 and t-test was applied to compare the mean birth weight in both groups. P value <0.05 was considered as statistically significant.
Results: The mean birth weight was 3459.9 +-238.9 grams. In metformin group, the mean neonatal birth weight was 3557.02 +-232.34 grams. In insulin group, the mean neonatal birth weight was 3362.79 +-203.72grams. There was significant difference between both groups and insulin group showed less birth weight as compared to metformin group (p 200mg/dl) before pregnancy, deranged LFTs (ALT >40IU, AST >40IU) and RFTs (serum creatinine >1.2mg/dl); and mental disabilities (through medical record) were excluded from this study. GDM was operationally defined as following: After an overnight fast of 10 hours, OGTT was performed by giving 75-g glucose and serial measurements were taken. The cut-off values were taken according to American Diabetes Association (ADA) criteria 2011 (fasting plasma glucose [greater than or equal to]92, one hour [greater than or equal to]180 and two hour [greater than or equal to]153 mg/dl). GDM was confirmed after one or more anomalous values.
Informed consent was obtained from all individuals who participated in this study. Demographic profile (name, age, gestational age, parity and medical illnesses) were obtained from each patient. Liver and kidney function tests were repeated at monthly interval for monitoring of side effects. Routine antenatal care was provided. Home blood sugar monitoring was done every two weekly with glucometer. Dose adjustments were made based on the glycaemic status. In group A, during first week of trimester, metformin was administrated in 750 mg once daily dose, two times per day during second week and it was given three times daily during the rest of testing period. In group B, the administration of insulin was carried out conferring the guidelines of hospital: long acting insulin was used to normalize fasting, and rapid-acting insulin was used to normalize postprandial glucose concentrations. Patients were followed till delivery and birth weight of baby was noted. All this information was recorded on proforma.
Data were analyzed using SPSS-17. For quantitative variables like age, gestational age and birth weight, calculation of mean and standard deviation was done. Frequency and percentage was calculated for the qualitative variables like parity. t-test was applied to compare the mean birth weight in both groups. Data was stratified for BMI (normal, under and overweight and obese). T-test was applied to see the effect of BMI on mean birth weight. The p value 0.05
Table 2: Comparison of birth weight of neonates in both groups after stratification of BMI of females
Overall mean age was 30 +-6.14 years. The mean age of females in metformin group was 29.9 +-6.05 year while the mean age of females in insulin group was 30.1+-6.25 year. In both groups, mean height, mean weight, mean BMI are shown in Table 1. The minimum weight of patient was 50 kg while maximum weight was 80 kg. The mean birth weight of neonates in both groups was determined (Table 1). There was significant difference between both groups and insulin showed less birth weight as compared to metformin (p <0.05). The frequency of females with underweight, normal BMI and obesity is given in Figure 1. Among normal BMI, overweight, obese and under weight females, the mean of neonatal birth weight randomized to metformin group and to insulin group is given in Table 2. There was significant difference observed in the mean birth weight of neonates randomized to metformin and neonates randomized to insulin group in each stratified BMI group (p<0.05).
We conducted a randomized trial on 360 females with the mean age of 30+-6.14 years and BMI of 24.14+-4.4kg/ m2. About 14-46% of those receiving metformin require additional insulin for glycemic control and to minimize the frequency of macrosomia and its associated risks to the infant8,9. Metformin seems to be an active and non-toxic agent used for the management and treatment of GDM. Nevertheless, patients with numerous risk factors for development of resistance to insulin may not encounter their treatment aims with metformin alone and may entail additional insulin injection. Evidence proposes the use of metformin instead of insulin in women with GDM in view of maternal weight gain and neonatal outcomes10. In our trial, mean neonatal birth weight was noted as 3459.9 +-238.9 grams. There was significant difference between both groups and insulin showed less birth weight (3362.79 +-203.72 gm) as compared to metformin (3557.02 +-232.34 gm), with a p value 0.05). In their recent study, Tertti et al13 reported birth weight with metformin as 3604 +-488 gm while with insulin it was 3589+-448 gm.
Although the difference was again found to be insignificant (p >0.05) but the mean birth weight with insulin was low as compared to metformin. Ijas et al14 found that with metformin the mean birth weight was higher 3712 +-432 gm as compared to insulin 3558 +-593 gm. The difference was insignificant but it favored the insulin which can control birth weight more than metformin. Moore et al15 found that with metformin the mean birth weight was higher 3451.8 +-727.5 gm as compared to insulin 3500.2 +-700.5 gm. The difference was insignificant (p >0.05). Niromanesh et al16 demonstrated that with metformin the mean birth weight was higher 3300 +-400 gm as compared to insulin 3400 +-400 gm. The difference was insignificant (p >0.05). In other studies, it has been found that with metformin the mean birth weight was higher 3143.7+-446.6 gm as compared to insulin 3237.6 +-586.8 gm. The difference was insignificant (p >0.05)17-20.
We stratified data for different BMI statuses of pregnant females included in our study. There were 8.9% females who were underweight, 49.4% had normal BMI, 31.4% were overweight and 10.3% were obese. Significant differences were observed in both study groups in each stratified BMI group (p<0.05).
Insulin was found to be more beneficial in maintaining weight of fetus as compared to metformin. Insulin is therefore recommended for management of gestational diabetes to prevent babies from development of macrosomia which may also help in planning vaginal delivery and can reduce cesarean sections rate as well.
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|Author:||Siddique, Nasir; Shakil, Muhammad; Anwar, Seemab; Mehmood, Nimra; Ullah, Muhammad Ikram|
|Publication:||Journal of Postgraduate Medical Institute|
|Date:||Sep 30, 2018|
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