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Zika and Pregnancy

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Zika and Pregnancy

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Shaping the Caribbean's response to Zika, UWI’s Zika Task Force (www.uwi.edu/zika) is gathering and providing expert advice to develop a strategic, scientific approach for tackling the Zika virus.

Shaping the Caribbean's response to Zika, UWI’s Zika Task Force (www.uwi.edu/zika) is gathering and providing expert advice to develop a strategic, scientific approach for tackling the Zika virus.

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Zika and Pregnancy

  1. 1. Zika and Pregnancy Regional Task Force on Zika Symposium March 4 – 5, 2016 Barbados Rachel Albalak, PhD
  2. 2. Outline • Background • Zika in pregnancy • Maternal-fetal Zika transmission • Zika and microcephaly • Zika and pregnancy outcomes • Brazil case-control study • CDC travel recommendations: pregnant women • CDC guidelines: obstetric healthcare providers • What is CDC doing?
  3. 3. Background • Early October 2015 – Secretary of Health of Pernambuco State, Brazil alerted by clinicians to potential increase in cases of microcephaly – Investigation launched • October 22 – Secretariat confirmed the finding and alerted national authorities • October 23 – Brazil Ministry of Health sent notification through International Health Regulations of the occurrence of 26 cases of microcephaly in Pernambuco
  4. 4. Background • November 11 • Brazil declared national public health emergency and engaged international partners • December 28 – CDC received official request from Brazil Ministry of Health to assist them in evaluating the potential association of Zika virus infection during pregnancy and subsequent microcephaly in infants
  5. 5. Zika Transmission • Mosquito bites • Sexual contact • Blood transfusion • From a mother to her unborn baby
  6. 6. Zika in Pregnancy • Limited information available • Existing data show – No evidence of increased susceptibility – Infection can occur in any trimester – Incidence of Zika virus in pregnant women is not known – No evidence of more severe disease compared to non-pregnant people. • No reports of virus spread through breastfeeding
  7. 7. Maternal-Fetal Zika Transmission • Evidence of maternal-fetal transmission – Zika virus infection confirmed in infants with microcephaly in Brazil and in infants whose mothers traveled to Brazil but delivered in the US – Zika virus RNA identified in specimens of fetal losses – Zika virus detected prenatally in amniotic fluid • Two women at ~30 weeks gestation with a history of symptoms consistent with Zika infection • Fetal microcephaly and intracranial calcifications detected on ultrasound • Amniotic fluid testing positive for Zika virus RNA by RT-PCR
  8. 8. Maternal-Fetal Zika Transmission • Evidence of perinatal transmission (during time of delivery) – Zika outbreak in French Polynesia 2013-2014 • Two pregnant women with signs and symptoms consistent with Zika infection around the time of delivery • Both mothers tested positive for Zika virus RNA by RT-PCR • Zika virus infection was confirmed in the neonates, 1-3 days after delivery • Unlikely that neonates were exposed to mosquitoes • Outcomes regarding microcephaly were not reported
  9. 9. Zika and Microcephaly • Zika infection in pregnancy is linked to microcephaly – Microcephaly: birth defect in which a baby’s head is smaller than expected when compared to babies of the same sex and age – Previous infection will not affect future pregnancies
  10. 10. Range of Microcephaly Severity Baby with typical head size Baby with microcephaly Baby with severe microcephaly
  11. 11. Zika and Microcephaly • Brazil: >5200 cases of suspected microcephaly temporally linked with current Zika outbreak • French Polynesia: 17 cases of neurologic malformations among fetus and newborns temporally linked to 2013–2014 outbreak • Investigations in Brazil and French Polynesia ongoing
  12. 12. Zika and Microcephaly: What we know • Laboratory tests of a small number of cases in Brazil suggest a link between Zika in pregnancy and microcephaly • Microcephaly pattern consistent with Fetal Brain Disruption Sequence • Based on photos/scans of small number of affected infants from Brazil • Retrospective investigation in French Polynesia outbreak (2013- 2014) • Pattern seen in infants with other intrauterine infections (e.g. cytomegalovirus)
  13. 13. Zika and Microcephaly: What we don’t know • Causal relationship between Zika and microcephaly and other adverse pregnancy outcomes • Full spectrum of phenotypes in affected infants • Factors that may influence risk – impact timing of infection during pregnancy – severity of illness
  14. 14. Zika and Microcephaly: Investigating the link • Link between Zika and microcephaly was unexpected – Congenital defects have not been reported with other flavivirus infections in pregnancy • Certain maternal infections like rubella (1941) and cytomegalovirus (1962) can cause microcephaly • Identifying a new viral cause of a major birth defects is extremely rare • Association between microcephaly and Zika would be the 1st association between a maternal infection and birth defect to be detected in more than 50 years
  15. 15. Zika and Pregnancy Outcomes • Pregnant woman residing in Brazil – Symptoms of Zika virus disease at 18 weeks • Ultrasound findings – 16 weeks: Normal – 21 weeks: Fetal microcephaly with brain abnormalities – 27 weeks: Fetal microcephaly with more severe brain abnormalities – 40 weeks: Fetal microcephaly with calcifications
  16. 16. Zika and Pregnancy Outcomes • Testing – 28 weeks: Amniotic fluid positive for Zika virus RNA, serum and urine negative by Zika RT-PCR • Delivery at 40 weeks – Infant born with head circumference <1st percentile
  17. 17. Zika and Pregnancy Outcomes • Pregnant woman residing in Brazil – Symptoms of Zika virus disease at 10 weeks • Ultrasound findings – 22 weeks: Fetal mild hypoplasia of cerebellar vermis and head circumference <10th percentile – 25 weeks: Fetal microcephaly (head circumference <3rd percentile) with severe hypoplasia of cerebellar vermis, and other brain abnormalities
  18. 18. Zika and Pregnancy Outcomes • Testing – 28 weeks: Amniotic fluid positive for Zika virus RNA; serum and urine negative by Zika RT-PCR • Delivery – Infant born with severe ventriculomegaly, microphthalmia, cataracts and severe arthrogryposis
  19. 19. Zika and Pregnancy Outcomes • Pregnant woman residing in Brazil from preconception until 29 weeks of gestation – Symptoms of Zika virus disease at 13 weeks • Ultrasound findings – 14 & 20 weeks: normal fetal growth & anatomy – 29 weeks: evidence of fetal anomalies – 32 weeks: intrauterine growth restriction, microcephaly, and other brain abnormalities
  20. 20. Zika and Pregnancy Outcomes • Two pregnant women in Brazil had clinical signs of Zika virus disease during first trimester • Infants born with microcephaly at 36 and 38 weeks gestation – Died within 20 hours of birth • Zika virus RNA detected in only brain tissue of both infants • Significant histopathologic changes in the brain
  21. 21. Zika and Pregnancy Outcomes • Two additional women in Brazil had clinical signs of Zika virus disease during the first trimester – Two fetal losses at 11 & 13 weeks gestation • Zika virus RNA detected in products of conception • Zika viral antigen detected by immunohistochemistry in one case • Histopathologic changes in one case – Calcification and fibrosis in the chorionic villi
  22. 22. Zika and Pregnancy Outcomes • Termination at 32 weeks – Brain weight 4 SD below normal. – Zika virus RNA detected in fetal brain tissue. – Almost complete agyria and internal hydrocephalus of lateral ventricles
  23. 23. Study on Zika infection and Microcephaly • Primary objective: – Assess the causal relationship of Zika virus infection and microcephaly • Location: Northeastern Brazil • Data collection: February – March 2016 • Study design: Matched case-control
  24. 24. Primary Endpoints • Proportion of infants with and without microcephaly who are Zika virus IgM positive • Proportion of infants with and without microcephaly with Zika virus neutralizing antibodies • Proportion of mothers (of infants with and without microcephaly) with Zika virus IgM antibodies • Proportion of infants with Zika virus IgM antibodies whose mothers are negative for Zika virus IgM antibodies
  25. 25. Secondary Objectives • To assess the rates of dengue IgM antibodies and neutralizing antibodies • To describe rates of exposures to other causes of microcephaly among cases and controls
  26. 26. Sample size Zika virus IgM positivity rate in controls 1 % 5 % 10 % # cases 616 137 78 # controls 1848 411 234 • To obtain odds ratio of 3 (0.8 power, 0.05 prob of type 1 error, correlation coefficient (Phi) for exposure between matched cases and controls of 0.2, 3 matched controls per case)
  27. 27. Results • Preliminary results expected in mid-May
  28. 28. Surveillance • CDC working with the Puerto Rico Department of Health to establish a Zika Virus Active Pregnancy Surveillance System to follow women infected with Zika during their pregnancy and the outcomes of their infants up to 1 year of age • CDC establishing a US Zika Pregnancy Registry which will follow women infected with Zika during pregnancy and their infants for up to 1 year of age
  29. 29. CDC Recommendations: Pregnant Women Considering Travel • Pregnant women in any trimester should consider postponing travel to areas where Zika is present – If a woman must travel to one of these areas, she should talk to her healthcare provider first and strictly follow steps to prevent mosquito bites during the trip – If she has a male partner who lives in or has traveled to an area where Zika is spreading, either do not have sex or use condoms the right way, every time, during her pregnancy
  30. 30. Latest travel notices: wwwnc.cdc.gov/travel/page/zika-travel-information
  31. 31. CDC Guidelines for Healthcare Providers Morbidity and Mortality Weekly Reports • For Obstetrical Health Care Providers – “Interim Guidelines for Pregnant Women During a Zika Virus Outbreak — United States, 2016” (Jan. 22, 2016) – “Update: Interim Guidelines for Healthcare Providers Caring for Pregnant Women and Women of Reproductive Age with Possible Zika Virus Exposure – United States, 2016” (Feb. 5, 2016) • For Pediatric Health Care Providers – Interim Guidelines for the Evaluation and Testing of Infants with Possible Congenital Zika Virus Infection — United States, 2016 (Jan. 29, 2016) – Update: Interim Guidelines for Health Care Providers Caring for Infants and Children with Possible Zika Virus Infection — United States, February 2016 (Feb. 19, 2016)
  32. 32. Updated Interim Guidelines Recommendations for Pregnant Women Residing in Areas with Ongoing Zika Virus Transmission
  33. 33. Evaluating Pregnant Residents • Healthcare providers should – Evaluate for symptoms of Zika virus infection – Perform appropriate testing according to algorithm • Recommendations – Offer serologic testing at Initiation of prenatal care and follow up mid-2nd trimester – Routine ultrasound screening recommended for all pregnant women at 18–20 weeks of gestation – Pregnant women with male partners who have or are at risk of Zika virus infection should use condoms or abstain from sexual activity for the duration of pregnancy
  34. 34. Symptomatic Pregnant Women Residing in Areas With Ongoing Zika Virus Transmission
  35. 35. Symptomatic Pregnant Women Residing in Areas With Ongoing Zika Virus Transmission
  36. 36. Symptomatic Pregnant Women Residing in Areas With Ongoing Zika Virus Transmission
  37. 37. Symptomatic Pregnant Women Residing in Areas With Ongoing Zika Virus Transmission
  38. 38. Symptomatic Pregnant Women Residing in Areas With Ongoing Zika Virus Transmission
  39. 39. Asymptomatic Pregnant Women Residing in Areas With Ongoing Zika Virus Transmission
  40. 40. Asymptomatic Pregnant Women Residing in Areas With Ongoing Zika Virus Transmission
  41. 41. Asymptomatic Pregnant Women Residing in Areas With Ongoing Zika Virus Transmission
  42. 42. Asymptomatic Pregnant Women Residing in Areas With Ongoing Zika Virus Transmission
  43. 43. Asymptomatic Pregnant Women Residing in Areas With Ongoing Zika Virus Transmission
  44. 44. Zika and Pregnancy: Clinical Management • Positive or inconclusive Zika virus testing results – Antepartum • Consider serial ultrasounds every 3–4 weeks • Referral to maternal-fetal medicine specialist is recommended – Postpartum • Histopathologic examination of the placenta and umbilical cord • Testing of frozen placental tissue and cord tissue for Zika virus RNA • Testing of cord serum for Zika and dengue virus IgM and neutralizing antibodies
  45. 45. What is CDC doing? • Working with partners to: – Educate healthcare providers and the public about Zika – Post travel notices and other travel-related guidance – Provide state and territorial health laboratories with diagnostic tests
  46. 46. What is CDC doing? • Working with partners to: – Monitor and report cases – Support mosquito control programs both in the United States and around the world – Conducting studies to learn more about Zika and microcephaly and Guillain-Barré syndrome
  47. 47. Discussion • Findings to date (pathological, sonographic, etc) building the evidence for an association between Zika virus and microcephaly and adverse pregnancy outcomes • Further studies needed for definitive evidence of causality • CDC is continually evaluating any new or emerging data that may inform future recommendations • As more information becomes available, CDC will update the CDC Zika website, guidelines and recommendations
  48. 48. Thank you to Zika team at CDC Headquarters! Acknowledgement
  49. 49. References Slide 6: Zika in Pregnancy Centers for Disease Control and Prevention, CDC Health Advisory: Recognizing, Managing, and Reporting Zika Virus Infections in Travelers Returning from Central America, South America, the Caribbean and Mexico, 2016. Besnard, M., et al., Evidence of Perinatal Transmission of Zika Virus, French Polynesia, December 2013 and February 2014. Euro Surveill, 2014. 19(14): p. 1-5. Oliveira Melo, A., et al., Zika Virus Intrauterine Infection Causes Fetal Brain Abnormality and Microcephaly: Tip of the Iceberg? Ultrasound in Obstetrics & Gynecology, 2016. 47(1): p. 6-7. Slide 7: Maternal-Fetal Zika transmission Oliveira Melo, A., et al., Zika virus intrauterine infection causes fetal brain abnormality and microcephaly: tip of the iceberg? Ultrasound in Obstetrics & Gynecology, 2016. 47(1): p. 6-7.
  50. 50. References Slide 8: Maternal-fetal Zika transmission Besnard, M., et al., Evidence of perinatal transmission of Zika virus, French Polynesia, December 2013 and February 2014. Euro Surveill, 2014. 19(14): p. 1-5. Victora CG, Schuler-Faccini L, Matijasevich A, Ribeiro E, Pessoa A, Barros FC. Microcephaly in Brazil: how to interpret reported numbers? Lancet 2016 Feb 13;387(10019):621-4. European Centre for Disease Prevention and Control. Zika virus epidemic in the Americas: potential association with microcephaly and Guillain-Barre syndrome. 21 January 2016. Stockholm: ECDC; 2016. Besnard M, Mallet H. Increase of cerebral congenital malformations among newborns and fetus in French Polynesia 2014-2015. 15 November 2015. Polynesie Francaise. Slide 11: Zika virus and microcephaly Calvet Detection and sequencing of Zika virus from amniotic fluid of fetuses with microcephaly in Brazil: a case study. Lancet Infect Dis 2016. Epub February 17, 2016. Slide 15 - 18: Zika and pregnancy outcomes
  51. 51. References Martines RB, Bhatnagar J, Keating MK, et al. Notes from the Field: Evidence of Zika Virus Infection in Brain and Placental Tissues from Two Congenitally Infected Newborns and Two Fetal Losses — Brazil, 2015. MMWR Morb Mortal Wkly Rep 2016;65(Early Release):1–2. Slide 20: Zika and pregnancy outcomes Martines RB, Bhatnagar J, Keating MK, et al. Notes from the Field: Evidence of Zika Virus Infection in Brain and Placental Tissues from Two Congenitally Infected Newborns and Two Fetal Losses — Brazil, 2015. MMWR Morb Mortal Wkly Rep 2016;65(Early Release):1–2. Slide 21: Zika and pregnancy outcomes Mlakar J, Korva M, Tul N, et al. Zika Virus Associated with Microcephaly. NEJM 2016 Feb 10. Slide 19: Zika and pregnancy outcomes
  52. 52. Questions?

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