Preconception Care of Women With Diabetes

American Diabetes Association

Originally approved 1995. Most recent review/revision, 1999. Reprinted with permission from Diabetes Care 23 (Suppl 1):S65-68, 2000.

To prevent early pregnancy loss and very costly congenital malformations in infants of diabetic mothers, optimal medical care and patient education and training must begin before conception. This is best accomplished through a multidisciplinary team approach including a diabetologist, internist or family practice physician, obstetrician, diabetes educators including registered nurse, registered dietitian, and social worker, and other specialists as necessary. Ultimately, the woman with diabetes must become the most active member of the team, calling upon the other members for specific guidance and expertise to help her toward her goal of a healthy pregnancy and offspring.

The primary purpose of these guidelines is to define the elements of a preconception care program. This program should be sufficient to minimize congenital malformations and thereby substantially reduce health care costs. This document describes the recommended intensive outpatient treatment plan, based on risk assessment, health promotion, and intervention, and outlines effective team work strategies to implement the plan before and during early pregnancy.

The diabetes preconception and early pregnancy health care described in this document is an interactive model. This model includes patient education about the interaction of diabetes, pregnancy, and family planning; education in diabetes self-management skills; and counseling by a mental health professional when indicated to reduce stress and improve adherence to the diabetes treatment plan; as well as physician-directed medical care and laboratory tests. All elements of the model of care are important for patients to achieve the level of sustained glycemic control necessary to prevent congenital malformations.

Women with type 1 or 2 diabetes who intend to become pregnant are eligible for the diabetes preconception care program. Because unplanned pregnancies continue to occur in about two-thirds of women with diabetes, all diabetic women of child-bearing potential should be counseled about the risks of unplanned pregnancy and their use of appropriate contraception should be assured until metabolic control is achieved and conception is attempted.

An additional purpose of these guidelines is to facilitate reimbursement for all elements of the program by health insurance organizations. No reimbursement means no diabetes preconception care program and no cost savings. Payers realize that the preconception program must be used by clients for it to be effective in reducing costs of complications. This implies that a marketing plan, which might include financial incentives, will be necessary to inform patients about the program and to motivate them to seek preconception care.

SPECIFIC GOALS OF TREATMENT
Setting individual patient glycemic targets should take into account the results of both basic science and clinical trials examining the effects of metabolic control and pregnancy outcome. In addition, treatment goals should take into account the patient's capacity to understand and carry out the treatment regimen, the patient's risk for severe hypoglycemia, and other patient factors that may increase or decrease benefit.

The desired outcome of glycemic control in the preconception phase of care is to lower glycated hemoglobin so as to achieve maximum fertility and optimal embryo and fetal development. To achieve these goals, the woman with diabetes must be empowered to take control of her own disease process. This requires effective patient education and integrated care by the diabetes health care team in sharing knowledge of the rationale for tight metabolic control. Motivation for intensive self-management is dependent on the team's approach to imparting knowledge and skills to women with diabetes. Practical self-management skills essential for glycemic control and preparation for pregnancy include the following:

• Using an appropriate meal plan
• Timing meals and snacks
• Planning physical activity
• Choosing time and site of insulin injections
• Using carbohydrate and glucagon for hypoglycemia
• Reducing stress, coping with denial
• Testing capillary blood glucose
• Self-adjusting insulin doses

The amount of information to be imparted is extensive and overwhelming to most patients. Printed materials should be developed that the woman can take home and share with a primary care physician or obstetrician in another office. This is an effective means of making sure that the primary care physician is aware of the patient's expectations regarding care. The above constitutes an integrated model of care, demanding coordination of the roles of the different team members to listen, support, and consider the psychological problems that can interfere with successful diabetes self-management. A designated physician often performs the supervising/coordinating role.

Medical and Obstetric History
Physicians providing ongoing care to women with diabetes must recognize their responsibility to provide prepregnancy counseling, including information on the risk of congenital malformations and the means to prevent them. Contraception, timing of conception, control of the metabolic state, self-management techniques, assessment of diabetic complications, and other medical complications should all be evaluated. Concomitant care with other team members is necessary, and if not available, referral to specialty services is appropriate.

A complete history and physical assessment is imperative before planning for pregnancy. This should include, but not be limited to the following:

• Duration and type of diabetes (type 1 or type 2)
• Acute complications, including history of infections, ketoacidosis, and hypoglycemia
• Chronic diabetic complications, such as retinopathy, nephropathy, hypertension, atherosclerotic vascular disease, and autonomic and peripheral neuropathy
• Diabetes management, including insulin regimen, prior or current use of oral glucose-lowering agents, self-monitoring of blood glucose (SMBG) regimens and results, medical nutrition therapy (MNT), and exercise
• Concomitant medical conditions and medications, thyroid disease in particular
• Menstrual/pregnancy history; contraceptive use
• Support system, including family and work environment

An initial individual educational evaluation session with a nurse educator, a registered dietitian, and, if possible, a psychosocial expert is valuable. Members of the patient's immediate family are encouraged to attend and participate in these learning sessions. In conjunction with the primary care physician, these other professionals will review the patient's current management plan and develop a comprehensive treatment plan. This review should include but not be limited to the following:

• SMBG; the patient's familiarity with the techniques, the availability of the necessary equipment, and quality control of the patient actually performing the test
• Current medications, insulin regimens, and insulin adjustment techniques
• Hypoglycemia; review with the patient her history of hypoglycemic reactions including frequency, severity, signs and symptoms, and self-treatment
• Hyperglycemia/sick day routine; the patient's sick day plan; ketone testing, dietary adjustments, and insulin adjustments
• Nutrition history including weight changes, history of eating disorders, gastrointestinal problems, and lifestyle considerations. Diet recall or food diaries may be of benefit in identifying specific problems within the meal plan
• Calculation of caloric needs based on height, weight, age, and activity level with development of a meal plan, including distribution of calories, carbohydrate, fat, and protein to achieve optimal nutrition while maintaining appropriate weight and acceptable glycemic control
• MNT acceptable to the patient that meets the goals of the above assessment
• Psychosocial status including adherence issues, social support network, and stress factors related to both diabetes and pregnancy

The health professionals conducting the individual educational evaluation session should provide necessary intervention for both the patient and her family to maximize adherence to the designated treatment plan and to establish a positive self-image for the patient.

Physical Examination
A physical examination should be performed during the initial evaluation. High risk of diabetic complications and potential risks for pregnancy-related complications require a detailed physical examination with special emphasis on the following:

• Blood pressure measurement, including orthostatic changes
• Dilated retinal examination by an ophthalmologist or optometrist who is knowledgeable and experienced in the management of diabetic retinopathy; any woman with diabetes who is planning pregnancy should be examined before conception
• Cardiovascular examination in those with diabetes for more than 10 years or with other coronary artery disease risk factors or with complications of diabetes
• Neurological assessment, including autonomic function if necessary
• Lower extremity examination for evidence of vascular disease, neuropathy, deformity, or infection
• Pelvic examination including pap smear

Laboratory Evaluation
Blood glucose testing and urine ketone testing should be available in the office for immediate use as needed. In addition, each patient should undergo laboratory tests that are appropriate to the evaluation of the individual's general medical condition. Certain tests are critically important before conception to evaluate level of metabolic control, presence of diabetic complications, or concomitant disease. These may include the following:

• Glycated hemoglobin
• Baseline assessment of renal function by measurement of serum creatinine and urinary microalbumin measurement (albumin-to-creatinine ratio or 24-h collection with creatinine, allowing the simultaneous measurement of creatinine clearance) undertaken before conception and followed at regular intervals because of the impact of pregnancy on proteinuria and the impact of renal insufficiency on fetal growth and development
• Measurement of serum thyroid stimulating hormone and/or free thyroxine level in women with type 1 diabetes because of the 5­10% coincidence of hyper- or hypothyroidism)
• Other tests as indicated by physical exam or history

Management Plan
Discussions with the patient and her partner concerning management goals during pregnancy, the role of SMBG and glycated hemoglobin measurement, and maternal and fetal risks and complications will enable them to make an informed decision concerning both their desire for pregnancy as well as the optimal timing for conception. Counseling incorporates discussion of the following:

• Risk of congenital anomalies and means of prevention
• Fetal and neonatal complications
• Maternal complications including both diabetes-specific complications and obstetric complications
• Contraception
• Cost implications of care and pre- venting complications

Conception should be deferred until this initial evaluation is completed and specific goals of therapy have been achieved. Appropriate dietary adherence (including sufficient vitamins, iron, and supplemental folic acid), monitoring of capillary blood glucose, and evaluation or treatment of any abnormal physical or laboratory findings should be completed before conception. Since the safety of currently available oral glucose-lowering agents in pregnancy is not well established, women with type 2 diabetes who are taking such agents should be switched to insulin therapy for the preconception period and for pregnancy. All patients should be instructed in insulin adjustment algorithms with the goal of achieving SMBG results of

and a glycated hemoglobin value within or near the upper limit of normal for the laboratory or within three standard deviations of the normal mean. These goals may be modified depending upon the patient's recognition of hypoglycemia and risk of severe neuroglycopenia. Outpatient management is the appropriate forum for achieving preconception goals.

Hypertension, retinopathy, renal dysfunction, gastroparesis, and other neuropathies should be thoroughly evaluated, tested, and stabilized before pregnancy is planned. Antihypertensive agents that are safe for pregnancy should be used (avoid angiotensin-converting enzyme [ACE] inhibitors, -blockers, and diuretics).

CONTINUING CARE
Continuing care is essential in the management of every patient with diabetes contemplating pregnancy. At each visit, the patient's progress in achieving treatment goals should be evaluated by the health care team, and problems that have occurred should be reviewed. If goals are not being met, the management plan needs to be revised and/or the goals need to be reassessed.

VISIT FREQUENCY
The initial preconception evaluation should be comprehensive in scope. After that, the patient should be seen at approximately monthly intervals. Weekly telephone contact should also be considered. After appropriate glycemic control is achieved, glycated hemoglobin is repeated at 6- to 8-week intervals until conception occurs. If conception does not occur within 1 year, the patient is reassessed from a fertility standpoint.

Follow-up visits with members of the health care team are imperative. The frequency and particular member of the team contacted is determined by the specific needs of the individual patient.

Self-management techniques are reviewed and modified as necessary. These sessions are used primarily for patient education, motivation, and instruction in more effective management strategies. These sessions should do the following:

• Evaluate SMBG; observe patient's technique and correlate test with the laboratory; review her testing log for appropriate timing of testing, frequency of testing, and values
• Review the number of hypoglycemic and hyperglycemic episodes; evaluate the frequency, duration, timing, and treatment of these episodes; attempt to identify the cause of  hypoglycemia and hyperglycemia with the patient in an effort to prevent future episodes
• Review the exercise plan, including timing, duration, and intensity as it relates to her tolerance of the activity
• Evaluate the patient's understanding of insulin algorithms and reinforce her correct usage of insulin adjustment rules when reviewing the testing log; identify problem areas and reinstruct; alert other team members of actual or potential problems and modify the algorithms as necessary
• Identify social factors that may interfere with learning or self-care activities
• Review food records in reference to the blood glucose monitoring log, urinary ketone determinations, weight changes, blood pressure, and pertinent laboratory data
• Review patient motivation, understanding, and compliance with the designated meal plan
• Review weight changes and determine the appropriateness of the prescribed meal plan and adjust as necessary
• Explore compliance issues and resistance
• Counsel the patient concerning the impact of care plan on her work, family, and personal life
• Explore the impact of stress on pregnancy and on diabetes and how to cope with it
• Assess negative health behaviors in patient and her family including historical and current substance abuse, smoking, or subclinical food issues
• Discuss ethnic/cultural issues as they relate to diabetes management and pregnancy
• Inquire about response from family and partner to pregnancy and to diabetes
• Explore financial stress of pregnancy, diabetes, and parenthood; assess available resources and support
• Reinforce the importance of the overall treatment plan with the patient

LABORATORY DETERMINATIONS
Glycated hemoglobin is the best available measure of overall metabolic control during the preconception period. Determinations should be made on a monthly basis initially. Glucose determinations are obtained periodically as necessary for validation of SMBG testing technique and quality control. After glycemic control is achieved, glycated hemoglobin is repeated at 6- to 8-week intervals until conception.

Appropriate follow-up of observed abnormalities of electrolytes, renal function, thyroid function, or lipids should be undertaken as clinically indicated.

Hospitalizations
As a general rule, it is anticipated that preconception care with appropriate regulation of blood glucose levels and glycated hemoglobin can be achieved on an outpatient basis. Occasionally, it may become necessary to hospitalize individuals for initiation of intensive therapy based on the complexity of the care program and the limitations of the patient support system. In addition, hospitalization may be required for treatment of intercurrent illness and acute diabetic complications such as diabetic ketoacidosis, hyperosmolar nonketotic syndromes, or severe hypoglycemia.

Hypoglycemia
The occurrence of severe, frequent, or unexplained episodes of hypoglycemia may be due to a number of factors such as defective counterregulation, hypoglycemia unawareness, insulin dose errors, and excess alcohol intake. It is quite clear from the Diabetes Control and Complications Trial that attempts to achieve normal glycemic control in patients with type 1 diabetes increase the risk of severe hypoglycemia. While there is no solid evidence that such hypoglycemia is an independent risk to the developing human embryo, there is clear risk to the mother. Thus, it is imperative that this risk be explained to the woman with diabetes contemplating pregnancy, and means of prevention or ultimate treatment be provided to her and her family. Inclusion of family members and close associates of the patient in both education and management is imperative. Frequent contact with the patient for readjustment of the treatment program is integral to the prevention of severe hypoglycemia.

Retinopathy
Diabetic retinopathy may accelerate during pregnancy. The risk can be reduced by gradual attainment of good metabolic control before conception and by preconceptual laser photocoagulation in women with standard indications for that therapy. Thus, a baseline dilated comprehensive eye examination is necessary before conception, and women with preexisting diabetes should be counseled on the risk of development and/or progression of diabetic retinopathy. In settings where a retina specialist is unavailable, other experienced examiners may be acceptable. Follow-up ophthalmological examination should be anticipated during pregnancy for all women with diabetes.

Hypertension
Hypertension is a frequent concomitant or complicating disorder of diabetes. Patients with type 1 diabetes frequently develop hypertension in association with diabetic nephropathy as manifested by the presence of microalbuminuria or albuminuria. Patients with type 2 diabetes more commonly have hypertension as a concomitant disease. In addition, pregnancy-induced hypertension is a potential problem for the woman with diabetes, particularly when microalbumin is present before conception. Aggressive monitoring and control of hypertension in the preconception state is imperative to reduce the rate of progression of diabetic nephropathy, cerebrovascular disease, retinopathy, and cardiovascular disease. It is critical to keep in mind the potential interactions of antihypertensive agents with the developing conceptus. ACE inhibitors, -blockers, and diuretics should be avoided in women contemplating pregnancy.

Nephropathy
Baseline assessment of renal function by serum creatinine and some measure of urinary protein excretion (urine albumin-to-creatinine ratio or 24-h albumin excretion) should be undertaken before conception and followed at regular intervals because of the impact of pregnancy on proteinuria and the impact of renal insufficiency on fetal growth and development. Women with incipient renal failure (serum creatinine >3 mg/dl or creatinine clearance <50 ml/min) should be counseled to avoid pregnancy unless renal function can be stabilized by renal transplantation. In subjects with less severe nephropathy, renal function worsens during pregnancy in only 8–30% and at a rate no different than background; therefore, it should not serve as a contraindication to conception and pregnancy.

Neuropathy
The presence of autonomic neuropathy, particularly manifested by gastroparesis, urinary retention, hypoglycemic unawareness, or orthostatic hypotension may complicate the management of diabetes in pregnancy. These complications should be identified, appropriately evaluated, and treated before conception. Peripheral neuropathy, especially compartment syndromes such as carpal tunnel syndrome, may be exacerbated by pregnancy.

Cardiovascular Disease
The presence of coronary artery disease (CAD) suggests a high mortality rate during pregnancy. Evidence of CAD should be sought in any woman who has had diabetes for more than 10 years or in the presence of complications. Severe CAD should be adequately addressed before conception.

Early Pregnancy Management
At the earliest possible time after conception, pregnancy should be confirmed by laboratory assessment and the woman should be seen by the health care team. Reinforcement of management goals and therapeutic techniques is undertaken with further emphasis on the following:

• Meal planning to include appropriate calcium, folic acid, and other vitamin intake
• Appropriate modification of the meal plan to address nausea and vomiting
• Gestational weight gain goals
• Risk assessment and prevention of fasting hypoglycemia
• Insulin adjustment algorithms to achieve target glucose control
• Quality control in SMBG
• Psychosocial concerns including family, job, and financial stressors and coping mechanisms for stress

BIBLIOGRAPHY

Kitzmiller JL, Buchanan TA, Kjos S, Combs CA, Ratner R: Preconception care of diabetes, congenital malformations, and spontaneous abortions (Technical Review). Diabetes Care 19:514­41, 1996.

Copyright © 2000American Diabetes Association
Updated 7/00
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