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The Burden of Preterm Birth A SPOTLIGHT ON THE IMPORTANCE OF EACH WEEK OF PREGNANCY

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Page 1: The Burden of Preterm Birth - AMAG Pharmaceuticals...Preterm birth, including late preterm birth, can lead to health problems Length of pregnancy is one of the most important factors

The Burden of Preterm Birth A SPOTLIGHT ON THE IMPORTANCE OF EACH

WEEK OF PREGNANCY

Page 2: The Burden of Preterm Birth - AMAG Pharmaceuticals...Preterm birth, including late preterm birth, can lead to health problems Length of pregnancy is one of the most important factors

Preterm birth is a serious health concern and the leading cause of infant morbidity and mortality in the United States.

Page 3: The Burden of Preterm Birth - AMAG Pharmaceuticals...Preterm birth, including late preterm birth, can lead to health problems Length of pregnancy is one of the most important factors

More than 1,000 babies are born preterm every day.1,2

As of November 2016, the U.S. PTB rate is 9.6%, meaning approximately 1 in every 10 babies is born preterm.1

ACOG suggests that preterm birth rates have increased because of a dramatic rise in late preterm births, as late preterm newborns are the fastest growing subset of neonates.3

(28–31 weeks)

(<28 weeks)(36 weeks)

(32–33 weeks)

(34 weeks)

(35 weeks)

28–31 weeks

<28 weeks

36 weeks

32–33 weeks

34 weeks

35 weeks

39%

19%

7%

10%

12%

13%

39%

19%

7%

13%

12%

10%

39% 19% 13% 12% 10% 7%

20% 60% 100%

Introduction

1

Preterm birth overview

71.3% of all preterm births in the United States are late preterm births.2,4

Page 4: The Burden of Preterm Birth - AMAG Pharmaceuticals...Preterm birth, including late preterm birth, can lead to health problems Length of pregnancy is one of the most important factors

Evolving terminology for late preterm and term birth

WEEK

37WEEK

38WEEK

39WEEK

41WEEK

40WEEK

35 3634WEEK

37WEEK

38WEEK

39WEEK

41WEEK

40WEEK

35 3634

Preterm is a birth of an infant before 37 weeks of gestation.

Late preterm, previously referred to as “near term,” is a birth of an infant between 340- 366 weeks gestation:• Prior to 2005, “late preterm” was known as “near term.”

This change was made because “near term” was believed to minimize the risks associated with delivering between 340-366 weeks gestation52

Definitions

Page 5: The Burden of Preterm Birth - AMAG Pharmaceuticals...Preterm birth, including late preterm birth, can lead to health problems Length of pregnancy is one of the most important factors

Evolving terminology for late preterm and term birth

WEEK

37WEEK

38WEEK

39WEEK

41WEEK

40WEEK

35 3634

Term is a birth of an infant after 37 weeks of gestation.

Early term is a birth of an infant between 370-386 weeks of gestation.

Full term is a birth of an infant between 390-406 weeks of gestation.

3In 2013, ACOG and SMFM redefined “term” into two subcategories, early term and full term, to underscore the importance of each week.6

Page 6: The Burden of Preterm Birth - AMAG Pharmaceuticals...Preterm birth, including late preterm birth, can lead to health problems Length of pregnancy is one of the most important factors

Some women are at higher risk than others.

While there are a variety of risk factors associated with preterm birth, leading risk factors include:1,7

• Maternal history of spontaneous preterm birth

• Short cervical length

• Pregnancy with multiples

• African American ethnicity

Identifying who is at increased risk for preterm birth

Preterm birth risk

PTB rates are ~50% higher in African American women compared to white women.1

Women who have delivered before 37 weeks gestation are up to 2x more likely to deliver preterm again.7

African American ethnicityMaternal history

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Page 8: The Burden of Preterm Birth - AMAG Pharmaceuticals...Preterm birth, including late preterm birth, can lead to health problems Length of pregnancy is one of the most important factors

Preterm birth, including late preterm birth, can lead to health problems

Length of pregnancy is one of the most important factors in a newborn’s overall health.

Compared to term infants, late preterm infants are:8

• 4x more likely to have at least 1 medical condition diagnosed

• 3½x more likely to have 2 conditions diagnosed

Additionally children born preterm face greater risks of serious and potentially lifelong disabilities as well as a variety of developmental and behavioral problems.3

Health problems

6

Page 9: The Burden of Preterm Birth - AMAG Pharmaceuticals...Preterm birth, including late preterm birth, can lead to health problems Length of pregnancy is one of the most important factors

Overall, preterm birth has a profound societal impact

Preterm birth by the numbers, based on published literature:

• 7x more likely to have morbidity during initial hospitalization than term infants9

• 23% risk of rehospitalization during the first year10

• 48% admitted to the NICU/NINT11*

* Neonatal Intensive Care Unit/Neonatal Intermediate Care

Societal impact

7

Page 10: The Burden of Preterm Birth - AMAG Pharmaceuticals...Preterm birth, including late preterm birth, can lead to health problems Length of pregnancy is one of the most important factors

Preterm brains are smaller and less mature than full-term babies

Brain growth

8

At week 34, brain weight is 65% of the weight of a term brain and formation is incomplete.12

• A nearly 10-fold increase in fetal brain volume takes place between weeks 18 and 3413

• During the last 6 weeks of gestation:12

• 50% increase of cortical volume

• 25% of cerebellar development occurs

• Exponential increase in relative percentage

of gray and myelinated white matter to total brain volume

Brain scan at 24-40 weeks gestation14

Page 11: The Burden of Preterm Birth - AMAG Pharmaceuticals...Preterm birth, including late preterm birth, can lead to health problems Length of pregnancy is one of the most important factors

A closer look at the late preterm stage

Late preterm development

Brain is still developing balance, coordination, learning and social function.3

Lung structure and function continues maturing. Babies born early may have trouble breathing.3,8

Temperature regulation is still developing. Body fat may be low leading to temperature instability.3,15

Hearing is still developing and may not be fully functional until full term.16

Liver is still maturing and may not be able to remove bilirubin and prevent jaundice.3,15

Sucking and swallowing reflexes continue to develop. Babies born early may have difficultly feeding or have nutrition problems.15,17

9

Page 12: The Burden of Preterm Birth - AMAG Pharmaceuticals...Preterm birth, including late preterm birth, can lead to health problems Length of pregnancy is one of the most important factors

Significant economic burdens

The annual cost associated with preterm birth, based on a 2007 Institute of Medicine report.18

The percentage of pregnancy costs associated with preterm birth.19

The average incremental cost during an infant’s first year of life.18,20

Preterm birth is associated with significant economic burdens

10

$26.2 Billion

50%

$50,000

Page 13: The Burden of Preterm Birth - AMAG Pharmaceuticals...Preterm birth, including late preterm birth, can lead to health problems Length of pregnancy is one of the most important factors

Hospitalization costs

Hospitalization costs for preterm infants by gestational age.

Although the cost of preterm birth is more expensive the earlier the case, the aggregate cost of all preterm gestational ages is high due to the disproportionate number of cases being attributed to late preterm birth.21,22

Aggregate cost is the total cost for all babies in that delivery category. Data derived from Gilbert et al, 2003, which examined a statewide California database, and adjusted for inflation to 2014 dollar values.

(n = 192)

(n = 251)

(n = 328)

(n = 402)

(n = 585)

(n = 797)

(n = 1194)

(n = 1921)

(n = 3172)

(n = 5788)

(n = 9898)

(n = 16,609)

Aggregate cost

$0 $50Million

$60Million

$70Million

$80Million

$90Million

25 weeks

26 weeks

27 weeks

28 weeks

29 weeks

30 weeks

31 weeks

32 weeks

33 weeks

34 weeks

35 weeks

36 weeks

11

Page 14: The Burden of Preterm Birth - AMAG Pharmaceuticals...Preterm birth, including late preterm birth, can lead to health problems Length of pregnancy is one of the most important factors

Why late preterm birth matters

4 key takeaways

1. More complications 2. Critical development 3. Economic burdens 4. Term reclassification

12

Compared to term, preterm birth including late preterm birth is associated with more complications in infancy and long-term social and emotional problems.

The last few weeks of gestation are critical for a baby’s physical and mental development.

Preterm birth is associated with significant economic burdens and the aggregate cost of late preterm birth is a high portion of preterm birth’s total economic impact.

The reclassification of late preterm, away from near-term, better reflects the impact and significance of this gestational period for a baby’s development.

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1. March of Dimes. 2016 Premature Birth Report Card – United States. http://www.marchofdimes.org/materials/premature-birth-report-card-united-states.pdf. Accessed March 23, 2017. 2. Martin JA, Hamilton BE, Osterman MJK, et al. Births: Final data for 2015. National vital statistics report; vol 66, no 1. Hyattsville, MD: National Center for Health Statistics. 2017. 3. Loftin RW, Habli M, Snyder C, et al. Late preterm birth. Rev Obstet Gynecol. 2010;3:10-19. doi:10.3909/riog0098 4. United States Department of Health and Human Services (US DHHS), Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS), Division of Vital Statistics. Natality public-use data 2007-2015, on CDC WONDER online database. February 2017. http://wonder.cdc.gov/natality-current.html. Accessed March 22, 2017. 5. Raju TN, Higgins RD, Stark AR, Leveno KJ. Optimizing care and outcome for late-preterm (near-term) infants: a summary of the workshop sponsored by the National Institute of Child Health and Human Development. Pediatrics. 2006;118(3):1207-14. 6. Committee Opinion no.579: definition of term pregnancy. Obstet Gynecol. 2013; 122:1139-1140. Reaffirmed 2015. 7. Practice bulletin no. 130: prediction and prevention of preterm birth. Obstet Gynecol. 2012;120 (4):964-73. doi: 10.1097/AOG.0b013e3182723b1b 8. Engle WA, Tomashek KM, Wallman C. “Late-preterm” infants: a population at risk. Pediatrics. 2007;120(6):1390-401. doi: 10.1542/peds.2007-2952 9. Shapiro-Mendoza CK, Tomashek KM, Kotelchuck M, et al. Effect of late-preterm birth and maternal medical conditions on newborn morbidity risk. Pediatrics. 2008;121(2):e223-32. doi: 10.1542/peds.2006-3629 10. Bird TM, Bronstein JM, Hall RW, Lowery CL, Nugent R, Mays GP. Late preterm infants: birth outcomes and health care utilization in the first year. Pediatrics. 2010;126(2):e311-9. doi: 10.1542/peds.2009-2869 11. March of Dimes. Special care nursery admissions. https://www.marchofdimes.org/peristats/pdfdocs/nicu_summary_final.pdf. Accessed March 6, 2015. 12. Kugelman A, Colin AA. Late preterm infants: near term but still in a critical developmental time period. Pediatrics. 2013;132(4):741-51. doi: 10.1542/peds.2013-1131 13. Roelfsema NM, Hop WC, Boito SM, Wladimiroff JW. Three-dimensional sonographic measurement of normal fetal brain volume during the second half of pregnancy. Am J Obstet Gynecol. 2004;190(1):275-80. doi: 10.1016/S0002-9378(03)00911-6 14. Kapellou O, Counsell SJ, Kennea N, et al. Abnormal cortical development after premature birth shown by altered allometric scaling of brain growth. PLoS Med. 2006;3(8):e265. doi: 10.1371/journal.pmed.0030265 15. Cleaveland K. Feeding challenges in the late preterm infant. Neonatal Netw. 2010;29:37-41. 16. Committee on Environmental Health. Noise: a hazard for the fetus and newborn. Pediatrics 1997;100;724-727. doi: 10.1542/peds.100.4.72 17. Hegyi H. The Late Preterm Birth Infant Presentation. New Jersey Hospital Association. http://www.njha.com/media/40836/obe_njhapfp_thomashegyi.pdf. Accessed August 2, 2016. 18. Behrman RE, Butler AS, eds. Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes. Preterm Birth: Causes, Consequences, and Prevention. Washington, DC: National Academies Press; 2007. 19. Society for Maternal-Fetal Medicine, The American College of Obstetricians and Gynecologists, and American College of Nurse-Midwives. Letter to US Department of Health and Human Services. August 13, 2014. 20. March of Dimes. Premature birth: the financial impact on business. http://www.marchofdimes.org/materials/premature-birth-the-financial-impact-on-business.pdf. Accessed March 6, 2015. 21. Gilbert WM, Nesbitt TS, Danielsen B. The cost of prematurity: quantification by gestational age and birth weight. Obstet Gynecol. 2003;102(3):488-92. doi: 10.1016/S0029-7844(03)00617-3 22. Bureau of Labor Statistics. Consumer price index-all urban consumers. http://www.bls.gov/data. Accessed April 11, 2016.

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©2017 AMAG Pharmaceuticals, Inc. | PP-NPM-US-00004 5/17AMAG Pharmaceuticals, Inc. Waltham, MA 02451

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