Educating Diabetic Women on the Potential Teratogenic Effects of Hyperglycemia on Fetal Development during Pregnancy

Millions of people in the United States have diabetes, and that number has increased exponentially in the past three decades. This has led to an increased incidence of pregnancies complicated by pregestational diabetes mellitus (PGDM). PGDM has also increased the number of infants admitted to the neonatal intensive care unit (NICU) for congenital malformations and other perinatal complications associated with poor glycemic control. Many diabetic women are unaware of their risk for poor pregnancy outcomes related to gestational hyperglycemia and are unaware of measures they can take to reduce these risks. This project looked at the current preconception education provided by primary care providers (PCPs) to women with diabetes. A review of the literature revealed that nearly two million women of childbearing age have diabetes. Hyperglycemia is a hallmark of diabetes and is a known fetal teratogen. Neonates of women who are diabetic are at increased risk of admission to the NICU. Diabetes is associated with a higher risk of anomalies in multiple fetal organ systems. Preconception counseling for diabetic women of reproductive age in primary care is a missed opportunity for prevention of poor pregnancy outcomes. An educational tool designed for women with diabetes specific to hyperglycemia and fetal outcomes helps PCPs provide education in a quick and easy format to all women with type 1 or type 2 diabetes. A Research Data Capture program survey sent to PCPs in two community clinics elicited current diabetic patient counseling practices related to pregnancy. Based on this feedback, an educational tool in the form of a handout was developed to inform diabetic women of fetal complications associated with poor glycemic control. Following chair and content expert approval of the tool, select providers received a copy for their input. Based on the feedback of these providers, the educational tool underwent minor revisions. Women of childbearing age with diabetes were recruited to evaluate the content and format of the educational tool. Each participant showed an improvement between the pre- and post-questionnaire. The comments were positive as to the ease of understanding and information given. As demonstrated by evaluation of participant responses, the educational tool improved knowledge and thereby has the potential to improve outcomes for women, their infants, and their communities. Discussion with a representative from EpicTM, a proprietary electronic health record (EHR), occurred regarding integration of the tool into the EHR patient education database. The tool was presented at the Utah Conference for Public Health in March 2017. Unplanned pregnancies are common, and women of reproductive age who have diabetes may not be aware of the increased risk to themselves and their infants when their diabetes is not well controlled. Every opportunity should be taken to educate women about these risks and their roles in reducing these risks, and primary care is currently a missed opportunity. The proposed educational tool addresses this need by providing PCPs with an accessible patient resource as an adjunct to their current health care counseling.

Running head TERATOGENIC EFFECTS OF DIABETES ON THE FETUS Educating Diabetic Women on the Potential Teratogenic Effects of Hyperglycemia on Fetal Development during Pregnancy Jeanette Seidel , BSN University of Utah College of Nursing In partial fulfillment of the requirements for the Doctor of Nursing Practice 1 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 2 Executive Summary Millions of people in the United States have diabetes, and that number has increased exponentially in the past three decades. This has led to an increased incidence of pregnancies complicated by pregestational diabetes mellitus (PGDM). PGDM has also increased the number of infants admitted to the neonatal intensive care unit (NICU) for congenital malformations and other perinatal complications associated with poor glycemic control. Many diabetic women are unaware of their risk for poor pregnancy outcomes related to gestational hyperglycemia and are unaware of measures they can take to reduce these risks. This project looked at the current preconception education provided by primary care providers (PCPs) to women with diabetes. A review of the literature revealed that nearly two million women of childbearing age have diabetes. Hyperglycemia is a hallmark of diabetes and is a known fetal teratogen. Neonates of women who are diabetic are at increased risk of admission to the NICU. Diabetes is associated with a higher risk of anomalies in multiple fetal organ systems. Preconception counseling for diabetic women of reproductive age in primary care is a missed opportunity for prevention of poor pregnancy outcomes. An educational tool designed for women with diabetes specific to hyperglycemia and fetal outcomes helps PCPs provide education in a quick and easy format to all women with type 1 or type 2 diabetes. A Research Data Capture program survey sent to PCPs in two community clinics elicited current diabetic patient counseling practices related to pregnancy. Based on this feedback, an educational tool in the form of a handout was developed to inform diabetic women of fetal complications associated with poor glycemic control. Following chair and content expert approval of the tool, select providers received a copy for their input. Based on the feedback of these providers, the educational tool underwent minor revisions. Women of childbearing age with diabetes were recruited to evaluate the content and format of the educational tool. Each participant showed an improvement between the pre- and post-questionnaire. The comments were positive as to the ease of understanding and information given. As demonstrated by evaluation of participant responses, the educational tool improved knowledge and thereby has the potential to improve outcomes for women, their infants, and their communities. Discussion with a representative from EpicTM, a proprietary electronic health record (EHR), occurred regarding integration of the tool into the EHR patient education database. The tool was presented at the Utah Conference for Public Health in March 2017. Unplanned pregnancies are common, and women of reproductive age who have diabetes may not be aware of the increased risk to themselves and their infants when their diabetes is not well controlled. Every opportunity should be taken to educate women about these risks and their roles in reducing these risks, and primary care is currently a missed opportunity. The proposed educational tool addresses this need by providing PCPs with an accessible patient resource as an adjunct to their current health care counseling. Expertise and support for this project were provided by the project committee, which includes Project Chair Pamela Phares, PhD, APRN; Neonatal Nurse Practitioner Specialty Track Director Kim Friddle, PhD, APRN, NNP-BC; Assistant Dean of MS and DNP Programs Pamela Hardin, PhD, RN, CNE; and content expert Dr. Nancy Allen, PhD, APRN. TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 3 Table of Contents Executive Summary 2 Acknowledgements 5 Introduction 6 Problem Statement 6 Clinical Significance 6 Purpose and Objectives 7 Literature Review 8 Search Strategy 8 Diabetes Mellitus in Women of Childbearing Age 9 Glycemic Control 10 Diabetes Mellitus and Congenital Anomalies 10 Diabetes Mellitus and Perinatal Complications 11 Diabetes Mellitus and Future Child Development 12 Increasing Awareness in Women with PGDM 12 Theoretical Framework 13 Implementation and Evaluation 15 Evaluation of Current Practices in Primary Care 15 Educational Tool Development 16 Dissemination to Specific Population 16 Dissemination to the Broader Public 18 Results ……………………………………………………………………………….……….18 Recommendations……………………………………………………………………………19 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS Doctor of Nursing Practice Essentials 4 20 Conclusion ……………………………………………………………………………………21 References 22 Appendices 27 Appendix A. Doctor of Nurse Practitioner Proposal Presentation 27 Appendix B. Final Poster for Project Defense 33 Appendix C. Institutional Review Board Approval 34 Appendix D. Needs Assessment - Provider Questionnaire 36 Appendix E. Maternal Diabetes and the Fetus Educational Tool 37 Appendix F. Participant Questionnaire: Pre-Test 39 Appendix G. Participant Questionnaire: Post-Test 40 Appendix H. Flesch-Kincaid Evaluation Tool 41 Appendix I. Acceptance to Speak at the UPHA Conference 42 Appendix J. PowerPoint Presentation for the UPHA Conference 44 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS Acknowledgements Thanks to the endocrinology clinic providers and staff for your support of this project Thank you to my family for your unwavering support and encouragement 5 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 6 Problem Statement Over 29 million people have diabetes, and another 85 million have prediabetes (American Diabetes Association, 2015). An increasing number of women of reproductive age have pregestational diabetes mellitus (PGDM). Diabetes has a known teratogenic effect on the fetus, therefore, these women need to be educated about the importance of glycemic control prior to and during pregnancy to decrease the risk of congenital anomalies and other perinatal complications. The specific cause of such complications is unknown, but it is likely that poor glycemic control plays a large part. Hyperglycemia in the first trimester of pregnancy is associated with multiple congenital anomalies and spontaneous abortion (Kitzmiller, Wallerstein, Correa, & Kwan, 2010). Fetal and perinatal risk declines in women who have optimal glycemic control both prior to becoming pregnant as well as during pregnancy (Roman, 2011). Public education about the teratogenic effects of diabetes on the fetus is necessary in order to inform women how they may improve pregnancy outcomes by improving their glycemic control. Clinical Significance The incidence of diabetes in women of reproductive age has increased, and admissions to the neonatal intensive care unit (NICU) for diabetes-related diagnoses correlate with this increase. One study found that women with type 2 diabetes (T2DM) were 11 times more likely to have an infant with a congenital anomaly than women without T2DM (Dunne, Brydon, Smith, & Gee, 2003). More recently, Castori (2013) found that the likelihood of congenital anomalies is two to five times more common in infants of mothers with diabetes. Diabetes has been associated with multiple congenital anomalies that include cardiac, renal, gastrointestinal, and neural tube defects (Castori, 2013). Diabetes mellitus (DM) can also result in complications at the time of TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 7 delivery. These complications can include infant hypoglycemia, respiratory distress syndrome, and macrosomia, among others (Fraser & Lawlor, 2014). These outcomes can be devastating and can result in extended stays in the NICU. Hyperglycemia is a hallmark of diabetes and is implicated as a major factor in congenital anomalies and perinatal complications (Macintosh et al., 2006; Ornoy, Reece, Pavlinkova, Kappen, & Miller, 2015; Roman, 2011). Educating women about the importance of glycemic control can help reduce the risk of congenital anomalies and perinatal complications (Kitzmiller, Wallerstein, Correa, & Kwan, 2010). Women who are engaged in their own health care have better health outcomes (James, 2013). Women who achieve euglycemia prior to pregnancy and are able to maintain it throughout pregnancy can avoid many of the complications of diabetes that adversely affect the fetus (Walsh, 2010). Providing an educational fact sheet to women of childbearing age is one way to encourage mothers with PGDM to improve their glycemic control before becoming pregnant. Providing this information to all diabetic women of childbearing age, not just to diabetic women seeking to become pregnant, would be an ideal catchment opportunity. For these women, knowledge is an important tool in taking responsibility for their own health and the health of their unborn children. Purpose and Objectives The purpose of this project was to develop an educational tool about the potential risks to a developing fetus from a diabetic mother with poor glycemic control. The tool is a handout for primary care providers (PCPs) to use in counseling women who have DM and who are of childbearing age. The objectives of the project were as follows: TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 8 1. To determine the current availability of educational resources provided to women with diabetes regarding optimal glycemic control and pregnancy outcomes. 2. To develop an educational tool that addresses potential health risks to the fetus and describes possible perinatal complications that may result when women of childbearing age with PGDM do not maintain optimal glycemic control before and during pregnancy. 3. To evaluate the educational tool ("Maternal Diabetes and Your Unborn Baby") based on its usability, feasibility, and acceptability by gathering provider and patient feedback on the tool. 4. To explore the feasibility of integrating the educational tool into the EpicTM electronic health record patient educational resource bank. 5. To prepare an abstract of the project's findings to submit for presentation at an appropriate professional conference and thus disseminate the educational tool content more broadly. Literature Review Search Strategy Databases used in this review included PubMed, CINAHL, and UpToDate. The search terms used included diabetes, pregestational, hyperglycemia, teratogen, diabetic embryopathy, preconception care, fetus, perinatal complications, anomalies, and educational effects on behavior change. Also included was content from professional organization websites and governmental resources that set guidelines for diabetes care. Articles published between 1990 and 2016 were included in the review. Only articles published between 2008 and 2016 were used in developing the educational tool. TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 9 Diabetes Mellitus in Women of Childbearing Age Prevalence of women with DM who are of childbearing age. T2DM has increased fourfold over the past 3 decades (Centers for Disease Control, 2015). In the United States, an estimated 1.85 million women of childbearing age have been diagnosed with diabetes (Congenital Heart Public Health Consortium, 2016). The American Diabetes Association (2015) reports that for every two women diagnosed with diabetes, there is one who remains undiagnosed. The older women get, the more likely they are to develop T2DM. At the same time, women are waiting longer to have children. These two facts combined means that more women with T2DM are likely to become pregnant than in the past. Diagnosis and risk. Timing of diagnosis related to pregnancy can help determine the type of risk to the fetus. Women diagnosed prior to pregnancy have PGDM (either T1DM or T2DM), and they are at increased risk of having infants with fetal anomalies (Beauhamais, Roberts, & Wexler, 2012). Gestational diabetes mellitus (GDM) develops related to changes in the bodies of pregnant women, but it can be the initial diagnosis of PGDM, especially when diagnosed early in pregnancy (Fleming & Corbett, 2010). Women with GDM have a lower risk of having infants with congenital anomalies than women with PGDM. Women in either category who have poor glycemic control are at risk of having perinatal complications (Fraser & Lawlor, 2014). Women with levels of glycosylated hemoglobin, or hemoglobin A1c (HbA1c), above 8% experience more fetal complications (Colstrup et al., 2013; Miller et al., 2013). HbA1c is a laboratory value that estimates average glucose for the 3 months prior to the test. Maternal-fetal medicine specialists recommend that pregnant diabetic women ideally maintain an HbA1c between 6.0% and 6.5% (American Diabetes Association, 2015). TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 10 Glycemic Control It would be easy to ascribe the same pregnancy risks to both T1DM and T2DM, but there is some evidence that pregnancy outcomes between the two vary slightly and that risk occurs at different levels of glycemic control (Owens, Sedar, Carmody, & Dunne, 2015). Hyperglycemia is implicated as a major factor in congenital anomalies and perinatal complications (Ornoy et al., 2015). Perinatal complications can include stillbirth, large size for gestational age, and hypoglycemia in infants. Researchers found that higher levels of HbA1c are associated with congenital fetal anomalies. An HbA1c greater than 8.35% is predictive for the presence of any anomaly and/or cardiovascular or vascular anomalies (Miller et al., 2013). Women with T2DM show poorer outcomes at lower HbA1c levels than those with T1DM (Owens, Sedar, Carmody, & Dunne, 2015). Other factors related to DM likely contribute to poor fetal outcomes (GilbertBarness, 2010; Kitzmiller, Wallerstein, Correa, & Kwan, 2010). Diabetes Mellitus and Congenital Anomalies T1DM and T2DM both result in hyperglycemia, but evidence suggests that they affect fetal development differently. Complications associated with T1DM are usually associated with extreme hyperglycemia in the first trimester. With T2DM, vascular complications are more common in the developing embryo and may be related to increased maternal age, obesity, and hypertension (Beauhamais, Roberts, & Wexler, 2012). As T2DM has become more prevalent, complications that were normally associated with T1DM have increased. Embryonic complications associated with maternal DM have become the leading cause of infant death in the United States (Dong et al., 2016). Though the exact mechanism is unknown, there are many theories as to how hyperglycemia influences the occurrence of congenital anomalies. Hyperglycemia is a result of TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 11 abnormal glucose metabolism, and several studies have looked at glucose metabolism and how it regulates specific developmental control genes during embryonic development (Sanders, Jung, & Loeken, 2014; Yang, Shen, Reece, Chen, & Yang, 2016; Zabihi & Loeken, 2010). The yolk sac formed in the first days of pregnancy, which acts as a primitive placenta, is especially vulnerable to hyperglycemia. In response to hyperglycemia, the sac can undergo vascular changes that lead to malformations in the embryo (Dong et al., 2016). Vascular changes have been directly linked to neural tube defects, which may be attributable to abnormal gene expression (Yang et al, 2016; Yu, Wu, & Yang, 2016). Complications early in pregnancy. The first 8 weeks are most critical in organ formation. Many anomalies associated with environmental exposure to teratogens, such as with DM, occur between the third and seventh weeks of pregnancy, before many women even suspect they are pregnant (Allen & Armson, 2007). Hyperglycemia in the first trimester of pregnancy is associated with multiple congenital anomalies and spontaneous abortion (Kitzmiller, Wallerstein, Correa, & Kwan, 2010). Multiple fetal organ systems start developing early in the first trimester, and high glucose levels during this period may result in a variety of malformations. Researchers found that the incidence of caudal regression sequence is high with PDGM (Garne et al., 2012; Ornoy, Reece, Pavlinkova, & Miller, 2015). They also found that nonchromosomal anomalies are more likely to occur with PGDM and that these anomalies could present in multiple systems. Diabetes Mellitus and Perinatal Complications DM can also result in complications at the time of delivery and during the infant's postnatal period. Complications can include respiratory distress syndrome and macrosomia, among others (Fraser & Lawlor, 2014). Infants of mothers with diabetes are more likely to have postnatal hypoglycemia related to poor glycemic control, requiring treatment in the NICU TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 12 (Owens, Sedar, Carmody, & Dunne, 2015). Infants of mothers with diabetes are also more likely to be large for gestational age, which can increase the risk of Cesarean delivery, shoulder dystocia, and other complications related to vaginal delivery. Women with T1DM are more likely to have poorly developed placentas, resulting in infants who are small for gestational age. Women with T2DM have an increased risk for placental infarcts, which may play a role in perinatal mortality (Beauhamais, Roberts, & Wexler, 2012). Diabetes Mellitus and Future Child Development Diabetes not only affects fetal and perinatal outcomes but can also have far-reaching effects on children. Some evidence indicates that children of mothers with diabetes have a higher risk of being overweight as well as a higher risk of poor cardiometabolic health in the future (Fraser & Lawlor, 2014). It has been theorized that increased glucose results in infants having greater adipose tissue mass at birth, which increases the risk for obesity as they get older. Fraser and Lawlor (2014) also found that these infants are more likely to develop diabetes later in life and that the girls among these infants are more likely to develop GDM. The cerebral cortex undergoes developmental changes during the second half of pregnancy, which is also the period during which GDM commonly develops. This results in children of mothers who had GDM exhibiting similar rates of developmental dysfunction as children whose mothers had PGDM (Ornoy, Reece, Pavlinkova, Kappen, & Miller, 2015). This dysfunction is generally not cognitive but rather related to motor function, attention span, and activity. Increasing Awareness in Women with PGDM Diabetic women of childbearing age need to be made aware of the risk of congenital anomalies associated with diabetes, and they need to understand how important it is to maintain TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 13 optimal glycemic control prior to and during pregnancy. The primary care setting, where many women of reproductive age receive health care, is an ideal place to educate those with PGDM about pregnancy-related risks as well as about their own roles in reducing those risks. Unfortunately, the opportunity for this education is often missed, but maternal education on the importance of glycemic control is imperative and can be beneficial at any time (Fleming & Corbett, 2010). It has been demonstrated that educating women about the importance of glycemic control can help reduce the risk of congenital anomalies in their offspring as well as help reduce the risk of perinatal complications (Kitzmiller, Wallerstein, Correa, & Kwan, 2010). Many pregnancies are unplanned, and therefore preconception counseling should occur in all diabetic women of childbearing age (Fleming & Corbett, 2010). Studies done over several decades show that preconception counseling is beneficial in reducing the risk of congenital anomalies (Goldman et al., 1986; McElvy et al., 2000; Pridjian, 2010; Roman, 2011; Steel, Johnstone, Hepburn, & Smith, 1990; Willhoite et al.,1993). Preconception counseling can decrease malformation and perinatal mortality rates to the rates seen in the background population (McElvy et al., 2000). The high prevalence of anomalies in women with elevated HbA1c levels stresses the importance of preconception counseling and lifestyle modification (Miller et al., 2013). Theoretical Framework Hochbaum, Kegels, and Rosenstock developed the health belief model (HBM) as part of a U.S. public health service project to understand why people do not participate in preventable health behaviors (Janz & Becker, 1984). The model has evolved to explain specific perceptions that result in individuals either changing their behavior or maintaining the same behavior. The HBM promotes five conceptual constructs to explain health behaviors: perceived susceptibility, TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 14 perceived seriousness, perceived benefits to taking action, barriers to taking action, and cues to action (Champion & Skinner, 2008). These five key constructs serve as a guide for educating patients so that they understand the risk of a behavior and the benefit of taking action to decrease the risk. This project focused on the perinatal risk to the fetus when the mother's glycemic control was not optimal prior to pregnancy. The HBM provided a framework for successful completion of this project. The educational tool addresses the perceived susceptibility of infants to diabetesrelated risks by providing information on the overall risk of fetal complications associated with maternal diabetes. The educational tool addresses susceptibility by pointing out the strong associations between poor glycemic control and the risk of negative fetal outcomes. Maternalfetal disease information may be an effective source of motivation to change behaviors (Gaston & Prapavessis, 2009). The tool highlights the perceived seriousness of these risks by explaining the types of complications that may occur in fetuses and newborns. The perceived benefits to taking action include a decrease in the risk of complications in the fetus and neonate; this decrease is the result of increased glycemic control. The educational tool focuses on what the mother can do to reduce the risk of complications to her baby. The desire to avoid adverse outcomes in the infant can serve as a motivator in maintaining optimal glycemic control (Fleming & Corbett, 2010). Each individual has different barriers to taking action; these barriers can include the cost of healthier foods, minimal support at home, and lack of knowledge. The health care provider and diabetes educator can address these barriers during consultations and offer other resources that may help. The cues to action are specific recommendations given on the tool regarding what to do to reduce risks to the fetus. TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 15 Implementation and Evaluation Evaluation of Current Practices in Primary Care The DNP project was presented and passed and approved by the University of Utah College of Nursing faculty (see Appendix A), and the implementation phase of the project began. An application to review this project was submitted to The University of Utah Institutional Review Board (IRB) and approved (see Appendix C). A search of the current patient education database was completed to determine available tools for clinicians. There were a number of tools about diabetes, but none were found that were specific to diabetes and how hyperglycemia can affect the fetus. Primary health care providers in two community clinics were surveyed to determine current practices for counseling women of childbearing age who have PGDM and to assess needs for a counseling educational tool. An email link to an electronic survey elicited current practices for advising diabetic women regarding pregnancy. The Research Data Capture program was used to administer the online survey tool. Each clinician was contacted personally before the survey was sent out, and reminder emails were sent at one-week intervals for three consecutive weeks in order to increase participation. Contact with clinicians who did not respond to the electronic survey was made via in-person visits to their clinics with paper copies of the questionnaire. At one community clinic, providers filled out paper copies of the survey during their monthly provider meeting. At the other community clinic, a luncheon was provided to encourage completion of the survey. A goal was set to obtain completed surveys from at least 20% of clinicians from the two target clinics. TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 16 Educational Tool Development The educational tool reflects the current evidence and expert opinion regarding potential adverse effects of poor glycemic control on fetuses in the perinatal period. Creating the educational tool involved integrating current evidence as well as discussions with providers and a diabetes content expert. Diabetes educators at an academic endocrinology clinic were also approached for information. Feedback from the content expert and project chair was elicited, and further revisions were made based on their feedback. The content expert evaluated and approved a completed draft of the educational tool. The clinicians who participated in the survey were provided a copy of the educational tool for further input. Their evaluation and input resulted in only minor revisions. Incorporating their input also helped promote buy-in of the project. The content expert and project chair reviewed the educational tool again and approved a final draft (see Appendix E). The Flesch-Kincaid literacy-level measure was used to evaluate the educational tool (Readable.io, 2017), and the tool was found to be written at no higher than a sixth-grade reading level (see Appendix H). Dissemination to Specific Population A flyer was developed to recruit diabetic women at a clinic to evaluate the educational tool. Due to clinic policy, however, the flyer could not be posted. An alternate plan for recruiting participants was required. Clinicians and diabetes educators assisted in recruiting 10 adult female participants to evaluate the educational tool and provide feedback regarding its content and format. Feedback was provided in the form of pre- and post-questionnaires (see Appendices F and G). Both questionnaires focused on the participants' understanding of the tool's content, format, and ease of reading. A post-questionnaire also solicited feedback. TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 17 The 10 women recruited were between the ages of 19 and 42 years. The first participant was located with the help of a clinician at one of the target clinics. She reported that the information in the educational tool was excellent and was very similar to what her endocrinologist had provided. The first participant completed the pre- and post-questionnaire within 15 minutes. This short time frame was beneficial, and participants were able to complete the project requirements while waiting for their providers. Because many clinicians at the first clinic refer their patients to the endocrinology clinic, it was decided that further participants would be recruited at the endocrinology clinic. Several clinicians and diabetes educators at the endocrinology clinic assisted in recruiting nine more women with PGDM. Each participant was approached while they waited to see a clinician or educator. The participants verbally consented, and each agreed to complete the pre-questionnaire, read the educational tool, and complete the post-questionnaire. All participants completed the questionnaires, and a brief discussion occurred regarding their perception of the educational tool. Microsoft Excel was used to evaluate the preand post-questionnaire answers. Participants' evaluation and comments were considered for incorporation into the final educational tool. During a consultation with Melissa Briley from the EpicTM IT team, she provided information for Darrin Doman, the primary contact person at EpicTM with whom to discuss integration of the tool into the patient education database. This would improve the ease of access for providers and result in increased use. Mr. Doman indicated that EpicTM uses education database resources from a designated medical education company only. An alternate way to disseminate the tool was needed. A copy of the educational tool was sent out via email to the medical directors at the target clinics with encouragement to disseminate it annually to all women with diabetes to promote optimal glycemic control prior to pregnancy. TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 18 Dissemination to the Broader Public An abstract was submitted and accepted for presentation at the March 28, 2017 Utah Conference for Public Health in Park City, Utah March 1, 2017 (see Appendix I). The PowerPoint presentation of the content presented at the conference is included (see Appendix J). Results Approximately 50% of the clinicians (n=12) between the two community clinics completed the survey. The survey consisted of eight yes/no questions and one multiple-choice question (see Appendix D). Many clinicians reported providing education to diabetic women about the importance of euglycemia but did not provide this education to all women with diabetes of childbearing age. Most clinicians referred patients to dietitians and endocrinology clinics. Many also provided a list of online resources. Every clinician who completed the survey reported their willingness to use an educational tool in their practice. Verbal feedback on the completed educational tool was positive and a majority of clinicians felt the information was relevant and helpful. Of note, only one clinician reported that the content was "too scary," but no details or explanation for this remark were given. A total of 10 women were recruited to evaluate the educational tool. The first participant reported that the information in the educational tool was excellent and was very similar to what her endocrinologist had provided. The only participant older than 40 years of age reported that the information was good and that education is important. She also shared with the author that the pregnancy risks associated with DM were the reason she did not have children. Another participant reported a prior pregnancy that resulted in an infant with caudal regression syndrome. This participant reported that the information on the tool was "awesome" and "very helpful." Other participants commented that the information was "good," "excellent," and "easy to read." TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 19 Several participants were appreciative of the information and felt it was helpful. All participants showed improvement between the pre- and post-questionnaires. These results indicate that the handout can be a useful educational tool in outpatient care settings to improve education for all women with PGDM regarding potential risks to the fetus. Although this educational tool cannot be integrated into EpicTM , a conversation was started with Mr. Doman about the need for education covering this content. The Utah Public Health Association Conference was an appropriate venue for broader dissemination of this topic. Recommendations Knowledge is key for enhancing self-agency in health care and health promotion. Women with diabetes should be given pragmatic and evidence-based information on the importance of glycemic control prior to and during pregnancy. Based on clinicians' survey responses, this information is not being consistently delivered in the primary care setting. The limited number of questions and the dichotomous responses limited the ability of the survey to determine current educational practice. In hindsight, adding qualitative components to the survey questions would have been helpful in fully evaluating the current education provided. Further questioning of the clinicians would have clarified specific websites and sources for the handouts they use to educate patients. The educational tool was written in English, and this limited the participant pool substantially. Translating the educational tool into other languages would increase relevance and dissemination of the information. Pregestational diabetes has a higher incidence in nonCaucasian populations and translation of the tool into other languages would capture populations at increased risk for pregnancy complications related to uncontrolled diabetes. The time TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 20 constraint and lack of financial resources limited evaluation of the tool to English-speaking patients only. Education that addresses glycemic control prior to and during pregnancy with regard to fetal outcomes should be included as a resource in electronic medical records (EMR). Policy governing educational content in the EpicTM database precluded inclusion of the educational tool in this institution's EMR. Inclusion would have given PCPs the tool in an easy-to-access format. Primary care providers will likely use an educational tool that is available in the EMR rather than a handout that takes time to locate. Although this educational offering cannot be included in the EMR, contact with Mr. Doman resulted in consideration of similar content being added from their medical education resource company to address the gap in their current patient education resources. Brenda Gulliver, RN, nurse manager of the community clinics affiliated with the academic medical center used for this project, has requested presentations of this educational tool be given in several community clinics. These presentations were not included as an objective for this project but will serve as additional opportunities to disseminate the educational tool. Doctor of Nursing Practice Essentials This project met DNP Essential III: Clinical Scholarship and Analytical Methods for Evidence-Based Practice (American Association of Colleges of Nursing, 2006). The literature addresses DM frequently, and preconception care has far-reaching benefits (Castori, 2012). This project included a review of current research and recommendations for practice. Applying this research by developing an educational tool reflected DNP Essential III because it involved translating research into practice and disseminating information. TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 21 This project met DNP Essential VII: Clinical Prevention and Population Health for Improving the Nation's Health (American Association of Colleges of Nursing, 2006). This project focused on improving clinical outcomes for the population of diabetic women of childbearing age and their infants. Perinatal complications increase the morbidity and mortality of both mothers and their offspring, leading to increased national health care costs and an increased societal health burden (Fleming & Corbett, 2010). Developmental anomalies and perinatal complications have the potential to affect the health of infants throughout their lives. Conclusion The incidence of diabetes in women of childbearing age is rising, thus increasing the need for timely and relevant education about the importance of glycemic control prior to and during pregnancy. Preconception care begins before pregnancy occurs. Many pregnancies are unplanned, and therefore some women may not have received any education prior to becoming pregnant. This lack of timely information increases the risk for poor fetal and maternal outcomes. Studies have shown that improving knowledge about fetal harm and pregnancy risks in women with PGDM can reduce the risk of fetal complications related to diabetes and can affect the long-term health outcomes of future generations. In order to address a lack of preconception education, medically accurate information must be available to patients in easy-to-understand language. A handout is a viable educational tool that can serve to start the conversation between PCPs and their patients. In order to be effective, an educational handout must be evidence-based and at a literacy level appropriate to each clinical setting. This project has provided a useful educational tool to promote self-agency in women with PGDM by teaching them what they can do to reduce risk to their unborn children and increase the chance for a healthier pregnancy. TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 22 References Allen, V.M., & Armson, B.A. (2007). Teratogenicity associated with pre-existing and gestational diabetes. SOGC Clinical Practice Guideline, 200. Retrieved from sogc.org/wpcontent/uploads/2013/01/guiJOGC200CPG0711.pdf American Association of Colleges of Nursing (2006). The Essentials of doctoral education for advanced nursing practice. Retrieved from http://www.aacn.nche.edu/dnp/Essentials.pdf American Diabetes Association. (2015). Diabetes statistics. Retrieved from http://www.diabetes.org/diabetes-basics/statistics/ Beauhamais, C.C., Roberts, D.J. & Wexler, D.J. (2012). High rate of placental infarcts in type 2 compared with type1 diabetes. Journal of Clinical Endocrinology and Metabolism, 97(7), E1160-1164. doi: 10.1210/jc.2011-3326 Castori, M. (2013). Diabetic embryopathy: A developmental perspective from fertilization to adulthood. Molecular Syndromology, 4(1-2), 74-86. doi: 10.1159/000345205 Centers for Disease Control and Prevention. (2015). Diabetes public health resource. Retrieved from www.cdc.gov/diabetes/statistics/prevalence_national.htm Champion, V.L. & Skinner, C.S. (2008). The health belief model. In K. Glanz, B.K. Rimer & K. Viswanath (Eds.), Health behavior and health education: Theory, research and practice (4th Ed., pp. 45-63). San Francisco, CA: John Wiley & Sons Inc. Colstrup, M., Mathiesen, R.E., Damm, P., Jensen, D.M., & Ringholm, L. (2013). Pregnancy in women with type 1 diabetes: Have the goals of St. Vincent declaration been met concerning foetal and neonatal complications? The Journal of Maternal-Fetal & Neonatal Medicine, 26(17), 16821686. doi: 10.3109/14767058.213.794214 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 23 Congenital Heart Public Health Consortium. (2016). Diabetes. Retrieved from www.aap.org/enus/advocacy-and-policy/aap-health-initiatives/chphc/Pages/Prevention-Diabetes.aspx Dong, D., Reece, E.A., Lin, X., Wu, Y., AriasVillela, N., & Yang, P. (2016). New development of the yolk sac theory in diabetic embryopathy: Molecular mechanism and link to structural birth defects. American Journal of Obstetrics & Gynecology, 214(2), 192-202. doi: 10.1016/j.ajog.2015.09.082 Dunne, F., Brydon, P., Smith, K., & Gee, H. (2003). Pregnancy in women with type 2 diabetes: 12 years outcome data 1990-2002. Diabetic Medicine, 20(9), 734-738. doi: 10.1046/j.14645491.2003.01017.x Fleming, S.E., & Corbett, C. (2010). Promoting stringent glycemic control before and during pregnancy. AWHONN, 14(4), 281-288. doi: 10.1111/j.1751-486X.2010.01558.x Fraser, A. & Lawlor, D.A. (2014). Long-term health outcomes in offspring born to women with diabetes in pregnancy. Current Diabetes Reports, 14(5), 489. doi: 10.1007/s11892-014-0489-x Garne, E., Loane, M., Dolk, H., Barisic, I., Addor, M.C., Arriola, L., Bakker, M., Calzolari, E., Dias, C.M., Doray, B., Gatt, M., Melve, K.K., Nelen, V., O'Mahony, M., Pierini, A., RandrianaivoRanjatoelina, H., Rankin, J., Rissmann, A., Tucker, D., Verellun-Dumoulin, C., & Wiesel, A. (2012). Spectrum of congenital anomalies in pregnancies with pregestational diabetes. Birth Defects Research (Part A), 94(3), 134-140. doi: 10.1002/bdra.22886 Gaston, A., & Prapavessis, H. (Maternal-fetal disease information as a source of exercise motivation during pregnancy. Health Psychology, 28(6), 726-733. doi: 10.1037/a0016702 Gilbert-Barness, E. (2010). Teratogenic causes of malformations. Annals of Clinical & Laboratory Science, 40(2), 99-114. Retrieved from annclinlabsci.org/content/40/2/99.full.pdf+html TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 24 Goldman, J.A., Dicker, D., Feldberg, D., Yeshaya, A., Samuel, N., & Karp, M. (1986). Pregnancy outcome in patients with insulin-dependent diabetes mellitus with preconceptional diabetic control: A comparative study. American Journal of Obstetrics & Gynecology, 155(2), 293-297. doi: 10.1016/0002-9378(86)90812-4 James, J. (2013). Health policy brief: Patient engagement. Robert Wood Johnson Foundation. Retrieved from http://healthaffairs.org/healthpolicybriefs/brief_pdfs/healthpolicybrief_86.pdf Janz, N.K. & Becker, M.H. (1984). The health belief model: A decade later. Health Education Quarterly, 11(1), 1-47. Retrieved from https://deepblue.lib.umich.edu/bitstream/handle/2027.42/66877/10.1177_109019818401100101. pdf Kitzmiller, J.L., Wallerstein, R., Correa, A., & Kwan, S. (2010). Preconception care for women with diabetes and prevention of major congenital malformations. Birth Defects Research. Part A, Clinical and molecular teratology, 88(10), 791-803. doi: 10.1002bdna.20734 Macintosh, M.C.M., Fleming, K.M., Bailey, J.A., Doyle, Pl, Modder, J., Acolet, D., Golightly, S., & Miller, A. (2006). Perinatal mortality and congenital anomalies in babies of women with type 1 or type 2 diabetes in England, Wales, and Northern Ireland: Population based study. The British Medical Journal, 333, 177-183. doi: 10.1136/bmj.38856.692986.AE McElvy, S.S., Miodovnik, M., Rosenn, B., Khoury, J.C., Siddigi, T., Dignan, P.S., & Tsang, R.C. (2000). A focused preconceptional and early pregnancy program in women with type 1 diabetes reduces perinatal mortality and malformation rates to general population levels. The Journal of MaternalFetal Medicine, 9(1), 14-20. doi: 10.1002/(SICI)1520-6661(200001.02)9:1<14::AIDMFM5>3.0.CO.2-k TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 25 Miller, J.L., deVeciania, M., Turan, S., Kush, M., Manogura, A., Harman, C.R., & Baschat, A.A. (2013). First-trimester detection of fetal anomalies in pregestational diabetes using nuchal translucency, ductus venosus doppler, and maternal glycosylated hemoglobin. American Journal of Obstetrics and Gynecology, 208(5), 385.e1-8. doi: 10.1016/j.ajog.2013.01.041 Ornoy, A., Reece, A., Pavlinkova, G., Kappen, C., & Miller, R.K. (2015). Effect of maternal diabetes on the embryo, fetus, and children: Congenital anomalies, genetic and epigenetic changes and developmental outcomes. Birth Defects Research (Part C), 105, 53-72. doi: 10.1002/bdrc.21090 Owens, L.A., Sedar, J., Carmody, L., & Dunne, F. (2015). Comparing type1 and type 2 diabetes in pregnancy - similar conditions or is a separate approach required? BMC Pregnancy and Childbirth, 15, 69. doi: 10.1186/s12884-015-0499-y Pridjian, G. (2010). Pregestational diabetes. Obstetrics and Gynecology, 37(2), 143-158. doi: 10.1016/j.ogc.2010.02.014 Roman, M.A. (2011). Preconception care for women with preexisting type 2 diabetes. Clincial Diabetes, 29(1), 10-22. doi: 10.2337/diaclin.29.1.10 Readable.io. (2017). Measure text readability. Retrieved from https://readability-score.com/text/ Sanders, K., Jung, J.H. & Loeken, M.R. (2014). Use of a murine embryonic stem cell line that is sensitive to high glucose environment to model neural tube development in diabetic pregnancy. Birth Defects Research, 100(8), 584-591. doi: 10.1002/bdra.23281 Steel, J.M., Johnstone, F.D., Hepburn, D.A., & Smith A.F. (1990). Can prepregnancy care of diabetic women reduce the risk of abnormal babies? The British Medical Journal, 301, 1070-1074. doi: 10.1136/bmj.301.6760.1070 Walsh, N. (2010). Congenital anomalies linked to mom's diabetes. Retrieved from medpagetoday.com/OBGYN/Pregnancy/18065 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 26 Willhoite, M.B., Bennert, H.W., Palomaki, G.E., Zaremba, M.M., Herman, W.H., Williams, J.R. & Spear, N.H. (1993). The impact of preconception counseling on pregnancy outcomes: The experience of the Maine diabetes in pregnancy program. Diabetes Care, 16(2), 450-455. doi: 10.2337/diacare.16.2.450 Yang, P., Shen, W., Reece, A., Chen, X., & Yang, P. (2016). High glucose suppresses embryonic stem cell differentiation into neural lineage cells. Biochemical and Biophysical Research Communications, 472(2), 306-312. doi: 10.1016/j.bbrc.2016.02.117 Yu, J., Wu, Y., & Yang, P. (2016). High glucose-induced oxidative stress represses sirtuin deacetylase expression and increases histone acetylation leading to neural tube defects. Journal of Neurochemistry, 137, 371-383. doi:10.1111/jnc.13587 Zabihi, S., & Loeken, M.R. (2010). Understanding diabetic teratogenesis: Where are we now and where are we going? Birth Defects Research (part A), 88, 779-780. doi: 10.1002/bdra.20704 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS Appendix A Doctor of Nurse Practitioner Proposal Presentation Educating Diabetic Women on the Potential Teratogenic Effects of Hyperglycemia on Fetal Development During Pregnancy JEANETTE SEIDEL, DNP-NNP STUDENT In partial fulfillment of the requirements for the Doctor of Nursing Practice degree October 7, 2016 Background • 29 million people are diabetic and another 85 million have pre-diabetes in the U.S. • An increasing number of women have pregestational diabetes. • Most pregnancies are unplanned and women do not find out they are pregnant until they are past the first crucial stage of fetal development. • Poor glycemic control is associated with negative fetal outcomes • Hyperglycemia in the first trimester is associated with multiple congenital anomalies and spontaneous abortions (Kitzmiller, Wallerstein, Correa & Kwan, 2010). (American Diabetes Association, 2015). Background • 29 million people are diabetic and another 85 million have pre-diabetes in the U.S. • An increasing number of women have pregestational diabetes. • Most pregnancies are unplanned and women do not find out they are pregnant until they are past the first crucial stage of fetal development. • Poor glycemic control is associated with negative fetal outcomes • Hyperglycemia in the first trimester is associated with multiple congenital anomalies and spontaneous abortions (Kitzmiller, Wallerstein, Correa & Kwan, 2010). (American Diabetes Association, 2015). 27 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS Problem Statement An increasing number of women of reproductive age have pre-gestational diabetes. This corresponds to an increasing number of infants with associated congenital anomalies being admitted to neonatal intensive care units. Poor glycemic control is strongly implicated in these adverse outcomes to the fetus. The purpose of this project is to provide education to women of childbearing age with diabetes to promote euglycemia prior to and during pregnancy in order to decrease the risks to the fetus. Clinical Significance/Policy Implications • Women with diabetes are 2 to 5 times more likely to have an infant with a congenital anomaly (Castori, 2013). • Women that achieve euglycemia prior to pregnancy and throughout pregnancy can avoid many of the complications of diabetes on the fetus (Walsh, 2010). • Women who are engaged in their healthcare have better outcomes (James, 2013). • Decreased fetal complications results in fewer infants admitted to the NICU which in turn reduces the associated costs. Objectives • • Determine current availability of educational resources provided to women with diabetes regarding glycemic control and pregnancy outcomes. Develop a fact sheet regarding the perinatal risk to the fetus when the mother's glycemic control is not optimal prior to achieving pregnancy, which will target women of childbearing age with pregestational diabetes. • Explore the feasibility of integrating the fact sheet into the electronic patient educational resource bank in the Epic charting system. • Prepare an article for submission to a lay journal for broader dissemination of the fact sheet content. 28 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS Theoretical Framework: Health Belief Model Individual Beliefs Other Factors Action • Perceived Susceptibility: They must believe they are at risk. • Perceived Severity: They must believe the problem is severe. • Perceived Benefits: How will behavior change help decrease the risk? • Barriers: What is preventing change? • Cues to Action: Factsheet, Clinician counseling, etc. • Self efficacy: Belief in the ability to change Literature Review • • Prevalence • 1.8 million women of childbearing age have diabetes in the U.S. (Congenital Heart Public Health • For every 1 women diagnosed with diabetes there are 2 more undiagnosed (American Diabetes Association, 2015). Consortium, 2016) Glycemic Control • The higher the HgbA1c the higher the risk of fetal complications (Colstrup et al., 2013). • Euglycemia prior to pregnancy and during pregnancy results in a risk that is similar to the background population. Literature Review • • DM and Congenital Anomalies • Hyperglycemia in the first 8 weeks of pregnancy increases the risk of anomalies (Kitzmiller, Wallerstein, Correa & Kwan, 2010). • Affects multiple organ systems Perinatal Complications • Large for gestational age • Hypoglycemia 29 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 30 Literature Review • • Education • Women who are engaged in their healthcare have better outcomes (James, 2013). • Women who receive preconception care are more likely to have lower HgbA1c levels (Colstrup et al., 2013). Childhood • Microcephaly in the neonate is the result of poor brain growth which results in future mental delays in the child (Castori, 2013) . • Children are more likely to be overweight and become diabetic later in life (Castroi, 2013). Implementation and Evaluation Objective #1 Implementation Determine current availability of 1. Obtain IRB approval educational resources provided 2. Explore current educational practices that to women with diabetes address glycemic control prior to regarding glycemic control and pregnancy. pregnancy outcomes. 3. Evaluation 1. 20% of clinicians will complete the survey. 2. REDCap will be used to analyze results. Consult with clinicians, MA's, and Nurses about current education provided. 4. Send out survey to clinicians using REDCap. Implementation and Evaluation Objective #2 Develop an educational tool Implementation 1. regarding the perinatal risk to the fetus when the mother's A search of PubMed, CINAHL and other prior to achieving pregnancy, included. 3. childbearing age with pregestational diabetes. The educational tool will be written at a 6th grade level 5. 2. Send the educational tool to the clinics for review by the clinicians. Fleche Kincaid literacy tool will determine fact sheet is at no higher than a 6th grade literacy level. Review the content and compile the information into an educational tool. 4. expert and chair. Content from professional organization web sites and governmental resources will be An educational tool will be developed and approved by content databases will be performed. 2. glycemic control is not optimal which will target women of Evaluation 1. 3. Community clinic participants will review and approve the fact sheet. TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 31 Implementation and Evaluation (Cont.) Objective #3 Implement the Maternal Implementation Evaluation 1. 5 women from two clinics will be recruited to test the usability, Hyperglycemia and the Fetus feasibility and acceptability of the maternal hyperglycemia and the educational tool to determine its fetus education tool 1. Project chair must approve revised educational tool usability, feasibility, and acceptability. 2. A pre-test will be administered to the 10 women before reading the 2. educational tool. Project chair must approve your data analysis of pre- test and post- Explore the feasibility of integrating 3. Have each woman read the educational tool test. the fact sheet into the electronic 4. A post-test and evaluation questionnaire will be administered to the 10 3. Epic IT team will determine patient educational resource bank in the Epic charting system. integration into the educational women after reading the education tool. 5. Revise educational tool based on usability, feasibility and acceptability. tools for EPIC. 6. Stakeholders from 2 clinics will be asked to review content of revised educational tool 7. Meet with Epic IT team to explore integration into the educational tools for EPIC Implementation and Evaluation (Cont.) Objective #4 Implementation Prepare an abstract for 1. An abstract will be written. submission to a conference 2. Evaluation 1. The project chair will approve the Revision of the abstract will be abstract. for broader dissemination of completed based on comments from the 2. Submission of the abstract will be the fact sheet content. project chair and content expert. sent in December 2016. 3. Revisions will be made to the final document. 4. 3. Proof of submission will be included in the final paper. The abstract will be sent in for acceptance to the Public Health Conference in March 2017. Summary • The number of diabetic women of childbearing age is increasing, which has resulted in increased NICU admissions due to fetal complications. • A large number of pregnancies are unplanned and this means that education needs to be given to all women with diabetes who are of childbearing age. • Preconception counseling and becoming euglycemic prior to pregnancy can decrease the risks to a rate similar to that of the background population. TERATOGENIC EFFECTS OF DIABETES ON THE FETUS Acknowledgements • • Committee • Pam Phares, PhD, CNM, ANP, PNP • Kim Friddle, PhD, APRN, NNP-BC, Neonatal Program Director • Pam Hardin, PhD, RN, Assistant Dean for MS & DNP programs Content Expert • Nancy Allen, PhD, ANP Bibliography • American Diabetes Association. (2015). Diabetes statistics. Retrieved from http://www.diabetes.org/diabetes-basics/statistics/ • Castori, M. (2013). Diabetic embryopathy: A developmental perspective from fertilization to adulthood. Molecular Syndromology, 4(1-2), 74-86. doi: 10.1159/000345205 • Colstrup, M., Mathiesen, R.E., Damm, P., Jensen, D.M., & Ringholm, L. (2013). Pregnancy in women with type 1 diabetes: Have the goals of St. Vincent declaration been met concerning foetal and neonatal complications? The Journal of Maternal-Fetal & Neonatal Medicine, 26(17), 16821686. doi: 10.3109/14767058.213.794214 • Congenital Heart Public Health Consortium. (2016). Diabetes. Retrieved from www.aap.org/enus/advocacy-and-policy/aap-health-initiatives/chphc/Pages/Prevention-Diabetes.aspx • James, J. (2013). Health policy brief: Patient engagement. Robert Wood Johnson Foundation. Retrieved from http://healthaffairs.org/healthpolicybriefs/brief_pdfs/healthpolicybrief_86.pdf • • Kitzmiller, J.L., Wallerstein, R., Correa, A., & Kwan, S. (2010). Preconception care for women with diabetes and prevention of major congenital malformations. Birth Defects Research. Part A, Clinical and molecular teratology, 88(10), 791-803. doi: 10.1002bdna.20734 Walsh, N. (2010). Congenital anomalies linked to mom's diabetes. Retrieved from medpagetoday.com/OBGYN/Pregnancy/18065 32 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS Appendix B Final Poster for Project Defense 33 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 34 Appendix C IRB Approval IRB: IRB_00096599 PI: Jeanette Seidel Title: Educating Diabetic Women on the Potential Teratogenic Effects of Hyperglycemia on Fetal Development During Pregnancy Date: 12/12/2016 The above-referenced protocol has received an IRB exemption determination and may begin the research procedures outlined in the University of Utah IRB application and supporting documents. EXEMPTION DOCUMENTATION Review Type: Exemption Review Exemption Category(ies): Category 11 Exemption Date: 12/12/2016 Note the following delineation of categories: • • Categories 1-6: Federal Exemption Categories defined in 45 CFR 46.101(b) Categories 7-11: Non-Federal Exemption Categories defined in University of Utah IRB policy in Investigator Guidance Series, Exempt Research You must adhere to all requirements for exemption described in University of Utah IRB policy in (Investigator Guidance Series, Exempt Research ). This includes: • • • All research involving human subjects must be approved or determined exempt by the IRB before the research is conducted. All research activities must be conducted in accordance with the Belmont Report and must adhere to principles of sound research design and ethics. Orderly accounting and monitoring of research activities must occur. Ongoing Submissions for Exempt Projects TERATOGENIC EFFECTS OF DIABETES ON THE FETUS • • • • 35 Continuing Review: Since this determination is not an approval, the study does not expire or need continuing review. This determination of exemption from continuing IRB review only applies to the research study as submitted to the IRB. You must follow the protocol as proposed in this application Amendment Applications: Substantive changes to this project require an amendment application to the IRB to secure either approval or a determination of exemption. Investigators should contact the IRB Office if there are questions about whether an amendment consists of substantive changes. Substantive changes include, but are not limited to o Changes to study personnel (to secure Conflict of Interest review for all personnel on the study) o Changes that increase the risk to participants or change the risk:benefit ratio of the study o Changes that affect a participant's willingness to participate in the study o Changes to study procedures or study components that are not covered by the Exemption Category determined for this study (listed above) o Changes to the study sponsor o Changes to the targeted participant population o Changes to the stamped consent document(s) Report Forms: Exempt studies must adhere to the University of Utah IRB reporting requirements for unanticipated problems and deviations: http://irb.utah.edu/submit-application/forms/index.php Final Project Reports for Study Closure: Exempt studies must be closed with the IRB once the research activities are complete: http://irb.utah.edu/submit-application/final-project-reports.php SUPPORTING DOCUMENTS Informed Consent Document Seidel_ConsentCoverLetter.doc Surveys, etc. Seidel_Needs Assessment_ClinicianQuestions.docx Seidel_7702_ParticipantQuestionairre.docx Literature Cited/References Seidel_IRB_References.docx Recruitment Materials, Advertisements, etc. Seidel_Project_Flyer.docx Other Documents Seidel_7702_FactSheet.docx Click IRB_00096599 to view the application. Please take a moment to complete our customer service survey. We appreciate your opinions and feedback. TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 36 Appendix D Needs Assessment - Provider Questionnaire 1. Do you currently provide any type of education to diabetic women of reproductive age regarding uncontrolled diabetes and pregnancy? a. Yes b. No 2. How do you provide this education? a. Individual counseling during a visit b. Refer to a diabetes educator c. Refer to endocrinology d. Refer patients to online resources e. Handouts f. Other: 3. Do you provide education to diabetic women about hyperglycemia and the importance of euglycemia prior to becoming pregnant? a. Yes b. No 4. If yes, do you provide this education to all women of childbearing age? a. Yes b. No 5. Do you discuss hyperglycemia and potential teratogenic effects on the fetus? a. Yes b. No 6. If yes, do you provide this education to all diabetic women of childbearing age? a. Yes b. No 7. Would you utilize an education tool focused on hyperglycemia and the need for euglycemia prior to and during pregnancy? a. Yes b. No 8. Would you be willing to refer patients to evaluate this education tool (between 5 and 10)? a. Yes b. No Comments: TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 37 Appendix E Maternal Diabetes and Your Unborn Baby Everyone wants a healthy baby, but did you know that because you have diabetes your baby is at a higher risk of having problems? High Blood Sugar High blood sugar occurs as a sign of diabetes. High blood sugars in early pregnancy make it 2 to 5 times more likely that your baby will have a birth defect. This is before most women know they are pregnant. Possible Problems • • • • • • High blood sugar during the first few weeks of pregnancy may increase the risk of problems in many different parts of your baby's body. o The brain, spinal cord, heart, intestines and kidneys are the most common parts of the body at risk for problems. High blood sugars early in pregnancy may increase the risk of miscarriage. High blood sugars during pregnancy may increase the risk of having a baby born too early, a very large baby, the need for a c-section, a baby with low blood sugars, or the baby needing to stay in a special intensive care unit. Lab Tests Glucose check: this test tells you your blood sugar at one point in time. HbA1c is a test that shows how well you have kept your blood sugar controlled over a longer period of time than the glucose check. The higher this level is, the greater the risk of health problems in your baby. Try to keep your HbA1c level as close to 6.5% as you are able before and during pregnancy. The closer to normal that you are able to keep you HbA1c the better. Talk to your provider about the best level for you. TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 38 What can you do?  Maintaining control of your blood sugar before and during pregnancy can reduce the risk to your baby. o Your fasting glucose reading should be less than 100 mg/dL. o Your glucose reading 2 hours after a meal should be less than 120 mg/dL.  Maintaining your HgbA1c at close to normal will reduce your risk of anomalies to near that of women without diabetes.  Taking folic acid 3 months before becoming pregnant may help lower the risk of problems that affect your baby's brain and spinal cord.  Improve your diet and take a multivitamin. o Eat 6 to 8 servings of fruits and vegetables, nuts and foods high in fiber o Eat fewer simple carbs like sugary drinks, processed foods and foods high in sugar.  Increase your activity levels. o Exercise improves the body's ability to use insulin, which naturally lowers your blood sugar. o It is recommended that women with diabetes exercise for at least 150 minutes per week or more. Daily exercise is ideal. o Exercise should include large muscle groups (walking, swimming, biking), resistance training with weights, balance and flexibility exercises (yoga, tai chi).  Maintain a healthy weight. A body mass index of less than 25 before becoming pregnant is ideal.  Talk to your health care provider when you are planning to become pregnant for the best way to manage your diabetes. For more information, talk to your health care provider and visit: http://www.diabetes.org/living-with-diabetes/complications/pregnancy/prenatal-care.html TERATOGENIC EFFECTS OF DIABETES ON THE FETUS Appendix F Participant Questionnaire: Pre-Test 1. What should your goal HgbA1C be close to? a. 6 b. 6.5 c. 7 d. 7.5 2. What can you take to reduce the risk of some defects? a. Iron b. Folic Acid c. Fish Oil 3. When in pregnancy does the risk for most anomalies occur? a. Before pregnancy b. The first 8 weeks c. The last month 4. When should you start preparing to get pregnant? a. I don't need to prepare b. A month before getting pregnant c. At least 3 months before getting pregnant 5. How much should you exercise each week? a. 180 minutes b. 150 minutes c. 120 minutes d. 60 minutes 6. What should you do if you have more questions? a. Talk to your doctor b. Talk to a friend with diabetes c. Talk to your family 39 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS Appendix G Participant Questionnaire: Post-Test/Evaluation 1. What should the HgbA1C be close to? a. 6 b. 6.5 c. 7 d. 7.5 2. What can you take to reduce the risk of some defects? a. Iron b. Folic Acid c. Fish Oil 3. When in pregnancy does the risk for most anomalies occur? a. Before pregnancy b. The first 8 weeks c. The last month 4. When should you start preparing to get pregnant? a. I don't need to prepare b. A month before getting pregnant c. At least 3 months before getting pregnant 5. How much should you exercise each week? a. 180 minutes b. 150 minutes c. 120 minutes 6. What should you do if you have more questions? a. Talk to your doctor b. Talk to a friend with diabetes c. Talk to your family 7. Was the educational tool easy to understand? (1 - not at all, 5 - very helpful) a. 1 b. 2 c. 3 d. 4 e. 5 8. Was the educational tool helpful? (1 - not at all, 5 - very helpful) a. 1 b. 2 c. 3 d. 4 e. 5 9. Do you have any suggestions to make it better? _____________________________________________________________________ _____________________________________________________________________ 40 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 41 Appendix H Flesch-Kincaid Evaluation Tool Readability Grade Levels A grade level (based on the USA education system) is equivalent to the number of years of education a person has had. A score of around 10-12 is roughly the reading level on completion of high school. Text to be read by the general public should aim for a grade level of around 8. Readability Formula Grade Flesch-Kincaid Grade Level 5 Readability Scores These readability scoring algorithms do not provide grade levels. Please click on each score to find our more about what it represents and the ages it is appropriate for. Score Readability Formula Score Flesch-Kincaid Reading Ease 80.1 School Level Notes 5th grade Very easy to read. Easily understood by an average 11year-old student. 90.0-80.0 6th grade Easy to read. Conversational English for consumers. 80.0-70.0 7th grade Fairly easy to read. 70.0-60.0 8th & 9th grade Plain English. Easily understood by 13- to 15-yearold students. 60.0-50.0 10th to 12th grade Fairly difficult to read. 50.0-30.0 College Difficult to read. College Graduate Very difficult to read. Best understood by university graduates. 100.00-90.00 30.0-0.0 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 42 Appendix I Acceptance to Speak at the Utah Public Health Conference Dear Jeanette Thank you for your submission to the 2017 Public Health Conference for Utah: "Building a Culture of Health in Utah. The conference is on March 28-29, at the Park City Marriott, 1895 Sidewinder Dr, Park City, UT 84060. We are very happy to let you know that the Conference Planning Committee has APPROVED your Abstract for your presentation titled: The importance of glycemic control prior to and during pregnancy The details of your presentation are found on the attached page(s) and include the presentation date, times, room assignment and other specifics. As the information below will be published on the Conference App, please review this for accuracy and email us as soon as possible if there are changes that need to be made. Email address: [e-mail] NEXT PRELIMINARY STEPS: 1. Send Photo: Send us a photo for the online conference App. Again this year, presenter and presentation information will be published in an online App for smart phones and tablets. Presenter photos are also included on the App, so please send or email a small facial photo - head-face-neck - of yourself. The shape of the photo must be square, and the final size is 120X120 pixels in JPEG or PNG format. We can edit a photo of a larger size and format but please send us a square shaped photo. Attach your photo to a Reply to this email - or mail it to: UPHA Conference - App Photo PO Box 9387 Millcreek, UT 84109 2. Register: Please ensure that you (and your co-presenters) have registered and paid for the conference at: www.upha.org/conference/pages/registration.htm A discounted registration fee is offered for Presenters and Co-Presenters when you select the "Presenter" link on the registration page. Please note, student presenters should use the "Student" registration link to access our reduced student rates. Please check-in at the registration desk at least 15 minutes prior to the start of your presentation, where you will receive your presenter ID badge and directions to your TERATOGENIC EFFECTS OF DIABETES ON THE FETUS assigned room. Thank you again for your contribution to this conference Best Regards, 2017 Conference Agenda & Presenters Committee Leanne Johnston, Chair ~ 801-585-9971 Linda Bogdanow, Jim Bond, Paul Wightman, Dede Vilven, Heather Borski, Anna Dillingham, BettySue Hinkson, Jamie Pluta 43 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS Appendix J PowerPoint Presentation for the UPHA Conference 44 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 45 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 46 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 47 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 48 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 49 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 50 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 51 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 52 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 53 TERATOGENIC EFFECTS OF DIABETES ON THE FETUS 54