MAT/GUI/0510/THRVTE MATERNITY SERVICE GUIDELINE TITLE: Thromboprophylaxis and management of venous thromboembolism (VTE) in pregnancy and the puerperium Shohreh Beski – Consultant O&G, Peter MacCallum – Consultant Haematologist, Louise Bowles - Haematologist, Sarah Mills VTE Nurse Specialist, Emily Hill – Audit & Quality Midwife Shohreh Beski GUIDELINE LEAD: Guideline group RATIFIED BY: June 2010 ACTIVE DATE: May 2010 RATIFICATION DATE: May 2013 REVIEW DATE: Thromboprophylaxis and VTE management in APPLIES TO: pregnancy and the puerperium. None EXCLUSIONS: The severely ill parturient (2010) RELATED POLICIES Obesity in Pregnancy (2010) Maternity Training Needs Analysis (2010) Barts and The London VTE Guideline THIS DOCUMENT Thromboprophylaxis and treatment of venous thromboembolism (VTE) in pregnancy REPLACES (2007). Prophylaxis for Thromboembolism in Caesarean section (2006). AUTHORS: 1. INTRODUCTION/PURPOSE OF THE GUIDELINE 1.1. Venous thromboembolism (VTE) remains the major cause of direct maternal deaths (1.94 per 100,000 maternities) in the Confidential Enquiry into Maternal and Child Health Report 2003-5 (CEMACH, 2007). VTE can occur at any stage of pregnancy, during delivery and afterwards. This guideline is written with regard to relevant national guidelines: Reducing the risk of thrombosis and embolism during pregnancy and the puerperium (Royal College of Obstetricians and Gynaecologists (RCOG) 2009) RCOG guidelines on treatment of VTE in pregnancy (2007) National Institute of Clinical Excellence (NICE) guideline of prevention of venous thromboembolism in patients admitted to hospital (2010) This guideline states the risk factors for VTE in pregnancy and the puerperium and so provides guidance as to which women require thromboprophylaxis in and after pregnancy. The guideline also outlines the management of VTE during pregnancy and in the postnatal period. 1.2. 1.3. Page 1 of 14 MAT/GUI/0510/THRVTE 2. IMPLEMENTATION 2.1 2.4 The updated paper copy will be attached to guideline notice board, in each clinical area for four weeks. Electronic copies will be distributed to the lead Midwives in each clinical area. The guideline will be available via the trust intranet and circulated to guidelines folders. See Training Needs Analysis for training requirements. 3. ROLES AND RESPONSIBILITIES 3.1. It is the responsibility of the whole multi-professional team to actively risk assess women for risk of VTE Midwives should risk assess women at booking, when admitted into hospital and early in the postnatal period. Midwives should refer to the joint Antenatal High Risk clinic if deemed high risk, when the woman is in the antenatal period. Midwives should refer to obstetrician if women are in-patients or postnatal for appropriate management plan to be initiated. Medical professionals should ensure that when women are at risk of VTE, a management plan initiated Medical professionals have the responsibility to promptly refer woman appropriately if they suspect VTE. 2.2 2.3 3.2. 3.3. 3.4. 3.5. 3.6. 4. GUIDELINE 4.1. THE APPROPRIATE AND TIMELY RISK ASSESSMENT TO IDENTIFY THOSE AT RISK OF VENOUS THROMBOEMBOLISM (VTE) Algorithm available Appendix 1 4.2. 4.3. Assess all women regarding risk factors for VTE (Appendix 2) At booking On admission into hospital Early in the postnatal period DOCUMENTATION OF RISK ASSESSMENT AND INDIVIDUAL ACTION/ MANAGEMENT PLAN FOR THROMBOPROPHYLAXIS. Complete risk assessment stickers (for every risk assessment carried out) and place in hand held notes (ideally on management page). This should include an individual action plan (if required). GENERAL MEASURES All women should be encouraged to: keep mobile stop smoking The use of graduated compression stockings should be limited to women who are high risk and have contraindications to low molecular weight heparin (LMWH) or have had an operative delivery. As RCOG (2009) identified that Page 2 of 14 MAT/GUI/0510/THRVTE the evidence was limited in supporting the use of graduated compression stockings. 4.4. THROMBOPROPHYLAXIS IN PREGNANCY All antenatal women at high risk of VTE will need considering for prophylaxis. Therefore refer to high risk multi disciplinary antenatal clinic that comprises consultants in obstetrics, haematology, anaesthetics and rheumatology (please request next available appointment on 1 st or 3rd Tuesday of the month) The consultants will discuss the options for prophylaxis based on the RCOG guidelines (2009), taking account of the wishes of the individual woman. All antenatal admissions should be thromboprophylaxis risk assessed, if required as an in-patient. The Obstetrician should assess the women prior to discharge to see if thromboprophylaxis should be continued after discharge these women should be referred to high risk high-risk multidisciplinary clinic. If in doubt, discuss the case with a consultant Obstetrician and consultant Haematologist. Women deemed high risk should be considered to receive thromboprophylaxis for the whole pregnancy and postnatal period. The standard prophylaxis is clexane 40mg sc OD for women weight 50-90kg. Refer to RCOG (2009) guideline for dosing for weights <50kg and >90kg. See Appendix 3 for risks of low molecular weight heparin Measure FBC and anti Xa if advised by consultant Haematologist. 4.5. CARE DURING LABOUR AND DELIVERY OF WOMEN ON THROMBOPROHYLAXIS Thromboprophylaxis should be stopped, if women have any vaginal bleeding or once labour begins or 12 hours prior to region anaesthetic Graduated compression stockings are appropriate for high risk women in labour and/or when women have an operative delivery (RCOG, 2009) 4.6. POSTNATAL THROMBOPROPHYALIS A further risk assessment is required to identify risk factors If thromboprophylaxis was received antenatally, it should be continued for 6 weeks post-partum (unless individual plan states otherwise) 4.7. Common Signs and Symptoms of VTE Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) Pain/ tenderness in one leg Dyspnoea (73%) Unilateral oedema Pleuritic pain (66%) Superficial venous dilation Cough (37%) Skin discolouration Tachypnoea (70%) Crepitations (51%) Tachycardia (30%) Collapse (Blann and Lip 2006) 4.2. VTE can be asymptomatic Page 3 of 14 MAT/GUI/0510/THRVTE 4.8 DOCUMENTATION All women, requiring thromboprophylaxis or treatment for a diagnosed VTE should have a documented individual management plan in their maternity notes (preferably on the management page). Documentation should include the risks of VTE investigations and management where appropriate 4.9 THE SIGNIFICANCE OF SIGNS AND SYMPTOMS OF VTE Management of pregnant or postnatal women with suspected VTE All pregnant or postnatal women presenting with shortness of breath or chest pain must be suspected of having a pulmonary embolism. Women suspected of having VTE should be commenced on therapeutic doses of clexane, 1mg/kg bd, until diagnosis is confirmed or excluded (unless bleeding is a concern). For differential diagnosis see Appendix 3. Specific measures Consider risk factors for VTE (see appendix 2) Respiratory and cardiovascular system examination Temperature, pulse, blood pressure, O2 saturations ECG: Sinus tachycardia is the commonest finding, atrial fibrillation, right bundle branch block, S1Q3T3 pattern CXR Blood gases The presence of normal oxygen saturation, arterial blood gases, ECG and CXR does not exclude pulmonary embolism. Investigation during pregnancy Every effort should be made to confirm the diagnosis objectively. For suspected DVT, the initial investigation is Doppler ultrasonography (x7104), which detects DVT at the popliteal vein or more proximally - calf veins are not scanned. Sensitivity is 97% and specificity 94% for proximal leg DVT (Kearon et al., 1998). For suspected PE, if CXR is normal, a 50% dose perfusion lung scan (x3284) is requested +/- ventilation scan in discussion with nuclear medicine consultant. If CXR abnormal a CTPA should be requested. CTPA is also available out of hours and at weekends. In patient with suspected massive PE too ill to transfer to radiology department, a portable echocardiogram should be requested. Investigation post-partum Investigate as above. V/Q scan or CTPA for PE diagnosis. Page 4 of 14 MAT/GUI/0510/THRVTE Breast feeding should be discontinued for 24 hours following a V/Q scan – discuss with consultant in nuclear medicine (where possible, milk expressed prior to scan could be used). 4.10 TREATMENT OF VTE Antenatally Women with confirmed diagnosis of DVT or PE should be referred immediately to the on-call haematologist and/or medical registrar. Refer woman on discharge to anticoagulation clinic and high risk antenatal clinic. Treatment should continue for remainder of pregnancy and for 6 weeks postpartum or for 6 months, whichever is longer. Omit Enoxaparin from the onset of labour and resume as soon as possible postpartum if no excessive bleeding. Management of VTE close to term is particularly challenging. If delivery is anticipated within 2 weeks of start of anticoagulant treatment, and particularly if diagnosis is PE or the iliac veins are involved, insertion of an IVC filter should be considered. Delivery by caesarean section is usually preferable because it limits manipulation of the pelvic veins and the time off anticoagulants. Refer to Appendix 4 for management in delivery with regard to regional anaesthesia. Refer to Appendix 5 for management postnatally. Postnatal follow-up for women who develop VTE antenatally or postnatally An appointment should be made in the Thrombosis Clinic with the haematology team where the duration of anticoagulation should be reviewed and thrombophilia testing should be considered. Advice should be offered about thromboprophylaxis in further pregnancies 4.11 MANAGEMENT OF MASSIVE LIFE THREATENING PE IN PREGNANCY AND POSTNATAL See Appendix 7 for actions if suspected massive life threatening PE Admit to Accident and Emergency Department if in the community If stable enough perform CT pulmonary angiogram (CTPA) if unstable perform echocardiogram to diagnose pulmonary embolism If PE diagnosed and is associated with shock or systemic hypotension (systolic BP < 90 mmHg), urgent discussion should occur between consultant obstetrician, anaesthetist, haematologist, respiratory physician and interventional radiologist. IV heparin (loading dose 80 u/kg followed by continuous IV heparin infusion of 18 u/kg/hr with APTT checked at 6 hours and dose-adjusted to keep APTT ratio between 1.5-2.5). Thrombolysis (e.g. alteplase either 100 mg IV over 90 minutes if woman relatively stable or 50 mg iv bolus if deteriorating) Catheter–directed thrombolysis. For continuation of treatment post-partum liaise with anticoagulation team and consultant haematologist for dosing regime and duration. Page 5 of 14 MAT/GUI/0510/THRVTE 5. BREACH OF GUIDELINES/POLICIES The incident will be reviewed within the Risk Management framework. The impact of this incident will be reviewed by the appropriate lead clinician and feedback/training given to staff as required. 6. MONITORING COMPLIANCE Element to be monitored Lead Monitoring Tool Frequency Reporting arrangements Documented and appropriate risk assessment at booking, on admission to hospital and postnatal Audit and Quality Midwife Proforma 10 sets of maternity records per month Labour Ward Forum Supervisors of midwives meeting Management of signs and symptoms of VTE Proforma Lead Midwife Lead Midwife 10 sets of maternity records per month Proforma Change in practice and lessons to be shared Quarterly report will be circulated it all relevant clinical areas Emailed to all relevant staff groups Labour Ward Forum Quarterly report produced Results of report shared quarterly Labour Ward Forum, (multidisciplinary team) review results and recommendations This process with be documented in the meetings minutes 10 sets of maternity records per month Labour Ward Forum, (multidisciplinary team) review results and recommendations This process with be documented in the meetings minutes Quarterly report produced Results of report shared quarterly Acting on recommendations and Lead (s) Labour ward forum will undertake recommendations Required changes to practice will be identified and actioned within a specific time frame, at the Labour ward forum. A lead member will be identified to take each change forward. Lessons will be shared with the relevant staff groups Labour ward forum will undertake recommendations Quarterly report will be circulated it all relevant clinical areas Emailed to all relevant staff groups Required changes to practice will be identified and actioned within a Page 6 of 14 MAT/GUI/0510/THRVTE specific time frame, at the Labour ward forum. A lead member will be identified to take each change forward. Lessons will be shared with the relevant staff groups Appropriate prophylaxis/ care/treatment for high risk women (antenatal, intrapartum & postnatal) Lead Midwife Documentation of an appropriate individualised management plan, incl. postnatal management plan Lead Midwife Proforma 10 sets of maternity records per month Quarterly report produced Results of report shared quarterly Proforma 10 sets of maternity records per month Quarterly report produced Results of report shared quarterly Labour Ward Forum, (multidisciplinary team) review results and recommendations This process with be documented in the meetings minutes Labour ward forum will undertake recommendations Labour Ward Forum, (multidisciplinary team) review results and recommendations This process with be documented in the meetings minutes Labour ward forum will undertake recommendations Quarterly report will be circulated it all relevant clinical areas Emailed to all relevant staff groups Required changes to practice will be identified and actioned within a specific time frame, at the Labour ward forum. A lead member will be identified to take each change forward. Lessons will be shared with the relevant staff groups Quarterly report will be circulated it all relevant clinical areas Emailed to all relevant staff groups Required changes to practice will be identified and actioned within a specific time frame, at the Labour ward forum. A lead member will be identified to take each Page 7 of 14 MAT/GUI/0510/THRVTE change forward. Lessons will be shared with the relevant staff groups Postnatal follow-up for women diagnosed with VTE during pregnancy or postnatal period, with appropriate thrombophilia testing Lead Obstetrician Proforma Annual audit Results presented at Maternity and Gynaecology Audit Meeting Maternity and Gynaecology audit Committee Mini-report to be emailed to relevant staff groups Min-report to be displayed on the Audit Board in relevant clinical areas. Maternity and Gynaecology audit Committee will monitor action plan, which will address the required changes to practice will be identified and actioned within a specific time frame. A lead member will be identified to take each change forward. Management of massive life threatening Pulmonary thromboembolism in pregnancy Maternity Risk and Governance Manager Serious Incident (SI) investigation process Weekly or within 3 days if SI Trust Serious Incident framework Risk Management Committee, reporting to Maternity and Gynaecology Governance Board Required changes to practice will be identified and actioned within a specific time frame. A lead member will be identified to take each change forward. Action plan monitored by Risk Management Committee Page 8 of 14 MAT/GUI/0510/THRVTE REFERENCES Blann, A. & Lip, G. (2006) Venous thromboembolism. British Medical Journal; 332: 215-9. Confidential Enquiry into Maternity and Child Health (CEMACH) (2007). Saving Mother’s Lives. Reviewing maternal deaths to make motherhood safer 2003 – 2005. London: CEMACH. Kearon, C. Julian, JA. Newman, TE. & Ginsberg, JS. (1998) Noninvasive diagnosis of deep vein venous thrombosis. American College of Physicians. 128:633-77. National Institute for Health and Clinical Excellence (2010) Venous Thromboembolism – Reducing the risk. London: NICE. Royal College of Obstetrics and Gynaecologists (2007) Thromboembolic disease in pregnancy and the puerperium acute management (Green-top 28). London: RCOG. Royal College of Obstetrics and Gynaecologists (2009) Thrombosis and embolism during pregnancy and puerperium, reducing the risk (Green-top 37). London: RCOG. Page 9 of 14 MAT/GUI/0510/THRVTE APPENDIX 1 Thromboprophylaxis during pregnancy and postnatally 6.1. Use Risk assessment tool for all women At booking On admission into hospital Early in the postnatal period 6.2. 6.3. (Place sticker in maternity notes e.g. on management page) 6.4. 6.5. 6.6. Calculation total score Antenatal Total Score ≥ 3 Postnatal (remember to recalculate score) If woman having thromboprophylaxis during pregnancy to continue for 6 weeks. All women with BMI ≥ 40 Unless Contraindicated Refer to High Risk Antenatal clinic (please request next available appointment on 1st or 3rd Tuesday of the month) Total score 2 For thromboprohylaxis for at least 7 days Consider Thromboprophylaxis If thromboprohylaxis commenced while inpatient. Obstetrician to review if thromboprohylaxis is required following discharge. 6.8. Total Score ≥ 3 For thromboprohylaxis for 6 weeks 6.7. Standard Thromboprophylaxis is Clexane 40mg sc OD for women weight 50-90kg. See RCOG for dosing for weights <50kg and >90kg. Page 10 of 14 MAT/GUI/0510/THRVTE APPENDIX 2 SCORE 1 FOR EACH RISK FACTOR TICKED IN THIS GREEN BOX; Hospitalisation BMI > 30 Family history VTE Pre-eclampsia Dehydration/ hyperemesis/OHSS Current systemic infection Parity ≥ 3 Gross varicose veins Reduced Mobility Prolonged labour > 24 hours Mid-cavity or rotational forceps Age > 35 Smoker Multiple pregnancy/ ART PPH (> 1 litre or transfusion) Elective caesarean section SCORE 2 FOR EACH RISK FACTOR TICKED IN THIS AMBER BOX; BMI >40 Medical comorbidities Known thrombophilia Caesarean section in labour Surgical procedure in pregnancy or ≤ 6 weeks post partum SCORE 3 FOR EACH RISK FACTOR TICKED IN THIS RED BOX; Recurrent or previous venous thromboembolism PROPHYLAXIS PLAN; (Exclude Bleeding Risks) ANTENATAL : POSTNATAL : ≥ 3 risk factor score CONSIDER ENOXAPARIN 2 risk factor score CONSIDER ENOXAPARIN for 7 days and referral to high risk antenatal clinic ≥3 risk factor score consider ENOXAPARIN FOR 6 WEEKS TOTAL SCORE …………………ACTION PLAN………………………………………………………………… SIGNATURE……………………………...….…..PRINT NAME………………………..DATE…………............ APPENDIX 3 Risks of heparin Active bleeding or potential for bleeding Heparin-induced thrombocytopenia – very uncommon with low-molecular-weight heparin. If suspected, stop heparin and discuss urgently with a consultant haematologist. Osteoporosis – low risk with low-molecular-weight heparin. Low-molecular-weight heparins do not have a full product licence for use in pregnancy but there is experience of their use internationally, and they have significant advantages over unfractionated heparin. Cautions and contraindications; antiplatelet agents, procedure with related bleeding risks, acute stroke (haemorrhagic or large infarct, inherited bleeding disorder, severe/acute liver disease (CrCl <30), Platelets <75, BP >230 systolic or >120 diastolic, Lumbar puncture/ epidural/spinal in previous 4 hours or within next 12 hours (for anticoagulants other than LMWH contact haematology SpR) APPENDIX 4 Differential Diagnosis for Shortness of Breath in Pregnancy Page 11 of 14 MAT/GUI/0510/THRVTE Physiological dyspnoea Chest infection Acute asthma Amniotic fluid embolism Anaemia Pulmonary oedema and preeclampsia Peripartum cardiomyopathy Haemorrhage APPENDIX 5 Delivery and Regional Anaesthesia Women on Enoxaparin at time of labour Prophylactic dose Therapeutic dose Do not proceed to regional Do not proceed to regional anaesthesia if the last anaesthesia if the last Enoxaparin Enoxaparin injection was within 24 hours injection was within 12 hours If required regional anaesthesia needed prior to time frame, discuss with consultant anaesthetist Omit any Enoxaparin due during labour Check for Normal Clotting Screening, Platelet count > 80 x 10 9/l and no sudden reduction in platelet count Epidural catheter should not be removed within 12 hours of an Enoxaparin injection Allow 4 hours minimum to elapse between removal of epidural catheter and next Enoxaparin injection (prophylactic dose) Avoid aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) It is not usually necessary to check antiXa level urgently pre-regional anaesthesia but this may occasionally be indicated in discussion with consultant haematologist. APPENDIX 6 Postnatal management of VTE Women diagnosed antenatally - Enoxaparin treatment can be switched to warfarin, which should be started when bleeding risk has reduced and should be overlapped with Enoxaparin for 5 days minimum and until INR 2.0 for 2 consecutive days. Alternatively, Enoxaparin can be continued if duration of postpartum anticoagulation is ≤ 6 weeks. Postpartum the treatment dose of Enoxaparin is 1.5 mg/kg/once daily. Page 12 of 14 MAT/GUI/0510/THRVTE Women diagnosed postnatally - Tinzaparin is the Trust’s LMWH of choice at a dose of 175 u/kg daily for minimum of 5 days, overlapping with warfarin, and continuing Tinzaparin until INR 2.0 for 2 consecutive days APPENDIX 7 Actions if suspect life-threatening Massive PE in Pregnancy Immediate management of Sudden Maternal Collapse should be the same regardless of cause A= Airway, B=Breathing C=Circulation Woman Unresponsive Open Airway Look for signs of life No pulse or respiration Call for Help use emergency buzzer where possible (ask for Midwife Co-ordinator) Call 2222 – State Cardiac Arrest & exact location Call 2222- State Obstetric Emergency & exact location Pulse and respiration present Call for Help use emergency buzzer where possible (ask for Midwife Co-ordinator) Call 2222- State Obstetric Emergency & exact location Page 13 of 14 MAT/GUI/0510/THRVTE Follow Adult Advance Life Support (2007) The following modification are required in Pregnancy; Uterine displacement (left lateral tilt) Increased chest wall compression force Use cricoid pressure if assistance available Early tracheal intubation Perimortem caesarean delivery if mother fails to respond within 4 minutes Consider other aetiologies e.g. MgSO4 Toxicity If resuscitation successful – Start PE investigations Recovery position Administer 100% oxygen by facial mask Insert 2 large venous cannula – take blood for FBC, Clotting, U&E’s LFTS X-Match Request 2 units X-Matched blood If GCS <8 or airway reflexes compromised, anaesthetist should intubate and ventilate If systolic pressure <90mmHg Ensure uterine displacement Infuse 1 litre colloid/crystalloid Consider ephedrine 6mg bolus Regular evaluate, A, B, C Assess fetal condition & consider urgent delivery of fetus Do CTPA (Echocardiogram if unstable) If PE diagnosed and is associated with shock or systemic hypotension (systolic BP < 90 mmHg), urgent discussion should be had between consultant obstetrician, anaesthetist, haematologist, respiratory physician and intervention radiologist. IV heparin (loading dose 80 u/kg followed by continuous IV heparin infusion of 18 u/kg/hr with APTT checked at 6 hours and dose-adjusted to keep APTT ratio 1.5-2.5). Thrombolysis (e.g. alteplase either 100 mg IV over 90 minutes if patient relatively stable or 50 mg iv bolus if deteriorating) Catheter–directed thrombolysis. Consider Urgent Embolectomy – Discuss with interventional radiologist Page 14 of 14