الفهرس 
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Abstract
pregestational diabetes is defined as diabetes that existed before conception. It may be:
Type I DM: is a condition of absolute insulin deficiency that result from β-cell destruction.
Type II DM: is a condition of insulin resistance and usually have relative rather than absolute insulin deficiency.
Diabetes mellitus (DM) is a significant contributor to adverse obstetric and perinatal outcome. There is now clear evidence that adverse pregnancy outcomes are strongly linked to maternal hyperglycemia, both in the peri-conception period and throughout gestation. Although strict glycemic control does improve outcomes, there is still a higher rate of complications in women with DM and poorer perinatal outcomes, as well as exacerbation of existing maternal comorbidities including hypertension, thyroid disease, pre-eclampsia and eclampsia.
This study was done at high risk pregnancy unit, department of obstetrics and gynecology, Beni-Suef University Hospital, from first of January 2019 to first of October 2019, including 80 uncontrolled diabetic pregnant women (type I) in the 3rd trimester (28-32 weeks of pregnancy) divided equally among the study group and control group, to compare the usage of both metformin and insulin instead of using insulin alone in controlling diabetes in pregnant females with type I DM.
group A (study group); included 40 patients who were treated with metformin given at a dose of 2000 mg, divided into two doses, taken with the 2 main meals, in addition to previous adjusted insulin dose. group B (control group); included 40 patients who were treated with insulin alone. Insulin therapy was given subcutaneous by insulin syringes, the dose was calculated as 0.7 to 1.0 units/kg/d, the total dose was given in two divided doses of a mixture of regular insulin and neutral protamine Hagedorn insulin (NPH) at a ratio of 3:7, 100 IU/ml: two-thirds in the early morning (7–8 am) and one third in the evening (5–7 pm). (ACOG Practice Bulletin, 2017a).
Glycemic response to metformin and insulin therapy treatment was assessed by checking fasting and 2-h postprandial blood glucose and HbA1C after the treatment was started and repeated at regular intervals.
Follow up of the mothers at the high risk antenatal care clinic was done, including maternal evaluation by history, examination and investigations. Fetal follow up also was done by obstetric US, CTG and Doppler studies. Cases with poor glycemic control were admitted in the high risk pregnancy unit for close observation and follow up till delivery.
Our study showed no statistically significant differences between the two groups concerning; age, duration of DM (in years), maternal weight gain, blood pressure, mode of delivery and time of delivery. The number of hypoglycemic attacks were non-significantly lower in group A than in group B. Abnormal fetal CTG changes of both groups before termination showed no statistically significant difference between both groups. Also at time of termination, the estimated fetal weight by ultrasound was similar in group A and group B. The AFI was non-significantly lower in group A than in group B. The Resistance index (RI) of umbilical artery Doppler was non-significantly higher in group A than in group B.
No statistically significant differences were found as regard data of neonatal outcomes
As regards the change in insulin dose, the increase in insulin dose was 30% in the metformin group and 80% in the insulin only group, (p-value being 0.03), while 60% of the metformin group and 20% of the insulin only groups did not change the dose of insulin (p-value < 0.05), which adds to the benefits of using combined metformin and insulin. Maternal weight gain and hospital stay in a high risk pregnancy unit in days were more in patients of group B, where there was an apparent statistically significant difference between both groups.
Finally the study showed that Oral metformin therapy is an effective and safe additrional treatment option for women with type I diabetes during pregnancy to lower the insulin requirements and hospital stay and to lower most of maternal, fetal and neonatal complications and this appears of a very high beneficial effect especially in settings with limited economic resources and poor strict followup for pregnant diabetic mothers.
Future studies on larger sample of patients are needed to expand our understanding of the effect of combined metformin and insulin therapy in pregnancies associated with type I DM.