الفهرس 
Gestational DiabetesOnly 14 pages are availabe for public view
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Abstract
Gestational diabetes mellitus (GDM) is a major global public health issue, with prevalence increasing in recent years due to the epidemic of obesity and type 2 diabetes.
GDM is defined as a condition in which a woman without diabetes develops the glucose intolerance resulting in hyperglycemia of variable degree during pregnancy.
Risk factors of developing GDM include being overweight, polycystic ovary syndrome, maternal age, and a family history with type 2 diabetes. GDM generally exhibit no symptoms, but it increases the risk of preeclampsia, depression, and the incidence of cesarean section.
Moreover, children born to mothers with badly treated GDM are at higher risk of LGA, hypoglycemia, and jaundice or at increased risk of being overweight and developing type 2 diabetes. So the management of GDM is primarily aimed at glycemic control to reduce the incidence of adverse pregnancy outcomes.
Insulin therapy is the most validated treatment option when medical nutrition therapy fails to achieve the target glycemic control. Despite emerging evidence supporting the use of glyburide or metformin in the management of GDM, many guidelines continue to recommend insulin as the first-line therapy.
This is primarily the result of two factors: pregnancy category B for insulin except glulisine and glargine and safety data indicating clinically insignificant amounts of human insulin that cross the placenta.
Two RCTs demonstrated that insulin compared with usual prenatal care in the management of GDM resulted in decreased numbers of births associated with shoulder dystocia, macrosomia, and preeclampsia.
Traditionally, insulin therapy had been considered standard practice for women with gestational diabetes mellitus who could not have been controlled by medical nutrition therapy and physical activity. Insulin therapy can be difficult for pregnant women due to multiple injection requirements, risk of hypoglycemia, and weight gain.
Metformin is a biguanide oral hypoglycemic agent. Metformin decreases hepatic gluconeogenesis, improves peripheral and hepatic sensitivity to insulin and does not induce hypoglycemia or maternal weight gain. However, as metformin crosses the placenta there are more than 10 studies assessing metformin safety and efficacy.
The largest study was known as Metformin in Gestational Diabetes (MiG) study and involved 751 pregnant women with GDM. Some smaller studies have been later performed. Globally, the results have been favorable to metformin.
Compared to women taking insulin, those under metformin had no difference in maternal glycemic control, congenital abnormalities, macrosomia, rates of neonatal hypoglycemia or other maternal or neonatal adverse outcomes. Moreover, it has been reported less maternal hypoglycemia with the use of metformin in comparison to insulin regimes.
Metformin is an alternative to insulin and is effective in the treatment of women with gestational diabetes mellitus. A meta-analysis of pregnancy outcomes after first trimester exposure to metformin didn’t show an increased risk of major malformations and other systematic reviews didn’t find substantial maternal or neonatal outcome differences with use of oral diabetes agents compared with insulin in women with gestational diabetes mellitus. Although it crosses the placenta, metformin appears to be safe in the second and third trimester of pregnancy.
This non inferiority randomized controlled trial was conducted at department of obstetrics and gynecology at Ain Shams University Maternity Hospital (ASUMH) in the period between September 2020 and February 2021.
This study compared different neonatal outcomes according to the different treatment modalities used in the management of GDM. Our hypothesis was that Metformin is as effective and safe as insulin in patients with gestational diabetes.
The participants of this study were 140 outpatient or admitted diabetic pregnant women for antenatal care with singleton pregnancy and diagnosed with gestational diabetes by using fasting (> 95 mg/dl )and 2 hrs postprandial ( >120 mg/dl ).
Women with pre-existing type 1 or type 2 diabetes, HbA1C > or = 6.5 in first trimester, taking treatment interfering with glucose metabolism as steroids, had allergies to one of the components of the treatment, underlying diseases such as severe chronic hypertension, thyroid disease, chronic renal insufficiency, hepatic disease, thrombophilia, systemic lupus erythromatosis and history of intrauterine growth retardation, macrosomia and/or congenital fetal malformation were excluded from the study.
Eligible women who consented to participate in the trial were divided into one of two groups:
• group A: women who were treated with Metformin (total 70).
• group B: women who were treated with insulin (total 70).
Statistical analysis of current study showed that there was no significant difference between Metformin and Insulin groups regarding age, enrollment BMI, parity and family history of DM. There was no significant difference between Metformin and Insulin groups regarding gestational age at enrollment and delivery as well as pregnancy duration after intervention. BMI at delivery, BMI increase as well as BMI increase rate were significantly lower in Metformin group. There were no significant differences between Metformin and Insulin groups regarding fasting, two-hour postprandial and HbA1c blood glucose at enrollment and throughout treatment as well as their reduction after intervention. Maternal complications as hypoglycemia, hyperglycemia and preeclampsia were non-significantly less frequent among Metformin group than among Insulin group. Compliance to treatment was significantly more frequent among Metformin group than among Insulin group. Cesarean delivery was non¬significantly less frequent among Metformin group than among Insulin group. There was no significant difference between Metformin and Insulin regarding birth weight APGAR-1, but APGAR-5 was significantly higher in Metformin group. Neonatal complications as IUFD, IUGR, macrosomia, congenital anomalies, neonatal hypoglycemia, respiratory distress and NICU admission were non-significantly less frequent among Metformin group.