Preconception Planning Care for Women With Diabetes Mellitus

1. Preconception Planning & Care for Women With Diabetes Mellitus� David Winmill, DNP, CDE, BC-ADM Intermountain Endocrine & Diabetes Clinic

2. Preconception Care: Objectives 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.

3. 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.

4. Pregnancy Complications & Diabetes Maternal Spontaneous abortion Hyperglycemia Severe hypoglycemia Diabetic ketoacidosis (DKA) Aggravation of end-organ disease (eye, heart & kidney) Preeclampsia Urinary tract infection Chronic anemia Cesarean delivery Injury to genital tract and/or surrounding viscera Postpartum hemorrhage Postpartum soft tissue infection Fetal Congenital anomalies Fetal Demise Growth restriction Polyhydramnios/Oligohydramnios Macrosomia Preterm Delivery Birth trauma Neonatal Respiratory distress syndrome Hypoglycemia Hyperbilirubinemia Serum electrolyte imbalance Death Most people are aware of the risk of macrosomic infants delivered by women with diabetes. In face a friend of mine, each week asks me how my fat baby project is going. Macrosomia is indeed a risk for women with diabetes with diabetes but it is only one of the many risks for women with diabetes and their babies. There are myriad complications and risks of pregnancy for women with diabetes. Greatest risk for spontaneous abortion and congenital anomalies associated with hyperglycemia in the first 7 weeks gestation. Majority of pregnancies are unplanned and pregnancies usually recognized at the end of this crucial period and hence the importance of preconception planning for women who have diabetes.Most people are aware of the risk of macrosomic infants delivered by women with diabetes. In face a friend of mine, each week asks me how my fat baby project is going. Macrosomia is indeed a risk for women with diabetes with diabetes but it is only one of the many risks for women with diabetes and their babies. There are myriad complications and risks of pregnancy for women with diabetes. Greatest risk for spontaneous abortion and congenital anomalies associated with hyperglycemia in the first 7 weeks gestation. Majority of pregnancies are unplanned and pregnancies usually recognized at the end of this crucial period and hence the importance of preconception planning for women who have diabetes.

5. Pregnancy Complications & Diabetes Risk for congenital anomalies associated with hyperglycemia in first 7-8 weeks of pregnancy. Committee Chair is Ann Deneris Content experts are Jack Wahlen, medical director of the Endocrine & Diabetes Clinic in Ogden, Joan Ware, consultant for the Chronic Diseases Division, Utah Department of Health and Brenda Ralls, statistician for the Utah Diabetes Prevention & Control Program at the Utah Dept. of Health.. Special thanks to Linda Griffen, a study coordinator and consultant with extensive experience in studies related to diabetes.Committee Chair is Ann Deneris Content experts are Jack Wahlen, medical director of the Endocrine & Diabetes Clinic in Ogden, Joan Ware, consultant for the Chronic Diseases Division, Utah Department of Health and Brenda Ralls, statistician for the Utah Diabetes Prevention & Control Program at the Utah Dept. of Health.. Special thanks to Linda Griffen, a study coordinator and consultant with extensive experience in studies related to diabetes.

6. 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.

7. Fetal Complications: Anencephaly

8. Fetal Complications: Spina bifida with myelomeningocele

9. Caudal Regression & Limb Agenesis

10. 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. . .

11. 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

12. 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.

13. 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).* Women with IDDM have an increased risk of coronary artery disease and seem to lose the protective effect of estrogen that limits the incidence of coronary artery disease in women without diabetes [4].The experience at the Joslin Clinic has suggested that, in patients with IDDM, arterial age equals chronologic age plus the number of years of diabetes. Thus, the risk of a 30-year-old women with IDDM for 20 years might approximate that of a 50-year-old individual [5].Diabetic patients with nephropathy, including those who are pregnant (Class F), seem to be at the highest risk for coronary artery disease [6]. The incidence of myocardial infarction in pregnancy has been reported to be 1:10,000 (0.01 percent) and fewer than 100 cases have been reported. Gordon, M. C., Landon, M. B., Boyle, J., Stewart, K. S., & Gabbe, S. G. (1996). Coronary artery disease in insulin-dependent diabetes mellitus of pregnancy (class H): a review of the literature. Obstet Gynecol Surv, 51(7), 437-444.Women with IDDM have an increased risk of coronary artery disease and seem to lose the protective effect of estrogen that limits the incidence of coronary artery disease in women without diabetes [4].The experience at the Joslin Clinic has suggested that, in patients with IDDM, arterial age equals chronologic age plus the number of years of diabetes. Thus, the risk of a 30-year-old women with IDDM for 20 years might approximate that of a 50-year-old individual [5].Diabetic patients with nephropathy, including those who are pregnant (Class F), seem to be at the highest risk for coronary artery disease [6]. The incidence of myocardial infarction in pregnancy has been reported to be 1:10,000 (0.01 percent) and fewer than 100 cases have been reported. Gordon, M. C., Landon, M. B., Boyle, J., Stewart, K. S., & Gabbe, S. G. (1996). Coronary artery disease in insulin-dependent diabetes mellitus of pregnancy (class H): a review of the literature. Obstet Gynecol Surv, 51(7), 437-444.

14. 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

15. 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)

16. 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. Cross sectional study of 435 pregnancies with type 1 diabetes All women with type 1 or type 2 diabetes and a single pregnancy who de- livered between January 2000 and December 2001 were recruited for the study. Gestational diabetes and multiple pregnancies were excluded. All data were prospectively collected using the Obstetrical Quality Indicators and Data Collection aggregated database (11), which consists of the following categorical variables: preconception care; HbA1c ??8% during the first and third trimesters; retinopathy, nephropathy, and their progression; gestational hypertension or pre-eclampsia; pregnancy outcomes (perinatal mortality, major congenital malformations, preterm delivery); macro- somia; mode of delivery; and neonatal complications. Preconception care included information about the need for optimization of glycemic control before pregnancy, assessment of diabetes complications, re- view of dietary habits, intensification of capillary blood glucose self-monitoring (before and 2 h after each of the three. The overall perinatal mortality rate was 4.4% (Table 2). Among the 19 peri- natal deaths, 15 were stillbirths, 4 were neonatal deaths, and 8 were associated with major congenital malformations. Congenital malformations occurred in 18 infants (4.1%) born to type 1 diabetic mothers in 13 cases and to type 2 diabetic mothers in 5 cases. The overall preterm delivery rate was 38.2%. Women whose HbA1c was ??8% had higher rates of peri- natal mortality (9.2 vs. 2.5%; OR 3.9; 95% CI 1.5�9.7; P ?? 0.005), major congenital malformations (8.3 vs. 2.5%; 3.5; 1.3� 8.9; P ?? 0.01), and preterm delivery (57.6 vs. 24.8%; 1.4; 1.1�1.7; P ?? 0.005) than those whose first trimester HbA1c was > 8%. Cross sectional study of 435 pregnancies with type 1 diabetes All women with type 1 or type 2 diabetes and a single pregnancy who de- livered between January 2000 and December 2001 were recruited for the study. Gestational diabetes and multiple pregnancies were excluded. All data were prospectively collected using the Obstetrical Quality Indicators and Data Collection aggregated database (11), which consists of the following categorical variables: preconception care; HbA1c ??8% during the first and third trimesters; retinopathy, nephropathy, and their progression; gestational hypertension or pre-eclampsia; pregnancy outcomes (perinatal mortality, major congenital malformations, preterm delivery); macro- somia; mode of delivery; and neonatal complications. Preconception care included information about the need for optimization of glycemic control before pregnancy, assessment of diabetes complications, re- view of dietary habits, intensification of capillary blood glucose self-monitoring (before and 2 h after each of the three. The overall perinatal mortality rate was 4.4% (Table 2). Among the 19 peri- natal deaths, 15 were stillbirths, 4 were neonatal deaths, and 8 were associated with major congenital malformations. Congenital malformations occurred in 18 infants (4.1%) born to type 1 diabetic mothers in 13 cases and to type 2 diabetic mothers in 5 cases. The overall preterm delivery rate was 38.2%. Women whose HbA1c was ??8% had higher rates of peri- natal mortality (9.2 vs. 2.5%; OR 3.9; 95% CI 1.5�9.7; P ?? 0.005), major congenital malformations (8.3 vs. 2.5%; 3.5; 1.3� 8.9; P ?? 0.01), and preterm delivery (57.6 vs. 24.8%; 1.4; 1.1�1.7; P ?? 0.005) than those whose first trimester HbA1c was > 8%.

17. Multi-centric Survey of Pregnancy Outcomes

18. Serious Adverse Pregnancy Outcomes

19. 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. Population-based sample of 85 women with diabetes recruited retrospectively within 6 months post-partum. Population-based sample of 85 women with diabetes recruited retrospectively within 6 months post-partum.

20. 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).

21. Diabetes Preconception Care Preconception Counseling Glycemic Control Identification and Management of Complications General Pre-pregnancy Care

22. 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.

23. 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.

24. Outcomes: Respondent Demographics; N=69 Over 66% of respondents between the ages of 45 -64. In responding to questions regarding their professional or clinical role, respondents were allowed multiple responses. Note that the majority of CDE�s are either registered nurses of dieticians. Interestingly, one physician was a CDE. Over 66% of respondents between the ages of 45 -64. In responding to questions regarding their professional or clinical role, respondents were allowed multiple responses. Note that the majority of CDE�s are either registered nurses of dieticians. Interestingly, one physician was a CDE.

25. Outcomes: Respondent Demographics (N=69) Majority of respondents were either Bachelors or Masters prepared. Greater than 50% had at least 10 years in diabetes related practic, just under 50% had under 10 years practice.Majority of respondents were either Bachelors or Masters prepared. Greater than 50% had at least 10 years in diabetes related practic, just under 50% had under 10 years practice.

26. Respondents Providing PCC Majority of respondents provided preconception counseling 63.8%. Just over 47% reported providing PCC at least 75% of the time. Majority of respondents provided preconception counseling 63.8%. Just over 47% reported providing PCC at least 75% of the time.

27. Survey Results: Who Provides PCC

28. Outcomes: CDE Status Diabetes educators were significantly more likely to provide preconception care, than non educators.Diabetes educators were significantly more likely to provide preconception care, than non educators.

29. Outcomes: CDE Status of Registered Nurses Also analyzed were differences in provision of PCC services of RNs who were CDE�s and dieticians who were CDEs. RNs significantly more likely to provide PCC if they also are CDEs. Also analyzed were differences in provision of PCC services of RNs who were CDE�s and dieticians who were CDEs. RNs significantly more likely to provide PCC if they also are CDEs.

30. Outcomes: CDE status of Dietitians P=.052 almost significant! By comparison, 80% of dieticians who were also CDEs provided PCC as compared to 25% of those who were not. This was almost significant at p=0.52.P=.052 almost significant! By comparison, 80% of dieticians who were also CDEs provided PCC as compared to 25% of those who were not. This was almost significant at p=0.52.

31. Outcomes: Evaluation of Barriers

32. 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

33. 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 counseling should be provided to all women of child-bearing potentialPreconception counseling should be provided to all women of child-bearing potential

34. 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.

35. 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.

36. 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

37. 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.

38. Thank You!

39. 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.

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