Title of Guideline (must include the word “Guideline” (not protocol, policy, procedure etc) Guideline for The Management of Postpartum Haemorrhage Contact Name and Job Title (author) Ghada El Senoun, Consultant obstetrician Directorate & Speciality Family Health, Obstetrics Implementation date February 2014 Version Five Supersedes Original Guideline produced in 1999 and updated 2005 by Dr Ramsay, Consultant in Feto-maternal medicine, 2010 by Ghada El Senoun,Sr city hospital February 2014 Date of submission Date on which guideline must be reviewed (this should be one to three years) Explicit definition of patient group to which it applies (e.g. inclusion and exclusion criteria, diagnosis) February 2019 Abstract This guideline describes the management of postpartum haemorrhage both medical and surgical techniques Key Words PPH, obstetric haemorrhage,factorVII,’Syntocinon’, ‘carboprost’, ‘oxytocics’,’uterotonics’,’B-lynch suture’,’uterine artery embolism’ ,’bilateral ligation’, balloon, Rusch, Statement of the evidence base of the guideline – has the guideline been peer reviewed by colleagues? Yes Obstetric postpartum haemorrhage. Evidence base: (1-5) 1a meta analysis of randomised controlled trials 1b at least one randomised controlled trial 2a at least one well-designed controlled study without randomisation 2b at least one other type of well-designed quasiexperimental study 3 well –designed non-experimental descriptive studies (ie comparative / correlation and case studies) 4 expert committee reports or opinions and / or clinical experiences of respected authorities 5 recommended best practise based on the clinical experience of the guideline developer Consultation Process NUH Maternity Guideline Development Group Target audience Midwives, Obstetricians, Amaesthetists Meta analysis of randomised controlled trials, Cochrane review 2007,2014. Expert committee reports or opinions and/or clinical experience of respected authorities (RCOG green top guideline 52) 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. Page 2 of 36 Contents 1. Background: 2. Definition and risk factors 2.1 Signs and symptoms of obstetric haemorrhage 2.2 Key signs of massive obstetric haemorrhage 3. Management 3.1 Communication 3.2 Resuscitation 3.3 Fluid therapy and blood product transfusion 3.4 Monitoring and Investigation: 3.5 Identification of the cause and arrest of bleeding 3.5.1 Uterine atony – first line treatment 3.5.2 If first line utero-tonics are not efficient consider second line group 3.5.3 Suspected or actual retained products 3.5.4 Suspected surgical cause 3.5.5 Failure of second line uterotonics 3.6 Surgical measures to control the bleeding 3.6.1 Uterine tamponade: 3.6.2 Uterine haemostatic sutures: 3.6.3 Internal iliac artery ligation: 3.7 Tranexamic acid 3.8 Recombinant factor VIIa: 3.9 Failure of the above measures? 3.9.1 Selective arterial occlusion or embolisation by interventional radiology: 3.9.2 Hysterectomy 4. Care following the control of haemorrhage 5. Risk management 5.1 Documentation: 5.2 Debriefing: 6. Risk factors for primary postpartum haemorrhage (PPH). Table 1: Risk factors presenting antenatally Table 2: Risk factors becoming apparent during labour /delivery Monitoring Plan References Page 3 of 36 Appendices Appendix 1 Interventional Radiology Appendix 2 A pictorial guide to aid estimation of estimated blood loss in major obstetric haemorrhage Appendix 3. (Summary) A flow chart of the different steps for the management of major postpartum haemorrhage . Appendix 4 Haemostatic uterine sutures Appendix 5. Protocol for use of Recombinant Coagulation Factor VIIa Appendix 6 Rational for protocol for rVIIa Appendix 7 Background and rationale for the protocol Appendix 8 Obstetric haemorrhage flow chart Appendix 9 Communication Appendix 10 Risk factors for primary postpartum haemorrhage(PPH) Page 4 of 36 MANAGEMENT OF PRIMARY POST PARTUM HAEMORRHAGE 1. Background Obstetric haemorrhage is one of the major causes of maternal morbidity and mortality in both developed and developing countries. In the 2006–2008 report of the UK Confidential Enquiries into Maternal Deaths, haemorrhage was the sixth highest direct cause of maternal death (3.9 deaths/million maternities) (CMACE; 2011). Substandard care was identified in 66% of cases, with 6 out of 9 cases in the 2006–2008 triennium judged to have received ‘major substandard care’. For four women it was considered that different treatment may have altered the outcome. 2. Definition and risk factors Primary post partum haemorrhage (PPH) is defined as bleeding from the genital tract in excess of 500 mls within 24 hours of the birth of a baby (Cochrane Database Syst Rev 2007). The Royal College of Obstetricians and Gynaecologists defines primary PPH as minor (500–1000 ml) or moderate (1000 - 2000 ml) or severe ( more than 2000ml) in its Green Top Guideline (RCOG Green-top Guideline No. 52) and recommends blood loss of more than 1500mls as the trigger for an incident form (RCOG Clinical Governance Advice Sept 09). Risk factors may present antenatally or intrapartum. Tables 1 and 2 (see section 6) summarise known risk factors and associated odds ratios for the risk of primary PPH. Attempts should be made during pregnancy to identify women at risk of excessive bleeding following delivery and if there are sufficient risk factors they should be advised to deliver in a Consultant Led Unit for the wellbeing and safety of both the mother and the baby. Uterine atony accounts for 80% of cases of major postpartum haemorrhage. Other causes include retained or morbidly adherent placental tissue, uterine and genital tract trauma, surgical haemorrhage, or coagulopathy secondary to abruption, sepsis, preeclampsia, or amniotic fluid embolus. This is recalled as the ‘four T’s’ – tone, tissue, trauma, thrombin. Abnormally adherent placenta (placenta accreta and the more severe Page 5 of 36 forms: increta or percreta) is associated with catastrophic haemorrhage and carries a high morbidity, surgical interventions and maternal mortality. Evidence is accumulating suggesting that the incidence of morbid adhesion of the placenta is rising and it has been linked to the increase in caesarean section, particularly repeat caesarean section (You and Zahn, 2006). Several investigators have reported on the prophylactic use of interventional radiology, including balloon occlusion or selective pelvic artery embolisation, for the management of cases of antenatally diagnosed placenta accreta with variable success rates (Mitty et al, 1993; Dubois et al, 1997; Hansch et al, 1999). See appendix 1 for details of the indications for interventional radiology and how to contact the team. Women who decline blood transfusion should be identified and managed according to Trust guideline Management of Women Declining Blood and Blood Products During Pregnancy and Labour. Their refusal of transfusion and management plan should be clearly documented in the antenatal record/Medway and transferred in labour to the intrapartum record. In the event of haemorrhage, there should be prompt direct involvement of the consultant in each of the key specialities; obstetrics, anaesthesia and haematology. 2.1 The signs and symptoms of obstetric haemorrhage In most cases blood loss will be obvious. There is good evidence that clinical staff underestimate blood loss at delivery by up to 40% and a chart showing common amounts of blood loss can be used to guide estimates (Appendix 2 - Pictorial Reference Guide to Aid Visual Estimation of Blood Loss in Obstetric Haemorrhage). Persistent ‘trickling’ over several hours can result in substantial loss. The Confidential Enquiry (CMACE; 2011) has also identified delay of response to early clinical signs of shock as a contributing factor. Estimation of blood loss should be as accurate as possible All women who deliver on delivery suite should have blood loss quantification. Blood loss should be measured in a measuring jug or similar, swabs, incontinence pads etc should be weighed (dry weight of the swab/pad should be subtracted, 1g is equivalent to 1ml of blood). In theatre, the amount of fluid in the suction bottle should be noted. Liquor should be measured at the time of delivery and Page 6 of 36 this figure subtracted from the total volume in the suction bottle to give blood loss. All swabs should be weighed (dry weight of the swabs subtracted, 1g is equivalent to 1ml of blood). The total blood loss includes blood in the suction bottle, weighed from swabs and any clots collected in receivers. 2.2 Key signs of massive obstetric haemorrhage are: a. Rising pulse rate b. Pallor c. Fall in blood pressure d. Altered conscious level e. Rising respiratory rate f. Decreased urine output g. Deviations from normal on the Early Warning Score 3. Management The management of major primary PPH requires a multidisciplinary approach with rapid and good communication between clinical specialities. Once primary PPH has been identified, management involves four components, all of which must be undertaken simultaneously: - communication - resuscitation - monitoring and investigation - and arresting the bleeding An outline for the management of this condition is described in appendix 3. 3.1 Communication The key to successful management is prompt involvement of experienced staff, trained in the management of haemorrhage. The guidance below is not rigid, and it is the woman’s clinical state, rather than measured blood loss that should determine actions (remember estimated blood loss is often an underestimate) Page 7 of 36 Basic measures for minor PPH (blood 500 - 1000ml, no clinical shock, bleeding not ongoing): Assess placenta is complete, examine for trauma, rub a contraction, empty bladder, consider Syntocinon Alert the delivery suite coordinator/midwife-in-charge of the clinical area Basic measures for moderate PPH (blood 1000 - 2000ml, no clinical shock, blood loss not ongoing): Assess placenta is complete, examine for trauma, rub a contraction, empty bladder, consider Syntometrine or Syntocinon Alert the delivery suite coordinator/midwife-in-charge of the clinical area Bleep the obstetric SHO to assess the woman Bleep the obstetric registrar to review the woman Early Warning Scores will inform the urgency of the situation Full protocol for major PPH – potentially life-threatening (blood loss more than > 2000ml OR clinical shock OR ongoing blood loss): In Community The attending midwife must dial 999 and request the paramedic ambulance for transfer into maternity unit. If the second midwife is not already present, he/she must be summoned urgently. The attending midwife must telephone the Labour Suite Co-ordinator and inform her of the clinical situation and estimated time of arrival. Maternity Unit The attending midwife must request a 2222 ‘major obstetric haemorrhage’, which will alert key Obstetric, anaesthetic/theatre team and midwifery staff, haematology as outlined in Appendix 8. The most senior midwife in the clinical area will delegate a staff member to run samples (Runner) this would normally be a midwife or midwifery assistant. Porters may be able to help in extreme situations. The runner will take samples to the lab and fetch blood products. The automated chute system should not be used in these circumstances Page 8 of 36 Someone to record events (Scribe). This would normally be an attending midwife The Obstetrician leading the management of the haemorrhage or the co-ordinating Midwife will identify a team member to communicate with the laboratories The laboratory staff will be informed that it is a “major obstetric haemorrhage” and they will facilitate appropriate haemoglobin estimation and blood products. In situations where there is ongoing haemorrhage Six units crossmatched Blood (electronic, O-neg, type specific - according to need)are to be requested. Further products as required will be issued after discussion between leading clinician and blood bank. The leading clinician is likely to be most senior anaesthetist. Only one person should communicate with blood bank. Once the woman and the situation are stable the Haematology team should be thanked and “stood down”. - Systematic under estimation of blood loss is a recognized problem. Where possible use visual algorithm to determine degree of blood loss and advise the leader of the resuscitation team (senior obstetrics and anaesthetic staff) (Appendix 2). - Early involvement of appropriate senior staff and laboratory specialists is fundamental to the management of PPH. - The use of the term ‘controlled major obstetric haemorrhage’ or ‘ongoing major obstetric haemorrhage’ may be used to define the urgency for the need of the team. - Communication with the woman and her birthing partner is important and clear information of what is happening should be given, as this is a very frightening event. Also make sure baby is safe 3.2 Resuscitation A primary survey of a collapsed or severely bleeding woman should follow a structured approach of simple ‘ABC’, with resuscitation Page 9 of 36 taking place as problems are identified; that is, a process of simultaneous evaluation and resuscitation. 3.3 Assess airway Assess breathing Evaluate circulation Oxygen by mask at 10–15 litres/minute, regardless of maternal O2 concentration Intravenous access (14/16gauge cannula x 2) Position flat (if postpartum) or 30° tilt if baby in utero . Raising the legs can increase blood flow to the central circulation. There is no advantage to a ‘head down’ position Keep the woman warm using appropriate available measures (patient warming device). Foley catheter to monitor hourly urine output (with urometer). Transfuse blood as soon as possible. Until blood is available, infuse up to 3.5 litres in total of preferably warmed crystalloid including Hartmann’s solution (2 litres) and/or colloid (1–2 litres) as rapidly as required. The best equipment available should be used to achieve rapid warmed infusion of fluids. Fluid therapy and blood product transfusion: In a major obstetric haemorrhage(MOH), when MOH is called, Blood Bank will do the checking and any member of staff can then collect the blood . Individuals collecting the blood only require a hospital swipe card so that they can get into blood bank and a patient identifier eg a sticker with the patient’s name on it. The blood does not need to be prescribed before collection Crystalloid - Up to 2 litres Hartmann’s solution Colloid - Up to 1.5 litres until blood arrives (remember risk of anaphylaxis) Page 10 of 36 Blood - Cross matched - If unavailable give uncrossmatched group specific blood OR give ‘O RhD negative’ blood. - Do not give group O RhD negative blood to patients known to have anti-c antibodies. Fresh frozen - 4 units for every 6 units of red cells plasma - or if prothrombin time/activated partial thromboplastin time > 1.5 x normal (12–15 ml/kg or total 1 litre). Platelets - If platelet count < 50 x 109. Cryoprecipitate - If fibrinogen < 2 g/l. Cell salvage is available on both sites for planned cases. It is usually available at all times on the Queen’s site for emergency cases, and is usually available on the City site, though this would need to be discussed with theatres to ensure a practitioner trained in cell salvage is available. The British Committee for Standards in Haematology (Stainsby et al 2006) summarises the main therapeutic goals of management of massive blood loss is to maintain: ● haemoglobin > 80g/l ● platelet count > 75 x 109/l ● prothrombin < 1.5 x mean control ● activated prothrombin times < 1.5 x mean control ● fibrinogen > 2.0 g/l Page 11 of 36 3.4 Monitoring and Investigation: All women should have observations done every 15 minutes and recorded on Obstetric early warning score chart. Basic measures for MINOR PPH blood loss 500-1000ml, no clinical shock and cessation of bleeding: Consider venepuncture (20ml) for: - group and save - full blood count - coagulation screen and specify fibrinogen - pulse, blood pressure and respiratory rate recording every 15 minutes. Consider Hartmann’s infusion Full protocol for moderate or severe PPH blood loss greater than 1000ml and continuing to bleed OR clinical shock Take 30 mls of blood as these are needed for: - full blood count (one purple top) - coagulation screen and specify including fibrinogen (one blue top; must be filled to level given) - crossmatch at least 4 units (2 pink top) - renal and liver function for baseline (one yellow top). Always send blood samples to the labs by a Runner, rather than the automated chute system Monitor temperature every 15 minutes Continuous pulse, blood pressure recording and respiratory rate (using oximeter, electrocardiogram and automated blood pressure recording) Hourly fluid balance - Including hourly urine output and fluid input (type, volume, and intravenous site) Fundal height and tone Blood loss Medication administered record on prescription chart 3.5 Identification of the cause and arrest of bleeding Causes for primary PPH may be related to one or more of ‘the four Page 12 of 36 Ts’: tone (abnormalities of uterine contraction) tissue (retained placenta and membranes. Ensure that the placenta has been examined and is complete) trauma (of the genital tract) thrombin (abnormalities of coagulation). 3.5.1 Uterine atony (Tone)– first line treatment - rub up contraction - ensure that the bladder is empty - Syntometrine (Syntocinon 5iu/ergometrine 0.5mg) or Syntocinon 5iu if Syntometrine is contra-indicated should be given by slow IV injection or intramuscularly - Syntocinon infusion 40iu in 500mls 0.9% Sodium Chloride to run at 125mls /hr. it is expected that most women with uterine atony will respond to this management. 3.5.2 If first line utero-tonics are not effective consider second line group and perform bimanual compression a. Carboprost 0.25 mg by intramuscular injection repeated at intervals of not less than 15 minutes to a maximum of 8 doses (should be used with caution in women with asthma) (RCOG Clinical Governance Advice Sept 09) b. Misoprostol 600 micrograms rectally (can be used in women with asthma). Repeat dosages should not be given within 2 hours. Shivering fever and diarrhoea are common side effects. Maternal pyrexia is usually self limiting and responds well to paracetamol (if these occur, wait 6 hrs before repeating the dose) (RCOG Clinical Governance Advice Sept 09) 3.5.3 Suspected or actual retained products (Tissue) If there is retained placenta or placental tissue is suspected arrangement should be made for transfer to theatre for evacuation of retained products once the woman is stabilised. 3.5.4 Suspected trauma cause (Trauma) Adequate inspection of the lower genital tract is required to rule out surgical causes; use pressure if necessary to initially stop bleeding, then arrange formal repair. If known bleeding diathesis discuss with haematology. Page 13 of 36 3.5.5 Failure of second line management If pharmacological measures fail to control the haemorrhage, initiate surgical haemostasis sooner rather than later. Consideration should be given to examination in theatre where the uterus appears to be well contracted. Furthermore, evidence of coagulopathy should be sought. Options when second line uterotonics fail assess uterine tone and continue utero-tonics. assess blood loss and its rate re-assess initial diagnosis bimanual compression of the uterus. re-assess level of blood transfusion provision 3.6 Surgical measures to control the bleeding 3.6.1 Uterine tamponade: - Intrauterine balloon using Bakri balloon (Bakri et al 2001) or Rusch catheter (Keriakos et al 2006) is an appropriate ‘surgical’ intervention for most women where uterine atony is the only or main cause of haemorrhage. - The balloon can be filled with warm saline with volume that varies between 400-500mls. However, the use of smaller and bigger volumes have been described (Keriakos et al 2006). - Ultrasound scan may be used to guide the process of insertion. It is advisable to use 50ml syringe for inflation of the balloon. - It is recommended to observe bleeding and fundal height after insertion and oxytocin infusion should be continued for 24 hours. - Consider prophylactic antibiotics: Guideline for Antibiotics in Obstetrics 3.6.2 Uterine haemostatic sutures: - Current evidence from published case series and audits suggest that uterine compression suture can reduce the rate of hysterectomies in women with major primary PPH. - They include B-lynch suture (B-Lynch 1997), modified B-lynch or simple Brace suture (Hayman 2002), and multiple square sutures (Cho 2000). Appendix 4 describes the technique of each one with a Page 14 of 36 simple diagram. It is advisable to use 2 vicryl on a straight or large curved needle. - The choice of technique should be individualised by the consultant obstetrician, but a blunt taper point 70mm monocryl or vicryl is suggested 3.6.3 Internal iliac artery ligation: Current evidence suggests that the success rate of bilateral internal iliac artery ligation to control major primary PPH is under 50% (RCOG Green-top Guideline No. 52). Therefore, available balloon tamponade and haemostatic sutures may be simple and more effective than internal iliac artery ligation. 3.7 Tranexamic acid Tranexamic acid is an anti-fibrinolytic agent and is well established for controlling haemorrhage. 1g can be given intravenously three times each day. Consider early use in appropriate cases. 3.8 Recombinant factor VIIa: - The use of recombinant factor VIIa (rVIIa) should be considered prior to the decision to carry out hysterectomy. The rational behind using rVIIa is summarised in Appendix 5,6,7. It also highlights the exact dose and steps that should be taken before given the drug. - The use of rVIIa may be considered as a treatment for life- threatening post-partum haemorrhage. However, it should not be considered as a substitute for, nor should it delay the performance of a lifesaving procedure such as embolisation or surgery. - If body weight is not known it is advisable to give a dose 7.2 mg where body weight is expected to be less than 90kg and is 9.6mg where body weight over 90kg. 3.9 Failure of the above measures 3.9.1 Selective arterial occlusion or embolisation by interventional radiology: It should be considered if the interventional radiologist is available and the general condition of the patient allows time for insertion (see appendix 1). Page 15 of 36 3.9.2 Hysterectomy - Subtotal hysterectomy may be sufficient in most cases to arrest haemorrhage. - Resort to hysterectomy sooner rather than later especially in cases of placenta accreta. (RCOG Green-top Guideline No. 52) - Where hysterectomy is being considered the on-call consultant gynaecologist should attend. 4. Care following the control of haemorrhage Following massive obstetric haemorrhage women should be cared for in an area equipped to provide Advanced Obstetric Care (AOC). - Documentation should be carried out on an obstetric early warning score chart (OEWS) chart. 1. This should be at 30 minute intervals for the first hour. 2. Then hourly for 4 hours. 3. Then 4 hourly until 24 hours post procedure. - uterine contraction should be maintained by an infusion (40 units of oxytocin in 500ml at 125 ml/hr), keep an eye on uterine tone and vaginal bleeding - hourly fluid balance - repeat blood sampling should be individualized - postnatal transfusion should rarely be considered where the haemoglobin is more than 70g/l - women and their families should be offered an opportunity to discuss events with a senior member of the clinical team before discharge from hospital. -Remove Bakri balloon ,if used, after 24 hours by slow deflation 5. Risk management 5.1 Documentation: Inadequate documentation in obstetrics can lead to potential medico-legal consequences. It is important to document: • the staff in attendance and the time they arrived • the sequence of events • the time of administration of different pharmacological agents given, their timing and sequence • the time of surgical intervention, where relevant Page 16 of 36 • the condition of the mother throughout the different steps • the timing of the fluid and blood products given. • Complete the PPH continuous audit proforma. The proforma must be photocopied and the photocopy placed in the women’s hospital notes. The original must be put with the other completed continuous audit proformas (NB the photocopy is put in the woman’s notes because audit is unable to scan non-original audit forms). • Complete the online incident reporting form for all PPH>1500ml. 5.2 Debriefing: Major obstetric haemorrhage can be traumatic to the woman, her family and the birth attendants. It is therefore recommended that a senior member of the team who was involved at the time of events offers debriefing at the earliest opportunity. This should include arrangements for follow-up and investigations as necessary, such as screening for coagulopathies if there are other indicators and screening for the rare complication of panhypopituitarism (Sheehan syndrome) secondary to hypotension 6. Risk factors for primary postpartum haemorrhage (PPH) Table 1: Risk factors presenting antenatally and associated with an increase in the incidence of PPH: Risk Factor Four ‘T’s Odds ratio for PPH (99%CI) ● Suspected or proven placental abruption Thrombin 13 (7.61–12.9) ● Known placenta praevia Tone 12 (7.17–23) ● Multiple pregnancy Tone 5 (3–6.6) Page 17 of 36 ● Pre-eclampsia/gestational hypertension Thrombin 4 ● Previous PPH Tone 3 ● Asian ethnicity Tone 2 (1.48–2.12) ● Obesity (BMI >35) Tone 2 (1.24–2.17) ● Anaemia(<9g/dl) - 2 (1.63–3.15) Table 2: Risk factors becoming apparent during labour/delivery which should prompt extra vigilance among clinical staff: Risk Factor Four ‘T’s Odds ratio for PPH (99%CI) ● Emergency Caesarean section Trauma 4 (3.28–3.95) ● Elective Caesarean section Trauma 2 (2.18–2.80) ● Induction of labour - 2 (1.67–2.96) ● Retained placenta Tissue 5 (3.36–7.87) ● Mediolateral episiotomy Trauma 5 ● Operative vaginal delivery Trauma 2 (1.56–2.07) Page 18 of 36 ● Prolonged labour (>12 hours) Tone 2 ● Big baby (>4 kg) Tone/Trauma 2 (1.38–2.60) ● Pyrexia in labour Thrombin 2 ● Age (>40)(not multiparity) Tone 1.4 (1.16–1.74) Staff Training Staff will be provided training on post partum haemorrhage in line with the Nottingham University Hospitals Maternity Services Training Needs Analysis (2010). Monitoring Plan The Guideline for The Management of Postpartum Haemorrhage will be monitored in conjunction with the NUH Maternity Services Clinical and Operational Monitoring Plan. References Bakri YN, Amri A, Abdul Jabbar F. Tamponade-balloon for obstetrical bleeding. Int J Gynaecol Obstet 2001;74:139–42. B-Lynch C, Coker A, Lawal AH, Abu J, Cowen MJ. The B-Lynch surgical technique for the control of massive postpartum haemorrhage: an alternative to hysterectomy? Five cases reported. BJOG 1997;104:372–5. Cho JH, Jun HS, Lee CN. Hemostatic suturing technique for uterine bleeding during cesarean delivery. Obstet Gynecol. 2000; 96:129-31. Confidential Enquiry into Maternal and Child Health. Saving Mothers Lives 2003–2005. Seventh Report on Confidential Enquiries into Page 19 of 36 Maternal Deaths in the United Kingdom. London: CEMACH; 2006 [www.cemach.org.uk/getattachment/ 927cf18a-735a-47a0-9200cdea103781c7/Saving-Mothers--Lives2003-2005_full.aspx]. Dubois J, Garel L, Grignon A, Lemay M, Leduc L. Placenta percreta: balloon occlusion and embolization of the internal iliac arteries to reduce intraoperative blood losses. Am J Obstet Gynecol 1997;176:723–6. Hansch E, Chitkara U, McAlpine J, El-Sayed Y, Dake MD, Razavi MK. Pelvic arterial embolization for control of obstetric haemorrhage: a five-year experience. Am J Obstet Gynecol 1999;180:1454–60. Hayman RG, Arulkumaran S, Steer PJ. Uterine compression sutures: surgical management of postpartum hemorrhage. Obstet Gynecol 2002;99:502–6. Joshi VM, Otiv SR, Majumder R, Nikam YA, Shrivastava M. Internal iliac artery ligation for arresting postpartum haemorrhage. BJOG 2007;114:356–61. Keriakos R, Mukhopadhyay A.The use of the Rusch balloon for management of severe postpartum haemorrhage. J Obstet Gynecol 2006;26:335–8. Mitty HA, Sterling KM, Alvarez M, Gendler R. Obstetric haemorrhage: prophylactic and emergency arterial catheterization and embolotherapy.Radiology 1993;188:183–7. Mousa HA, Alfirevic Z. Treatment for primary postpartum haemorrhage. Cochrane Database Syst Rev 2007;(1): CD003249. Royal College of Obstetricians and Gynaecologists Green-top Guideline No. 52. Prevention and management of postpartum haemorrhage. Royal College of Obstetricians and Gynaecologists Clinical Governance Advice Sept 09: Improving Patient Safety – Risk Management for Maternity and Gynaecology Page 20 of 36 Stainsby D, MacLennan S, Thomas D, Isaac J, Hamilton PJ. Guidelines on the management of massive blood loss. Br J Haematol 2006;135:634–41. You WB, Zahn CM. Postpartum haemorrhage: abnormally adherent placenta, uterine inversion, and puerperal haematomas. Clin Obstet Gynecol 2006;49:184–97. Page 21 of 36 APPENDIX 1 INTERVENTIONAL RADIOLOGY Vascular Interventional Guidelines for Post Partum Haemorrhage There are two patient groups who may benefit from Vascular Interventional Radiology support in management of major obstetric haemorrhage. 1) Predicted high risk patients 2) Unpredicted post partum haemorrhage Contact: There are currently 5 vascular interventional radiologists who can provide vascular obstetric services. Drs O’Neill, Whitaker, Ramjas, Habib and Travis. There is a daytime (0800-1800 Monday to Friday) duty consultant at QMC who can be contacted via the secretaries (Exts 70487 and 70488), or via the angiography suite (Ext 67142). There is an interventional radiology on call service across the trust. Referral to this service must be made at Consultant to Consultant level. 1) Predicted high risk patients These to include: a) Previous major obstetric haemorrhage b) Previous placenta accreta or percreta c) US or MRI evidence of current accreta or percreta d) Uterine vascular malformation For identified high risk patients placement of internal iliac balloons / catheters should be considered. This is to facilitate balloon occlusion of the anterior division of the internal iliac artery following delivery Page 22 of 36 with the option to embolise the anterior division of the internal iliac artery. There is currently little evidence in the published literature for this excepting short case series. These series present conflicting views. Whilst the inflation of balloons may not significantly alter the course of haemorrhage the ability to embolise via those balloons is probably of benefit. As soon as a high risk patient is identified the consultant obstetrician should contact a consultant interventional radiologist (as listed above) to discuss if intervention is appropriate. If intervention is agreed upon a date for elective caesarean should be decided with booking of the angiographic suite and C-arm theatre fluoroscopy for 0900 hours. Technique Pre procedure: Informed consent should be obtained by a consultant radiologist prior to the procedure. In addition to preparation on the ward the patient should have a urinary catheter and epidural catheter (if required) placed prior to attendance in the angiographic suite. Procedure in Angiographic Suite: Midwifery and anaesthetic staff should be in attendance. Bilateral common femoral artery 6 french sheaths connected to pressure bags. Placement of crossing, bilateral Co-rail conformable balloons, or alternate, within the anterior division of the internal iliac arteries. If the anterior division cannot be successfully cannulated then the main internal iliac trunk can be used. Wires should be left in the balloon shafts to avoid kinking. Pressure bags to be connected to the lumens. Test inflations should be undertaken to establish volume required to occlude. 1ml medallion syringes to be connected via flow switches to balloons. All sheaths and catheters should be fixed in place and patient to be transferred to obstetric theatre. Page 23 of 36 Procedure in Obstetric Theatre: Initial check of catheter position with portable C-arm. Subsequent to delivery and clamping of cord balloons to be inflated blind and time recorded. If blood loss >3000ml or at request of consultant obstetrician blind embolisation with gelfoam slurry should be considered. When surgical intervention has finished discussion as to whether to remove arterial access should be undertaken. Ideally a closure device such as angioseal should be used. If there is continued haemorrhage transfer to the angiographic suite should be considered for targeted embolisation if surgical methods of control have failed. 2) Unpredicted post partum haemorrhage If interventional radiology is considered for post partum haemorrhage uncontrolled by medical and surgical manoeuvres then the current lack of an on-call rota should not deter a consultant interventional radiologist from being contacted. It would reasonable to ask for attendance to enable discussion as to the merits of embolisation. Undertaking embolisation in obstetric theatre would be exceptionally challenging with portable equipment and thus those patients most likely to benefit from embolisation are those who can be stabilised and transferred to the angiographic suite. It takes approximately 30 minutes to have the angiographic suite staffed and ready for a patient to undergo embolisation. Decisions should be taken between all consultant staff present as to the most appropriate management pathway. The method of embolisation will depend on the findings at angiography and the interventional radiology consultant will decided on the method used. Patients transferred to the angiographic suite will need to be accompanied by anaesthetic and obstetric staff. If embolisation is initially successful further embolisation can be considered if re-bleeding occurs. Page 24 of 36 Appendix 2 Page 27 of 40 Summary Appendix 3. A flow chart of the different steps for the management of major postpartum haemorrhage. Resuscitation, monitoring, investigation and treatment should occur simultaneously. Call for help If at home dial 999 request paramedic ambulance,(midwife must escort women in ambulance) Senior midwife/Obs & Anaes Initiate the Major Obstetric Haemorrhage protocol(dial 2222) Alert Consultant Obstetrician on call Resuscitation Airway Breathing Circulation Oxygen mask (15L) Fluid balance (2L Hartmann's, 1.5L colloid) Blood transfusion (ORhD neg or group specific blood) Blood products (FFP, PLT, cryoprecipitate) Keep patient warm Monitoring and investigations Medical treatment - 14/16g cannulae x2 - FBC, coagulation including fibrinogen, U&Es, LFTs - X-Match (4U, FFP, PLT, cryoprecipitate) - ECG, oximeter - O2 mask - Foley catheter - Blood products - Commence record chart - Weigh all swabs and estimate blood loss - Rub A contraction - Empty bladder - Oxytocin 5iu x2 (slow IV) - Ergometrine 500 μg (slow IV) - Oxytocin infusion (40 u in 500ml) If bleeding persist - Carboprost 250 μg IM every 15mns up to 8 times (contraindicated in asthmatics) - Misoprostol 600 μg rectally (can be used in asthmatics) -Bimanual uterine compression Theatre - Is the uterus contracted? - Examination under anaesthetic - Has any clotting abnormality been corrected? - Bimanual compression. - Intrauterine balloon tamponade. - Laparotomy bimanual compression. - Haemostatic uterine sutures. - Bilateral internal iliac artery ligation. - Recombinant factor VIIa - Consider HDU (high dependency ITU. Page 30 of 40 - Hysterectomy (gynae consultant) - Uterine Artery embolosation unit). Or Appendix 4 Page 31 of 40 Appendix 5 Guideline for use of Recombinant Coagulation Factor VIIa (NovoSeven ®) in uncontrolled haemorrhage It is recommended that blood product replacement and use of rVIIa is discussed with the on-call haematologist. Massive uncontrolled haemorrhage defined as: 1.Consider after 6 units of blood have been given 2. Definite after 8 units of blood have been No rVIIa not indicated Yes All accepted and available surgical measures to control bleeding attempted, or surgical measures impossible/inappropriate. No rVIIa not indicated unless/until surgical control attempted. Yes Appropriate haemostatic replacement therapy given? 1. FFP 10-15ml/kg (2 standard units for adults). Aim for PT and APTT < 1.5x control 2. Cryoprecipitate 1-1.5 packs / 10kg. Aim for fibrinogen > 0.5g/L, ideally >1g/L 3. Platelets 1-2 adult doses. Aim for platelet 9 count > 50 x 10 / L 4. Tranexamic acid 1g 3 times a day by slow IV injection (adult dose) Haemostatic replacement therapy should be given and situation reassessed. There may be a role for unlicensed use of QuickClot® No Yes pH 7.2 Fibrinogen > 0.5g/L (ideally > 1g/L) Platelets 9 > 50 x 10 / L . Aim Core Temperature > 35 oC No Correct pH and give appropriate haemostatic replacement therapy Reassess bleeding and need for rVIIa. Yes Consultant responsible for patient authorises uses of rVIIa. If use of rVIIa is approved: 1. Telephone request to Blood Bank 2. Give patient details, weight and name of authorising consultant and fill in Blood Bank request form. 3. rVIIa should be collected from Blood Bank (will only be issued following receipt of appropriately completed request form.) Dose by IV bolus < 55kg = 5mg (1x 5mg vial) 55 - 75kg = 7mg (1x 2mg vial + 1x 5mg vial) 76 – 100kg = 9mg (1x 5 mg + 2 x 2mg vials) 101 -120kg = 11mg (2x 5mg vials + 1x 1mg vial) >120kg = 11mg (2x 5mg vials + 1x 1mg vial) ( >120kg dose based on lean body mass) Reassess bleeding after 20 min. Check coagulation screen and fibrinogen. If bleeding uncontrolled, it is recommended that repeat doses are discussed with on-call haematologist. Page 29 of Recent 35 caution: thrombosis or high risk (eg PE, MI, thrombotic stroke in last 6months; prosthetic heart valve Appendix 6 Page 33 of 40 Appendix 7 Background and rationale for the guideline for rVIIa Recombinant activated factor VIIa (rFVIIa) is licensed for the treatment of haemophilia with inhibitors, FVII deficiency and Glanzmann’s thrombasthenia with platelet refractoriness. It’s off label use as a haemostatic agent in massive uncontrolled bleeding in a wide range of clinical scenarios is rapidly expanding, but no evidence-based guidelines are available. Uncontrolled massive bleeding after trauma or complicated surgical procedures is frequently a combination of surgical and coagulopathic bleeding. Treatment of coagulopathic bleeding centres on replacement therapy with appropriate blood products, but may be unsuccessful in some cases of massive blood loss, predicting a poor outcome. Mechanism of action of rVIIa rVIIa is identical to the human plasma protein with only minor difference in post-translational carboxylation, hydroxylation and glycosylation. Its half-life is short: 2-3 hours in haemophiliacs with inhibitors, and less in children and bleeding individuals. Coagulation models suggest that rVIIa enhances haemostasis at the site of injury without a systemic hypercoagulable effect. This is thought to explain the good safety profile of rVIIa with respect to thrombosis. Its haemostatic effects are mediated by the thrombin it generates by both tissue factor (TF) dependent and independent mechanisms. The TF independent mechanism requires platelets for the direct activation of Factor X on their surface by rVIIa. It is likely that in the presence of TF, the more efficient TF-dependent mechanism predominates. It is probable that the action of rVIIa requires the presence of adequate substrate for the reactions involved in securing adequate haemostasis. The minimum levels of other coagulation factors required are not known, but some authors have suggested minimum levels of fibrinogen required for an adequate response. Although there are case reports of the successful use of rVIIa in severe thrombocytopenia, the only randomised controlled trial in thrombocytopenic individuals suggested that a low platelet count is likely to predict a poor response to rVIIa therapy. Page 36 of 40 Both clinical and experimental data suggest that acidosis inhibits response to rVIIa treatment. Significant acidosis is very likely in severely ill bleeding patients, and may predict a poor response to rVIIa. There is currently no evidence that correction of acidosis prior to treatment improves the response to rVIIa. Clinical studies of rVIIa treatment Currently there is little evidence that the use of rVIIa in uncontrolled haemorrhage as a result of trauma or surgery reduces mortality. The limited randomised controlled trial data available showed a reduction in the transfusion of red blood cell units was observed with rV11a (estimated reduction of 2.0 RBC units per patient treated, p=0.07). The need for transfusions of 20 units of RBC was significantly reduced (14% vs. 33% of patients, p=0.03). There was also a nonsignificant reduction in mortality and trend toward fewer critical complications. Preliminary data suggests that relative to placebo rV11a may be a cost effective therapy. Clinical decision making in these situations remains very difficult and should involve senior medical staff. References: Boffard KD et al. Recombinant factor V11a as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomised placebo-controlled double-blind clinical trials. J Trauma 2005; 59: 8-18 Spahn D et al. Management of bleeding following major trauma: a European guidance. Critical Care 2007; 11: R17 Vincent JL. Recommendations on the use of recombinant activated factor V11 as an adjunctive treatment for massive bleeding- a European perspective. Critical Care 2006; 10: R120 Page 36 of 40 Appendix 8 - Communication Maternity Unit Communication in a Major Obstetric Haemorrhage – day time “major obstetric haemorrhage” “ attending midwife or theatre staff to ask for 2222 obstetric haemorrhage state delivery suite room number or obstetric theatre or ward this calls obstetric consultant obstetric registrar obstetric SHO on-call obstetric anaesthetist Labour Suite Co-ordinator Haematology/blood bank } } to attend } the patient } immediately } } and the delivery suite co-ordinator who will identify a person to liaise with haematology and blood bank. Once the situation and the woman are stable thank and “stand down” the haematology service Page 36 of 40 Maternity Unit Communication in a Major Obstetric Haemorrhage – night time “major obstetric haemorrhage” “ attending midwife or theatre staff to ask for 2222 obstetric haemorrhage state delivery suite room number or obstetric theatre or ward this calls obstetric registrar obstetric SHO on-call obstetric } } to attend the } patient anaesthetist } immediately Labour Suite Co-ordinator } and the delivery suite co-ordinator who will identify a person to liaise with Haematology/blood bank Once the situation and the woman are stable thank and “stand down” the haematology Page 37 of 40 Community Communication in a Major Obstetric Haemorrhage Call 999 paramedic ambulance Contact labour suite at the appropriate maternity unit QMC: 8754672 City: 9627710 Inform on call Supervisor of Midwives following transfer in Page 38 of 40 Appendix 10 6. Risk factors for primary postpartum haemorrhage (PPH) Table 1: Risk factors presenting antenatally and associated with an increase in the incidence of PPH: Risk Factor Four ‘T’s Odds ratio for PPH (99%CI) ● Suspected or proven placental abruption Thrombin 13 (7.61–12.9) ● Known placenta praevia Tone 12 (7.17–23) ● Multiple pregnancy Tone 5 (3–6.6) ● Pre-eclampsia/gestational hypertension Thrombin 4 ● Previous PPH Tone 3 ● Asian ethnicity Tone 2 (1.48–2.12) ● Obesity (BMI >35) Tone 2 (1.24–2.17) ● Anaemia(<9g/dl) - 2 (1.63–3.15) Page 39 of 40 Table 2: Risk factors becoming apparent during labour/delivery which should prompt extra vigilance among clinical staff: Risk Factor Four ‘T’s Odds ratio for PPH (99%CI) ● Emergency Caesarean section Trauma 4 (3.28–3.95) ● Elective Caesarean section Trauma 2 (2.18–2.80) ● Induction of labour - 2 (1.67–2.96) ● Retained placenta Tissue 5 (3.36–7.87) ● Mediolateral episiotomy Trauma 5 ● Operative vaginal delivery Trauma 2 (1.56–2.07) ● Prolonged labour (>12 hours) Tone 2 ● Big baby (>4 kg) Tone/Trauma 2 (1.38–2.60) ● Pyrexia in labour Thrombin 2 ● Age (>40)(not multiparity) Tone 1.4 (1.16–1.74) Page 40 of 40
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