drugset / Trial / NCT04726631

Insulin in Treatment of Diabetes Mellitus With Pregnancy

NCT04726631

Completed 110 enrolled Assiut University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The prevalence of diabetes melilites is rapidly increasing over years and consequently during pregnancy. In 2017, there were 21.3 million pregnant women who experienced hyperglycemia, of which 86.4% of them were diagnosed with gestational diabetes melilites. Pregnancy in women with diabetes is associated with an intensification in adverse maternal, fetal and perinatal outcomes including spontaneous abortions, congenital malformations, preterm labor, and macrosomia. Several studies have confirmed that poor glycemic control in women with either gestational, type 1 or type 2 diabetes during pregnancy is associated with poor pregnancy outcomes. In the same line, proper glycemic control before, early, and through all pregnancy markedly improves both maternal and fetal outcomes. Insulin therapy is the standard treatment of diabetes melilites with the pregnancy if dietary control and exercise fail. However, insulin therapy has its difficulties like approaches to mimicking postprandial insulin release, providing adequate background insulin, balancing insulin dosage, food, activity, hypoglycemic episodes, overall glycemia. This is always a struggle for doctors and patients and much affecting their lifestyle

Timeline

Start
2015-01-01
Primary completion
2019-09-01
Completion
2019-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic
Subject Neutral Protamine Hagedorn Unknown

Indications