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Medical

1. Recent Developments in the Management of PPH Hadiza Galadanci (MBBS, MSc, DLST&H, FWACS, FRCOG) Professor of Obstetrics and Gynaecology Aminu Kano Teaching Hospital Director Africa Center Of Excellence For Population Health And Policy, Bayero University Kano WACS UPDATE COURSE 2024

2. Outline Introduction the scale of the problem of PPH Why PPH continues to be a problem Causes of PPH/Risks of PPH Explain the concept of EMOTIVE Bundle Communication amongst providers Respectful maternity Care Brief on the result of EMOTIVE Trial Conclusion WACS UPDATE COURSE 2024

3. Postpartum haemorrhage (PPH) is the leading cause of maternal death worldwide. Postpartum haemorrhage (PPH) is commonly defined as a blood loss of 500 ml or more within 24 hours after birth. Globally, nearly one quarter of all maternal deaths are associated with PPH. In most low-income countries, it is the main cause of maternal mortality. 1. The global burden of postpartum haemorrhage 99% of all maternal deaths occur in low- and middle-income countries (LMICs). section 01

4. Scale of the problem Why aren’t things getting better? Women with PPH (vaginal birth) = 14,941,643 Women with PPH (caesarean section) = 8,798,467 Women dying from PPH/ year = 74,511 Women with PPHs = 23,740,110 WHY?

5. Why PPH continues to be problem? (at the facility level) Missed or delayed diagnosis of PPH Challenge Missed or delayed treatment of PPH Challenge Missed or delayed escalation of refractory PPH Challenge 01 02 03 WHY?

6. Missed diagnosis: Visual estimation Visual estimation = blind estimation Blood loss assessment experiment WHY?

7. Treatment of PPH; evidence from the multi-country WHO CHAMPION trial Missed diagnosis: WHO Champion data 50% 100% Women treated with uterotonics 0/99 100/199 200/299 300/399 400/499 500/599 600/699 700/799 800/899 900/999 1000/1099 1100/1199 1200/1299 1300/1399 1400/1499 1500/1599 1600/1699 1700/1799 1800/1899 1900/1999 >=2000 Blood loss increments (100ml) 95% confidence intervals Only 26% of women with PPH received a treatment uterotonic drug Even with severe PPH>1000ml 30% of women did not receive a treatment uterotonic drug Women with missed PPH (1252/2670, 46.9%) WHY?

8. How can we improve diagnosis? Non-calibrated blood collectors Kelly’s pad with basin Standardised cloth mat icddr,b Q-Mat WHY?

9. How can we improve diagnosis? Non-calibrated blood collectors Kelly’s pad with basin Standardised cloth mat icddr,b Q-Mat Calibrated drape WHY?

10. Missed or delayed treatment Usual care: sequential treatment WHO ‘MOTIVE’ bundle Massage Oxytocic drugs Tranexamic acid Other Treatment WHY?

11. Causes of PPH Most common causes for PPH: Remember the 4Ts 1 1. Mavrides et al. Prevention and management of postpartum haemorrhage. BJOG Int J Obstet Gynaecol . 2016;124:e106–ee49 Uterine atony 70% Genital tract trauma 20% Retained placenta 10% Maternal bleeding disorders 1% TONE TRAUMA TISSUE THROMBIN T T T T WACS UPDATE COURSE 2024

12. Risk factors for PPH Although the majority of women with PPH have no identifiable risk factor, some conditions are associated with an increased risk of bleeding after birth. Grand multiparity Prolonged labour Prior history of PPH Prolonged administration of oxytocin , leading to desensitization   of oxytocin receptors ( OTRs ) Administration of drugs such as halogenated anaesthetic agents, nitrates, nonsteroidal anti- inflammatory drugs ,  magnesium sulphate , beta- sympathomimetics , and nifedipine Uterine distention (e.g. multiple gestation ) Obesity Coagulation disorders Preeclampsia Caesarean childbirth , especially after prolonged labour Antepartum haemorrhage Furthermore, anaemia is a common aggravating factor WACS UPDATE COURSE 2024

13. The E-MOTIVE intervention Current practice E-MOTIVE bundle Early and accurate diagnosis Bundled treatment Rapid escalation E E MOTIV PPH diagnosis Escalation Refractory treatment First response treatment WHY?

14. IMPORTANT MESSAGE EMOTIVE is not bringing in any new PPH intervention ALL EMOTIVE interventions are already proven intervention EMOTIVE is only bringing in new APPROACH to how we detect and Manage women with PPH WACS UPDATE COURSE 2024

15. What is a bundle A clinical Bundle is a set of interventions that when performed as soon as a specific condition is identified, has been proven to improve patient outcome All components of a bundle are given in the shortest possible time, without waiting for a response to individual interventions WACS UPDATE COURSE 2024

16. 1a E-MOTIVE within 15 minutes E arly detection MOTIVE WACS UPDATE COURSE 2024

17. 6a E arly detection of PPH What we do now 1. Visual estimation of blood loss 2. Observations recorded in case records once postpartum 3. Clinical judgement to diagnose PPH *What is new* 1. Calibrated drape to collect and assess blood loss 2. Observations recorded in blood loss monitoring chart every 15 minutes (pulse and BP only once if normal) ACT QUICKLY WACS UPDATE COURSE 2024

18. When do you Trigger the EMOTIVE Bundle Clinical judgement to diagnose PPH 500mls blood loss on drape 300mls + any abnormal observation WACS UPDATE COURSE 2024

19. How do you provide EMOTIVE Bundle All interventions in the bundle will be given in the shortest possible time 15minutes Give ALL the bundle interventions regardless of any improvement after any of the intervention. If you are alone, you will have to do all the interventions by yourself as quickly as possible If you have help. Assign staff to each intervention and make sure all interventions have been done WACS UPDATE COURSE 2024

20. Sequential Approach More time may be lost More lives may be lost Some treatments not done Bleeding may appear to subside externally but often the women may continue to bleed in the uterus WACS UPDATE COURSE 2024

21. 6a M assage the uterus What we do now Massage the uterus is not well defined and practice is variable *What is new* 1. Massage the uterus until contracted and if after 1 minute the uterus remains soft, quickly move to giving a uterotonic 2. If contracted, check the tone every 15 minutes WACS UPDATE COURSE 2024

22. M assage Provide other interventions Uterine massage may hurt, Tell the woman why you are doing it Teach the woman how to check the uterus and massage Teach her also to call the provider if the uterus is soft or they feel their bleeding has increased or they are not feeling well WACS UPDATE COURSE 2024

23. 6a Give O xytocic drugs What we do now 1. Oxytocin is given (10-40 IU) in 500-1000ml over a few minutes or hours 2. Maintenance not always given 3. Misoprostol 600-1000mcg PR often given *What is new* 1. Oxytocin 10 IU in 500ml given over 10 minutes 2. Oxytocin 20 IU in 1000ml given over 4 hours for maintenance 3. Misoprostol 800mcg PR/SL can be given at the same time WACS UPDATE COURSE 2024

24. The majority of deaths from PPH due to uterine atony could be prevented Say L, et al. Lancet Global Health 2014;2:323–333. World Health Organization. WHO recommendations for the prevention and treatment of postpartum haemorrhage . Published 2018. Available at https:// apps.who.int /iris/bitstream/handle/10665/277276/9789241550420-eng.pdf?ua=1&ua=1 (Last accessed: January 2021). Oxytocin, the current standard of care uterotonic, requires sustained cold-chain transport and storage at 2–8°C, typically in a refrigerator, to maintain its effectiveness 1,2 This poses a challenge in many LMICs , where access to sustained cold-chain storage is not readily available 1 WACS UPDATE COURSE 2024

25. 2. Interventions to reduce the burden of postpartum haemorrhage section 02 In 2016, the World Health Assembly and the United Nations Secretary-General updated the Every Woman, Every Child global strategy for ending all preventable deaths of women. As part of this programme, the UN Commission on Life-Saving Commodities for Women and Children was set up to increase availability, expand access and improve utilisation of 13 life-saving commodities. Two of them were oxytocin and misoprostol for prevention and treatment of PPH.

26. Give T ranexamic Acid (TXA) 1g IV over 10 minutes What we do now 1. Tranexamic acid is not given or given if oxytocin +/- misoprostol fail to stop the bleeding 2. Doctor’s prescription often required before administered *What is new* 1. Tranexamic acid 1g IV over 10 minutes is given for all women with PPH irrespective of the cause at the same time with oxytocin 2. Clinical protocol signed in all hospitals to allow midwives to administer TXA without a doctors prescription for the management of PPH WACS UPDATE COURSE 2024

27. T ranexamic acid TXA should be used in all cases of PPH if birth was less than 3 hours ago, regardless of the cause of bleeding TXA should not be used in women with contraindication to antifibrinolytic drugs, renal failure, history of convulsions or hypersensitivity to TXA Adverse effects are rare TXA is safe in women who plan to breastfeed WACS UPDATE COURSE 2024

28. Start an IV What we do now 1. IV fluid administration varies widely for the management of PPH *What is new* 1. 500ml of crystalloid is given together with oxytocin over 10 minutes to all women with PPH 2. Further 1lt of crystalloid is given with the 20 IU of oxytocin for maintenance over 4 hours 3. Additional crystalloid to be given only if required for fluid resuscitation and may require a 2 nd cannula 13a WACS UPDATE COURSE 2024

29. E xamine: Check the bladder, perineum and placenta What we do now 1. Examination is very variable and sometimes is only visual inspection with more detailed examination taking place if bleeding does not stop *What is new* 1. Check and empty the bladder for all women with PPH 2. Evacuate clots and check for tears with an internal examination for all women with PPH 3. Check the placenta for completeness for all women with PPH WACS UPDATE COURSE 2024

30. Still bleeding and Cause(s) clear and able to manage Uterine atony Retained placenta or fragments Lacerations Coagulopathy 22a WACS UPDATE COURSE 2024

31. 23a Still bleeding - Causes(s) unclear and/or unable to manage OR Still bleeding after management → Escalate WACS UPDATE COURSE 2024

32. 24a WACS UPDATE COURSE 2024

33. Implementation strategy Trolley and/or carry case Training Champions Audit and feedback WHY?

34. Communication Effective communication is extremely important in emergencies such as PPH Communicate clearly with your assistances Communicate respectfully with other providers Good communication helps build and maintain good relationships and trust Situation-Background-Assessment-Recommendation (SBAR) technique WACS UPDATE COURSE 2024

35. Poor communication Patient safety at risk Critical information may not be shared Information may not be understood Orders may be unclear Right care may not be given Changes in status may be missed WACS UPDATE COURSE 2024

36. Providing respectful Care Every woman deserves respectful maternity care (RMC) RMC saves lives Also women have a right to privacy and confidentiality Be honest Respect her views A;ways obtain informed consent Give appropriate information Use simple and clear language WACS UPDATE COURSE 2024

37. Nigeria: 38 Kenya: 14 Tanzania: 14 South Africa: 14 80 hospitals (clusters) Cluster (unit of randomization) Hospitals (1,000-5,000 births a year and can provide comprehensive obstetric care with ability to perform surgery for PPH) Women (unit of analysis) Population: Countries, sites, HCPs, Women All women giving vaginal birth in the study facilities HOW?

38. Characteristics E-MOTIVE (N = 49,101, Clusters = 39) * Usual Care (N = 50,558, Clusters = 39) * Hospital Number of vaginal births per hospital, median [IQR] 1,136 [775 to 1,881] 1,263 [787 to 1,854] Availability of bundle components, median [IQR] Oxytocin, TXA and IV fluids   100 [100 to 100]    100 [100 to 100] Age (years), median [IQR] 26 [21, 31] 26 [21, 30] Previous births 1-4 5 or greater   17,719 (37.2) 25,447 (51.9) 4,379 (9.2)   17,642 (36.6) 25,805 (51.0) 4,781 (9.9) Previous caesarean section 1456/48,911 (3.0%) 1281/50,364 (2.5%) Postpartum haemorrhage in previous pregnancy 487/47,869 (1.0%) 405/48,925 (0.8%) Multiple pregnancy 804 (1.6) 960 (1.9) Instrumental birth 358 (0.7) 278 (0.5) Birthweight (g), mean (SD) 3,033 (559) 3,044 (552) Gestational age (weeks), median [IQR] 39 [37, 40] 38 [37, 39] Gestational age <37 weeks 6,877 (15.5) 8,565 (17.5) Antepartum haemorrhage 372 (0.8) 275 (0.6) Preeclampsia 1,038 (2.2) 1,182 (2.4) Labour augmented or induced 6,811 (13.9) 9,323 (18.4) Retained placenta or manual removal of placenta 566 (1.2) 1,072 (2.1) Results: Hospital and clinical characteristics WHAT?

39. Results: Primary outcome Outcomes E-MOTIVE (N = 49,101, Clusters = 39) Usual Care (N = 50,558, Clusters = 39) Risk Ratio (95% CI) P value Risk Difference (95% CI) P value Primary outcome Composite of severe postpartum haemorrhage (blood loss ≥ 1000 ml); laparotomy for bleeding; and maternal mortality from bleeding 794 /48,678 ( 1.6 ) 2,139 /50,044 ( 4.3 ) 0.40 (0.32 to 0.50) <0.001 -2.53 (-3.04 to-2.02) <0.001 WHAT? 60% reduction

40. Results: Primary outcome over time Primary outcome rate (%) Month Baseline Transition Post-randomization Randomization WHAT?

41. Results: Key implementation outcomes PPH detection and bundle compliance Outcomes E-MOTIVE (N = 49,101, Clusters = 39) Usual Care (N = 50,558, Clusters = 39) Risk Ratio (95% CI) Risk Difference (95% CI) Key Implementation Outcomes Postpartum haemorrhage detection 3,870/4,158 ( 93.1 ) 4,244/8,299 ( 51.1 ) 1.58 (1.41 to 1.76) 33.3 (26.9 to 39.8) Compliance with MOTIVE bundle 3,791/4,158 ( 91.2 ) 1,623/8,351 ( 19.4 ) 4.94 (3.88 to 6.28) 70.2 (64.6 to 75.7) WHAT?

42. Results: Secondary outcomes Outcomes E-MOTIVE (N = 49,101, Clusters = 39) Usual Care (N = 50,558, Clusters = 39) Risk Ratio (95% CI) Risk Difference (95% CI) Secondary Outcomes Postpartum haemorrhage (blood loss ≥ 500 ml) 4,158/48,678 (8.5) 8,351/50,043 (16.7) 0.51 (0.44 to 0.60) -8.15 (-9.74 to-6.56) Severe postpartum haemorrhage (blood loss ≥ 1000 ml) 786/48,678 (1.6) 2,129/50,043 (4.3) 0.39 (0.31 to 0.49) -2.57 (-3.09 to-2.05) Maternal mortality from bleeding 12/49,101 (0.02) 18/50,558 (0.04) 0.80 (0.38 to 1.68) -0.01 (-0.03 to 0.02) All cause maternal mortality 17/49,101 (0.03) 28/50,558 (0.06) 0.73 (0.40 to 1.31) -0.02 (-0.04 to 0.01) Blood transfusion 1,074/49,101 (2.2) 1,296/50,558 (2.6) 0.87 (0.69 to 1.10) -0.36 (-0.93 to 0.21) Blood transfusion for bleeding 580/49,101 (1.2) 944/50,558 (1.9) 0.71 (0.55 to 0.90) -0.57 (-0.95 to-0.19) Blood loss up to 2 hours postpartum as a continuous variable (mL) 160 [100 to 280] 220 [120 to 380]   WHAT?

43. WACS UPDATE COURSE 2024

44. Conclusion Early Detection and Treatment of Postpartum Hemorrhage Using the WHO MOTIVE “First Response” Bundle is the answer to reducing the thousands of women that die from excessive bleeding WACS UPDATE COURSE 2024

45. Thank you WACS UPDATE COURSE 2024