Adding Metformin to Insulin in controlling pregestational and gestational diabetes mellitus and improving neonatal outcome regarding birth weight (A Randomized controlled trial)

Amr Saad Mahmoud Ahmed


Abstract


The proportion of pregnant women with gestational and pregestational diabetes mellitus (DM) is increasing, mainly from an increase in type 2 DM. Obesity, low level of physical activity, and, possibly, the exposure to diabetes in utero are major contributors to the increase in type 2 diabetes Insulin has been the drug of choice for treating DM with pregnancy, because of its safety in pregnancy, lack of significant transplacental passage and long history of use. In the 21st century, oral hypoglycemic agents have been included in the armamentarium of treatment modalities for gestational diabetes mellitus (GDM). Earlier concerns with use of these agents in pregnancy were the unknown risk of teratogenicity and neonatal hypoglycemia caused by transplacental passage. Metformin is a biguanide that improves insulin sensitivity, probably by activating adenosine monophosphate (AMP) kinase. In contrast to insulin, metformin is not associated with weight gain or hypoglycemia. Reported outcomes of its use during pregnancy have been favorable . The safety of use of metformin during pregnancy are mainly derived from reports of women with polycystic ovarian syndrome (PCOS) who got pregnant while using metformin . Metformin is now categorized by the FDA regarding its safety for use in pregnancy as category B. To our best knowledge, oral hypoglycemic agents have not been suggested as alternative to insulin in women with pregestational DM. The current recommendation is to switch women with type 2 DM, who have been maintained on metformin and get pregnant, to insulin even if unexpected pregnancy occurs. The promising results of the few randomized trials on the use of metformin as an alternative to insulin in women with GDM, encourages us to try it, not as an alternative to insulin, but as an ‘adjuvant’ in women with DM with pregnancy who show insulin resistance. The current study was performed at Ain Shams University Maternity Hospital during the period betweenJuly2016 and January 2017. A total of 62 pregnant women with uncontrolled diabetes mellitus were recruited in the trial. A written informed consent was obtained from all patients before participation. The aim of the study was to prove benefits of adding metformin to insulin for controlling pregestational and gestational diabetes mellitus and improving neonatal outcome. All recruited women were subjected to history taking, general and abdominal examination, insulin therapy, follow up and outcome measures. Maternal outcome included hospital stay, time till reaching glycemic control, bouts of hypoglycemia or hyperglycemia and need for another hospital admission for uncontrolled diabetes. While, neonatal outcome was a composite of gestational age at delivery, mode of delivery, birth weight, 1- and 5-min Apgar score, neonatal hypoglycemia, Congenital Malformations and need for neonatal ICU admission. Recruited women were randomized into one of two groups: Group I: women received oral metformin at a dose of 1500 mg divided into three doses in addition to insulin at the last reached dose. Glycemic response to metformin treatment was assessed by checking fasting and two-hour postprandial blood glucose 5 days after the treatment was started. If the target blood glucose concentrations were not attained yet, the dose of metformin was to be raised to 2000 mg per day for further 5 days. Women who did not reach the target blood glucose concentrations 10 days after initiating metformin were switched to the insulin dose raising regimen. Group II: women who did not receive oral metformin and were kept up with raising insulin dose at the mentioned rate, till reaching the target glycemic control. In this study the results were: - There were no significant differences between women of both groups regarding age, parity, no. of previous miscarriages, gestational age at recruitment, BMI and type of DM. - Among the 31 women of Metformin Group proper glycemic control on adding metformin was achieved in 24 (77.4%) women; 12 (38.7%) on a daily dose of 1500 mg, and 12 (38.7%) on a daily dose of 2000 mg. On the contrary, 7 (22.6%) women needed raising the dose of insulin to achieve proper glycemic control. - The rates of hospital admission for proper glycemic control were slightly lower in women of group I when compared to women of group II . - The rates of maternal hypoglycemic bouts were lower in women of group I when compared to women of group II . - The rate of Cesarean delivery was comparable in both groups. - There was no significant difference between women of both groups regarding gestational age at delivery . - The proportion of macrosomic newborns was slightly higher in women of group II when compared to women of group I . - There were no significant differences between newborns of both groups regarding 1-min and 5-min Apgar scores. - There were two cases of congenital malformations; 1 in group I in the form of cleft lip and in group II in the form of atrial septal defect (ASD). - The rate of neonatal hypoglycemia was significantly lower in women of group I when compared to women of group II . - The rate of RDS was higher in women of group II when compared to women of group I . - The rate of NICU admission was lower in women of group I when compared to women of group II .


Other data

Other Titles دور إضافة عقار الميتفورمين للأنسولين في علاج السكري الحملي و تأثيره على وزن المولود
Issue Date 2017
URI http://research.asu.edu.eg/handle/12345678/2561


File SizeFormat 
J 1005.pdf491.39 kBAdobe PDFView/Open
Recommend this item

CORE Recommender
1
Views

1
Downloads


Items in Ain Shams Scholar are protected by copyright, with all rights reserved, unless otherwise indicated.