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. 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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. 12 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. 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