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COCA Conference Call – National Obstetric Grand Rounds: Pandemic (H1N1) 2009 Influenza and Pregnancy The findings and conclusions in this report are those.

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Presentation on theme: "COCA Conference Call – National Obstetric Grand Rounds: Pandemic (H1N1) 2009 Influenza and Pregnancy The findings and conclusions in this report are those."— Presentation transcript:

1 COCA Conference Call – National Obstetric Grand Rounds: Pandemic (H1N1) 2009 Influenza and Pregnancy The findings and conclusions in this report are those of the author and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Denise J. Jamieson, MD MPH Division of Reproductive Health Centers for Disease Control and Prevention Sonja A. Rasmussen, MD, MS National Center on Birth Defects and Developmental Disabilities Centers for Disease Control and Prevention Kevin Ault, MD Department of Gynecology & Obstetrics Emory University School of Medicine

2 Continuing Education Disclaimer In compliance with continuing education requirements, all presenters must disclose any financial or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters as well as any use of unlabeled product(s) or product(s) under investigational use. CDC, our planners, and our presenters wish to disclose they have no financial interests or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters. This presentation does not involve the unlabeled use of a product or product under investigational use. There is no commercial support.

3 Accrediting Statements CME: The Centers for Disease Control and Prevention is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The Centers for Disease Control and Prevention designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit. Physicians should only claim credit commensurate with the extent of their participation in the activity. CNE: The Centers for Disease Control and Prevention is accredited as a provider of Continuing Nursing Education by the American Nurses Credentialing Center's Commission on Accreditation. This activity provides 1 contact hour. CEU: The CDC has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 8405 Greensboro Drive, Suite 800, McLean, VA The CDC is authorized by IACET to offer 0.1 CEU's for this program. CECH: The Centers for Disease Control and Prevention is a designated provider of continuing education contact hours (CECH) in health education by the National Commission for Health Education Credentialing, Inc. This program is a designated event for the CHES to receive 1 Category I contact hour in health education, CDC provider number GA0082.

4 National Obstetric Grand Rounds: Pandemic (H1N1) 2009 Influenza and Pregnancy Overview of influenza (Dr. Jamieson) Infection Control Guidance (Dr. Jamieson) Testing and Treatment (Dr. Rasmussen) Vaccination (Dr. Rasmussen) The Atlanta Experience (Dr. Ault)

5 No evidence that they are more susceptible Increased mortality from influenza during previous pandemics (1918 & 1957) Increased risk of complications related to seasonal influenza Pregnant women at increased risk for severe influenza illness

6 Risk of Hospital Admission for Respiratory Illness during Influenza Season by Pregnancy Status* among Women with No Comorbidity, Nova Scotia, Dodds et al., CMAJ 176:463-8, 2007 *Compared to year before pregnancy

7 Mechanical, hormonal, immunologic alterations in pregnancy Changes in respiratory and cardiovascular systems - increased heart rate, stroke volume, and oxygen consumption; decreased lung volumes Immunologic changes – shift away from cell- mediated immunity These changes render pregnant women more susceptible and more severely affected by certain viral pathogens Why are pregnant women at increased risk for severe influenza illness?

8 Effects of influenza on the fetus are unknown and difficult to predict In seasonal influenza, viremia is believed to occur infrequently and placental transmission appears to be rare – may differ with novel influenza strains Hyperthermia is a risk factor for some types of birth defects and other adverse outcomes Fetal concerns regarding influenza during pregnancy

9 Guidelines regarding nonpharmaceutical interventions might present special challenges Pregnant women will require health care access (prenatal care and delivery services) Pregnant women might be reluctant to comply with recommendations because of concerns about fetus Special Health Care Delivery Challenges for Pregnant Women

10 Lu et al., Vaccine 26: , 2008 Data from National Health Interview Survey Influenza Vaccination Coverage among Recommended Adult Populations, National Health Interview Survey,

11 Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team, N Engl J Med 361, 2009

12 Pandemic (H1N1) 2009 Influenza Illness resulted from quadruple reassortment virus of human, avian and swine influenza virus genes Viruses susceptible to oseltamivir and zanamivir, resistant to amantadine and rimantadine Median age – 20 years, range 3 months to 81 years; 60% were 18 years or younger (based on 642 confirmed cases reported 4/15-5/5/2009) Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team, N Engl J Med 361, 2009 CDC, MMWR Morb Mortal Wkly Rep 58:536-41, 2009 and 58: , 2009

13 Pandemic (H1N1) 2009 Influenza (continued) In the US, most confirmed cases characterized by self-limited, uncomplicated febrile respiratory illness: similar to seasonal influenza (cough, sore throat, rhinorrhea, headache, and myalgia) – 38% with vomiting or diarrhea (based on 642 confirmed cases reported 4/15- 5/5/2009) Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team, N Engl J Med 361, 2009 CDC, MMWR Morb Mortal Wkly Rep 58:536-41, 2009 and 58: , 2009

14 Jamieson DJ et al., Lancet 374:451-8, 2009

15 Pandemic (H1N1) 2009 Influenza and Pregnancy Jamieson DJ et al., Lancet 374:451-8, confirmed or probable cases of pandemic (H1N1) 2009 influenza in pregnant women (April 15-May 18, 2009) in US (34/5469 or 0.62% of total) 11 women (32%) were admitted to hospital 6 deaths among pregnant woman with pandemic (H1N1) 2009 influenza (April 15- June 16, 2009) (6/45 or 13% of total)

16 Presenting manifestationsN (%) Fever33 (97%) Cough32 (94%) Rhinorrhea20 (59%) Sore throat17 (50%) Headache16 (47%) Shortness of breath14 (41%) Vomiting6 (18%) Diarrhea4 (12%) United States, April 15 to May 18, 2009 Presenting Manifestations in Pregnant Women with Pandemic (H1N1) 2009 Influenza United States, April 15 to May 18, 2009 Jamieson DJ et al., Lancet 374:451-8, 2009

17 Pregnancy Trimester at Time of Pandemic (H1N1) 2009 Influenza Infection United States, April 15-May 18, 2009 Jamieson DJ et al., Lancet 374:451-8, 2009

18 Population Admission Rate per 100,000 (95% CI) Pregnant women0.32 ( ) General Population0.076 ( ) United States, April 15 to May 18, 2009 Admission Rates for Pregnant Women and General Population with Pandemic (H1N1) 2009 Influenza United States, April 15 to May 18, 2009 Jamieson DJ et al., Lancet 374:451-8, 2009 Risk Ratio 4.3, 95% CI

19 Case # Age (years) Weeks’ gestation Underlying Medical Conditions 13335Mild asthma, psoriasis 22432Obesity 32027None 42111Factor V Leiden deficiency 52236None 630 None United States, April 15 to June 16, 2009 Deaths in Pregnant Women due to Pandemic (H1N1) 2009 Influenza United States, April 15 to June 16, 2009 Jamieson DJ et al., Lancet 374:451-8, 2009

20 Additional Clinical Information on Deaths among Pregnant Women All patients developed primary viral pneumonia with subsequent ARDS requiring mechanical ventilation Pregnancy outcomes: 5 with cesarean delivery (27-36 weeks gestation – 3 in ICU or ED), 1 fetal loss at 11 weeks Length of time from symptom onset to receipt of antiviral medication was 6-15 days (median 9) Length of time from presentation for medical care until receipt of antiviral treatment was 2-14 days (median 4.5)

21 Updated Information on Deaths among Pregnant Women ~ 5% of deaths in US from pandemic (H1N1) 2009 Influenza are among pregnant women (based on 484 H1N1 deaths reported to CDC by August 20, 24 of whom were pregnant) Pregnant women ~1% of the general population

22 Infection Control in Obstetric Settings: General Principles Keep pregnant outpatients and inpatients separated from ill and potentially ill patients Requires system for rapidly assessing influenza-like symptoms and triaging patients

23 Considerations regarding novel H1N1 in obstetric settings (July 6, 2009) Place surgical mask on ill mother during labor & delivery, if tolerable Mother should consider avoiding close contact with infant until: –antiviral medication for 48 hours –fever has fully resolved –she can control coughs and secretions When in contact with the infant, mother should do following until 7 days after symptom onset and symptom-free for 24 hours: –wear a facemask –change to clean gown or clothing –adhere to strict hand hygiene and cough etiquette

24 CDC Interim Guidelines Testing for 2009 H1N1 influenza Antiviral treatment and prophylaxis Seasonal and 2009 H1N1 influenza vaccination

25 Influenza Diagnostic Testing TestMethod Time to Process Sensitivity for 2009 H1N1 Distinguishes 2009 H1N1? Rapid influenza diagnostic tests Antigen detection 0.25 hour 10-70%No Direct and indirect immunofluorescence assays (DFA/IFA) Antigen detection 2-4 hours 47-93%No Nucleic acid amplification tests (e.g., rRT-PCR*) RNA detection hours %Yes Virus isolation in tissue cell culture Virus isolation 2-10 days --Yes *rRT-PCR – real-time reverse transcriptase polymerase chain reaction

26 Testing and Treatment Treatment is recommended for pregnant women with suspected or confirmed influenza, regardless of trimester of pregnancy Do not delay treatment because of a negative rapid influenza diagnostic test or inability to test or while awaiting test results

27 Treatment Oseltamivir (Tamiflu®) –75 mg po bid for 5 days –BEST if started within 48 hours of symptom onset Oseltamivir (Tamiflu®) and zanamivir (Relenza®) are FDA pregnancy category C –Available data suggest not human teratogens Tanaka et al. CMAJ 181:55-8, 2009 Considering severity of disease, treatment benefit outweighs potential risk Acetaminophen for fever

28 Treatment Rapid access to antiviral medications is essential Actions that might reduce delays in treatment initiation –Informing pregnant women of signs and symptoms of influenza and need for early treatment –Ensuring rapid access to telephone consultation and clinical evaluation –Considering empiric treatment of patients at higher risk for influenza complications based on telephone contact

29 Post-exposure Chemoprophylaxis Consider if close contact with suspected or confirmed case Zanamivir (Relenza®) Two 5mg inhalations qd Oseltamivir (Tamiflu®) 75 mg qd 10 day duration Close monitoring and early treatment is an alternative to chemoprophylaxis

30 Post-exposure Chemoprophylaxis Close contact: defined as having cared for or lived with a person who is a confirmed, probable, or suspected case of influenza, or having been in a setting where there was a high likelihood of contact with respiratory droplets and/or body fluids of such a person Examples –sharing eating or drinking utensils –physical examination –any other contact between persons likely to result in exposure to respiratory droplets

31 ACIP Recommendations for Seasonal Flu Vaccination Influenza vaccine is recommended for people at increased risk of severe infection, including women who will be pregnant during influenza season This includes all pregnant women in any trimester

32 Need for Seasonal Flu Vaccine Pregnant women who get influenza are at higher risk for serious complications Influenza vaccine given during pregnancy prevents febrile respiratory illness in pregnant women and infants and lab-proven influenza in infants up to 6 months of age Zaman et al., NEJM 359: , 2008

33 ACIP Recommendations for 2009 H1N1 Vaccination Pregnant women Household contacts and caregivers for children younger than 6 months of age Healthcare and emergency medical services personnel All people from 6 months through 24 years of age Persons aged 25 through 64 years who have health conditions associated with higher risk of influenza-related complications

34 Need for 2009 H1N1 Vaccine Pregnant women who get 2009 H1N1 influenza at higher risk for hospitalization, severe illness and death Seasonal flu vaccine not expected to protect against 2009 H1N1 influenza Jamieson DJ et al., Lancet 374:451-8, 2009

35 Vaccine Types Live attenuated vaccine (not licensed for use in pregnant women) Multidose inactivated vaccine Prefilled single dose inactivated vaccine (preservative-free)

36 When to Administer Can be given at any time during pregnancy Can also be given postpartum, providing indirect protection for infants <6 months Recommended even for women who have had influenza-like illness

37 How to Administer Inactivated vaccines against seasonal flu and 2009 H1N1 can be administered simultaneously –Use different anatomic sites 2009 H1N1 vaccine - ancillary supplies will also be provided (needles, syringes, sharps containers, alcohol swabs, vaccination record card) 2009 H1N1 vaccine approved by FDA –One dose for persons > 10 years of age

38 How to Obtain 2009 H1N1 Vaccine Vaccine expected to be available in October CDC will allocate vaccine to states based on population States will determine where vaccine will be shipped (mix of public and private settings) Contact state health department to express interest in receiving vaccine (list of contacts on CDC website)

39 2009 H1N1 Vaccine Financing Vaccine available at no-cost for providers Providers CANNOT charge a fee for vaccine since it is being provided free of charge by the federal government Providers can bill insurance or charge the patient a vaccine administration fee –Patient cannot be charged more than regional Medicare vaccine administration fee

40 2009 H1N1 Vaccine Financing (continued) Providers are encouraged to vaccinate under- or uninsured patients If unable, providers should refer these patients to public health settings

41 2009 H1N1 Vaccine Safety Anticipated to be similar to seasonal flu vaccine Clinical trials in pregnant women began mid-September

42 CDC Interim Guidelines nant.htm

43 Conclusions During an influenza pandemic, pregnant women are expected to be a high-risk population, based on the experience with previous pandemics and with seasonal influenza Data available thus far suggest that pregnant women are at increased risk for complications and death from 2009 H1N1 influenza

44 Conclusions Pregnant women should be informed about the signs and symptoms of 2009 H1N1 influenza Pregnant women who present with signs and symptoms consistent with influenza should be treated empirically with oseltamivir Post-exposure prophylaxis with zanamivir or oseltamivir can be considered for pregnant women

45 Conclusions Both seasonal and 2009 H1N1 influenza vaccines recommended for pregnant women 2009 H1N1 vaccine safety expected to be similar to seasonal influenza vaccine Providers should contact state health department to express interest in obtaining 2009 H1N1 vaccine

46 Kevin A. Ault MD Department of Gynecology and Obstetrics Emory University School of Medicine Atlanta GA USA

47 “On the Ground” Planning GA State Meeting August 2009 Most troublesome issues –Isolation of mothers with illness –Masks during labor –Planning for new H1N1 vaccine

48 Influenza Vaccine During Pregnancy Pregnancy Risk Assessment and Monitoring System (PRAMS) from Georgia and Rhode Island reported in MMWR on Sept 11, 2009 Questionnaire mailed to women 2-6 months postpartum GA and RI collected influenza vaccine information starting in 2004

49 Influenza Vaccine During Pregnancy From MMWR Sept 11, 2009

50 Reasons given for not receiving influenza vaccination --- Pregnancy Risk Assessment Monitoring System, Georgia, 2006 ReasonPercentage “I don’t usually get flu vaccine”69.4 % “My physician did not mention anything about a flu vaccine during my pregnancy” 44.5 % “I was worried that the flu vaccination might harm my baby” 28.1 % “I was in my first trimester during the flu season “ 25.2 %

51 Potential interventions to improve influenza vaccination rate in pregnant women Standing orders in office and hospital settings Broadcast to all employees Professional education at all levels “Best practices” review with department head by individual provider ie quality control Vaccine “champion” Adopted from Mouzoon et al

52 Safety of influenza vaccination during pregnancy 11 studies published between 1964 and 2008 about safety of influenza vaccination during pregnancy None identified maternal or fetal problems with influenza vaccination One prospective randomized trial showed significant benefits to mothers and newborns

53 Data from Bhat et al ’05 – seasonal flu

54 Laboratory-Proven Influenza in Infants Whose Mothers Received Influenza Vaccine vs Controls Zaman et al., New Eng Journal of Medicine, 2008

55 Thank you!

56 Continuing Education Credit/Contact Hours for COCA Conference Calls Continuing Education guidelines require that the attendance of all who participate in COCA Conference Calls be properly documented. ALL Continuing Education credits/contact hours (CME, CNE, CEU and CECH) for COCA Conference Calls are issued online through the CDC Training & Continuing Education Online system Those who participate in the COCA Conference Calls and who wish to receive continuing education and will complete the online evaluation by August 14, 2009 will use the course code EC1265. Those who wish to receive continuing education and will complete the online evaluation between August 15, 2009 and July 15, 2010 will use course code WD1265. CE certificates can be printed immediately upon completion of your online evaluation. A cumulative transcript of all CDC/ATSDR CE’s obtained through the CDC Training & Continuing Education Online System will be maintained for each user.


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