Inpatient management of women with gestational and pregestational diabetes in pregnancy.

For women with type 1 diabetes (T1DM), type 2 diabetes (T2DM), and gestational diabetes (GDM), poor maternal glycemic control can significantly increase maternal and fetal risk for adverse outcomes. Outpatient medical and nutrition therapy is recommended for all women with diabetes in order to facilitate euglycemia during the antepartum period. Despite intensive outpatient therapy, women with diabetes often require inpatient diabetes management prior to delivery as maternal hyperglycemia can significantly increase neonatal risk of hypoglycemia. Consensus guidelines recommend maternal glucose range of 80-110 mg/dL in labor. The most optimal inpatient strategies for the prevention of hyperglycemia and hypoglycemia proximate to delivery remain unclear and will depend upon factors such as maternal diabetes diagnosis, her baseline insulin resistance, duration and route of delivery etc. Low dose intravenous insulin and dextrose protocols are necessary to achieve optimal predelivery glycemic control for women with T1DM and T2DM. For most with GDM however, euglycemia can be maintained without intravenous insulin. Women treated with a subcutaneous insulin pump during the antepartum period represent a unique challenge to labor and delivery staff. Strategies for self-managed subcutaneous insulin infusion (CSII) use prior to delivery require intensive education and coordination of care with the labor team in order to maintain patient safety. Hospitalization is recommended for most women with diabetes prior to delivery and in the postpartum period despite appropriate outpatient glycemic control. Women with poorly controlled diabetes in any trimester have an increased baseline maternal and fetal risk for adverse outcomes. Common indications for antepartum hospitalization of these women include failed outpatient therapy and/or diabetic ketoacidosis (DKA). Inpatient management of DKA is a significant cause of maternal and fetal morbidity and remains a common indication for hospitalization of the pregnant woman with diabetes. Changes in maternal physiology increase insulin resistance and the risk for DKA. A systematic approach to its management will be reviewed.

Medication history-wide association studies for pharmacovigilance of pregnant patients.

Background: Systematic exclusion of pregnant people from interventional clinical trials has created a public health emergency for millions of patients through a dearth of robust safety data for common drugs. Methods: We harnessed an enterprise collection of 2.8 M electronic health records (EHRs) from routine care, leveraging data linkages between mothers and their babies to detect drug safety signals in this population at full scale. Our mixed-methods signal detection approach stimulates new hypotheses for post-marketing surveillance agnostically of both drugs and diseases-by identifying 1,054 drugs historically prescribed to pregnant patients; developing a quantitative, medication history-wide association study; and integrating a qualitative evidence synthesis platform using expert clinician review for integration of biomedical specificity-to test the effects of maternal exposure to diverse drugs on the incidence of neurodevelopmental defects in their children. Results: We replicated known teratogenic risks and existing knowledge on drug structure-related teratogenicity; we also highlight 5 common drug classes for which we believe this work warrants updated assessment of their safety. Conclusion: Here, we present roots of an agile framework to guide enhanced medication regulations, as well as the ontological and analytical limitations that currently restrict the integration of real-world data into drug safety management during pregnancy. This research is not a replacement for inclusion of pregnant people in prospective clinical studies, but it presents a tractable team science approach to evaluating the utility of EHRs for new regulatory review programs-towards improving the delicate equipoise of accuracy and ethics in assessing drug safety in pregnancy.

New strategies for glucose control in patients with type 1 and type 2 diabetes mellitus in pregnancy.

Over the past 5 decades, perinatal outcome in pregnancies complicated by diabetes mellitus has improved dramatically due in large part to better maternal glycemic control. Self-blood glucose monitoring in combination with flexible or intensive insulin treatment including the use of newer insulin analogs and insulin pump therapy has dramatically improved glucose control in most pregnancies complicated by diabetes. In developing an insulin regimen, careful attention must be paid to both basal and prandial insulin needs. Every effort must be made to avoid hypoglycemia and prevent ketoacidosis. A team approach including the patient, diabetes nurse educator, nutritionist, and social worker is ideal.