Neonatal herpes simplex virus infection can be devastat anti-viral medications by benbenzhou

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									OBSTETRICS
                                                                OBSTETRICS



Acceptance of a Rapid Herpes Test in Labour:
Survey of Attitudes of Patients and Health Care
Providers
Julie van Schalkwyk, MD,1 Neda Amiri, BSc,1 Sayrin Lalji, MD,1 Carolyn Gardella, MD, MPH,2
Anna Wald, MD, MPH,3 Deborah Money, MD1
1
Department of Obstetrics and Gynaecology, Children’s and Women’s Health Centre of British Columbia, Vancouver BC
2
Department of Obstetrics and Gynecology, University of Washington, Seattle WA
3
Department of Medicine and Epidemiology, University of Washington, Seattle WA


Abstract                                                                      Méthodes : Une étude transversale a été menée auprès de femmes
                                                                                enceintes ambulatoires et de leurs fournisseurs de soins de santé
    Objective: To determine the acceptability to pregnant women and             (obstétriciens, médecins de famille et sages-femmes) au BC
      their health care providers of a rapid test for genital herpes            Women’s Hospital and Health Centre.
      simplex virus (HSV) in labour.
                                                                              Résultats : Chez les femmes enceintes sollicitées, 207 (92 %) ont
    Methods: A cross-sectional survey was conducted with outpatient             rempli le sondage; 90 % d’entre elles n’ont signalé aucun
      pregnant women and their health care providers (obstetricians,            antécédent d’herpès génital. Le dépistage rapide du VHS pendant
      family physicians and midwives) at BC Women’s Hospital and                le travail était considéré acceptable par 85 % des femmes
      Health Centre.                                                            enceintes. Chez les 133 femmes qui planifiaient un accouchement
    Results: Of pregnant women approached, 207 (92%) completed the              vaginal, 63 % étaient disposées à envisager un accouchement par
      survey; 90% reported no history of genital herpes. Rapid HSV              césarienne et 53 % étaient disposées à envisager la prise
      testing in labour was acceptable to 85% of pregnant women.                d’antiviraux intrapartum, si la présence du VHS au sein du tractus
      Among the 133 women who were planning a vaginal delivery, 63%             génital en venait à être constatée. Chez les 51 fournisseurs de
      were willing to consider delivery by Caesarean section and 53%            soins de santé sondés, 98 % ont indiqué que le fait de savoir si
      were willing to consider intrapartum anti-viral medications if HSV        leur patiente présentait une infection au VHS nouvellement
      was present in the genital tract. Of 51 health care providers             acquise les intéressait, tandis que 84 % ont indiqué que le fait de
      surveyed, 98% indicated interest in knowing if their patient had a        savoir si leur patiente présentait une réactivation de l’infection les
      newly acquired HSV infection, while 84% indicated interest in             intéressait. Lorsque la présence du VHS au sein du tractus génital
      knowing if the patient had a reactivation of infection. If HSV was        de leur patiente était constatée, 36 % des fournisseurs de soins
      detected in their patient’s genital tract, 36% indicated they would       ont indiqué qu’ils recommanderaient la mise en œuvre d’une
      recommend a Caesarean section, and 25% would consider                     césarienne, tandis que 25 % d’entre eux envisageraient le recours
      antiviral medication as an investigational intrapartum treatment.         à des antiviraux à titre de traitement intrapartum expérimental. Fait
      Interestingly, both of these proportions increased if the patient had     intéressant, ces deux proportions connaissaient une hausse si la
      ruptured membranes for more than four hours.                              patiente connaissait une rupture des membranes remontant à plus
                                                                                de quatre heures.
    Conclusion: Most pregnant women and their health care providers
      are receptive to the use of a rapid polymerase chain reaction test      Conclusion : La plupart des femmes enceintes et de leurs
      to detect genital HSV shedding in labour. This supports the               fournisseurs de soins de santé sont ouverts à l’utilisation d’un test
      development of HSV rapid testing and antiviral therapy trials in the      d’amplification en chaîne par polymérase rapide visant à dépister
      labour setting.                                                           l’élimination du VHS génital pendant le travail. Cela soutient
                                                                                l’élaboration d’un test de dépistage rapide du VHS et la tenue
                                                                                d’essais sur le traitement antiviral pendant le travail.
Résumé
                                                                              J Obstet Gynaecol Can 2008;30(9):776–780
    Objectif : Déterminer l’acceptabilité, auprès des femmes enceintes
      et de leurs fournisseurs de soins de santé, d’un test de dépistage
      rapide du virus de l’herpès simplex (VHS) génital pendant le            INTRODUCTION
      travail.
                                                                                    eonatal herpes simplex virus infection can be devastat-

    Key Words: Neonatal herpes, herpes simplex virus, HSV, genital,
                                                                              N     ing. The rate of vertical transmission may be as high as
                                                                              1 in 1500 deliveries.1 Infected neonates risk significant mor-
    pregnancy, prevention
                                                                              bidity (60% develop neurologic sequelae) and mortality
    Competing Interests: None declared.
                                                                              (60% who develop disseminated disease will die).2 Vertical
    Received on November 15, 2007
                                                                              transmission is high (30–50%) during a maternal primary
    Accepted on March 17, 2008
                                                                              infection, and a small risk (2–4%) still exists if there is


776       l SEPTEMBER JOGC SEPTEMBRE 2008
                                Acceptance of a Rapid Herpes Test in Labour: Survey of Attitudes of Patients and Health Care Providers



recurrent disease during vaginal delivery.3 Genital HSV              METHODS
shedding occurs in the presence of signs and symptoms of             Ethics approval for the study was obtained from the Behav-
genital herpes, but it can also occur without signs or symp-         ioural Research Ethics Board of the University of British
toms. More than 60% of neonatal infections occur in the              Columbia and the Children’s and Women’s Research
absence of recognized maternal disease, often in the setting         Review Committee at the Children’s and Women’s Health
of a subclinical newly acquired infection.4 There is currently       Centre of British Columbia.
no clinically available method to identify women who have
HSV in the genital tract at the time of labour.                      The survey of patient attitudes was conducted through the
                                                                     outpatient department of BC Women’s Hospital and
The prevention strategies for neonatal HSV target women              Health Centre, Vancouver BC, and in the offices of health
with known genital herpes and centre on maternal prophy-             care providers. Pregnant women of any gestational age were
lactic antiviral therapy near term to decrease the likelihood        approached for this study. Women who were under 18
of genital lesions and/or shedding at the time of vaginal            years of age or who were unable to understand and read
delivery. Caesarean section is recommended if lesions or             English were excluded. The two-part patient survey
symptoms are present at the time of labour.5 Unfortunately,          included a brief information sheet on HSV in pregnancy
50% to 60% of neonatal cases occur in infants born to                (Appendix 1) to ensure a basic common knowledge. This
women without a known history of genital HSV                         informed subjects that completion of the survey implied
infection.6–8                                                        their consent for study participation. The second part con-
The current standard for HSV diagnosis—viral culture of              sisted of a multiple-choice, self-administered questionnaire
swabs from genital ulcers—is limited by poor sensitivity.            to assess the subject’s knowledge of and attitudes toward
PCR technology has been developed for rapid diagnosis of             HSV testing in pregnancy and labour (Appendix 2). Health
a number of infectious agents.9–12 A recent feasibility study        care providers, including obstetricians, family physicians,
has shown that a real-time HSV PCR is highly reproducible,           and midwives, were approached to complete a separate sur-
provides results in less than four hours, and has a higher           vey (Appendix 3) at hospital rounds and clinic service areas.
detection rate and is more labour efficient than viral culture       The survey was anonymous and self-administered.
techniques.13 Rapid technology to identify women shedding            Questions in both surveys addressed the acceptability of the
HSV in labour could define the women who are at risk of              testing, choice of delivery method, and use of antiviral
vertical transmission. Women with a positive genital tract           medication based on rapid testing results. Completed
HSV PCR test could be offered Caesarean section, and neo-            questionnaires were entered into an Excel database. The
nates could be monitored for early signs and symptoms of             cross-sectional survey data were analyzed using descriptive
HSV infection and treated accordingly. As an alternative to          statistics.
Caesarean section, women found to be shedding HSV
could be considered for experimental intrapartum antiviral           RESULTS
therapy.
Prior to initiating a study of rapid HSV PCR in the labour           Pregnant Women’s Attitudes
and delivery room, an assessment of acceptability among              In total, 207 of 226 women (91.5%) who were approached
care providers and patients was needed. Rapid testing                agreed to complete the survey. Ten percent of women indi-
would prove useful only if patients and care providers               cated a known history of genital herpes, and 90% denied
found it acceptable and if test results would influence clini-       prior history.
cal management. Therefore, we surveyed obstetrical
patients and care providers to determine their attitudes             When asked about mode of delivery, 87% expected a vagi-
regarding a rapid HSV test during labour. To evaluate the            nal delivery, while 13% planned to have a Caesarean section
acceptability of such an assay, we conducted a survey of             (primary or planned repeat). Sixty percent of the women
pregnant women and their care providers.                             had prenatal care provided by an obstetrician, 35% by a
                                                                     family physician, and 5% by a midwife.
                                                                     Eighty-five percent of respondents were willing to undergo
                                                                     a rapid HSV PCR test during labour. When responses were
                                                                     stratified by history of genital HSV, 96% of women with a
                       ABBREVIATIONS                                 known history of genital herpes, compared with 84% of
                                                                     women without a history, found such a test acceptable. Of
 HSV     herpes simplex virus
                                                                     those who would not accept the test, five of 31 (16%) were
 PCR     polymerase chain reaction
                                                                     planning to have a Caesarean section.


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OBSTETRICS



Patients were asked for their preferred mode of delivery or          Health care providers were interested in knowing if the
labour management if the test results indicated that they            shedding was related to a primary or recurrent infection;
had HSV in the genital tract during labour. More than 87%            this is an important factor in the degree of vertical transmis-
indicated the results would influence their choice. If testing       sion risk.3
during labour was positive, 51% would consider delivery by           Unfortunately, rapid PCR testing for HSV in genital sam-
Caesarean section and 37% would consider undergoing                  ples cannot distinguish between primary or recurrent infec-
antiviral therapy (with or without Caesarean section). Of            tion in the absence of rapid serological testing. Several
note, 8% wished to proceed with a vaginal delivery in the            point-of-care HSV serologic tests have been developed, but
presence of a positive HSV PCR.                                      unfortunately none are available for clinical use in Canada.15
                                                                     These point-of-care tests are sensitive and specific and
Health Care Providers’ Attitudes                                     would be a useful adjunct to rapid PCR testing. Together,
Fifty-one health care providers were surveyed: 47% were              these two technologies would help distinguish between
obstetricians, 35% were midwives, and the remaining 18%              women who have newly acquired genital herpes and those
were family physicians. The mean number of deliveries                who have reactivation of pre-existing HSV infection.
attended annually by each care provider was 112 (range:              Women who have newly acquired HSV infection in the
20–500).                                                             third trimester have an extremely high risk of having a child
All but one health care provider indicated that they would           with neonatal herpes, and most authorities recommend
like to know if their patient had a primary HSV infection at         delivery by Caesarean section for such women.16 Women
the time of labour, and 84% indicated that they would be             who reactivate HSV in labour have a 2% to 4% risk of trans-
interested in knowing if their patient had a recurrent infec-        mitting infection to the neonate. Strategies for management
tion. If HSV shedding was detected in labour, 36% indi-              besides our current approach of advising Caesarean section
cated that they would recommend Caesarean section, and               are needed for women with recurrent lesions or prodromal
25% would consider antiviral therapy as an experimental              symptoms in labour. Surprisingly, some women (8%)
treatment. Of note, the frequency of both of these manage-           would elect to proceed with vaginal delivery even with HSV
ment strategies increased if the patient had ruptured mem-           detected in the genital tract, suggesting that informed con-
branes for more than four hours.                                     sent for vaginal delivery of women with recurrent HSV may
                                                                     be reasonable. Therefore, we feel HSV serotesting to deter-
DISCUSSION                                                           mine the stage of infection is a necessary adjunct to viral
                                                                     detection for guiding clinical management; we hope it is an
The only management option currently available to mini-              adjunct that will be available in the future.
mize the risk of vertical transmission of HSV after the onset
of labour is to offer Caesarean section when prodromal               CONCLUSION
symptoms or lesions are present.5 Prophylactic acyclovir
                                                                     The results of this study indicate that using new rapid PCR
initiated at 36 weeks’ gestation and continuing until delivery
                                                                     technology during labour to improve the detection of geni-
minimizes the risk of recurrence and the need for Caesarean
                                                                     tal HSV and decrease neonatal HSV disease is feasible, and
section because of HSV infection.14 These strategies are
                                                                     that a clinical study would have a favourable reception from
only useful if the diagnosis of genital HSV is known, and
                                                                     patients and care providers. Such technology will challenge
most women with genital herpes are unaware that they have
                                                                     us to provide appropriate interventions for those who test
it. Viral shedding in the genital tract is the cause of almost all
                                                                     positive.
neonatal HSV infections4; therefore, it would be ideal to
identify shedding at the onset of labour to target potential         ACKNOWLEDGEMENT
interventions for women who are truly at risk of transmit-
ting HSV to their infant. PCR technology represents a                This study was supported in part by National Institutes of
means of identifying such women.                                     Health grants P01 AI30731 and K24 AI071113.
In our study, over 80% of pregnant women and all but one             REFERENCES
of their health care providers would accept rapid HSV test-           1. Sullivan-Bolyai J, Hull HF, Wilson, C, Corey L. Neonatal herpes simplex
ing in labour if it were clinically available. Women with                virus infection in King County, Washington: increasing incidence and
known HSV were more likely to accept the test, probably                  epidemiologic correlates. JAMA 1983;250:3059–62.
reflecting their increased knowledge or understanding of              2. Whitley R, Arvin A, Prober C, Corey L, Burchett S, Plotkin S, et al.
                                                                         Predictors of morbidity and mortality in neonates with herpes simplex virus
HSV. Most pregnant women felt that a positive HSV result                 infections. N Engl J Med 1991;324:450–4.
would influence their chosen mode of delivery or labour               3. Kimberlin DW. Neonatal herpes simplex infection. Clin Microbiol Rev
management, as did most of the health care providers.                    2004;17:1–13.



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 4. Brown ZA, Wald A, Morrow RA, Selke S, Zeh J, Corey L. Effect of                     the standard culture method for screening for group B streptococcus
    serologic status and caesarean delivery on transmission rates of herpes             carriage in pregnant women. J Clin Microbiol 2006;44:725–8.
    simplex virus from mother to infant. JAMA 2003;289:203–9.
                                                                                     11. Scaramozzino N, Ferrier-Rembert A, Favier AL, Rothlisberger C, Richard S,
 5. ACOG Practice Bulletin. Clinical management guidelines of                            Crance JM, et al. Real-time PCR to identify variola virus or other human
    obstetrician-gynecologists. No. 82 June 2007. Management of herpes in                pathogenic orthopox viruses. Clin Chem 2007;53:606–13.
    pregnancy. Obstet Gynecol 2007;109(6):1489–98.
                                                                                     12. Svraka S, Rolain JM, Bechah Y, Gatabazi J, Raoult D. Rickettsia prowazekii
 6. Kropp R, Wong T, Cormier L, Ringrose A, Burton S. Neonatal Herpes                    and real-time polymerase chain reaction. Emerg Infect Dis 2006;12:428–32.
    Simplex virus infections in Canada: results of a 3-year national prospective
    study. Pediatrics 2006;117:1955–62.                                              13. Ramaswamy M, McDonald C, Smith M, Thomas D, Maxwell S,
                                                                                         Tenant-Flowers M, et al. Diagnosis of genital herpes by real time PCR in
 7. Whitley R, Nahmias A, Visintine A, Flemin C, Alford C. The natural history           clinical practice. Sex Transm Infect 2004;80(5):406–10.
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    1980;66:489–94.                                                                  14. Watts DH, Brown ZA, Money D, Selke S, Huang ML, Sacks SL, et al. A
                                                                                         double-blind, randomized, placebo-controlled trial of acyclovir in late
 8. Yeager A, Arvin A. Reasons for the absence of a history of recurrent genital         pregnancy for the reduction of herpes simplex virus shedding and cesarean
    infections in mothers of neonates infected with herpes simplex virus.                delivery. Am J Obstet Gynecol 2003;188(3):836–43.
    Pediatrics 1984;73:188–93.
                                                                                     15. Wald A, Ashley-Morrow R. Serological testing for herpes simplex virus
 9. Bergseng H, Bevanger L, Rygg M, Bergh K. Real-time PCR targeting the sip             (HSV)-1 and HSV-2 infection. Clin Infect Dis 2002;35(Suppl 2):S173–S182.
    gene for detection of group B Streptococcus colonization in pregnant
    women at delivery. J Med Microbiol 2007;56:223–8.                                16. American Academy of Pediatrics. Herpes Simplex. In: Pickering LK, Baker
                                                                                         CJ, Long SS, McMillan JA, eds. Red Book: 2006 Report of the Committee
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Appendix 1
SUBJECT and CARE PROVIDER FACT SHEET                                                 obvious lesions. Babies infected by HSV during birth can
                                                                                     become infected and get very ill; possibly die.
Herpes Simplex Viral Shedding in the Genital Tract
Greater than 60% of adults are herpes simplex virus (HSV)                            Both HSV I, but more often HSV II, can cause significant
type I positive and 20% percent of adults have herpes virus                          disease in the newborn. Although it is estimated that many
type II.                                                                             more are exposed at the time of delivery, approximately
                                                                                     1/3000 newborn babies are born with infection
At the time of initial infection in the genital tract (by HSV 1
or HSV 2), the virus may be present in large quantities. It is                       In women with known genital HSV, medication (Acyclovir)
at this time that there is greatest risk to the newborn of neo-                      can be given during the last four weeks of pregnancy to help
natal herpes (30-50%). The risk is still present but lower                           reduce recurrences and viral shedding at the time of
(2-4%) with recurrent disease, even in the absence of                                delivery.

Appendix 2
HERPES VIRUS STUDY                                                                   2. In the past several months, there has been a lot of
Survey of Attitudes toward Rapid Herpes Testing in                                      discussion in the media about mode of delivery in
Labor and Mode of Delivery                                                              a normal healthy pregnancy. If you could choose
Pregnant Patient Questionnaire                                                          the method of delivery for your baby, would you
                                                                                        have a:
Date: ______________________ (day/month/year)
                                                                                         a. Vaginal delivery.
A new rapid test has been developed to look for herpes virus in
laboring women. This survey has been designed to ask women if they                       b. Cesarean section (for the first time).
would be interested in this information and how it might influence                       c. Planned repeat cesarean section.
their delivery. Thank you for answering the following questions.
Please circle one response per question.                                             3. This survey is about herpes in pregnancy.
                                                                                        Do you have or have you ever had genital herpes?
1. Who is taking care of you during this pregnancy?
   (Circle all that apply)                                                               a. Yes
   a. Doula                                                                              b. No
   b. Midwife                                                                        Genital herpes is a common infection amongst sexually active
   c. GP                                                                             women. There is a risk of transmission to your baby at the time of
   d. Obstetrician                                                                   vaginal delivery. The risk is up to 50% in women who have


                                                                                                             SEPTEMBER JOGC SEPTEMBRE 2008 l                    779
OBSTETRICS



acquired herpes infection at the end of their pregnancy. It is much         6a. If a new test was able to show that you had
lower (2-4%) in women who have recurrent genital herpes. In those              herpes virus in the genital tract, would this
situations where active herpes infection is diagnosed immediately prior        information influence how you would want to
to or during labour, delivery by caesarean section is offered to decrease      deliver your baby?
the risk of transmission to the fetus. Many women do not know
                                                                                a. Yes
that they have herpes and have no symptoms. A rapid test has been
developed to detect herpes virus in laboring women.                             b. No
4. If the new rapid test were offered today, would                          6b. If yes, would you be (Circle all that apply):
    you be willing to have a vaginal swab for herpes
    virus testing when you come to the hospital in                              a. More likely to consider vaginal delivery.
    labor?                                                                      b. More likely to consider cesarean section.
      a. Yes                                                                    c. More likely to consider antiviral medication during
      b. No                                                                        vaginal delivery.
5. If the new rapid test were offered today, would                          Thank you for your time.
    you be interested in knowing whether you are
    infected with herpes?
      a. Yes
      b. No



Appendix 3
HERPES SIMPLEX VIRUS (HSV) STUDY                                                time of labor? Risk of vertical transmission is 2-4%
                                                                                in recurrent infections.
Survey of Attitudes toward Rapid HSV Testing in                                 a. Yes
Labor and Mode of Delivery
A Questionnaire for Health Care Providers                                       b. No
Date: ______________________ (day/month/year)                               5. What would you do if a rapid PCR test detected
                                                                               HSV in the genital tract of your patient who
1. Are you a:                                                                  presents in labor?
      a. Midwife                                                                a. Proceed with vaginal delivery.
                                                                                b. Arrange for cesarean section.
      b. Family doctor
                                                                                c. Consider IV Acyclovir as an experimental treatment
      c. Obstetrician                                                              to reduce vertical transmission and proceed with
2. Approximately how many deliveries do you attend                                 vaginal delivery.
   each year?________________                                                   d. Other _______________________
3. Would you want to know if your patient has primary                       6. If the rapid PCR test was positive for HSV and the
   HSV shedding in the genital tract at the time of                            woman was known to have ruptured membranes
   labor? Risk of vertical transmission is 50% in                              for more than four hours, how would you proceed?
   primary infections.                                                          a. Proceed with vaginal delivery.
      a. Yes                                                                    b. Arrange for cesarean section.
                                                                                c. Consider IV Acyclovir as an experimental treatment
      b. No                                                                        to reduce vertical transmission and proceed with
4.     Would you want to know if your patient has                                  vaginal delivery.
      recurrent HSV shedding in the genital tract at the                    Thank you for your time.




780     l SEPTEMBER JOGC SEPTEMBRE 2008

								
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