Title of Guideline
GUIDELINE FOR IDENTIFYING AND TESTING
HEPATITIS B POSITIVE PREGNANT WOMEN AND
NEONATES (To be used in conjunction with Routine infectious
diseases screening in pregnancy)
Author
Dr Charalampos Stamatopoulos Obs & Gyn SpR
Dr Berry Louise Microbiology SpR
Angie Godfrey Antenatal and Newborn Screening
Coordinator
Emma Haworth Antenatal and Newborn Screening
Coordinator
Dr Steven Ryder Consultant Gastrenterologist
Dr Soo Shing Consultant Virologist
Dr Dulip Jayasinghe Consultant Neonatologist
Professor William Irwing Virologist
Directorate & Speciality
Family Health , Obstetrics and Maternity
Date of submission
October 2014
Explicit definition of patient group to which it applies (e.g.
inclusion and exclusion criteria, diagnosis)
All pregnant women
Version
Three
If this version supersedes another clinical guideline please be
explicit about which guideline it replaces including version
number.
Version 2
GUIDELINE FOR IDENTIFYING AND TESTING
HEPATITIS B POSITIVE PREGNANT WOMEN
AND NEONATES
Level 4,5
Statement of the evidence base of the guideline
Evidence base: (1-6)
1
NICE Guidance, Royal College Guideline, SIGN
(please state which source).
2a
meta analysis of randomised controlled trials
2b
at least one randomised controlled trial
3a
at least one well-designed controlled study without
randomisation
3b
at least one other type of well-designed quasiexperimental study
4
well –designed non-experimental descriptive
studies (ie comparative / correlation and case
studies)
5
expert committee reports or opinions and / or
clinical experiences of respected authorities
6
recommended best practise based on the clinical
experience of the guideline developer
Consultation Process
Senior Midwifery staff, Senior Medical staff, Senior
Pharmacy staff.
Ratified by:
Maternity Clinical Guidelines Group
Date:
Target audience
6/10/14
Ward and delivery suite (QMC & NCH)
Community Midwives
Neonatal Unit (QMC & NCH)
Microbiologist
Review Date: (to be applied by the Integrated Governance Team)
October 2019
A review date of 5 years will be applied by the Trust. Directorates
can choose to apply a shorter review date, however this must be
managed through Directorate Governance processes.
This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The
interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in
doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date.
HEPATITIS B IN PREGNANCY
Introduction
Hepatitis B is an infection of the liver caused by hepatitis B virus (HBV). The
World Health Organisation (WHO) estimates 350 million people worldwide
are chronically infected. High prevalence regions for HBV are found in SubSaharan Africa, most of Asia and the Pacific Islands. Intermediate prevalence
regions include Amazon, southern parts of Eastern and Central Europe, the
Middle East and the Indian Subcontinent. Low prevalence regions include
most of Western Europe and North America. The overall prevalence of chronic
HBV infection among antenatal women in the UK is around 0.14% although
there are regional variations with some inner cities rising to  1% (DH 2013).
Transmission (Green Book DH 2013)
The virus is transmitted by parenteral exposure to infected blood or body
fluids.
Perinatal transmission from mother to child is one of the major risk factors for
transmission of HBV worldwide. Others include child to child transmission early
in life (these 2 routes account for >95% of HBV infection worldwide) and
sexual or other forms of blood to blood contact such as injecting drug use.
Infants who are infected during pregnancy and birth are at high risk (90%) of
becoming chronic carriers. Appropriate immunisation can, however, prevent
the infant developing chronic infection in over 90% of cases. (DH 2013)
Screening Pregnant Women
Screening for infectious diseases is an integral aspect of antenatal care.
Routine screening is offered to all pregnant women on the basis that early
detection and treatment can reduce adverse perinatal outcomes. These
guidelines incorporate generic infectious disease screening guidelines as well
as disease specific sections.
The Head of Midwifery (HOM) is the lead professional with overall
accountability and responsibility for the screening programme. The HOM is a
core member of the Trust Antenatal and Newborn Screening Quality Group
and the Local Area Team Antenatal and Newborn Screening Programme
Board, and supports the Antenatal and Newborn screening coordinators at
clinical and directorate governance level to ensure all programme standards
are met.
Standards to be achieved
 All pregnant women are offered screening for Hepatitis B
 Women arriving in labour who have not received antenatal care are to be
offered infectious diseases screening. This can take place after delivery
if it was inappropriate to offer screening in labour.
 Information on infectious disease screening is available to all pregnant
women in a variety of languages.
 Details of the information given, the tests offered, whether they were
accepted and subsequent actions are recorded in the medical record.
 Screening is only performed with documented consent. This does not
require a signature from the mother.
 Professional codes of conduct for confidentiality should be adhered to.
NUH Trust data is submitted only to appropriate national reporting
bodies, i.e. National Screening Committee (NSC)/ Key Performance
Indicators (KPI’S) / Health Protection Agency (HPA) / HIV & Syphilis
National Surveillance
Screening results for Hep B
 Screening for HBV is undertaken by testing for HBV surface antigen (HBsAg),
 If a screening sample is HBsAg positive, then further testing is performed on
the screening sample to include: Anti-HBc
(Hepatitis B core antibody),
HBeAg
(Hepatitis B e antigen),
Anti- HBe
(Hepatitis B e antibody)
Anti-HBc IgM (Hepatiitis B core IgM).
 Each of these are reported as POSITIVE or Negative. A comment on the
interpretation of these results will appear as below.
HBsAg
POSITIVE
Anti-HBc
POSITIVE
HBeAg
POSITIVE/Negative
Anti-HBe
POSITIVE/Negative
Anti-HBc IgM
Negative
A further sample for HBsAg should be sent to confirm identity, including
an EDTA blood for HBV DNA.
Positive Hepatitis B serology
 Positive results will be notified by EMPATH to the relevant campus antenatal
services staff specified on the contact tree by telephone and results should
be evident on NOTIS.
 Where there is an indication of positive Hepatitis B on a referral letter but no
result found on NOTIS, the midwife must contact the community midwife and
check a hard copy of the result has been seen. If there is no evidence of a
positive result the woman should be rescreened
NB. Women booked and screened prior to 01.04.2014 may have had
their sample tested by the Northampton laboratory 01604523303. These
women will not have an electronic result on NOTIS
The NUH antenatal services midwife receiving the positive result must
complete the following actions;
 Positive Hepatitis B results should be recorded on the infectious diseases
audit form. All relevant actions should be recorded, dated and signed then
documented on Medway and linked to maternal and paediatric alerts. (Refer
to Medway maternity standard operating procedure).
 Check that the stated campus is the correct place for delivery. If this is not the
case the midwife must inform the laboratory. The laboratory is then
responsible for contacting the correct Campus. If the woman has not booked
for care at NUH, the laboratory will subsequently contact the sample
requester and confirm where the woman plans to deliver.
 Organise a review in a consultant antenatal clinic (ANC). This should be the
consultant under whom the woman is already booked.
QMC booking- If she is midwifery led care then she should be sent an
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appointment for Mr McEwan’s/Dr Gemma Wright’s general antenatal clinic.
CITY booking-should be given the next available consultant clinic.
Complete the standard referral form to Dr Ryder on the day the positive result
is received. This should be faxed immediately to him as it does not require a
doctor’s signature. (see appendix 1and 2 for City and QMC versions).
Commence a paediatric alert form on the same day that the result is
received. Print and attach the relevant NOTIS report to the paediatric alert
form.
Complete the request form for HEP B DNA levels.
Insert the paed alert/result, blood request form and HBIG request form where
applicable into the plastic sleeve and insert into notes in readiness for the
consultant appointment.
The woman’s name should be added to the hepatitis B register by the
antenatal clinic midwife indicating from the EMPATH result if the baby
requires HBIG. The register will be held in the positive Hep B result folder in
the ANC office. This list will be reviewed at each weekly paediatric alert
meeting in order to failsafe HBIG receipt for those babies requiring HBIG.
The antenatal clinic midwife in receipt of a Hepatitis B positive serology and
subsequent DNA levels should check the result with a second midwife /
screening coordinator / doctor against the defined HBIG criteria as below.
Reduction of risk of transmission of Hep B to newborn
Hep B vaccine
Hep B vaccine + HBIG
All babies born of Hep B surface antigen
positive mothers
All babies living in the same household with
a known HBV carrier
All babies born to women who are
intravenous drug abusers regardless of the
mothers Hep B status
Mother is HBsAg positive and HBeAg
positive
If the mother lacks antibodies to the
HBeAg, whatever the HBeAg status
If the mother has acute HBV infection
in pregnancy
If e-markers have not been
determined
Mother is HBsAg positive and has a
viral load DNA > 106 IU/ml
If the baby has a birthweight of
<1500g regardless of the e-antigen
status of the mother
If mother is Hep B e Antigen positive
and viral load DNA > 106 IU/ml,
discuss with consultant virologist
The duty virologist can be contacted via the microbiology phone line at Ext.
61163
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Actions of doctors in consultant antenatal clinic visit
The paediatric alert form is completed by doctors in ANC and left in the tray in
Fetal Care Unit (FCU) (City hospital ANC) or in the FMM office at QMC.
Repeat Hep B serology, DNA levels and liver functions tests (LFTs). Proceed
however on the assumption that the screening result is correct. The request
form should read ‘Antenatal HBV testing with HBV DNA levels (viral titre),
EDTA blood sample is required for this.
All women with overt liver disease should be referred to the Tuesday morning
maternal medicine clinic at QMC. This team will liaise with Dr Ryder.
Information must be given regarding the results and their implications.
The woman should be advised to attend Dr Ryder’s clinic if they receive an
appointment.
At this visit further information and family screening/immunisation will be
discussed.
Document results and all consultations on the maternity Medway system.
Information should also be written in the Part I (handheld records) after
obtaining consent from the woman.
If the LFTs are normal, and there are no obstetric issues, an open
appointment can be given.
Ordering HBIG
 HBIG should be pre-ordered from the Health Protection Agency (HPA) at
Colindale. Complete and send the “Issue of Hepatitis B Immunoglobin for
infants at risk of Hepatitis B Infection” form to order the HBIG. (Appendix 3)
 Receipt of HBIG will be monitored via the FMM / FCU / paediatric alert
meeting as described above.
 Where the details of the ‘authorised person’ are requested on the form, the
box ‘Sister in charge’ should be ticked and the authorised person given as
‘Sister in Charge of Neonatal Unit’ (NNU). The appropriate hospital campus
should be completed.
 The HBIG will be issued 6-8 weeks prior to the EDD and will be sent to the
appropriate NNU for storage in their fridge (it should not go to the ANC or
labour suite).
 It is the responsibility of the sister in charge of NNU receiving the HBIG to
inform the antenatal clinic midwife it has arrived and in the NNU fridge. The
ANC midwife is then responsible for documenting this on MEDWAY and
completing the HBIG register.
 If notice of HBIG arrival has not been received 3 weeks prior to the expected
date of delivery (EDD) the ANC midwife needs to contact NNU and check
whether HBIG has been received. If not the ANC midwife need to re-order it.
 In the event of the named HBIG vial not being used (eg. stillbirth, delivery of
the woman outside NUH) it can be returned to pharmacy. It cannot be reissued, and will be wasted.
 An emergency supply is available if the system fails or the woman books late
or delivers prematurely (see later).
 The order form can be down loaded from: www.hpa.org.uk Click on search
the site bar, and enter HBIG request form. A table appears, select
‘REQUEST FORM FOR ISSUE OF HEPATITIS B IMMUNOGLOBULIN’
‘Emergency’ HBIG. When HBIG is indicated but has not been pre-ordered.
 Pharmacy at QMC holds two emergency vials for neonatal use. This can
be accessed by contacting the virologists (see above for details) or the
on call microbiologist, if out of hours, who will take details of the case. If
HBIG is advised; please prescribe “Hepatitis B immunoglobulin 200
units” on to the newborn drug chart and contact pharmacy for supply via
the normal routes. The paediatric doctor involved will need to be prepared to
pass on case details to the microbiologist, or may be asked to complete a
form so that the vial can be replaced soon after by Colindale Emergency
HBIG must only be requested by an ST3 or above, and then only after
discussion with the on-call consultant Microbiologist. A thorough check of
both NNU fridges on both campuses must be made before emergency stock
is requested.
Intrapartum Management
Although there is no evidence to suggest fetal scalp electrodes and fetal blood
sampling increase risk, these procedures should be avoided where possible.
After Birth
 As soon as possible after delivery, and with parental consent, babies born to
carrier mothers should start their 4 dose course of immunisation with hepatitis
B vaccine (0-within 24hrs of age, 1, 2 and 12 months of age). At 12 months a
blood sample from the baby should be sent to the lab to test for HBsAg.
 Documentation of that should be in discharge letter and in the Red Book.
 Where indicated HBIG should always be given within 24 hours of birth
 It is vital that all infants born to infected mothers receive a complete course of
immunisation. See Perinatal Management: Nottingham Neonatal Service
– Clinical Guideline 5:10.
Breastfeeding
 Breastfeeding should be encouraged and supported. There is no contraindication to breastfeeding when a baby born to a carrier mother begins
immunisation. Mothers should not donate milk.
Failsafes, Audit and Performance Management
Refer to antenatal infectious diseases guideline
Training and Education
Refer to antenatal infectious diseases guideline
Staff
 Department of Health guidance requires all staff and students who may
perform exposure prone procedures to be screened for Hepatitis B infection
and offered immunisation against hepatitis B.
 All staff should understand and use rigorous infection control procedures at
all times.
 For needlestick inuries or splash of body fluid to eyes/mouth from patients
with hepatitis B please consult the intranet for immediate management and
advice.
(http://nuhnet/diagnostics_clinical_support/occupational_health/Pages/Sharps
_Needlestick_Injuries.aspx)
References
Dept of Health 2000 HBV Information for Midwives, Hepatitis B Testing in
Pregnancy
www.dh.gov.uk/publicationsandstatistics/publications/publicationpolicyandgui
dance
Dept of Health 2003 Screening for Infection Diseases in Pregnancy. Standards to
Support the UK Antenatal Screening Programme
www.dh.gov.uk/publicationsandstatistics/publications/publicationpolicyandgui
dance
Empath University Hospitals of Leicester and Nottingham University Hospitals
Departments of Blood Sciences and Microbiology- Antenatal Screening Services,
Blood Groups, Red Cell Antibodies and Microbiology 2014
Nottingham Neonatal Service Clinical Guideline 5:10 Hepatitis B Screening in
Pregnancy and the Subsequent Management of the Affected Infant
NICE Guideline 2003 Antenatal Care: Routine Care for the Healthy Pregnant
Woman www.nice.org.uk/pdf/CG6ANCNICEguideline.pdf
Dept of Health 2013 Immunisation Against Infectious Diseases ‘The Green
Book’ www.dh.gov.uk/policyandguidance/healthandsocialcaretopics.greenbook
Patient Information
Hepatitis B: How to Protect your Baby
www.dh.gov.uk/publicationsandstatistics/publications/publicationspolicyandgu
idance/publicationsandguidancearticle/fs/en?contentID=4008337&chk=jAv1fw
National Screening Committee 2012 booklet Screening tests for you and your baby
UK NSC London www.screening.nhs.uk
The Pregnancy Book Health Promotion, England – Dept of Health, PO Box 777,
London SE1 6XH Tel 08701 555 455 Available for download
http://www.publichealth.hscni.net/publications/pregnancy-book-0
APPENDIX 1
Dear Steve Ryder
Consultant Gastroenterologist
QMC Campus
Nottingham University Hospitals NHS Trust
Derby Road
Nottingham
NG7 2UH
Antenatal Clinic
City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
Tel. 0115 9691169 ext.55244
Date……………………………..
Dear Dr. Ryder
HEPATOLOGY SCREENING
We request a review in your clinic within 6 weeks from the date of this referral, in line with Infectious
Diseases in Pregnancy Standards (regardless of whether or not this lady is already known to your service)
for further counselling, management and family screening / vaccination.
The following woman is pregnant with an EDD of …………………………..
Name……………………………………………………………………………
DOB……………………….NHS number……………………………………
Address…………………………………………………………………………..
…………………………………………………………………………………….
GP name and Address…………………………………………………………….
…………………………………………………………………………………….
Routine Antenatal Infectious disease screening by Empath has shown positive Hepatitis B serology. The
results can be accessed on NOTIS.
An obstetric consultant appointment has been arranged with;
…………………………………………………………………………………………….
Date………………………………………………………………………………………………
At this appointment the following will be taken. LFT’s, repeat serology and DNA titres.
The paediatricians have been informed and HBIG will be ordered where necessary
Kind Regards
APPENDIX 2
Antenatal Clinic
QMC Campus
Derby Road
Nottingham
NG7 2UH
Tel. 0115 9249924 ext. 66857
Dear Steve Ryder
Consultant Gastroenterologist
QMC Campus
Nottingham University Hospitals NHS Trust
Derby Road
Nottingham
NG7 2UH
Dear Dr. Ryder
Date……………………………..
HEPATOLOGY SCREENING
We request a review in your clinic within 6 weeks from the date of this referral, in line with Infectious
Diseases in Pregnancy Standards (regardless of whether or not this lady is already known to your service)
for further counselling, management and family screening / vaccination.
The following woman is pregnant with an EDD of …………………………..
Name……………………………………………………………………………
DOB……………………….NHS number……………………………………
Address…………………………………………………………………………..
…………………………………………………………………………………….
GP name and Address…………………………………………………………….
…………………………………………………………………………………….
Routine Antenatal Infectious disease screening by Empath has shown positive Hepatitis B serology. The
results can be accessed on NOTIS.
An obstetric consultant appointment has been arranged with;
…………………………………………………………………………………………….
Date………………………………………………………………………………………………
At this appointment the following will be taken. LFT’s, repeat serology and DNA titres.
The paediatricians have been informed and HBIG will be ordered where necessary
Kind Regards
Nottingham University Hospitals
NHS Trust
Antenatal Clinic
City Campus
Hucknall Road
Nottingham
NG5 1PB
TEL 0115 969116
Ext 55244
Antenatal Clinic
QMC Campus
Derby Road
Nottingham
NG7 2UH
TEL. 0115 9249924
Ext.61888
FAX Sheet for Antenatal Liver Referral
F.A.O: Digestive diseases / Gateway
AT: Hepatology Gateway I and Liver secretaries
FAX: (0115) 9705715`
FROM: Antenatal Clinic : CITY
QMC
FAX NO: CITY (0115) 8404700
QMC (0115) 8493331
Number of pages faxed, including this page…………..
The information contained in this fax is strictly confidential and must not be read by anyone
other than the addressee. If you receive this communication in error please advise us
immediately. Thank you.
Ref NHS fax sheet
Chairman Dr Peter Barret
Chief executive: Dr Peter Homa
Trust HQ: C floor, Queens Medical Centre Campus, Derby Road, Nottingham, NG7 2UH
Appendix 3