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Preconception Planning & Care for Women With Diabetes Mellitus David Winmill, DNP, CDE, BC-ADM Intermountain Endocrine & Diabetes Clinic Preconception Care: Objectives 1. Identify the risks and complications associated with hyperglycemia in early pregnancy. 2. Review and discuss the benefits of preconception planning and care. 3. Identify the components of preconception care for diabetes and discuss how these may be implemented as part of clinical practice. Diabetes & Pregnancy: Statistics • Diabetes affects 3.6% of the 4.1 million births registered in the US each year. • Pre-gestational diabetes (type 1 and type 2) affects between 1-2 % of all births. • In Utah, pre-gestational diabetes reported in 334 (0.6%) of 55,063 births. • Poor glycemic control carries significant risk for both mother and fetus. Jovanovic & Nakai, Endo & Metab Clin, 35(1) 2006 Baksh, Birth Statistics. (2009) Pregnancy Complications & Diabetes Maternal Fetal • Spontaneous abortion • Congenital anomalies • Hyperglycemia • Fetal Demise • Severe hypoglycemia • Growth restriction • Diabetic ketoacidosis (DKA) • Polyhydramnios/Oligohydramnio • Aggravation of end-organ s disease (eye, heart & kidney) • Macrosomia • Preeclampsia • Preterm Delivery • Urinary tract infection • Birth trauma • Chronic anemia Neonatal • Cesarean delivery • Respiratory distress syndrome • Injury to genital tract and/or • Hypoglycemia surrounding viscera • Hyperbilirubinemia • Postpartum hemorrhage • Serum electrolyte imbalance • Postpartum soft tissue infection • Death Sources: Bernasko, Obstet & Gynec Surv, 59(8) 2004 Leguizamón et al, Obstet & Gynec Clin 34(2) 2007 Pregnancy Complications & Diabetes Risk for congenital anomalies associated with hyperglycemia in first 7-8 weeks of pregnancy. System Manifestations Neurologic Anencephaly, microcephaly, holoprosencephaly, neural tube defects Transposition of great vessels, aortic coarctation with or without VSD or patent Cardiovascular ductus arteriosus, atrial septal defect, single ventricle, hypoplastic left ventricle, pulmonic stenosis, pulmonary stenosis, pulmonary valve atresia, double outlet right ventricle truncus arteriosus Gastrointestinal Duodenal atresia, imperforate anus, anorectal atresia, small left colon syndrome, situs inversus Genitourinary Ureteral duplication, renal agenesis, hydronephrosis Skeletal Caudal regression syndrome (sacral agenesis), hemivertebrae Other Single umbilical artery Tyrala, Obstet & Gyn Clin 23(1) 1996 Pregnancy Complications & Diabetes Mechanisms of Fetal Death and Anomaly • Hyperglycemia • Maternal vascular disease • Uteroplacental insufficiency • Possible immunologic factors • DNA fragmentation due to changes in regulation of apoptosis regulatory gene. Jovanovic & Nakai, Endo & Metab Clin, 35(1) 2006 Moley et al. Nat Med, 4(12) 1998 Fetal Complications: Anencephaly www.humpath.com Fetal Complications: Spina bifida with myelomeningocele www.humpath.com Caudal Regression & Limb Agenesis Source: www.humpath.com Diabetes & Pregnancy: The Dilemma • Organogenesis occurs within first 7 weeks after conception. • Pregnancy is recognized after critical period and glycemic control established, but fetal malformation may already have occurred. • Despite the known risk, 50% of women do not plan their pregnancies, and thus do not participate in preconception planning. • Once pregnancy is recognized, optimal blood sugars must be established quickly. But, the dilemma continues. . . Maternal Risk in Diabetes Retinopathy • Retinopathy may worsen during pregnancy; not as likely to present de novo. • Strict glycemic control associated with worsening retinopathy dependent on: – Level of existing retinal disease – Rapid reduction of hyperglycemia. • Milder forms of retinopathy typically regress after pregnancy, but more severe forms may persist or progress. • Gradual normalization of glucose levels recommended Jovanovic and Nakai, Endo Metab Clin 35 (1) 2006 Maternal Risk in Diabetes Nephropathy • Microalbuminuria and nephropathy associated with increased risk preterm birth often due to preeclampsia. • Nephropathy when not associated with hypertension does not impact fetal outcome unless kidney function is more than 50% impaired. • Pregnancy not associated with permanent worsening of renal function in absence of uncontrolled HTN or if serum creatinine < 1.5mg/dL. Jovanovic & Nakai, Endo Metab Clin 35 (1) 2006 Maternal Risk in Diabetes: Cardiovascular Disease • Type 1 diabetes (after 10 years) increases risk of MI from 1 in 10,000 in general population to 1 in 350.* • Odds ratio for pregnancy related MI for women with diabetes is 3.2 (1.5–6.9) p<0.01. ** • Unrecognized and untreated coronary artery disease associated with (38%) maternal or fetal death. No deaths reported with recognition and revascularization (CABG).* *Leguizamon, et al. Obstet Gynecol Clin, 34(2) 2007 **James et al, Circulation, 113(12) 2006 Diabetes Preconception Planning & Care Care and management provided prior to pregnancy to reduce risk of fetal and maternal complications, consisting of the following components: • Preconception Counseling • Glycemic Control • Management of Complications • General Pre-pregnancy Care History of Diabetes Preconception Care • Discovery of Insulin in 1922 a landmark in care of patients with type 1 diabetes. • Increased longevity of life but introduced problem of long-term complications • Advances in insulin therapy in the 1970 and 1980s improved quality of life and reduced long-term complications; fetal abnormalities and complications remained high. • Preconception Care programs began emerging in the late 1980s and 1990s • Diabetes Complications & Control Trial (1993) Multi-centric Survey Pregnancy Outcomes Outcomes of 435 pregnancies with diabetes mellitus type 1 (n=289) and type 2 (n=146) compared to general population – Overall perinatal mortality- 4.4% vs. 0.7% – Major congenital malformations - 4.1% vs. 2.2% – Preterm delivery rate - 38.2 vs. 4.7% – Maternal Complications • Progression of retinopathy 39 (39.4%) • Progression of nephropathy 23 (67.6%) • Pre-eclampsia noted in 54 (18.7%) type 1 subjects and 26 (17.8%) type 2 subjects. Boulot et al, Diabetes Care 26(11) 2003 Multi-centric Survey of Pregnancy Outcomes Comparison by first trimester HgA1C HgA1C HgA1C Odds 95% Confidence > 8.0% < 8.0% Ratio Interval Perinatal Mortality 9.2% 2.5% 3.9 1.5-9.7; p<0.05 Congenital Anomaly 8.3% 2.5% 3.5 1.3-8.9 p<0.05 Preterm Delivery 57.6% 24.8% 1.5 1.1-1.7, P<0.005 1st Trimester HgA1C > 43.5% 4.0% 18.5 8.3-40.9; p<0.005 8.0% non-PCC vs. PCC Key Point: 80-90% of perinatal deaths and congenital abnormalities were in unplanned pregnancies and in subjects with A1C greater than 8.0% Boulot et al, Diabetes Care 26(11) 2003 Serious Adverse Pregnancy Outcomes Prospective study of 1,215 pregnancies in 933 subjects with type 1 diabetes mellitus (58% attended PCP). HgA1C >10.4 Study Gen Pop RR 95% C.I. Congenital Anomaly 10.9% 2.8% 7.3 1.8-7.8* Perinatal Mortality 5.5% 0.75% 3.9 2.5-19.8* Adverse Outcome 16.3% 3.5% 4.7 2.5-8.1* HbA1C < 6.9% Congenital Anomaly 3.9% 2.8% 1.4 0.8-2.4 Perinatal Mortality 2.1% 0.75% 2.8 1.3-6.1* Adverse Outcome 5.6% 3.5 1.6 1.0-2.6 *p<0.05 Jensen et al, Diabetes Care 32(6) 2009 Why Women Don’t Plan Pregnancies • Retrospective study of 85 women with diabetes recruited 6 months postpartum from 52 Washington hospitals • 35 (41%) planned • 50 (59%) unplanned • 94% of women with planned and 68% with unplanned pregnancies knew of need for diabetes control. • All women with planned pregnancies were married, 48% of women with unplanned pregnancies were not married • Women with unplanned pregnancies often told they shouldn’t get pregnant. Holing et al, Diabetes Care, 21(6), 1998 Why Women Don’t Plan Pregnancies • Women with planned pregnancies (71%) more likely to have positive relationship with provider vs. 28% for women with unplanned pregnancies • 75% of women with planned pregnancies received encouraging advice about desire for pregnancy vs. 38% of women with unplanned pregnancies. • Women with unplanned pregnancies no more likely to plan subsequent pregnancies (regardless of outcome). Diabetes Preconception Care • Preconception Counseling • Glycemic Control • Identification and Management of Complications • General Pre-pregnancy Care Barriers to Preconception Counseling • Questionnaire developed by a team: endocrinologist, nurse practitioner, registered nurse, dietitian and statistician. • Questions to be Answered What professionals are providing PCC What barriers do they experience in providing PCC What resources do they need to better provide PCC • Survey piloted among small group of diabetes educators & providers prior to obtaining IRB approval. Barriers to Preconception Counseling • 400 individuals contacted and invited to participate through a listserv maintained by the Utah Department of Health. • 75 individuals (18.75%) responded by completion of the online survey, 69 involved in diabetes care, counseling or education. • 41 Certified Diabetes Educators (CDEs) responded to the survey representing 59.4% of response but 51.3% of CDEs in the state. Outcomes: Respondent Demographics; N=69 Age in Years Respondents Percentage 25-34 8 11.6% 35-44 14 20.3% 45-54 25 36.2% 55-64 21 30.4% 65-74 1 1.4% Professional or Clinical Role* CDE** 41 59.4% Dietitian 14 20.3% Registered Nurse 32 46.4% Nurse Practitioner 6 8.7% Physician 4 5.8% Social Worker 1 1.4% Other 6 8.7% *Multiple responses allowed **Certified Diabetes Educator Outcomes: Respondent Demographics (N=69) Level of Education Associates Degree 10 14.5% Bachelors Degree 32 46.4% Masters Degree 20 29.0% Doctorate 3 4.3% Medical Doctor 3 4.3% Other 1 1.9% Years in Practice (n=66) < 5 Years 14 21.2% 5-9 Years 18 27.2% 10-14 Years 17 25.7% 15+ 17 25.7% Respondents Providing PCC No. Respondents (n=69) providing preconception counseling for women of reproductive age (13-49) who have diabetes. Response No. Respondents Percentage Yes 44 63.8% No 25 36.2% For respondents providing preconception counseling (N=44), percentage of their patients that receive preconception counseling. Less than 25% 13 29.5% 25-49% 6 13.6% 50-74% 3 6.8% 75-99% 5 11.3% All 16 36.3% Does Not Apply 1 2.3% Barriers to Preconception Counseling • Summary of Findings – 36.2% of respondents did not provide preconception planning – Certified Diabetes Educators (CDE’s) as likely to provide PCC as physicians. – More experienced CDEs more likely to provide PCC. – Barriers include: • Lack of prompt or reminder • Lack of patient education materials • Inadequate staff training Preconception Care Preconception Counselling: • Information provided consistently to all women of childbearing age (13-49) regarding risks for pregnancy if blood sugars uncontrolled at time of conception. • Importance of planning pregnancy and establishing optimal blood sugar control (glycated hemoglobin <6.9%) • Effective use of contraception until blood sugar control maintained for 3-6 months. Preconception Care Glycemic Control • Effective insulin/glucose management (target HbA1C <6.9) maintained for 3-6 months prior to conception. • Effective dietary management • Evaluation of hypoglycemic response (unawareness). • Consideration of insulin pump and/or continuous glucose sensor. Preconception Care Identification & Management of Complications • Ophthalmologic consult and management. • Evaluation of renal function (24 hour urine) and consult. • Evaluation of neuropathy (gastroparesis, autonomic neuropathy). • Cardiovascular screening. Components of Preconception Care General Principles • Blood pressure & lipid management: Discontinuation of ACE inhibitors, statins, anti-coagulants. • Adequate nutrition: folic acid supplements • Reduce exposure to toxic substances – Avoid alcohol – Limit caffeine – Limit exposure to toxic substances • Dental care Preconception Planning & Care Summary • With preconception planning & care, women with diabetes can reduce their risk of complications to that of women who do not have diabetes. • 50% of women do not plan their pregnancies. • Preconception counseling should be provided regularly to all women of child-bearing age/potential. • Certified diabetes educators recognize their role in providing preconception counseling. Thank You! REFERENCES Bernasko, J. (2004). Contemporary management of type 1 diabetes mellitus in pregnancy. Obstetrical & Gynecological Survey, 59(8), 628-636. Boulot, P., Chabbert-Buffet, N., d'Ercole, C., Floriot, M., Fontaine, P., Fournier, A., et al. (2003). French multicentric survey of outcome of pregnancy in women with pregestational diabetes. Diabetes Care, 26(11), 2990-2993. DCCT (1993). The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. New England Journal of Medicine, 329(14), 977-986. Holing, E. V., Beyer, C. S., Brown, Z. A., & Connell, F. A. (1998). Why don't women with diabetes plan their pregnancies? Diabetes Care, 21(6), 889- 895. Jensen, D. M., Korsholm, L., Ovesen, P., Beck-Nielsen, H., Moelsted- Pedersen, L., Westergaard, J. G., et al. (2009). Peri-conceptional A1C and risk of serious adverse pregnancy outcome in 933 women with type 1 diabetes. Diabetes Care, 32(6), 1046-1048. References James, A. H., Jamison, M. G., Biswas, M. S., Brancazio, L. R., Swamy, G. K., & Myers, E. R. (2006). Acute myocardial infarction in pregnancy: a United States population-based study. Circulation, 113(12), 1564-1571. Jovanovic, L., & Nakai, Y. (2006). Successful pregnancy in women with type 1 diabetes: from preconception through postpartum care. Endocrinology and Metabolic Clinics of North America, 35(1), 79-97, vi. Leguizamón, G., Igarzabal, M. L., & Reece, E. A. (2007). Periconceptional care of women with diabetes mellitus. Obstetric & Gynecololic Clinics of North America, 34(2), 225-239, vi Moley, K. H., Chi, M. M., Knudson, C. M., Korsmeyer, S. J., & Mueckler, M. M. (1998). Hyperglycemia induces apoptosis in pre-implantation embryos through cell death effector pathways. Nature Medicine, 4(12), 1421-1424. Tyrala, E. E. (1996). The infant of the diabetic mother. Obstetrics & Gynecologic Clinics of North America, 23(1), 221-241.
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