Preconception Planning

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.

Jovanovic Nakai, Endo Metab Clin, 35(1)
2006 Baksh, Birth Statistics. (2009)
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

Sources Bernasko, Obstet Gynec Surv, 59(8)
2004 Leguizamón et al, Obstet Gynec Clin
34(2) 2007
5
Pregnancy Complications Diabetes

• Risk for congenital anomalies associated with
  hyperglycemia in first 7-8 weeks of pregnancy.

System Manifestations
Neurologic Cardiovascular Gastrointestinal Genitourinary Skeletal Other Anencephaly, microcephaly, holoprosencephaly, neural tube defects Transposition of great vessels, aortic coarctation with or without VSD or patent ductus arteriosus, atrial septal defect, single ventricle, hypoplastic left ventricle, pulmonic stenosis, pulmonary stenosis, pulmonary valve atresia, double outlet right ventricle truncus arteriosus Duodenal atresia, imperforate anus, anorectal atresia, small left colon syndrome, situs inversus Ureteral duplication, renal agenesis, hydronephrosis Caudal regression syndrome (sacral agenesis), hemivertebrae Single umbilical artery
Tyrala, Obstet Gyn Clin 23(1) 1996
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.

Jovanovic Nakai, Endo Metab Clin, 35(1)
2006 Moley et al. Nat Med, 4(12) 1998
7
Fetal Complications Anencephaly
www.humpath.com
8
Fetal Complications Spina bifida with
myelomeningocele
www.humpath.com
9
Caudal Regression Limb Agenesis
Source www.humpath.com
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. . .

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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
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 lt 1.5mg/dL.

Jovanovic Nakai, Endo Metab Clin 35 (1) 2006
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 (1.56.9) plt0.01.
• 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
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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 (n289) and type 2 (n146)
  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
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Multi-centric Survey of Pregnancy Outcomes
Comparison by first trimester HgA1C Comparison by first trimester HgA1C Comparison by first trimester HgA1C Comparison by first trimester HgA1C Comparison by first trimester HgA1C
HgA1Cgt 8.0 HgA1Clt 8.0 Odds Ratio 95 Confidence Interval
Perinatal Mortality 9.2 2.5 3.9 1.5-9.7 plt0.05
Congenital Anomaly 8.3 2.5 3.5 1.3-8.9 plt0.05
Preterm Delivery 57.6 24.8 1.5 1.1-1.7, Plt0.005
1st Trimester HgA1C gt 8.0 non-PCC vs. PCC 43.5 4.0 18.5 8.3-40.9 plt0.005
Key Point 80-90 of perinatal deaths and congenital abnormalities were in unplanned pregnancies and in subjects with A1C greater than 8.0 Key Point 80-90 of perinatal deaths and congenital abnormalities were in unplanned pregnancies and in subjects with A1C greater than 8.0 Key Point 80-90 of perinatal deaths and congenital abnormalities were in unplanned pregnancies and in subjects with A1C greater than 8.0 Key Point 80-90 of perinatal deaths and congenital abnormalities were in unplanned pregnancies and in subjects with A1C greater than 8.0 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
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Serious Adverse Pregnancy Outcomes
Prospective study of 1,215 pregnancies in 933 subjects with type 1 diabetes mellitus (58 attended PCP). Prospective study of 1,215 pregnancies in 933 subjects with type 1 diabetes mellitus (58 attended PCP). Prospective study of 1,215 pregnancies in 933 subjects with type 1 diabetes mellitus (58 attended PCP). Prospective study of 1,215 pregnancies in 933 subjects with type 1 diabetes mellitus (58 attended PCP). Prospective study of 1,215 pregnancies in 933 subjects with type 1 diabetes mellitus (58 attended PCP).
HgA1C gt10.4 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 lt 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
plt0.05 plt0.05 plt0.05 plt0.05 plt0.05
Jensen et al, Diabetes Care 32(6) 2009
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Why Women Dont 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
  shouldnt get pregnant.

Holing et al, Diabetes Care, 21(6), 1998
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Why Women Dont 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).

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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.

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Outcomes Respondent Demographics N69
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 Professional or Clinical Role 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
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Outcomes Respondent Demographics (N69)
Level of Education Level of Education 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 (n66) Years in Practice (n66) Years in Practice (n66)
lt 5 Years 14 21.2
5-9 Years 18 27.2
10-14 Years 17 25.7
15 17 25.7
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Respondents Providing PCC
No. Respondents (n69) providing preconception counseling for women of reproductive age (13-49) who have diabetes. No. Respondents (n69) providing preconception counseling for women of reproductive age (13-49) who have diabetes. No. Respondents (n69) 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 (N44), percentage of their patients that receive preconception counseling. For respondents providing preconception counseling (N44), percentage of their patients that receive preconception counseling. For respondents providing preconception counseling (N44), 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
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Survey Results Who Provides PCC

Certified Diabetes Educator
28
Outcomes CDE Status
p lt .001
29
Outcomes CDE Status of Registered Nurses
30
Outcomes CDE status of Dietitians
31
Outcomes Evaluation of Barriers
Barriers to Preconception Counseling (N69) No. of Responses Percentage
Patients too young or old 26 37.6
Lack of educational materials 17 24.6
No prompt or reminder 17 24.6
Not enough time 15 21.7
Doesnt cross my mind 11 15.9
Lack of training 10 14.5
Belief parental consent needed 7 10.0
Patients often refuse information 6 8.7
Religious beliefs of patient 1 1.4
Religious beliefs of provider 0 0
Respondents allowed to make multiple responses
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Barriers to Preconception Counseling

• Summary of Findings
• 36.2 of respondents did not provide
  preconception planning
• Certified Diabetes Educators (CDEs) 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

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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
  lt6.9)
• Effective use of contraception until blood sugar
  control maintained for 3-6 months.

34
Preconception Care

• Glycemic Control
• Effective insulin/glucose management (target
  HbA1C lt6.9) 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.

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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.

40
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.