Preventing Recurrence of Neural Tube Birth Defects Produced by Georgia Folic Acid Task Force Sponsored by Georgia Dep

1. Welcome to the course Preventing Recurrence of Neural Tube Birth Defects (NTDs). This course was designed and produced by members of the Georgia Folic Acid Task Force and is sponsored by the Georgia Department of Human Resources. Welcome to the course Preventing Recurrence of Neural Tube Birth Defects (NTDs). This course was designed and produced by members of the Georgia Folic Acid Task Force and is sponsored by the Georgia Department of Human Resources.

2. The goal of this course is to help you feel more confident, comfortable, and sensitive in working with parents who have had a pregnancy affected by a neural tube birth defect. You may be the first health care contact in your area for these parents so you will need to be aware of the problems and how to guide them to the proper resources. This course is not intended to prepare you to be a genetic counselor nor a grief counselor, rather to understand the need for those resources. Your mission is important. You will have the opportunity to listen to the parents, assess their needs, direct them to the appropriate resources, and follow up to make sure they connected with those resources. You are a coordinator, a resource person, an initiator of services. Today we will: Review neural tube birth defects Discuss the research and recommendations to prevent recurrence of NTDs Talk about educating parents and patients Review the grieving process and how to talk with parents The goal of this course is to help you feel more confident, comfortable, and sensitive in working with parents who have had a pregnancy affected by a neural tube birth defect. You may be the first health care contact in your area for these parents so you will need to be aware of the problems and how to guide them to the proper resources. This course is not intended to prepare you to be a genetic counselor nor a grief counselor, rather to understand the need for those resources. Your mission is important. You will have the opportunity to listen to the parents, assess their needs, direct them to the appropriate resources, and follow up to make sure they connected with those resources. You are a coordinator, a resource person, an initiator of services. Today we will: Review neural tube birth defects Discuss the research and recommendations to prevent recurrence of NTDs Talk about educating parents and patients Review the grieving process and how to talk with parents

3. For some of you, this will be a review of neural tube birth defects. Others of you may be learning about NTDs for the first time. We will discuss the three main types of NTDs, how common they are in the U. S. and Georgia, and the risk factors associated with them. We will also talk about the importance of folic acid in preventing many of these birth defects, the sources of folic acid, and other potential benefits of folic acid. We want to help you understand the research behind this health communication campaign and the process of changing health behavior so that you can more effectively “spread the word.” We will discuss the target audiences and how to best work with them. For some of you, this will be a review of neural tube birth defects. Others of you may be learning about NTDs for the first time. We will discuss the three main types of NTDs, how common they are in the U. S. and Georgia, and the risk factors associated with them. We will also talk about the importance of folic acid in preventing many of these birth defects, the sources of folic acid, and other potential benefits of folic acid. We want to help you understand the research behind this health communication campaign and the process of changing health behavior so that you can more effectively “spread the word.” We will discuss the target audiences and how to best work with them.

4. Anencephaly occurs when the top part of the skull and the brain fail to form properly. Babies with this birth defect are miscarried, stillborn, or die shortly after birth. This birth defect is always fatal. Spina bifida occurs when the spine does not form properly. An opening in the spine causes damage to the lining of the spinal column and frequently to the spinal cord itself. Often there is a sac filled with part of the spinal cord, some spinal nerves, and fluid that forms on the baby’s back. The damage that occurs may lead to muscle weakness, paralysis, and loss of bowel and bladder control. Hydrocephalus (water on the brain) also occurs frequently in these babies. Most of these babies grow into adulthood with different degrees of disabilities. Encephalocele is a rarer form of neural tube defect. It occurs when the skull does not form properly, allowing part of the baby’s brain to be outside the skull. Babies who survive may have moderate to severe mental and physical disabilities. Anencephaly occurs when the top part of the skull and the brain fail to form properly. Babies with this birth defect are miscarried, stillborn, or die shortly after birth. This birth defect is always fatal. Spina bifida occurs when the spine does not form properly. An opening in the spine causes damage to the lining of the spinal column and frequently to the spinal cord itself. Often there is a sac filled with part of the spinal cord, some spinal nerves, and fluid that forms on the baby’s back. The damage that occurs may lead to muscle weakness, paralysis, and loss of bowel and bladder control. Hydrocephalus (water on the brain) also occurs frequently in these babies. Most of these babies grow into adulthood with different degrees of disabilities. Encephalocele is a rarer form of neural tube defect. It occurs when the skull does not form properly, allowing part of the baby’s brain to be outside the skull. Babies who survive may have moderate to severe mental and physical disabilities.

5. This is a picture of a newborn infant with spina bifida. You can see a protruding sac on the baby’s spine. It most likely contains part of the spinal cord. The spine is usually repaired (the hole is closed) shortly after birth. However, damage has already been done to the spinal cord and nerves by then. The time to prevent this birth defect is before and during the first four weeks of pregnancy! This is a picture of a newborn infant with spina bifida. You can see a protruding sac on the baby’s spine. It most likely contains part of the spinal cord. The spine is usually repaired (the hole is closed) shortly after birth. However, damage has already been done to the spinal cord and nerves by then. The time to prevent this birth defect is before and during the first four weeks of pregnancy!

6. NTDs occur at a rate of about 1 per 1000 pregnancies in the U.S., or about 4,000 pregnancies each year. Researchers estimate that about 2,500 infants are born with neural tube defects each year in the U.S., and 1,500 fetuses are miscarried or terminated after diagnosis. In a study conducted in Georgia in 1996, the Division of Public Health found an average of 100 pregnancies with NTDs a year. The chances of a woman with no risk factors having a baby affected by NTDs is 1 in 1,000. NTDs occur at a rate of about 1 per 1000 pregnancies in the U.S., or about 4,000 pregnancies each year. Researchers estimate that about 2,500 infants are born with neural tube defects each year in the U.S., and 1,500 fetuses are miscarried or terminated after diagnosis. In a study conducted in Georgia in 1996, the Division of Public Health found an average of 100 pregnancies with NTDs a year. The chances of a woman with no risk factors having a baby affected by NTDs is 1 in 1,000.

7. Ninety-five percent of women with NTD-affected pregnancies have no personal or family history of NTDs. If you can get pregnant, your pregnancy can be affected by an NTD. While it is not possible to predict which women will have a pregnancy affected by an NTD, there are some things that we know increase a woman’s risk. A previous NTD-affected pregnancy increases a woman’s chance of having another NTD-affected pregnancy twenty times! If you know of anyone who has had a child with spina bifida or anencephaly be sure they know about folic acid. In fact, a woman who has previously had an NTD-affected pregnancy should take a higher dose of folic acid under the supervision of her health care provider. A few medications can also increase a woman’s chances of having an affected pregnancy, like certain anti-seizure medicines. Diabetes and medically-diagnosed obesity increase the risk as well. It is best that these conditions be brought under control before a woman gets pregnant. Most importantly, when a woman with a medical problem wants to become pregnant she should consult her doctor before trying to conceive. Sometimes women who are exposed to high temperatures in early pregnancy, such as prolonged fevers or staying in a hot tub for long periods of time, have a greater chance of having an affected pregnancy. Also, NTDs are more common among white women than black women and more common among Hispanic women than non-Hispanic women. Please remember that even if a woman has an increased risk, it doesn’t mean that she will have a pregnancy affected by NTDs. And again, most NTD-affected pregnancies occur in women that don’t have an increase risk—so it is important to reach out to all women! Ninety-five percent of women with NTD-affected pregnancies have no personal or family history of NTDs. If you can get pregnant, your pregnancy can be affected by an NTD. While it is not possible to predict which women will have a pregnancy affected by an NTD, there are some things that we know increase a woman’s risk. A previous NTD-affected pregnancy increases a woman’s chance of having another NTD-affected pregnancy twenty times! If you know of anyone who has had a child with spina bifida or anencephaly be sure they know about folic acid. In fact, a woman who has previously had an NTD-affected pregnancy should take a higher dose of folic acid under the supervision of her health care provider. A few medications can also increase a woman’s chances of having an affected pregnancy, like certain anti-seizure medicines. Diabetes and medically-diagnosed obesity increase the risk as well. It is best that these conditions be brought under control before a woman gets pregnant. Most importantly, when a woman with a medical problem wants to become pregnant she should consult her doctor before trying to conceive. Sometimes women who are exposed to high temperatures in early pregnancy, such as prolonged fevers or staying in a hot tub for long periods of time, have a greater chance of having an affected pregnancy. Also, NTDs are more common among white women than black women and more common among Hispanic women than non-Hispanic women. Please remember that even if a woman has an increased risk, it doesn’t mean that she will have a pregnancy affected by NTDs. And again, most NTD-affected pregnancies occur in women that don’t have an increase risk—so it is important to reach out to all women!

8. The hope for preventing approximately 50% to 70% of NTDs currently lies in folic acid. Experts predict that folic acid can prevent between 2,000 and 3,000 cases nationally, and between 50 and 70 cases in Georgia. It is important to remember that folic acid will not prevent 100 percent of the neural tube defects that will occur, but it can prevent many of them. Folic acid is a B vitamin that is necessary for proper cell growth and development of the embryo. A complex form of this vitamin, folate, is found naturally in some foods. The simple form, folic acid, is now part of the U.S. fortification program and is included in bread, pasta, rice, breakfast cereals and other grain products labeled as “enriched.” Scientific evidence supporting the protective effect of folic acid accumulated for several years showing up to a 70% reduction in the risk of NTD affected pregnancies among women consuming folic acid daily. In 1992, the U.S. Public Health Service made a formal recommendation that all women capable of becoming pregnant should consume 400 micrograms (400 mcg) which is the same thing as 0.4 milligrams (0.4 mg) of folic acid daily. The hope for preventing approximately 50% to 70% of NTDs currently lies in folic acid. Experts predict that folic acid can prevent between 2,000 and 3,000 cases nationally, and between 50 and 70 cases in Georgia. It is important to remember that folic acid will not prevent 100 percent of the neural tube defects that will occur, but it can prevent many of them. Folic acid is a B vitamin that is necessary for proper cell growth and development of the embryo. A complex form of this vitamin, folate, is found naturally in some foods. The simple form, folic acid, is now part of the U.S. fortification program and is included in bread, pasta, rice, breakfast cereals and other grain products labeled as “enriched.” Scientific evidence supporting the protective effect of folic acid accumulated for several years showing up to a 70% reduction in the risk of NTD affected pregnancies among women consuming folic acid daily. In 1992, the U.S. Public Health Service made a formal recommendation that all women capable of becoming pregnant should consume 400 micrograms (400 mcg) which is the same thing as 0.4 milligrams (0.4 mg) of folic acid daily.

9. The folic acid message is critical for ALL women who can become pregnant including teens and women who think they have completed their families. With over 50% of U.S. pregnancies not being planned, the best defense is for all women to have sufficient amounts of folic acid in their bodies at all times. Also, in many cases, especially when a woman is not expecting a pregnancy, the neural tube has already formed before the woman even realizes that she is pregnant. The recommended amount is 400 micrograms every day. Some women may be concerned about getting too much folic acid. Folic acid is not toxic, even in high amounts, and excess folic acid in the body is excreted through urine. However, with the exception of women who have had a prior NTD-affected pregnancy, it is recommended that women consume no more than 1,000 micrograms of folic acid daily. NOTE: Very large amounts of folic acid may hide the ability to quickly diagnose a vitamin B-12 deficiency, a sign of pernicious anemia. This disease can lead to serious brain and nerve damage if not treated with vitamin B-12. Pernicious anemia is rare in young and middle-aged people. Today, doctors can use a definitive test to check individuals for a B-12 deficiency, even when large amounts of folic acid are present. Folic acid is consumed through vitamin supplements, fortified foods, and/or certain fruits and vegetables. The folic acid message is critical for ALL women who can become pregnant including teens and women who think they have completed their families. With over 50% of U.S. pregnancies not being planned, the best defense is for all women to have sufficient amounts of folic acid in their bodies at all times. Also, in many cases, especially when a woman is not expecting a pregnancy, the neural tube has already formed before the woman even realizes that she is pregnant. The recommended amount is 400 micrograms every day. Some women may be concerned about getting too much folic acid. Folic acid is not toxic, even in high amounts, and excess folic acid in the body is excreted through urine. However, with the exception of women who have had a prior NTD-affected pregnancy, it is recommended that women consume no more than 1,000 micrograms of folic acid daily. NOTE: Very large amounts of folic acid may hide the ability to quickly diagnose a vitamin B-12 deficiency, a sign of pernicious anemia. This disease can lead to serious brain and nerve damage if not treated with vitamin B-12. Pernicious anemia is rare in young and middle-aged people. Today, doctors can use a definitive test to check individuals for a B-12 deficiency, even when large amounts of folic acid are present. Folic acid is consumed through vitamin supplements, fortified foods, and/or certain fruits and vegetables.

10. An easy way to be sure you are getting the right amount of folic acid is to take a tablet containing only folic acid or to take a multivitamin with 400 mcg of folic acid. Most multivitamins do contain 400 micrograms of folic acid. Another easy way to get the full recommended amount is to eat a bowl of cereal that has been fortified with 100% of the DV (Daily Value) of folic acid. The synthetic folic acid used in vitamin pills and to fortify cereal and grain products is the easiest form for the body to absorb and use. Multivitamin pills and smaller tablets containing only folic acid can be found in grocery, discount, and drug stores. If cost is a factor, then the tablets with just folic acid cost about a penny per day and are small and easy to swallow. A national survey conducted by the March of Dimes found that most women of childbearing age reported not taking a multivitamin containing folic acid. In this survey, only 25% of women who were ages 18-35 took multivitamins daily. This behavior requires a sustained behavior change. All of us know how hard it is to change our behaviors. Many of us know people who have vowed to start exercising regularly, and fail to stick with it. Taking vitamins daily requires effort. Helpful tips such as taking a vitamin after brushing your teeth, or something else you do every day may make it easier to get folic acid into your daily routine. An easy way to be sure you are getting the right amount of folic acid is to take a tablet containing only folic acid or to take a multivitamin with 400 mcg of folic acid. Most multivitamins do contain 400 micrograms of folic acid. Another easy way to get the full recommended amount is to eat a bowl of cereal that has been fortified with 100% of the DV (Daily Value) of folic acid. The synthetic folic acid used in vitamin pills and to fortify cereal and grain products is the easiest form for the body to absorb and use. Multivitamin pills and smaller tablets containing only folic acid can be found in grocery, discount, and drug stores. If cost is a factor, then the tablets with just folic acid cost about a penny per day and are small and easy to swallow. A national survey conducted by the March of Dimes found that most women of childbearing age reported not taking a multivitamin containing folic acid. In this survey, only 25% of women who were ages 18-35 took multivitamins daily. This behavior requires a sustained behavior change. All of us know how hard it is to change our behaviors. Many of us know people who have vowed to start exercising regularly, and fail to stick with it. Taking vitamins daily requires effort. Helpful tips such as taking a vitamin after brushing your teeth, or something else you do every day may make it easier to get folic acid into your daily routine.

11. Recognizing the importance of folic acid in preventing neural tube defects, the FDA ruled that starting January 1, 1998, all cereals and grain products labeled “enriched” must be fortified with folic acid. This was done to have a wide-reaching effect with no behavior change required. It was estimated that women would eat, on average, about 100 micrograms more of folic acid per day with this addition, which may STILL NOT BE ENOUGH to fully prevent all folic acid preventable NTDS. Even if you eat folate-rich foods and fortified foods you still may not get the recommended 400 micrograms needed daily to prevent neural tube defects. There are some cereals that now have the full 400 micrograms of folic acid in one serving. Be sure to check the cereal labels for “Folic Acid” or “Folate” to see how much there is in one serving. Getting 400 micrograms of synthetic folic acid every day from fortified foods alone requires very careful planning. Talk with a nutrition counselor before using this approach to ensure you get the recommended amount needed every day. Recognizing the importance of folic acid in preventing neural tube defects, the FDA ruled that starting January 1, 1998, all cereals and grain products labeled “enriched” must be fortified with folic acid. This was done to have a wide-reaching effect with no behavior change required. It was estimated that women would eat, on average, about 100 micrograms more of folic acid per day with this addition, which may STILL NOT BE ENOUGH to fully prevent all folic acid preventable NTDS. Even if you eat folate-rich foods and fortified foods you still may not get the recommended 400 micrograms needed daily to prevent neural tube defects. There are some cereals that now have the full 400 micrograms of folic acid in one serving. Be sure to check the cereal labels for “Folic Acid” or “Folate” to see how much there is in one serving. Getting 400 micrograms of synthetic folic acid every day from fortified foods alone requires very careful planning. Talk with a nutrition counselor before using this approach to ensure you get the recommended amount needed every day.

12. Folate-rich foods include green, leafy vegetables, such as collards, spinach, and romaine lettuce; fruits such as oranges, orange juice, strawberries and kiwi; and dried beans and peas. Folate in these foods occurs naturally. It is not added. The average daily intake of folate from foods is about 200 micrograms. Since folate is a more complex form of folic acid, it is not absorbed and used by the body as well as folic acid. It is estimated that only one half of the folate consumed is usable. So, of the 200 micrograms that are eaten, only about 100 micrograms are actually used by the body. In addition, the folate in foods can also be lost through processing and cooking which reduces the amount of available folate even further. It is very difficult to get enough folate in the average person’s diet to meet the daily requirements (400 micrograms). The Institute of Medicine, a prestigious panel of medical experts, issued a recommendation in 1998 stating that all women of childbearing age should consume 400 micrograms of synthetic folic acid daily and eat a healthy, varied diet. Folate-rich foods are healthy foods because they have a variety of important nutrients. We encourage everyone to include lots of folate-rich foods for a healthy diet in addition to consuming 400 micrograms of synthetic folic acid daily. Folate-rich foods include green, leafy vegetables, such as collards, spinach, and romaine lettuce; fruits such as oranges, orange juice, strawberries and kiwi; and dried beans and peas. Folate in these foods occurs naturally. It is not added. The average daily intake of folate from foods is about 200 micrograms. Since folate is a more complex form of folic acid, it is not absorbed and used by the body as well as folic acid. It is estimated that only one half of the folate consumed is usable. So, of the 200 micrograms that are eaten, only about 100 micrograms are actually used by the body. In addition, the folate in foods can also be lost through processing and cooking which reduces the amount of available folate even further. It is very difficult to get enough folate in the average person’s diet to meet the daily requirements (400 micrograms). The Institute of Medicine, a prestigious panel of medical experts, issued a recommendation in 1998 stating that all women of childbearing age should consume 400 micrograms of synthetic folic acid daily and eat a healthy, varied diet. Folate-rich foods are healthy foods because they have a variety of important nutrients. We encourage everyone to include lots of folate-rich foods for a healthy diet in addition to consuming 400 micrograms of synthetic folic acid daily.

13. Researchers are studying other potential benefits of sufficient folic acid. They include: Possible prevention of other birth defects, such as - Cleft lip/palate - Heart defects - Limb defects Possible decrease in cardiovascular disease and stroke - Folic acid lowers homocysteine levels in the blood. Homocysteine is a an amino acid (protein) and high levels in the blood are associated with heart disease. Possible cancer prevention in some cancers, such as colon and cervix. There needs to be more research conducted before we can say that folic acid definitively improves these conditions. However, there are women who believe that taking this simple vitamin can be good for the health of their future babies and also for their own long-term health. Researchers are studying other potential benefits of sufficient folic acid. They include: Possible prevention of other birth defects, such as - Cleft lip/palate - Heart defects - Limb defects Possible decrease in cardiovascular disease and stroke - Folic acid lowers homocysteine levels in the blood. Homocysteine is a an amino acid (protein) and high levels in the blood are associated with heart disease. Possible cancer prevention in some cancers, such as colon and cervix. There needs to be more research conducted before we can say that folic acid definitively improves these conditions. However, there are women who believe that taking this simple vitamin can be good for the health of their future babies and also for their own long-term health.

14. The folic acid message is important because it can save lives and make Georgia’s communities healthier in the long run. And, we need your help to spread the word about folic acid. Our first step in the campaign is to make sure everyone knows about the importance of folic acid and when and how to get it (increase knowledge). The next step is to change attitudes about folic acid. Many people feel that they don’t need to add a vitamin because they “eat right” already or because they don’t like to take pills or because this message doesn’t apply to them. We want to help them see the need to consume 400 mcg of folic acid daily for their own health and for the health of any future babies that they may or may not be planning. We want to overcome those barriers and encourage the next step, the new behavior of consuming sufficient folic acid every day! When attitudes are altered and behavior changes are begun, we want to help people find motivators, or ways to keep up their behavior change so that it becomes a positive lifestyle habit. It’s a big job, and that’s why we’re asking you to help! The folic acid message is important because it can save lives and make Georgia’s communities healthier in the long run. And, we need your help to spread the word about folic acid. Our first step in the campaign is to make sure everyone knows about the importance of folic acid and when and how to get it (increase knowledge). The next step is to change attitudes about folic acid. Many people feel that they don’t need to add a vitamin because they “eat right” already or because they don’t like to take pills or because this message doesn’t apply to them. We want to help them see the need to consume 400 mcg of folic acid daily for their own health and for the health of any future babies that they may or may not be planning. We want to overcome those barriers and encourage the next step, the new behavior of consuming sufficient folic acid every day! When attitudes are altered and behavior changes are begun, we want to help people find motivators, or ways to keep up their behavior change so that it becomes a positive lifestyle habit. It’s a big job, and that’s why we’re asking you to help!

15. Because these two groups of women have different pregnancy intentions, the messages that reach them are different also. Contemplators have expressed that they are willing to do whatever it takes to have a healthy baby. Encouraging these women to take folic acid is easier than the non-contemplators. They just need to understand that folic acid needs to be taken before conception. The non-contemplators, on the other hand, feel that since they aren’t planning to get pregnant any time soon, if at all, then preparing for pregnancy doesn’t affect them. However, they need to understand that their bodies are ready for pregnancy even if their minds and lifestyles aren’t. And, 50% of all pregnancies in the U. S. are unplanned. If they are sexually active, they could become pregnant!! Helping them to make this link (about the possibility of pregnancy) may convince them that it is not too soon to change their behavior. Non-contemplators may also be influenced to consume folic acid because of its other prevention benefits or the other factors that motivate women in general to take multivitamins. Because these two groups of women have different pregnancy intentions, the messages that reach them are different also. Contemplators have expressed that they are willing to do whatever it takes to have a healthy baby. Encouraging these women to take folic acid is easier than the non-contemplators. They just need to understand that folic acid needs to be taken before conception. The non-contemplators, on the other hand, feel that since they aren’t planning to get pregnant any time soon, if at all, then preparing for pregnancy doesn’t affect them. However, they need to understand that their bodies are ready for pregnancy even if their minds and lifestyles aren’t. And, 50% of all pregnancies in the U. S. are unplanned. If they are sexually active, they could become pregnant!! Helping them to make this link (about the possibility of pregnancy) may convince them that it is not too soon to change their behavior. Non-contemplators may also be influenced to consume folic acid because of its other prevention benefits or the other factors that motivate women in general to take multivitamins.

16. Now we will proceed to the research related to recurrence of NTDs. We will talk about: Risk Reducing the risk Recommendation Special considerations Medication use Now we will proceed to the research related to recurrence of NTDs. We will talk about: Risk Reducing the risk Recommendation Special considerations Medication use

17. Women who have had a pregnancy resulting in a child with an NTD have a 2-3% risk for having another pregnancy with an NTD1 If one parent has spina bifida, the chances of having a child with spina bifida are between 1-5% 1. Little J, Elwood JM. Epidemiology of neural tube defects. In: Kiley M, ed. Reproductive and perinatal epidemiology. Boca Raton, Florida: CRC Press, 1991:251-336 Women who have had a pregnancy resulting in a child with an NTD have a 2-3% risk for having another pregnancy with an NTD1 If one parent has spina bifida, the chances of having a child with spina bifida are between 1-5% 1. Little J, Elwood JM. Epidemiology of neural tube defects. In: Kiley M, ed. Reproductive and perinatal epidemiology. Boca Raton, Florida: CRC Press, 1991:251-336

18. The British Medical Research Council (MRC) Vitamin Study? (1991) provided the strongest evidence that folic acid was the protective factor in reducing the risk of a second NTD affected pregnancy. It was conducted at 33 sites in seven countries, although most participants came from Great Britain and Hungary. The study included 1,817 women at risk of having an NTD-affected pregnancy because of a previous affected pregnancy. Each woman was randomly selected to be in one of four vitamin groups: 1) 4 mg folic acid daily, 2) other vitamins not including folic acid, 3) both folic acid and other vitamins, or 4) no vitamin supplements. Among 1, 195 pregnancies in which the outcome was known, women who had received folic acid (alone or with other vitamins) had an NTD-affected pregnancy rate of 1% and women who had not received folic acid had a rate of 3.5%, a significant 72% risk reduction among folic acid users. It should be noted that, although supplementation with folic acid reduced the risk of an NTD affected pregnancy, it did not prevent all the recurrences of NTDs since there may also be a genetic component involved. Two intervention studies preceded the MRC trials showing that vitamin supplementation may be preventive. In one study 0.36 mg2 of folic acid was used and in the other 4 mg.3 1. MRC Vitamin Study Research Group. Prevention of neural tube defects: results of the Medical Research Council Vitamin Study. Lancet 1991; 338:131-137. 2. Smithells RW, Nevin NC, Seller MJ et al. Further experience of vitamin supplementation for prevention of neural tube defect recurrences. Arch Dis Child 1981;56:911-918. 3. Laurence KM, James N, Miller MH, et al. Double-blind randomized controlled trial of folate treatment before conception to prevent recurrence of neural tube defects. BMJ 1981; 282:1509-1511. The British Medical Research Council (MRC) Vitamin Study? (1991) provided the strongest evidence that folic acid was the protective factor in reducing the risk of a second NTD affected pregnancy. It was conducted at 33 sites in seven countries, although most participants came from Great Britain and Hungary. The study included 1,817 women at risk of having an NTD-affected pregnancy because of a previous affected pregnancy. Each woman was randomly selected to be in one of four vitamin groups: 1) 4 mg folic acid daily, 2) other vitamins not including folic acid, 3) both folic acid and other vitamins, or 4) no vitamin supplements. Among 1, 195 pregnancies in which the outcome was known, women who had received folic acid (alone or with other vitamins) had an NTD-affected pregnancy rate of 1% and women who had not received folic acid had a rate of 3.5%, a significant 72% risk reduction among folic acid users. It should be noted that, although supplementation with folic acid reduced the risk of an NTD affected pregnancy, it did not prevent all the recurrences of NTDs since there may also be a genetic component involved. Two intervention studies preceded the MRC trials showing that vitamin supplementation may be preventive. In one study 0.36 mg2 of folic acid was used and in the other 4 mg.3 1. MRC Vitamin Study Research Group. Prevention of neural tube defects: results of the Medical Research Council Vitamin Study. Lancet 1991; 338:131-137. 2. Smithells RW, Nevin NC, Seller MJ et al. Further experience of vitamin supplementation for prevention of neural tube defect recurrences. Arch Dis Child 1981;56:911-918. 3. Laurence KM, James N, Miller MH, et al. Double-blind randomized controlled trial of folate treatment before conception to prevent recurrence of neural tube defects. BMJ 1981; 282:1509-1511.

19. The United States Public Health Service (USPHS),1 American Academy of Pediatrics (AAP ),2 American College of Obstetrics and Gynecology (ACOG),3 and the Canadian Task Force4 recommend that patients who have had a previous pregnancy affected by a neural tube defect and who are planning to become pregnant should be offered treatment with 4 mg of folic acid, which is 10x the amount recommended for all women of childbearing age. This should begin 1-3 months prior to planned conception and continuing through the first 3 months of pregnancy. CDC. Recommendations for the use of folic acid to reduce the number of cases of spina bifida and other neural tube defects. MMWR 1992;41(no. RR-14). American Academy of Pediatrics, Committee on Genetics. Folic acid for the prevention of neural tube defects. Pediatrics 1999;104:325-7. www.aap.org/policy/re9834.html American College of Obstetrics and Gynecologists. Folic acid for the prevention of neural tube defects. Pediatrics. 1993;92:493-494. Canadian Task Force on the Periodic Health Examination. Canadian guide to clinical preventive health care. Ottawa: Canada Communication Group, 1994:74-81. www.ctfphc.org/Sections/section01ch007.htm The United States Public Health Service (USPHS),1 American Academy of Pediatrics (AAP ),2 American College of Obstetrics and Gynecology (ACOG),3 and the Canadian Task Force4 recommend that patients who have had a previous pregnancy affected by a neural tube defect and who are planning to become pregnant should be offered treatment with 4 mg of folic acid, which is 10x the amount recommended for all women of childbearing age. This should begin 1-3 months prior to planned conception and continuing through the first 3 months of pregnancy. CDC. Recommendations for the use of folic acid to reduce the number of cases of spina bifida and other neural tube defects. MMWR 1992;41(no. RR-14). American Academy of Pediatrics, Committee on Genetics. Folic acid for the prevention of neural tube defects. Pediatrics 1999;104:325-7. www.aap.org/policy/re9834.html American College of Obstetrics and Gynecologists. Folic acid for the prevention of neural tube defects. Pediatrics. 1993;92:493-494. Canadian Task Force on the Periodic Health Examination. Canadian guide to clinical preventive health care. Ottawa: Canada Communication Group, 1994:74-81. www.ctfphc.org/Sections/section01ch007.htm

20. There is good evidence for women who have had a previous NTD affected pregnancy to take 4 mg of folic acid at least one month prior to pregnancy. However, other high risks groups have not been as well studied. It is not known whether folic acid supplementation will help prevent the recurrence of NTDs in offspring of parents with NTDs, of parents with a family history of NTDs in second or third degree relatives, and in women with diabetes mellitus. These women should be counseled by their physician about the risks and benefits of 4 mg of folic acid supplementation when beginning to plan a pregnancy. There is good evidence for women who have had a previous NTD affected pregnancy to take 4 mg of folic acid at least one month prior to pregnancy. However, other high risks groups have not been as well studied. It is not known whether folic acid supplementation will help prevent the recurrence of NTDs in offspring of parents with NTDs, of parents with a family history of NTDs in second or third degree relatives, and in women with diabetes mellitus. These women should be counseled by their physician about the risks and benefits of 4 mg of folic acid supplementation when beginning to plan a pregnancy.

21. Other groups of women could be taking medications that may increase their risk of having a child with an NTD. *These groups include epileptic women who are taking anti-seizure medication, such as valproic acid (Depacon?, Depakene?) or carbamazepine (Carbatrol?, Tegretol?, Tegretol X-R?), and women who take drugs that interfere with folate metabolism, such as methotrexate, pyrimethamine (Daraprim?), trimethoprim (found in Septra?, Bactrim?, Polytrim?, Primsol?), phenytoin (Dilantin?). It is recommended that women seek the advice of a physician prior to beginning folic acid supplementation. *Brand names are given for your convenience, in case of questions. (You don’t have to try to pronounce all of those!) Other groups of women could be taking medications that may increase their risk of having a child with an NTD. *These groups include epileptic women who are taking anti-seizure medication, such as valproic acid (Depacon?, Depakene?) or carbamazepine (Carbatrol?, Tegretol?, Tegretol X-R?), and women who take drugs that interfere with folate metabolism, such as methotrexate, pyrimethamine (Daraprim?), trimethoprim (found in Septra?, Bactrim?, Polytrim?, Primsol?), phenytoin (Dilantin?). It is recommended that women seek the advice of a physician prior to beginning folic acid supplementation. *Brand names are given for your convenience, in case of questions. (You don’t have to try to pronounce all of those!)

22. Women who have had a pregnancy resulting in a child with an NTD should be counseled about: Their increased risk in subsequent pregnancies The protective effect of folic acid Women should continue to take the recommended amount of folic acid (400 mcg) every day when not planning to become pregnant. They should consult their health care provider (HCP) as soon as they start thinking about another pregnancy to discuss the advisability of increased folic acid. When planning a pregnancy, they should take 4,000 mcg (4.0 mg) folic acid 1-3 months before and continuing through the first 3 months of pregnancy.Women who have had a pregnancy resulting in a child with an NTD should be counseled about: Their increased risk in subsequent pregnancies The protective effect of folic acid Women should continue to take the recommended amount of folic acid (400 mcg) every day when not planning to become pregnant. They should consult their health care provider (HCP) as soon as they start thinking about another pregnancy to discuss the advisability of increased folic acid. When planning a pregnancy, they should take 4,000 mcg (4.0 mg) folic acid 1-3 months before and continuing through the first 3 months of pregnancy.

23. Now we will talk about educating your clients. We will discuss important points to cover in your counseling and education sessions, the role of clinicians in this process, and steps and strategies for educating your clients. Now we will talk about educating your clients. We will discuss important points to cover in your counseling and education sessions, the role of clinicians in this process, and steps and strategies for educating your clients.

24. When a woman at high risk consults a health care provider about planning a pregnancy, she should be: Advised not to attempt to achieve doses by taking over-the-counter or prescription multivitamins because of the possibility of ingesting harmful levels of other vitamins (e.g., vitamin A) Cautioned that folic acid supplementation does not prevent all NTDs and does not preclude the need for prenatal testing of NTDs Counseled regarding methods available for detection of NTDs When a woman at high risk consults a health care provider about planning a pregnancy, she should be: Advised not to attempt to achieve doses by taking over-the-counter or prescription multivitamins because of the possibility of ingesting harmful levels of other vitamins (e.g., vitamin A) Cautioned that folic acid supplementation does not prevent all NTDs and does not preclude the need for prenatal testing of NTDs Counseled regarding methods available for detection of NTDs

25. Clinicians play a vital role in recurrence prevention. They could be considered the “first line of defense” for patients or clients just learning about a pregnancy affected by a neural tube defect (NTD), or for patients or clients who suffer a loss due to a NTD. When providing education and counseling to patients or clients about what they can do to prevent another pregnancy affected by neural tube defects, it is imperative that clinicians provide patients and clients with written recurrence material. Educational materials may help answer important questions that a patient or client is not yet ready to ask or discuss. Clinicians also act as a resource for follow-up and referral for patients or clients. Health care providers are a direct resource for prescriptions for patients or clients that need to take more folic acid –4,000 micrograms (4 mg) or ten times the amount. Clinicians play a vital role in recurrence prevention. They could be considered the “first line of defense” for patients or clients just learning about a pregnancy affected by a neural tube defect (NTD), or for patients or clients who suffer a loss due to a NTD. When providing education and counseling to patients or clients about what they can do to prevent another pregnancy affected by neural tube defects, it is imperative that clinicians provide patients and clients with written recurrence material. Educational materials may help answer important questions that a patient or client is not yet ready to ask or discuss. Clinicians also act as a resource for follow-up and referral for patients or clients. Health care providers are a direct resource for prescriptions for patients or clients that need to take more folic acid –4,000 micrograms (4 mg) or ten times the amount.

26. The 4 A’s are suggested action steps and strategies for clinicians conducting recurrence education The 4 A’s are suggested action steps and strategies for clinicians conducting recurrence education

27. About pregnancy intentions About multivitamin use It’s important to ask if your client or patient at risk for recurrence is planning a pregnancy, or would like to be pregnant in the near future. It is important to ask even if a patient or client is not planning a pregnancy, but is sexually active. More than half of pregnancies are unintended! Asking opens the door to dialogue and may even be a much needed reminder for everyone that pregnancy is a possibility even if it is not planned. It’s important to ask if your client or patient is taking folic acid in a multivitamin or single supplement. Knowledge that taking folic acid prevents up to 70% of birth defects is low for most women ( March of Dimes Surveys 1995-2000). Suggested strategies are: Implement an “every visit” or office-wide system in which each client or patient is asked questions about their pregnancy planning stage, and folic acid use For example, expand history interviews to include: “are you planning a pregnancy now or in the near future?” or “are you currently sexually active?” or “are taking a multivitamin or supplement?” or “have you had a pregnancy previously affected by neural tube defects?” It’s important to ask if your client or patient at risk for recurrence is planning a pregnancy, or would like to be pregnant in the near future. It is important to ask even if a patient or client is not planning a pregnancy, but is sexually active. More than half of pregnancies are unintended! Asking opens the door to dialogue and may even be a much needed reminder for everyone that pregnancy is a possibility even if it is not planned. It’s important to ask if your client or patient is taking folic acid in a multivitamin or single supplement. Knowledge that taking folic acid prevents up to 70% of birth defects is low for most women ( March of Dimes Surveys 1995-2000). Suggested strategies are: Implement an “every visit” or office-wide system in which each client or patient is asked questions about their pregnancy planning stage, and folic acid use For example, expand history interviews to include: “are you planning a pregnancy now or in the near future?” or “are you currently sexually active?” or “are taking a multivitamin or supplement?” or “have you had a pregnancy previously affected by neural tube defects?”

28. Be clear Personalize your message Encourage taking folic acid daily Remind patient to eat healthy In a clear, personalized manner, urge every client or patient at risk for recurrence of a neural tube defect (NTD) to take a vitamin with folic acid and to eat a healthy diet, rich in folate. Advice should be: Clear- “Folic acid is a B vitamin that prevents birth defects like spina bifida and anencephaly.” Personalized- “It’s healthy for you and your next baby to get enough folic acid every day through a multivitamin or folic acid pill and eat a healthy diet.” “A past pregnancy with a NTD puts you at greater risk for another.” In a clear, personalized manner, urge every client or patient at risk for recurrence of a neural tube defect (NTD) to take a vitamin with folic acid and to eat a healthy diet, rich in folate. Advice should be: Clear- “Folic acid is a B vitamin that prevents birth defects like spina bifida and anencephaly.” Personalized- “It’s healthy for you and your next baby to get enough folic acid every day through a multivitamin or folic acid pill and eat a healthy diet.” “A past pregnancy with a NTD puts you at greater risk for another.”

29. Be prepared to answer questions Plan ahead by reading this module! Provide educational materials Encourage a supportive staff Patients or clients who have recently experienced a loss of a child, or who have had a child with an NTD will have questions about their circumstance. Plan ahead by reading the general recommendations about women at risk for recurrence included in this module! Provide educational materials. Encourage your staff to be supportive and prepared to answer questions. Patients or clients who have recently experienced a loss of a child, or who have had a child with an NTD will have questions about their circumstance. Plan ahead by reading the general recommendations about women at risk for recurrence included in this module! Provide educational materials. Encourage your staff to be supportive and prepared to answer questions.

30. Assure Support behavioral change Remind patients routinely Provide prescription for folic acid Taking a vitamin with folic acid and eating foods high in folate require behavior change and a daily commitment to be effective. As a clinician, your job may require repeated intervention with your patients or clients. Parents affected by NTDs welcome verbal and written reminders, when they are ready. You know your patient or client and can gauge appropriate times and resources for reminders. Provide patients or clients who need to take more folic acid with a prescription for 4,000 mcg (4 mg) or ten times the usual amount. Taking a vitamin with folic acid and eating foods high in folate require behavior change and a daily commitment to be effective. As a clinician, your job may require repeated intervention with your patients or clients. Parents affected by NTDs welcome verbal and written reminders, when they are ready. You know your patient or client and can gauge appropriate times and resources for reminders. Provide patients or clients who need to take more folic acid with a prescription for 4,000 mcg (4 mg) or ten times the usual amount.

31. Most people will have the emotional stress of grief following the death of a family member. However, the death of a child is perhaps the most devastating loss a parent can experience. It is important to understand that grief is not a sign of weakness nor a lack of faith. Reference note: The Compassionate Friends, Inc. PO Box 3696; Oak Brook, IL 60522-3696 Toll Free (877) 969-0010; Fax (630) 990-0246 www.compassionatefriends.org Most people will have the emotional stress of grief following the death of a family member. However, the death of a child is perhaps the most devastating loss a parent can experience. It is important to understand that grief is not a sign of weakness nor a lack of faith. Reference note: The Compassionate Friends, Inc. PO Box 3696; Oak Brook, IL 60522-3696 Toll Free (877) 969-0010; Fax (630) 990-0246 www.compassionatefriends.org

32. Dr. Elisabeth Kubler-Ross studied people who were dying and those who were close to them. She observed that all of them go through stages of grief after becoming aware of impending death or loss of a loved one. The stages that she noted generally proceed from denial and isolation to finally acceptance. You have probably noticed these reactions in others: Denial and isolation is usually the first stage. People don’t want to accept that this unfathomable loss is going to touch (or has already touched) them. “ No, it couldn’t be right. You have the wrong person. The lab must have mixed up the results.” Anger may come next. In this stage, people sometimes try to blame others for what is happening. Health care professionals or spouses may be the target of this anger and blame. Bargaining is another stage through which many people go. This stage provides a measure of being in control. “If I do this now, maybe ‘it’ (death or loss) won’t happen.” Depression may precede acceptance. When the person finally realizes that death or loss will happen (or has happened), he or she may feel hopeless and helpless. Acceptance is the stage that, hopefully, all will reach. Dealing with the present and the future realistically occurs in this stage. People progress and regress through these stages in no specific timeframe or order. Acceptance may appear for a few minutes, only to be replaced by anger in the next hour. Many parents who suffer the loss of a child, or have a child born with a disability, may also experience guilt, shock, confusion, and disbelief as well as a number of other feelings. It is important to reassure parents that the feelings they have are healthy and appropriate, and will help them come to terms with their loss or feelings of anxiety. Reference Notes - Kubler-Ross, Elisabeth. On Death and Dying. New York: The Macmillan Company, 1969 - Conner, Michael G.; www.CrisisCounseling.org Dr. Elisabeth Kubler-Ross studied people who were dying and those who were close to them. She observed that all of them go through stages of grief after becoming aware of impending death or loss of a loved one. The stages that she noted generally proceed from denial and isolation to finally acceptance. You have probably noticed these reactions in others: Denial and isolation is usually the first stage. People don’t want to accept that this unfathomable loss is going to touch (or has already touched) them. “ No, it couldn’t be right. You have the wrong person. The lab must have mixed up the results.” Anger may come next. In this stage, people sometimes try to blame others for what is happening. Health care professionals or spouses may be the target of this anger and blame. Bargaining is another stage through which many people go. This stage provides a measure of being in control. “If I do this now, maybe ‘it’ (death or loss) won’t happen.” Depression may precede acceptance. When the person finally realizes that death or loss will happen (or has happened), he or she may feel hopeless and helpless. Acceptance is the stage that, hopefully, all will reach. Dealing with the present and the future realistically occurs in this stage. People progress and regress through these stages in no specific timeframe or order. Acceptance may appear for a few minutes, only to be replaced by anger in the next hour. Many parents who suffer the loss of a child, or have a child born with a disability, may also experience guilt, shock, confusion, and disbelief as well as a number of other feelings. It is important to reassure parents that the feelings they have are healthy and appropriate, and will help them come to terms with their loss or feelings of anxiety. Reference Notes - Kubler-Ross, Elisabeth. On Death and Dying. New York: The Macmillan Company, 1969 - Conner, Michael G.; www.CrisisCounseling.org

33. While we all express grief in different ways, most people experience peaks and valleys in their grief and share common feelings and reactions including: Sadness Anger Disbelief Despair Loneliness Personal Loss Fear Withdrawal Guilt Emptiness While we all express grief in different ways, most people experience peaks and valleys in their grief and share common feelings and reactions including: Sadness Anger Disbelief Despair Loneliness Personal Loss Fear Withdrawal Guilt Emptiness

34. Couple educational messages with compassionate, sensitive words: Parents report wanting to know what their child’s condition is and what they should expect. Educate and inform them about their child’s condition, using kind words and sensitivity. Let them know that there are places in their own communities that can help them. Offer them resource materials that they can take home and read at their own leisure. Couple educational messages with compassionate, sensitive words: Parents report wanting to know what their child’s condition is and what they should expect. Educate and inform them about their child’s condition, using kind words and sensitivity. Let them know that there are places in their own communities that can help them. Offer them resource materials that they can take home and read at their own leisure.

35. Many parents may not be well-informed about their child’s condition. It is important to be knowledgeable about the different types of neural tube defects, so that parents can receive accurate, up-to-date information. Just because a mother has been told that her baby has spina bifida, does not necessarily mean she has been told what spina bifida is, or has fully understood what she has been told. It is very important to offer parents resources that are available in their communities that will meet their specific needs. Making sure that parents are well-informed about these resources can help ease the feelings of anxiety they may be feeling. Don’t be afraid to make some phone calls with the parents in your office. Letting them know that there are others in their own communities who have experienced these same feelings of loss and anxiety, may help them feel a sense of support. Many parents may not be well-informed about their child’s condition. It is important to be knowledgeable about the different types of neural tube defects, so that parents can receive accurate, up-to-date information. Just because a mother has been told that her baby has spina bifida, does not necessarily mean she has been told what spina bifida is, or has fully understood what she has been told. It is very important to offer parents resources that are available in their communities that will meet their specific needs. Making sure that parents are well-informed about these resources can help ease the feelings of anxiety they may be feeling. Don’t be afraid to make some phone calls with the parents in your office. Letting them know that there are others in their own communities who have experienced these same feelings of loss and anxiety, may help them feel a sense of support.

36. How Do I Say It? BE HONEST about the child’s condition! Tell parents everything you know and be honest with them about things you DON’T know. Learn how to interpret body language Facial expressions, posture, arms folded, eye contact Listen! Allow and encourage parents to share their feelings of loss Give parents time to ask questions and respond with their thoughts and feelings Be patient Remember that it can take a long time to recover from a major loss. Don’t be afraid to show parents you care Touching is our most basic form of comfort. Put your arm around a parent’s shoulder or your hand on their arm. How Do I Say It? BE HONEST about the child’s condition! Tell parents everything you know and be honest with them about things you DON’T know. Learn how to interpret body language Facial expressions, posture, arms folded, eye contact Listen! Allow and encourage parents to share their feelings of loss Give parents time to ask questions and respond with their thoughts and feelings Be patient Remember that it can take a long time to recover from a major loss. Don’t be afraid to show parents you care Touching is our most basic form of comfort. Put your arm around a parent’s shoulder or your hand on their arm.

37. What’s Next? Refer and Follow-up: Services for Children Special Services Medical Specialists Children’s Medical Services Babies Can’t Wait Medicaid Children 1st Routine Health Care and Immunizations Local health center Pediatrician/Primary health care provider Children with NTDs will need services for special needs. Some needs may include: Specialized health care Neurology—brain and spine-related needs Orthopedics—bone and muscle-related needs Orthotics—appliances, such as splints, crutches, wheelchairs, made or fitted for the child. Adjusted or replaced as the child grows. Genito-urinary (GU)—bladder needs Training to deal with bowel and bladder incontinence Education Early development Learning disabilities Rarely, mental retardation Health insurance Medicaid PeachCare Children also need routine health care and immunizations from a primary health care provider, either a private one or one in the local health center. What are the resources in your area? How do you access them, and what is the referral process? Children with NTDs will need services for special needs. Some needs may include: Specialized health care Neurology—brain and spine-related needs Orthopedics—bone and muscle-related needs Orthotics—appliances, such as splints, crutches, wheelchairs, made or fitted for the child. Adjusted or replaced as the child grows. Genito-urinary (GU)—bladder needs Training to deal with bowel and bladder incontinence Education Early development Learning disabilities Rarely, mental retardation Health insurance Medicaid PeachCare Children also need routine health care and immunizations from a primary health care provider, either a private one or one in the local health center. What are the resources in your area? How do you access them, and what is the referral process?

38. What’s Next?Refer and Follow-Up: Services for Parents Special Services Grief counselor Genetic counselor Parent-to-Parent Help with Medicaid, PeachCare application Support groups Moms Dads Couples Kids Speakers of Spanish Routine Health Care Local health center Primary health care provider Obstetrician/gynecologist Parents who have had an NTD-affected pregnancy also need special services. Some special services that may be needed are: Grief and family counseling Genetic counseling Help with Medicaid/PeachCare applications Emotional support and practical ideas from others with similar experiences They also need routine health care from their primary health care providers, either private or from the local health center. What are the resources in your community? How do you access them, and what is the referral process? Parents who have had an NTD-affected pregnancy also need special services. Some special services that may be needed are: Grief and family counseling Genetic counseling Help with Medicaid/PeachCare applications Emotional support and practical ideas from others with similar experiences They also need routine health care from their primary health care providers, either private or from the local health center. What are the resources in your community? How do you access them, and what is the referral process?