Women Declining Blood and Blood Products During Pregnancy and

Title of Guideline (must include the word “Guideline” (not
protocol, policy, procedure etc)
Author: Contact Name and Job Title
Guideline for the management of women
declining blood and blood products during
pregnancy and labour.
Dr Hari Muppala, ST-7, O&G
Directorate & Speciality
Family Health, Obstetrics and Maternity
Date of submission
May 2015
Explicit definition of patient group to which it applies (e.g.
inclusion and exclusion criteria, diagnosis)
All pregnant woman booked at NUH who refuse
blood and blood products
Version
2
If this version supersedes another clinical guideline
please be explicit about which guideline it replaces
including version number.
Statement of the evidence base of the guideline – has the
guideline been peer reviewed by colleagues?
Guideline for the management of women
declining blood and blood products during
pregnancy and labour.
Level 1, 4,5
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
Ratified by:
Previous version under same headline, Dec
2011, by Dr Sarah Harper
Anaesthetists, Haematologists, Obstetricians
Maternity Clinical Guidelines Group
Date:
Target audience
Obstetricians, Anaesthetists, Haematologists,
and Midwifery staff
Review Date: (to be applied by the Integrated
Governance Team)
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.
1
Guideline for the management of women declining blood and blood
products in pregnancy and labour
Introduction:
 Women may refuse blood transfusion because of non-religious
reasons including fear of infection or fear of medical error and/or
deeply held religious convictions as in the case of Jehovah’s
Witnesses.
 Women, who decline blood or blood products, are at increased risk of
morbidity and mortality if haemorrhage occurs in pregnancy or
postpartum.
 Large retrospective study from Netherlands concluded that Women
who refuse blood products are six times more likely to die, and three
times more likely to have serious complications than average and 130
fold increased risk of death from major obstetric haemorrhage.
(NUH Guideline for dealing with maternal death)
(CMACE)
Contact numbers:
Hospital Liaison Committee for Jehovah’s Witnesses (email:
[email protected]) that can provide a list of clinicians prepared to
provide care to Jehovah’s Witnesses or others who decline blood
transfusion (See Appendix 3).The members of this committee support the
patient and advise the clinicians in the management or referral of individual
cases.
What
Jehovah’s
Won’t Accept
Witnesses What Jehovah’s Witnesses Will
Accept
Normal Saline, Ringer’s Lactate,
Dextrose
White blood cells (WBCs)
Dextran
Platelets
Gelofusine, Haemaccel
Plasma
Pentastarch, Hetastarch
Pre-donated autologous blood Desmopression, Vasoconstrictors,
(blood that has lost continuity with Tranexamic acid, Vitmain K
circulatory system)
Recombinant clotting factors
Erythropoiesis stimulating agents
Homologous blood, Packed RBC
2
What Jehovah’s Witnesses may or may not accept as matters of
conscience
Fractions derived from blood e.g. clotting factors (Factor VII), Albumin,
Fibrinogen concentrate, Anti-D, immunoglobulins, haemophilic
preparation and vaccines.
Intraoperative cell salvage with leucocyte depletion filters
Blood patch to treat headache (complication of Dural tap)
Use of medical equipment (non-blood primed) e.g. heart-lung machine
or haemodialysis
Antenatal Management:
Midwife at booking visit:
 Women who refuse blood products, warrant hospital booking in a
consultant–led unit.
 Recommend hospital delivery.
 If patient is keen on home birth, discuss risks and refer to Multidisciplinary meeting team for further discussion.
Obstetric management:
 A senior obstetrician must see the pregnant woman.
 If the woman has not already been referred to an anaesthetic clinic by
the Hospital Liaison Committee for Jehovah’s Witnesses then an
referral must be ensured.
 Women must be given an opportunity to see the consultant
obstetrician to speak with to with or without members of her religious
community or relatives as she wishes.
 Most Jehovah’s Witness women present with an Advance Decision
Document (also called Advanced directive) obtained from the Hospital
Liaison Committee, indicating their wishes.
 A copy of the advanced directive should be placed inside the cover of
the patient’s notes and an alert is recorded in the notes and on
Medway.
 Discuss advanced directive and obtain written consent. Can be
obtained by anaesthetist (CHN) or obstetrician (QMC).Complete trust
policy form on refusing blood products. (all forms available in the
ANC: “health care advance directive transfusion of blood and blood
components”, “advance decision to refuse specified medical
treatment”, all related leaflets and consent forms).
3
 Check full blood count and ferritin at booking and between 28 to 36
weeks. Prescribe iron supplementation if Haemoglobin (Hb) <110 or
ferritin <30. Check serum ferritin, folate and Vit B12 levels if Hb is low.
 Have low threshold for use of parenteral iron.
 Blood group and antibody screen should be checked and recorded in
the notes.
 There is no indication not to prescribe Aspirin if indicated until
delivery.
 Discuss delivery issues.
 Discuss advanced directive and obtain written consent. Complete
trust policy form on refusing blood products. (all forms available in the
ANC: “health care advance directive transfusion of blood and blood
components”, “advance decision to refuse specified medical
treatment”, all related leaflets and consent forms.
 A clear statement of what products and techniques she will accept
and what she refuses should be obtained. (Remember Anti-D if the
mother is rhesus negative).
Elements of this role may be undertaken by anaesthetist or consultant
obstetrician.
(Trust guideline: Management of patients refusing transfusion of blood and
blood components guideline)
(www.transfusionguidelines.org.uk. Care pathways for the management of
adult patients refusing blood transfusion (including Jehovah’s Witnesses)
Intrapartum Care:










Ideally should deliver in a consultant led unit
An experienced midwife should be involved in the care of the labour.
Patient must deliver on the consultant led side of the delivery unit.
Inform labour ward obstetric anaesthetist on admission.
Consultant obstetrician should be informed early and a consultant
haematologist involved when complications are anticipated.
The medical and midwifery staff must familiarise themselves with the
patient’s advance directive and particular aspects of the consent.
Active management of third stage of labour. An infusion of syntocinon
(40 units/500 mls of 0.9% saline at a rate of 125 mls /hour) should be
considered.
Discourage physiological third stage of labour.
Perineal trauma/episiotomies should be sutured promptly to avoid
unnecessary blood loss.
The blood loss should be carefully monitored and early action taken.
4
If a woman requests a home birth:
 Recommend that the woman should deliver in the consultant led unit.
 The delivery plan needs to be discussed in the antenatal period with
the woman and inform the supervisor of midwives. It would be good
practice to have a multidisciplinary meeting (involving consultant
obstetrician, community midwife and supervisor of midwives).
 Two midwives to attend for home birth. One of whom should be
experienced midwife from the early stages of labour.
 Community midwife to inform supervisor of midwives that they are
attending the home birth.
 Community midwife to inform labour suite co-ordinator when the
woman is in established labour.
 Third stage must be actively managed. Discourage physiological third
stage of labour.
 If the woman bleeds heavily after delivery call for paramedic
ambulance, arrange immediate transfer to hospital, inform labour
suite co-ordinator of anticipated admission and possible time of
arrival.
Elective Caesarean delivery:
 Use consent form 1 for any surgical procedure.
 A senior obstetrician should perform the caesarean delivery with an
experienced anaesthetist.
 A consultant anaesthetist may consider intraoperative normovolemic
haemodilution in women at risk of life threatening haemorrhage
(placenta praevia/accreta).
 Intraoperative cell salvage should be used if acceptable to the patient.
Be aware cell savage may not be available 24 hrs a day.
 Attention to meticulous haemostasis.
 Non-blood alternatives to blood transfusion such as crystalloids and
colloids should be employed in the first instance and clinical
strategies for managing haemorrhage should be considered.
Management of Active Postpartum Haemorrhage:
 Inform the women of the serious nature of their condition and confirm
with them which treatments they will accept and document.
 Consultant obstetrician and consultant anaesthetist should attend if
blood loss is 1500 mls and ongoing. Liaise with haematologist.
 Employ aortic compression, using a fist just above the umbilicus
directed back against the spine, while waiting for other measures to
work.
5
 Consider pharmacological strategies such as carboprost, misoprostol,
tranexamic acid, Vit K, desmopressin and recombinant factor VIIa.
 If the patient loses consciousness while bleeding, respect her
advanced directive.
 If the patient is conscious during bleeding episode, check if she still
wishes to follow advanced directive and respect her wishes.
(Transfusion Management of Massive Haemorrhage Procedure, trust
guideline)
(Postpartum haemorrhage, trust guideline)
(www.transfusionguidelines.org.uk. Care pathways for the management of
adult patients refusing blood transfusion)
Drug
Tranexamic acid
Recombinant FVIIa
Desmopression
Vit K
Dose and Frequency
Side effects
Active haemorrhage 1 gram IV over
10 minutes followed by 120 mg/hr
for 8 hours.
Mild haemorrhage or risk of
bleeding consider 10 mg/kg body
weight IV up to 3-4 times/day for
2-8 days.
90 micrograms/Kg given as bolus
dose after reconstitution with
normal saline. Given at 2 hourly
intervals until haemostasis is
achieved or until no risk of further
bleeding or drug is deemed
ineffective.
Thrombosis,
disturbance in
vision
Intranasal: 10-40 mcg/day or
divided 2-3 times/day. If giving by
IV/SC, the dose is 1/10th that of
intranasal.
Vit K, 5-10 mg IV (dilute in 50 mL
normal saline and infuse over 20
min)
Headache, raised BP
Thrombosis
May cause warfarin
resistance for one week.
(Expert advice will be available from haematologist) (www.drugs.org.)
 Early recourse to hysterectomy should be considered.
6
colour
 Anticipate coagulation problems and manage accordingly in
collaboration with a senior haematologist. Be aware it is likely that
clotting factors are not accepted as per advanced directive.
 It is accepted that there is a higher mortality for women who refuse
blood transfusion and support must be available for her relatives.
 It is very distressing for the staff to have to watch a woman bleed to
death while refusing effective treatment. Debriefing and support
should be promptly available for staff in these circumstances.
(www.rcseng.ac.uk. Code of Practice for the Surgical Management of
Jehovah’s Witnesses 2002)
Post Haemorrhage Care:
 If the woman survives massive haemorrhage but is severely anaemic,
recombinant human erythropoietin (rHuEPO) at doses either 300-600
IU/daily, 40,000 IU/weekly or 40,000 IU three times weekly should be
administered. Rise of Hb can be expected within seven days.
 Iron supplementation is essential. Parenteral iron may be preferable
to oral iron supplementation. But avoid blanket use of parenteral
preparations due to increased risk of infection and anaphylaxis.
 Consider strategies to maximise oxygen delivery including respiratory
support by elective ventilation on intensive care unit if warranted by
clinical situation. A patient showing signs of tissue hypoxia may
require more prolonged paralysis and deep sedation. Liaise with
anaesthetists and intensivists.
 If severe anaemia is the reason for sedation and mechanical
ventilation, Hb must be taken into account in addition to usual
extubation criteria. Aim Hb >45 g/L (experimental studies have shown
no evidence of tissue hypoxia with Hb >50 g/L in healthy patients).
 Prophylactic prescription of antithrombotic agents such as Low
molecular weight heparin should be individualised.
 Use micro sampling techniques such as HemoCue haemoglobin
analyser to minimise blood loss. Alternatively use paediatric sample
bottles.
 Mild anaemia: oral iron is sufficient. In case of moderate or severe
anaemia: liaise with haematologist for the use of erythropoietin and
parental iron.
7
Appendix 1:
Jehovah’s Witnesses; religious beliefs:
 Clinicians face a special challenge in treating Jehovah’s Witnesses.
 About 150,000 Jehovah’s Witnesses live in UK and strongly believe
that blood transfusion is forbidden. This deeply held conviction stems
from an interpretation of a literal translation of the Bible passages
such as “Only flesh with its soul-its blood-you must not eat” (Genesis
9:3-4);” [You must] pour its blood out and cover it with dust” (Leviticus
17:13-14); and “Abstain from-fornication and from what is strangled
and from blood” (Acts 15:19-21).
 Many Jehovah’s Witnesses feel that to receive non-consensual blood
transfusion would be a gross physical violation and deeply disturbing
to their conscience.
 Most Witnesses will carry with them an Advance Medical Directive
(living wills) in the form of a card that directs as to what products are
acceptable and instructs on a variety of issues. Many would have
provided copies to their GP, immediate family and friends as well as
to the Hospital Liaison Committee for Jehovah’s Witnesses.
 Clinically, it is important not to assume that a Jehovah’s Witness will
refuse all blood products. Indeed, in a 2004 study, almost half of
Jehovah’s Witnesses accepted some form of blood.
 Some Jehovah’s Witnesses may wear their own ‘No Blood’ wristband.
NSPA Safer Practice Notice No 24 (2007) states “patients who wish
to wear their own wristbands in hospital should be permitted to do so,
but advised of the dangers of confusion for staff”.
 It is important to discuss what products are acceptable with each
patient.
8
Appendix 2:
Medico-Legal and Ethical issues:
 Most Jehovah’s Witnesses and other women who decline blood
transfusion are well informed with regard to their legal position. The
decision to refuse blood or blood products has been upheld in court.
 “You must not assume that a patient lacks capacity to make a
decision solely because of their age, disability, appearance,
behaviour, medical condition (including mental illness), their beliefs,
their apparent inability to communicate, or the fact that they make a
decision that you disagree with”. So early assessment of their
capacity to consent, to refuse treatment and implications thereof
should be ascertained at booking and such assessment must remain
under review.
 Ensure that the patient is not under duress or undue influence from
Jehovah’s Witness groups, family or friends. No staff member should
put the patient under duress to accept a transfusion.
(www.gmc-uk.org/guidance. Consent: Patients and doctors making decision
together, Paragraphs 62-80)
Mother 18 years and over:
 Any adult patient who has the necessary mental capacity to
understand any medical procedure or treatment is entitled to accept
or refuse treatment, even if it is likely that refusal will result in patient’s
death. No other person is legally able to consent to treatment for that
adult or to refuse treatment on that person’s behalf.
Mother 16-18 years:
 If the mother is over 16 years and mentally competent to comprehend
fully what is proposed, she is able to give valid consent and thus have
the same rights as an adult. Her parents or a person with parental
responsibility cannot override her consent for treatment. However if
she refuses to have treatment, her parents or those with parental
responsibility may consent on her behalf, and treatment can lawfully
be given. This power to overrule a competent child’s refusal should
be used only when the consequences of non-treatment are grave
such as death of child. One should consider seeking court ruling on
what would be in the “best interests” of the mother.
Mother under 16 years:
 A mother under 16 is not automatically presumed to be legally
competent to make decision about her health care. However she will
be competent to give valid consent for treatment if she has “sufficient
understanding and intelligence to enable her to understand fully of
what is involved”. Her decision to accept a treatment cannot be
9
overridden by parents or those with parental responsibility although it
is still good practice to involve her family. If a mother under 16
refuses to have treatment then the consent of the parents or a person
with parental responsibility to accept treatment is sufficient for
clinicians to proceed, provided the treatment is deemed to be in the
best interests of the mother. The consent of any one person with
parental responsibility is sufficient for treatment to lawfully be given,
even if another person with parental responsibility does not agree.
 With the Jehovah’s Witness group it would be very unlikely for the
parents to override a minor mother’s refusal of blood, if anything they
will support her. In this situation, if the treatment that is in the opinion
of two doctors of Consultant status is crucial and lifesaving, it may be
necessary to involve Trust Solicitors and apply for a legal “Specific
Issue Order”. The court can decide what is in the mother’s best
interests.
 The High Court has emergency procedures to arrange for expedited
considerations of such applications. If there is no time to make an
application and a minor parent is likely to succumb without
transfusion, blood should be given notwithstanding the wishes of the
parents. The clinicians can override both the parents and the child
less than 18 years when it comes to refusal of life saving treatment or
treatment in the best interest of the mother. Ultimate decision should
be resolved in favour of preservation of life. In such situations the
hospital legal advisors must be notified after the event via hospital
manager.
 Full documentation of the decision by two consultants is essential and
the trust legal department / Duty Manager must be informed. The
parents, however, have a right to be involved and represented in legal
discussions. They are entitled to express their views at any meeting
and should in all circumstances be reminded of their right to seek
legal advice.
 In an elective situation, a less confrontational pathway may be taken.
A document setting out a written understanding between the parents
and clinicians should be prepared. This document should clearly state
that all possible alternatives to transfusion such as intravenous iron
and erythropoietin will be employed and blood transfusion will take
place under certain circumstances. The Trust solicitors should review
this document and inform parents of their right to legal advice.
(Gyamfi C and et al. Ethical and medico legal considerations in the obstetric
care of a Jehovah’s Witness. Obstet Gynecol 2003;102:173-80).
(Ref: www.gov.uk. Mental capacity act Code of practice 2005 including
making decisions Oct 2014).
(Consent to examination or treatment, trust guideline)
10
Patient unconscious or incompetent at the time of decision making:
 Some health professionals are willing to respect the patient’s
advanced directive for refusal of blood or treatment when
accompanied by information from appropriate surrogates that this
represents the current belief and values of the patient. Other
professionals may seek an emergency court order providing
permission for a lifesaving blood transfusion, in the light of the
possibility that the patient might have consented if awake and aware
of the circumstances.
Practical guidelines for addressing refusal of treatment for minor
patients:
1. Elicit the reasons for the refusal.
2. Clarify any misunderstandings about the patient’s condition,
prognosis, or treatment options.
3. Seek a private discussion with adolescent.
4. Acknowledge beliefs and values informing the recommendations.
5. Seek common ground.
6. Enlist assistance in identifying and evaluating options.
7. If conflict is intractable, make a considered moral judgement.
Application to court:
Before approaching court the following criteria should be fulfilled.
1. Trust legal advisors or Hospital Manager should be contacted
thorough switchboard.
2. Patient (depending on maturity) and parents or guardians with
responsibility must be notified of the intended actions and they must
be invited to case conference.
3. Refer the case to child protection/social services.
4. Case has been referred to NUH clinical ethics committee.
5. Prior assistance has been sought from Hospital Liaision committee
for Jehovah’s Witnesses.
6. Risks and benefits of using and not using blood products have been
fully considered.
7. All non-blood medical management options have been explored.
8. Consideration has been given to whether another hospital willing to
treat and consider transfer without risk to patient.
11
HOSPITAL
LIAISON
COMMITTEE
A Health Care
Practitioner and
Patient Support
Service
“available to
assist at any
time at the
request of
either the
treating team or
the patient”
Education
“we are
available to
make
presentations,
facilitate
workshops and
answer
questions
regarding
treatment of
Jehovah’s
Witnesses…blood
conservation
techniques and
transfusion
alternative
strategies”
(Free Service)
Information
Resource
“we maintain a
specialised
database of
relevant medical
papers…dealing
with non-blood
management
strategies,
researched from
the world’s
medical
literature”
for
Jehovah’s Witnesses
NOTTINGHAM
[email protected]
Alan Cunningham
Chairman
T: 0115 9233242
M: 07931 732932
E: [email protected]
Paul Cutts
T: 01332 755434
M: 07711 771091
E: [email protected]
Mark James
T: 0115 8497130
M: 07971 551220
E: [email protected]
Alan Melville
T: 0115 9286698
M: 07513 904573
E: [email protected]
John Pye
T: 0115 9164740
M: 07901 835806
E: [email protected]
James Reid
T: 0115 9877746
M: 07886 246363
E: [email protected]
Paul Sharpe
M: 07736 846267
E: [email protected]
August 2015
References:
Van Wolfswinkel M and et al. Maternal mortality and serious maternal
morbidity in Jehovah’s witnesses in the Netherlands. BJOG 2009;116:110310.
Ashworth A and et al. Cell salvage as part of a blood conservation strategy
in anaesthesia. BJA 2010;105(4):401–16.
www.eoedeanery.nhs.uk. Clinical strategies for avoiding and controlling
haemorrhage and anaemia without blood transfusion in obstetrics and
gynaecology 2009.
Brezina PR and et al. Urgent medical decision making regarding a
Jehovah’s Witness minor: A case report and discussion. NC Med J
2007;68(5):312-6.
Breymann C and et al. Effectiveness of recombinant erythropoietin and iron
sucrose vs. iron therapy only, in patients with postpartum anaemia and
blunted erythropoiesis. Europ J Clin Invest 2000;30:154-61.
Gohel MS and et al. Avoiding blood transfusion in surgical patients
(including Jehovah’s Witnesses). Ann R Coll Surg Engl 2001;93(6):429-31.
www.aagbi.org. Management of Anaesthesia for Jehovah’s Witnesses 2nd
Edition 2005.
Catling S and et al. Cell salvage in obstetrics: the time has come. BJOG
2005;112:131-2.
Centre for Maternal and Child Enquiries (CMACE). Saving Mothers’ Lives:
reviewing maternal deaths to make motherhood safer: 2006–08. The Eighth
Report on Confidential Enquiries into Maternal Deaths in the United
Kingdom. BJOG 2011;118 (Suppl. 1):1–203.
Massiah N and et al. An audit of gynaecological procedures in Jehovah’s
Witnesses in an inner city hospital. J Obstet Gynaecol 2006;26:149-51.
Singla AK and et al. Are women who are Jehovah’s Witnesses at risk of
maternal death? Am J Obstet Gynecol 2001;185:893-5.
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Chalmers C and et al. Profound anaemia in a Jehovah’s Witness following
upper gastrointestinal haemorrhage: Intensive care management. JICS
2014;15(3):238-42.
Weinstein A and et al. Conservative management of placenta praevia
percreta in a Jehovah’s Witness. Obstet Gynecol 2005;105:1247-50.
Massiah N and et al. Obstetric care of Jehovah’s Witnesses; a 14-year
observational study. Arch gynecol Obstet 2007;276:339-43.
Gyamfi C and et al. Responses by pregnant Jehovah’s Witnesses on health
care proxies. Obstet Gynecol 2004;104:541-4.
Nash MJ and et al. Management of Jehovah’s Witness patients with
haematological problems. Blood Rev 2004;18:211-7.
McCormick TR and et al. Ethical issues inherent to Jehovah’s Witnesses.
Perioperative Nursing clinics 2008;3:253-8.
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