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Society for Maternal-Fetal Medicine Special Statement: Updated checklist for antepartum care of pregestational diabetes mellitus

Published:August 27, 2020DOI:https://doi.org/10.1016/j.ajog.2020.08.063
      Pregnancy in women with pregestational diabetes mellitus (type 1 and type 2) carries increased risks of both maternal and neonatal complications due to maternal hyperglycemia and underlying chronic conditions and comorbidities. To reduce the risk of pregnancy complications or to mitigate their effects, numerous interventions are recommended at various times during pregnancy. Since 2016, the Society for Maternal-Fetal Medicine has posted a Diabetes Antepartum Checklist on its website. An updated version of this checklist is presented here, along with suggestions for implementation into the standard antenatal care of patients with type 1 and type 2 diabetes mellitus.

      Key words

      Introduction

      The prevalence of diabetes mellitus among women of reproductive age in the United States exceeds 6%
      • Britton L.E.
      • Hussey J.M.
      • Crandell J.L.
      • Berry D.C.
      • Brooks J.L.
      • Bryant A.G.
      Racial/ethnic disparities in diabetes diagnosis and glycemic control among women of reproductive age.
      and has been increasing in recent decades in parallel with the increasing rate of obesity.
      • Rowley W.R.
      • Bezold C.
      • Arikan Y.
      • Byrne E.
      • Krohe S.
      Diabetes 2030: insights from yesterday, today, and future trends.
      The prevalence is much higher in African American (15%), Native American (10.1%), and Hispanic women (7.5%) than in non-Hispanic White (4.8%) and Asian women (4.5%).
      • Britton L.E.
      • Hussey J.M.
      • Crandell J.L.
      • Berry D.C.
      • Brooks J.L.
      • Bryant A.G.
      Racial/ethnic disparities in diabetes diagnosis and glycemic control among women of reproductive age.
      Pregnancy in women with pregestational diabetes mellitus (type 1 and type 2) carries increased risks of both maternal and neonatal complications attributable to the degree of maternal hyperglycemia and underlying chronic conditions and comorbidities of diabetes mellitus.
      American Diabetes Association. 14. Management of diabetes in pregnancy: standards of medical care in diabetes-2020.
      Maternal risks include increased rates of preeclampsia and other hypertensive disorders, worsening of diabetic retinopathy, and diabetic ketoacidosis.
      • Mohan M.
      • Baagar K.A.M.
      • Lindow S.
      Management of diabetic ketoacidosis in pregnancy.
      Perinatal risks include increased rates of miscarriage, stillbirth, major congenital anomalies, preterm birth, fetal macrosomia, fetal hypertrophic cardiomyopathy, neonatal hypoglycemia, hyperbilirubinemia, and respiratory distress syndrome.
      • Mitanchez D.
      • Yzydorczyk C.
      • Siddeek B.
      • Boubred F.
      • Benahmed M.
      • Simeoni U.
      The offspring of the diabetic mother--short- and long-term implications.
      Long-term risks to the offspring include increased rates of childhood obesity, childhood diabetes mellitus and prediabetes, and cardiovascular diseases in later life.
      • Mitanchez D.
      • Yzydorczyk C.
      • Siddeek B.
      • Boubred F.
      • Benahmed M.
      • Simeoni U.
      The offspring of the diabetic mother--short- and long-term implications.
      Several interventions are recommended during pregnancy to reduce the risk of pregnancy complications or to mitigate their effects. These interventions include strict glycemic control, screening for comorbidities (foot exam, eye exam, thyroid function screening, urinary protein evaluation, electrocardiogram), diagnostic testing (eg, fetal anatomy ultrasound and fetal echocardiogram), preeclampsia prophylaxis (eg, low-dose aspirin), fetal surveillance, and individualized planning regarding the timing and mode of delivery.
      American Diabetes Association. 14. Management of diabetes in pregnancy: standards of medical care in diabetes-2020.
      ,
      American Diabetes Association. 4. Comprehensive medical evaluation and assessment of comorbidities: standards of medical care in diabetes-2020.
      ,
      American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins—Obstetrics
      ACOG Practice Bulletin no. 201: pregestational diabetes mellitus.
      Because there are many care elements to consider and because they are distributed in time over the several months of pregnancy, there is a risk that practitioners will inadvertently omit 1 or more elements, thereby increasing the risk of an adverse outcome. A cognitive aid such as a checklist can help to minimize such errors of omission.
      • Bernstein P.S.
      • Combs C.A.
      • et al.
      Society for Maternal-Fetal Medicine (SMFM)
      The development and implementation of checklists in obstetrics.
      Since 2016, the Society for Maternal-Fetal Medicine has posted a Diabetes Antepartum Checklist on its website.
      Society for Maternal-Fetal Medicine
      SMFM patient safety checklists.
      An updated version of this checklist is presented here, along with suggestions about how practices might implement the checklist into the standard antenatal care of patients with type 1 and type 2 diabetes mellitus.

      Checklist

      A sample checklist is shown in the Box. This checklist should be considered an example. Individual practices should customize it by adding or deleting specific items as needed to reflect their actual local management.
      Sample checklist for antepartum care of pregestational (type 1 or type 2) diabetes mellitus
      Checklist for Antepartum Care of Pregestational (Type 1 or Type 2) Diabetes Mellitus (DM)
      • This checklist is a sample and should be modified as needed to fit individual practice circumstances.
      • Items on the checklist are in addition to routine prenatal care and routine diabetes care.
      • Routine pregnancy care is assumed (eg, complete history and exam, routine lab assessments, prenatal vitamins, etc.).
      • Routine diabetes care is assumed (eg, glucose monitoring, glycemic targets, and glucose-lowering medications as needed).
      Initial Visit
      • Record age at onset of DM
      • History of DM complications:
        • o
          Ketoacidosis
        • o
          Hypoglycemia
        • o
          Gastroparesis
        • o
          Nephropathy
        • o
          Neuropathy
        • o
          Retinopathy
        • o
          Hypertension
        • o
          Coronary artery disease
        • o
          Arterial occlusive disease
      • Physical exam of lower extremities
        • o
          Perfusion (color, pulses)
        • o
          Sensory exam (touch, pain)
        • o
          Proper fit of footwear
      • Referral for retinal examination
      • Pneumococcus vaccine
      • Patient education
        • o
          Relationship between glycemic control and adverse pregnancy outcomes (miscarriage, birth defects, fetal growth restriction, macrosomia, stillbirth, preterm birth)
        • o
          Maternal adverse effects (hypertension/preeclampsia, worsening retinopathy or nephropathy)
        • o
          Medic alert bracelet or necklace
      • Family education
        • o
          Recognition and management of hypoglycemia
        • o
          Use of glucagon kit
      • Laboratory Tests:
        • o
          Hemoglobin A1c
        • o
          Comprehensive metabolic panel
        • o
          Thyroid-stimulating hormone (TSH)
        • o
          Urinary albumin/creatinine or protein/creatinine ratio
        • o
          Electrocardiogram if age ≥35 yrs or cardiac symptoms or risk factors are present
      Second Trimester
      • Low-dose aspirin 81 mg daily (start between 12 and 28 weeks of gestation, optimally before 16 weeks)
      • Detailed fetal anatomy ultrasound
      • Fetal echocardiogram
      Third Trimester
      • Antepartum fetal surveillance starting at 32 to 34 weeks of gestation (eg, nonstress test, amniotic fluid assessment, biophysical profile)
      Delivery Planning
      • Ultrasound for fetal growth assessment
      • Consider cesarean delivery if estimated fetal weight ≥4500 g
      • Delivery timing:
        • o
          Good glycemic control, no vascular complications: deliver at 39 0/7 to 39 6/7 weeks of gestation
        • o
          Poor glycemic control, vascular complications, or prior stillbirth: deliver at 36 0/7 weeks to 38 6/7 weeks
        • o
          Pregnancy complications such as fetal growth restriction or preeclampsia: delivery timing individualized depending on complication severity
      Postpartum
      • Ensure transition of care to endocrinology or primary care provider
      Version: September 14, 2020.
      Hameed. SMFM Special Statement: Updated checklist for antepartum care of pregestational diabetes. Am J Obstet Gynecol 2020.
      The design of the form follows the guidelines published in A Checklist for Checklists by Ariadne Labs. For example, the checklist uses a sans-serif font with black text on a white background; avoids the use of color; fits on 1 page; has a simple, uncluttered format; includes a version date; and does not include routine items that are at low risk of being omitted.
      Updates from the 2016 version include condensing the form to 1 page and some minor changes in verbiage. To minimize clutter, references supporting the suggested interventions are cited in the text
      American Diabetes Association. 14. Management of diabetes in pregnancy: standards of medical care in diabetes-2020.
      ,
      American Diabetes Association. 4. Comprehensive medical evaluation and assessment of comorbidities: standards of medical care in diabetes-2020.
      ,
      American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins—Obstetrics
      ACOG Practice Bulletin no. 201: pregestational diabetes mellitus.
      ,
      American College of Obstetricians and Gynecologists. Committee Opinion no. 743: low-dose aspirin use during pregnancy.
      American College of Obstetricians and Gynecologists. Committee Opinion no. 741: maternal immunization.
      American College of Obstetricians and Gynecologists. Committee Opinion no. 764: medically indicated late-preterm and early-term deliveries.
      rather than in footnotes of the checklist. The interventions themselves are essentially unchanged.
      This checklist is focused on antepartum care. The American Diabetes Association recently introduced a separate checklist for preconception care for women with diabetes mellitus.
      American Diabetes Association. 14. Management of diabetes in pregnancy: standards of medical care in diabetes-2020.

      Suggestions for Implementation

      The checklist is primarily intended to be used in the prenatal care clinic and not the hospital. Its purpose is to increase the probability that obstetrical care professionals will perform all of the special tasks expected for the management of these complex pregnancies.
      Implementation typically starts with the assembly of a team of relevant and engaged providers to spearhead the process. The team should likely include at least 1 physician, nurse, diabetes mellitus educator, and practice manager.
      The team should first decide whether they want obstetrical care professionals to use the checklist or whether they expect them to rely on training and memory to perform all the tasks listed. Errors of omission are less likely to occur if the checklist is used.
      If the practice decides to use the checklist, the team should carefully review the checklist items to determine whether they are consistent with current local practice. If there are elements that are not consistent, then either the checklist should be modified to reflect actual practice or an education process should be developed to align the practice with the checklist. The team should also decide whether they wish to add items that we have omitted based on our assumption that they are so routine that they are unlikely to be omitted (eg, teaching about glucose monitoring and diet or routine prenatal care items).
      An important point for each practice to consider is whether to have each checklist exist as a digital form in the patient’s electronic health record, a paper form in a physical chart, or simply a task list for obstetrical care professionals to reference without specifically including the form in each patient’s record. If a practice wants to use digital forms, resources will need to be directed toward the development of a special module within the electronic charting system. Paper chart forms may be relatively easier to implement, but they raise additional questions. For example, does each entry need the obstetrical care professional’s signature, date, and time? Where will the paper form be kept if the practice primarily uses electronic charting? If a practice decides to use the checklist as a reference and not include it in the patient chart, will a copy of the checklist be kept in a location where the staff can quickly reference it, such as a laminated sheet placed at each desk, a wall chart in diabetes mellitus education rooms, a practice protocol binder, or a digital file?
      Another point to consider is whether and how checklists that are started in an outpatient clinic will be transferred to the hospital when patients are admitted for antepartum hospitalization or delivery. If the clinic and hospital share a common electronic record platform, integration of the checklist into the records at both sites will be relatively straightforward, but some technical support may be needed to accomplish this. If the clinic and hospital records are not integrated, then cross-site availability of the checklist will be more challenging.

      Quality Indicators and Revisions

      Once the checklist has been implemented, the team should consider tracking whether it is being used effectively. If the obstetrical care professionals are not using it routinely, then barriers to use should be identified and solved. A targeted quality audit can reveal areas that need additional attention. Useful indicators might include the percentage of gravidas with pregestational diabetes mellitus who (1) started low-dose aspirin at 12 to 16 weeks’ gestation (optimal timing),
      American College of Obstetricians and Gynecologists. Committee Opinion no. 743: low-dose aspirin use during pregnancy.
      (2) started low-dose aspirin at 12 to 28 weeks’ gestation (acceptable timing),
      American College of Obstetricians and Gynecologists. Committee Opinion no. 743: low-dose aspirin use during pregnancy.
      (3) had a baseline assessment of urinary albumin or total protein excretion,
      American Diabetes Association. 14. Management of diabetes in pregnancy: standards of medical care in diabetes-2020.
      ,
      American Diabetes Association. 4. Comprehensive medical evaluation and assessment of comorbidities: standards of medical care in diabetes-2020.
      and (4) received pneumococcus vaccine or had documentation of previous vaccination.
      American College of Obstetricians and Gynecologists. Committee Opinion no. 741: maternal immunization.
      Each of the above indicators should be stratified by race and ethnicity to ensure that the checklist is equitably implemented and to evaluate for possible unintended consequences in particular racial and ethnic groups.
      Revisions to the checklist may be needed to improve adherence, clarify questions that may arise, or align with new standards of care that may be introduced. If revisions are made, the version date should be edited, and any circulating copies of older versions should be discarded.

      References

        • Britton L.E.
        • Hussey J.M.
        • Crandell J.L.
        • Berry D.C.
        • Brooks J.L.
        • Bryant A.G.
        Racial/ethnic disparities in diabetes diagnosis and glycemic control among women of reproductive age.
        J Womens Health (Larchmt). 2018; 27: 1271-1277
        • Rowley W.R.
        • Bezold C.
        • Arikan Y.
        • Byrne E.
        • Krohe S.
        Diabetes 2030: insights from yesterday, today, and future trends.
        Popul Health Manag. 2017; 20: 6-12
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        • Mohan M.
        • Baagar K.A.M.
        • Lindow S.
        Management of diabetic ketoacidosis in pregnancy.
        Obstet Gynaecol. 2017; 19: 55-62
        • Mitanchez D.
        • Yzydorczyk C.
        • Siddeek B.
        • Boubred F.
        • Benahmed M.
        • Simeoni U.
        The offspring of the diabetic mother--short- and long-term implications.
        Best Pract Res Clin Obstet Gynaecol. 2015; 29: 256-269
      2. American Diabetes Association. 4. Comprehensive medical evaluation and assessment of comorbidities: standards of medical care in diabetes-2020.
        Diabetes Care. 2020; 43: S37-S47
        • American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins—Obstetrics
        ACOG Practice Bulletin no. 201: pregestational diabetes mellitus.
        Obstet Gynecol. 2018; 132: e228-e248
        • Bernstein P.S.
        • Combs C.A.
        • et al.
        • Society for Maternal-Fetal Medicine (SMFM)
        The development and implementation of checklists in obstetrics.
        Am J Obstet Gynecol. 2017; 217: B2-B6
        • Society for Maternal-Fetal Medicine
        SMFM patient safety checklists.
        (Available at:)
        • Ariadne Labs
        A checklist for checklists.
        (Available at:)
      3. American College of Obstetricians and Gynecologists. Committee Opinion no. 743: low-dose aspirin use during pregnancy.
        Obstet Gynecol. 2018; 132: e44-e52
      4. American College of Obstetricians and Gynecologists. Committee Opinion no. 741: maternal immunization.
        Obstet Gynecol. 2018; 131: e214-e217
      5. American College of Obstetricians and Gynecologists. Committee Opinion no. 764: medically indicated late-preterm and early-term deliveries.
        Obstet Gynecol. 2019; 133: e151-e155