FIGO recommendations on the management of postpartum hemorrhage 2022

The purpose of this document is to update key concepts in the management of postpartum hemorrhage (PPH) and give clear and precise tools to health personnel in low- and middle-income countries (LMICs) to perform evidence-based treatments, with the aim of reducing related maternal morbidity and mortality. Gynecologists, obstetricians, midwives, nurses, general practitioners, and other health personnel in charge of the care of pregnant women with PPH. The recommendations were developed as a synthesis and update of evidence from the literature. They are based on the FIGO Safe Motherhood and Newborn Health Committee (SMNH) guidelines that were published in 20121 and include research and consensus guidelines. For the present document, a bibliographic review was performed, and studies from LMICs and across regions were identified using the search engines PubMed, Medline, Embase, Science Direct, and Google Scholar. According to the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach, this update does not generate a universal level of evidence. However, each section and the generated conclusions and recommendations use the degrees of evidence that were identified in the bibliographic review. Conceptualization: MFE, AN, GT, EB, WN, DR, IL. Manuscript writing: MFE, AN, GT, TB, EB, WN, DR, IL, EC, SM, RB, GO, JC, IR, MAI, SL, DN. Review and approval of manuscript: MFE, AN, GT, EB, WN, DR. GT reports a research grant from the South African Medical Research Council to fund Sinapi Biomedical to develop the Ellavi UBT and conduct associated research. EB reports part ownership of BioIncept. EC was a member of the Guideline Development Group for the RCOG's PPH Greentop Guideline (2016), and the FIGO Guideline on Placenta Acreta Spectrum (2018). SM reports that Regents, University of California receives a royalty fee from LifeWrap-NASG for the use of the trademark name ("LifeWrap") for a Non-pneumatic Anti-Shock Garment (NASG). TB reports PPH research funded by the Gates Foundation; PPH Implementation efforts funded by RzHC; PPH Implementation efforts funded by UK AID; PPH Implementation efforts funded by Grand Challenges Canada; PPH efforts and research funded by USAID; PPH efforts by Norway Government. Other authors report no conflicts of interest. These FIGO recommendations are not intended to be a sole source of guidance or prescriptive protocol in managing PPH. They are designed to assist stakeholders by providing an evidence-based framework for decision-making in a PPH setting. The clinical judgment of the doctor or other practitioner, in the context of the clinical presentation of the patient and the available resources for diagnosis and treatment, should always inform the choice of clinical procedure and treatment plan. 6.1. Guidelines that address the prevention of postpartum hemorrhage 6.2 Guidelines that address the treatment of postpartum hemorrhage FIGO (International Federation of Gynecology and Obstetrics) is actively contributing to the global effort to reduce maternal death and disability around the world. Its mission statement reflects a commitment to promoting health, human rights, and well-being of all women, especially those at the most significant risk of death and disability associated with childbearing. FIGO provides evidence-based interventions that can reduce the incidence of maternal morbidity and mortality when applied with informed consent. Postpartum hemorrhage (PPH) continues to be the leading cause of maternal morbidity and mortality in most countries around the world. Despite multiple collaborative efforts at all levels, there is still a lack of implementation or adherence to the recommendations for management of PPH when faced with this obstetric emergency. In part, this delay in implementation lies in the lack of information from current evidence and a lack of unification of the multiple guidelines for diagnosis and strategies to control bleeding. To provide clear and practical tools to approach this obstetric emergency, especially for low- and middle-income countries (LMICs), the FIGO Safe Motherhood and Newborn Health Committee (SMNH), supported by a group of experts worldwide, developed this updated review. It aims to provide multiple alternatives for the diagnosis and management of PPH tailored to the resources available at the institutional, local, or regional level. This document reflects the best available evidence, drawn from scientific literature and expert opinion, on the prevention and treatment of PPH in low-resource settings. FIGO believes that the greatest impediment in the adoption of a given strategy is the absence of an effective implementation tool. Health workers at all levels of care (particularly in LMICs) need to have access to appropriate medications1 and training in PPH prevention and management procedures. All attempts should be made to reduce PPH using cost-effective, resource-appropriate interventions. At first, all should be done to avoid PPH and reduce the need for expensive, lifesaving surgical interventions. The routine use of active management of the third stage of labor by all attendants, regardless of where they practice, should be recommended.2 All birth attendants must know how to provide safe care (physiologic management) to prevent PPH in the absence of uterotonic drugs.3 Postpartum hemorrhage (PPH) is an obstetric emergency complicating 1%–10% of all deliveries.1 It continues to be the leading obstetric cause of maternal death.1 In 2015, it was reported to be responsible for more than 80 000 maternal deaths worldwide.1 Its distribution varies across regions, with the highest prevalence of 5.1%–25.7% reported in Africa, followed by North America at 4.3%–13% and Asia at 1.9%–8%.2 The incidence of PPH has also been on the rise,2-5 increasing from 5.1%–6.2% in Canada between 2003 and 2010,3 and from 2.9%–3.2% in the USA between 2010 and 2014.4 FIGO has made several recommendations in the past 20 years for the management and treatment of PPH (Table 1). This document will update the recommendations and discuss new approaches. The lack of consistency in the definition of PPH has been a major limitation to the ability to compare prevalence in different studies (Table 2). Classically, it was defined as quantified bleeding of more than 500 ml for vaginal deliveries and more than 1000 ml for cesarean deliveries, occurring within the first 24 h of delivery.1 However, this definition did not focus on clinical signs and symptoms of hemorrhage, and thus prevented early detection in many cases. Therefore, in 2017, the American College of Obstetricians and Gynecologists (ACOG) changed the definition to blood loss of more than or equal to 1000 ml, or blood loss that was accompanied by signs or symptoms of hypovolemia occurring within 24 h after birth, regardless of the mode of delivery.6 In contrast, the Royal College of Obstetricians and Gynaecologists (RCOG) defines PPH according to the volume of blood lost: minor (between 500 and 1000 ml) and major (>1000 ml).7 However, the volume of estimated blood loss remains unreliable in many cases, and therefore much attention should be directed to the general clinical status of the patient instead.8 Several tools for assessment of blood loss have been used as accurate estimation will directly influence the diagnosis and management of PPH. Many groups cite visual estimation as part of blood loss assessment, but as it has high potential to underestimate hemorrhage, use of additional tools for more objective estimation, such as gravimetric measurement, direct blood collection techniques, and evaluation of clinical parameters, have been proposed.9-17 Recently, some guidelines have incorporated the shock index9, 11, 14, 17 and obstetric early warning systems into their recommendations to evaluate bleeding.11, 14, 17 American College of Obstetricians and Gynecologists (2017) Dutch Society of Obstetrics and Gynecology (2012) >1000 ml regardless of route of delivery Any blood loss that causes hemodynamic instability Federation of Obstetric and Gynaecological Societies of India (2015) French College of Gynaecologists and Obstetricians/French Society of Anesthesiology and Intensive Care (2016) The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (2017) World Health Organization (2012) >500 ml regardless of route of delivery Severe PPH >1000 ml International Federation of Gynecology and Obstetrics (2012) Society of Obstetricians and Gynaecologists of Canada (2018) Vaginal delivery >500 ml, cesarean delivery >1000 ml Any blood loss that has the potential to produce hemodynamic instability >500 ml regardless of the route of delivery PPH mild: 500–1000 ml, moderate: 1000–2000 ml, severe: >2000 ml Uterine atony can be anticipated after prolonged labor particularly with the use of oxytocin, in pregnancies complicated with chorioamnionitis, high parity, general anesthesia, and other factors that lead to uterine overdistension such as multiple fetal gestation, polyhydramnios, and fetal macrosomia.6, 20 Trauma accounts for 15%–20% of cases,21 and is mostly attributed to perineal or cervical lacerations, perineal hematomas, episiotomies, or uterine rupture.6, 20 These occur in the setting of precipitous uncontrolled deliveries or operative vaginal deliveries.6 Retained products of conception can increase the risk of PPH by 3.5 times.22 Risk factors include succenturiate placenta and previous instrumentation.6 Coagulation problems can be divided into inherited, such as von Willebrand diseases, hemophilia, and idiopathic thrombocytopenic purpura, and acquired, such as the use of anticoagulant therapy20 and the occurrence of disseminated intravascular coagulopathy after placental abruption, pre-eclampsia with severe features, intrauterine fetal demise, sepsis, or amniotic fluid embolism.6, 20, 23 Other etiologies include uterine inversion and abnormal placentation. Multimodal strategies have been implemented in high-income countries to control pathologies with high mortality rates such as PPH. These initiatives that involve multiple intervention points and actors have been called "bundles" or intervention packages, which consist of the implementation of a group of interventions as well as multidisciplinary programs that standardize and comprehensively address the management of pathologies.1-6 Bundles represent a selection of existing guidelines and recommendations in a form that aids systematic implementation and a consistency of practice. The California Maternal Quality Care Collaborative (CMQCC) Working Group on obstetrical hemorrhage developed the Improving the Health Care Response to Obstetric Bleeding Toolkit in 2010 to help obstetric providers, clinical staff, hospitals, and healthcare organizations develop methods within their facility for timely recognition and an organized and rapid response to bleeding. In March 2015, version 2.0 was updated with the latest evidence-based changes.6 In 2015, work groups of the National Partnership for Maternal Safety — within the Council on Patient Safety in Women's Health Care that represents all major women's healthcare professional organizations in the USA — developed an obstetric hemorrhage safety bundle. The goal of the partnership was the adoption of the safety bundle by every birthing facility. This consensus bundle is organized into four action domains: readiness; recognition and prevention; response; and reporting and systems learning. There are 13 key elements within these four action domains (Table 3). In 2017, the World Health Organization (WHO) carried out a technical consultation among international maternal health experts to evaluate the development of care bundles for PPH. A total of 730 articles were reviewed and 430 were used for the construction of the theoretical framework of the process. The consultation led to a definition of two care bundles, which are summarized in Table 4. Uterotonic drugs Isotonic crystalloids Tranexamic acid Uterine massage Notes: Initial fluid resuscitation is performed together with intravenous (IV) administration of uterotonics. If IV uterotonics are not available, fluid resuscitation should be started in parallel with sublingual misoprostol or other parenteral uterotonics. If PPH is in the context of placental retention, the placenta should be extracted, and a single dose of antibiotics should be administered. If lacerations are encountered, they should be repaired. Compressive measures (aortic compression or bimanual uterine compression) Intrauterine balloon tamponade Non-pneumatic antishock garment Notes: A continuing dose of uterotonics (e.g. oxytocin diluted in isotonic crystalloids) and a second dose of tranexamic acid should be administered during the application of this bundle. The first response PPH bundle must be implemented at both the primary healthcare and hospital levels. The discussion about the response to refractory PPH bundle raised some controversy. For the first response PPH bundle, the next phase is the development of an implementation strategy, culminating in a model for use at the facility level in LMICs. For the response to refractory PPH bundle, it is a priority to solve pending controversies, including the operational definition of refractory PPH, and to better understand the effectiveness of various uterine balloon tamponade (UBT) devices. FIGO considers that the bundle care approach can improve patient outcomes when adherence to all components is high. Every health system needs to adopt a bundle and there are many available for use. Place the bundle in every maternity hospital and train to all elements of bundle, from arrival on obstetrics service to transfer to higher level of care. Shock refers to a reduction in tissue perfusion, which is insufficient to meet the metabolic requirements of tissues and organs. Insufficient blood flow may be clinically identified as the development of one or more of the following: lactic acidosis, altered mental status, oliguria, and tachycardia. Vital signs monitoring is key to hemodynamic assessment and prompt intervention.1 In healthy pregnant and postpartum women, cardiologic physiologic compensatory mechanisms prevent changes in vital signs until a large volume of blood has been lost (usually >1000 ml). Hence, changes in clinical and vital signs that result from hemorrhage appear late in the process and may not lead to early identification of PPH. This in turn makes it difficult to establish cutoff points to trigger clinical interventions. Moreover, because traditional vital signs change late and are less reliable as triggers for clinical actions, other indicators could help to characterize maternal hypovolemia caused by bleeding.2 Although the use of conventional individual vital signs (pulse and systolic blood pressure) may lack accuracy in the assessment of hypotension, a simple combination of both may transform routine clinical parameters into a more accurate indicator of hypovolemia, such as the shock index (SI). SI is defined as the ratio of heart rate to systolic blood pressure.3, 4 The SI may improve the predictive capability of individual clinical signs, which aids early identification of women at risk of hypovolemia as the result of obstetric causes.5 Moreover, the SI has been proposed as a reliable indicator of adverse maternal outcomes,6 and its values have been set to indicate clinical management.7 However, the association between shock parameters and advanced treatment modalities in severe PPH has yet to be reported. The essential cornerstone of management of PPH involves prompt diagnosis and rapid replacement of lost blood volume, as well as the oxygen-carrying capacity of blood, accompanied by immediate medical and surgical measures to address the underlying cause(s), and hence prevent more loss. To assess the patient's condition, SI has been introduced as a simple and clinically effective vital sign. The SI has been shown to have an inverse linear relationship with left ventricular stroke work in acute circulatory failure. Therefore, a concurrent reduction of left ventricular stroke work (induced by hemorrhage, trauma, or sepsis) was associated with an elevation of the SI and a deterioration in left ventricular mechanical performance. Poor left ventricular function or persistent abnormal elevation of the SI after aggressive therapy and hemodynamic stabilization was associated with increased mortality in critically ill, traumatized patients.8 In obstetric and nonobstetric circumstances, the absence of a significant drop in blood pressure in patients with PPH may mask the actual hypovolemic status due to physiological compensatory mechanisms.9 For that reason, the SI was the only promising marker that indicated the severity of blood loss.2, 5 The SI, together with the rule of 30, are important tools that may aid clinicians in an emergency to determine the amount of blood loss and the degree of hemodynamic instability. Before the fall in systolic blood pressure, heart rate rises to compensate for the blood loss, and thus the SI increases. The rule of 30 is an approximated blood loss of 30% of normal (70 ml/kg in adults, 100 ml/kg throughout pregnancy), defined by a fall of 30% in hematocrit, a fall of 30% in hemoglobin (approximately 3 g/dl), a fall of 30 mm Hg in systolic blood pressure, and a rise in pulse rate by 30 beats per minute.10 It has been shown that an SI ≥0.9 is associated with increased mortality and an SI>1 increases the likelihood of blood transfusion.11, 12 To date, standard obstetric SI has been defined as 0.7–0.9 compared with 0.5–0.7 for the nonpregnant population, taking into account that the hemodynamic changes of pregnancy may delay the recognition of hypovolemia.5 If intravascular volume depletion is suspected, a rapid clinical assessment is required because the patient's clinical condition can deteriorate, leading to the development of hemorrhagic shock rapidly. Proper medical record-taking skills may highlight symptoms associated with shock such as pain and overt blood loss, as well as general malaise, anxiety, and dyspnea. Notably, in settings where few PPH treatment options exist, and in cases of home deliveries, diagnosis and treatment or referral must occur even earlier than in hospital settings to improve outcomes. For that reason, SI may be a valuable threshold in LMICs, where mortality is highest and is often related to delays in complication recognition, transportation, and level of care at the facility.2 A threshold of SI ≥0.9 should be tested to alert community healthcare providers of the need for urgent transfer.13 FIGO considers that the shock index can be a marker of the severity of PPH and can alert teams to hemodynamic instability when its value is greater than 0.9. Guidelines are defined as systematically developed statements that assist practitioners to take decisions about appropriate health care in specific clinical circumstances.1 Over the past decades, many and international PPH guidelines have been developed and part of obstetric clinical around the world. PPH guidelines address (e.g. and treatment of but may in their These are because most of the recommendations are based on clinical and expert There are few available to produce recommendations for the management of PPH due to the emergency of the condition that this of In the absence of guidelines the best available evidence. In resources as well as and of may influence the and some management of third stage of labor is in There is consensus that all women should uterotonics after delivery as it has to reduce PPH has been as the of choice by most but its and route of administration especially when mode of In FIGO recommendations for the prevention of and in updated its for PPH prevention and the use of oxytocin or as the of also the use of or there are no or misoprostol in settings where oxytocin is not available or its be is also when the use of other uterotonics is not due to or to use such as in the context of 13 The Society of Obstetricians and Gynaecologists of Canada has updated its and the use of as a uterotonic for prevention at cesarean delivery or vaginal delivery with one risk The that during cesarean delivery can consist of oxytocin or Other strategies have been proposed in but many no consensus or no clear Table 5 various PPH prevention strategies by different of uterotonics after delivery Uterotonic at the of birth, late and administration of uterotonics after delivery Vaginal 5 may be used in the absence of not Uterine massage is of no for prevention of uterotonics after delivery 5 or or IV At can be performed as as it does not administration of uterotonics after delivery or has no on and placenta delivery or If uterotonics are not 100 or its is to other effective uterotonics Vaginal oxytocin is not available or oxytocin is not available or PPH guidelines a multidisciplinary approach for effective early control of bleeding. should be directed to the specific cause of PPH trauma, and should from the less to the more and A set of measures also to be in most guidelines and consist of of two large IV of monitoring of women, crystalloids and measures to avoid and evaluate the PPH If atony is the most guidelines mechanical such as uterine massage or uterine bimanual with concurrent are the treatment for uterine oxytocin is the and route of but its varies oxytocin to control PPH, guidelines the use of an additional such as or as a uterotonic available for and the guidelines highlight that the use of to PPH is not (Table or in of normal at per oxytocin in of IV fluid at per until hemorrhage If oxytocin is not available or administration is not dose of or every in every be used as in of is with or sublingual than are with than with or can be every to a of is a 100 or IV in ml of IV If it is followed by oxytocin in as a of oxytocin can be administered only If with adverse should not be used as IV not If uterotonics are not or administration of oxytocin may be If uterotonics are 500 in 500 ml IV Initial 100 1000 h or application is use to be as of the World Maternal tranexamic acid an has been incorporated into PPH guidelines around the 13 has updated this and the use of as as within the first 3 h from birth, at a dose of regardless of the route of 13 However, some guidelines not cite or not it in a because their update the that has been in many guidelines is for there is no consensus about its treatment in hemorrhage, guidelines some and more surgical The available guidelines are summarized in Table The most are uterine balloon tamponade uterine and Uterine with is also in some but its use is 5 the use of a with guidelines cite the use of intrauterine with a with a to the lack of evidence, guidelines not these in a and their on the of professional with and clinical UBT is indicated as the treatment of choice when uterine atony is refractory to uterotonics after vaginal delivery as it is less than the other This should be after out products of or vaginal or cervical as a contributing If UBT to control bleeding in these cases, by most by surgical are (Table are to avoid when is The most in guidelines are the most are uterine less and can also be used uterine for atony at vaginal uterotonics or are not Uterine is not than discuss with a second is of the the uterine Research was to evaluate the potential and of this intervention uterine when uterotonics and bimanual uterine massage If balloon system is not available, with treatment for atony to medical and can be associated with less uterine uterine until measures are or when medical therapy for uterine uterine uterine compression does not other with at not Uterine with with not be or left should be for placental the procedure of choice for atony Uterine massage compression of bleeding after uterine