Advanced Life Support in Obstetrics (ALSO) Provider Manual PDF

ADVANCED Life Support in OBSTETRICS PROVIDER MANUAL NINTH EDITION ® Editors Authors Lawrence M. Leeman, MD, MPH...

ADVANCED Life Support in OBSTETRICS PROVIDER MANUAL NINTH EDITION ® Editors Authors Lawrence M. Leeman, MD, MPH Hypertensive Disorders of Pregnancy, Lawrence Leeman, MD, MPH Janice M. Anderson, MD, FAAFP Malpresentations, Malpositions, and Medical Editor Postpartum Hemorrhage Multiple Gestation Lee Dresang, MD R. Eugene Bailey, MD, FAAFP Paul Lewis, RM Jeffrey D. Quinlan, MD, FAAFP Intrapartum Fetal Surveillance Birth Crisis Susanna R. Magee, MD, MPH Melissa Beagle, MD Susanna R. Magee, MD, MPH, Associate Medical Editors First-Trimester Pregnancy Complications FAAFP Rebecca L. Benko, MD, FAAFP Assisted Vaginal Delivery AAFP Staff Preterm Labor and Prelabor Rupture of Neil J. Murphy, MD Sarah Meyers, MHA Membranes CME Maternity Care Manager, Continuing Maternal Resuscitation and Trauma, Professional Development Division Timothy Canavan, MD, MSc Cesarean Delivery Third- and Fourth-Degree Perineal Lauren Plante, MD, MPH Gaylynn Butts, BSN, RN Lacerations ALSO Program Strategist, Editorial Cardiac Complications of Pregnancy Assistant, Continuing Professional Brendon Cullinan, MD Stephen Ratcliffe, MD, MSPH Development Division Maternal Resuscitation and Trauma Labor Dystocia Carla Cherry Mark Deutchman, MD, FAAFP Elizabeth Rochin, PhD, RN ALSO Program Specialist, Continuing Diagnostic Ultrasound in Labor and Safety in Maternity Care Professional Development Division Delivery, First-Trimester Pregnancy Complications Jose A. Rojas-Suarez, MD Jennifer Head Maternal Sepsis ALSO Program Specialist, Continuing Lee Dresang, MD Professional Development Division Safety in Maternity Care, Venous Sara Shields, MD, FAAFP Thromboembolism in Pregnancy Labor Dystocia Elaine Kierl Gangel Managing Editor, Journal Media Division Ann E. Evensen, MD, FAAFP Niza Suarez Rueda, MD Postpartum Hemorrhage Maternal Sepsis Brandon Nelson Associate Editor, Journal Media Division Robert W. Gobbo, MD, FAAFP Mary Beth Sutter, MD, FAAFP Shoulder Dystocia Assisted Vaginal Delivery Stacey Herrmann Production Design Manager, Journal Jessica T. Goldstein, MD, FAAFP Barbara A. True, RN Media Division Cardiac Complications of Pregnancy Intrapartum Fetal Surveillance R. Shawn Martin Gretchen Heinrichs, MD, OB/GYN Johanna B. Warren, MD Executive Vice President and Late Pregnancy Bleeding Shoulder Dystocia Chief Executive Officer Kim Hinshaw, MBBS, FRCOG Kerry Watrin, MD Clif Knight, MD, FAAFP Shoulder Dystocia Preterm Labor and Prelabor Rupture Senior Vice President for Education of Membranes Caroline S. Homer, MScMed, PhD Medical Illustrations by Lisa Clark Birth Crisis Helen Welch, CNM Birth Crisis Sarah Jones, MD, FAAFP Venous Thromboembolism in Pregnancy Paul Koch, MD Diagnostic Ultrasound in Labor and Delivery Conflicts of interest: It is the policy of the AAFP that all individuals in a position to control content disclose any relationships with commercial interests upon nomination/invitation of participation. Disclosure documents are reviewed for potential conflicts of interest and, if identified, con- flicts are resolved prior to confirmation of participation. Only those participants who had no conflict of interest or who agreed to an identified resolution process prior to their participation were involved in this CME activity. The following individual(s) in a position to control content for this activity have disclosed the following relevant financial relationships: Mark Deutchman, MD disclosed a consultant or advisory board relationship with Signostics – Echonous Ultrasound, research/grant support with Signostics – Echonous Ultrasound (diagnostic ultrasound), stock/bond holdings with Signostics – Echonous Ultrasound (diagnostic ultra- sound), and he holds a US patent on a medical device (fetal vacuum extractor) with Cooper Surgical. Related Chapter(s): Diagnostic Ultrasound All other individuals in a position to control content for this activity have indicated they have no relevant financial relationships to disclose. — Provider Manual i Preface Copyright The ALSO Provider Course is an educational program The American Academy of Family Physicians (AAFP) designed to assist health professionals in developing and owns the ALSO copyright and trademark on all of the maintaining the knowledge and skills needed to effectively course materials, including the Provider Manual, slide sets, manage the emergencies which arise in maternity care. The and written exam. Use of portions of the materials outside course includes required reading, lectures, and hands-on of an authorized ALSO course is strictly prohibited with- workstations. Evaluation is by a written exam and skills out prior written approval from the AAFP. assessment stations. There are many appropriate ways of managing emergencies. The treatment guidelines presented Course Disclaimer in ALSO do not necessarily represent the only way to man- The material presented at this course is being made avail- age problems and emergencies. Instead, these guidelines able by the AAFP for educational purposes only. This are presented as reasonable methods of management in material is not intended to represent the only, nor neces- obstetrical emergencies. Each maternity care clinician must sarily best, methods or procedures appropriate for the ultimately exercise his or her own professional judgement medical situations discussed, but rather is intended to in deciding on appropriate action in emergency situations. present an approach, view, statement, or opinion of the Completion of the ALSO Provider Course does not imply faculty which may be helpful to others who face simi- competency to perform the procedures discussed in the lar situations. The AAFP disclaims any and all liability course materials. for injury, or other damages, resulting to any individual attending this course and for all claims which may arise Overall Course Objectives out of the use of the techniques demonstrated therein by Discuss methods of managing pregnancy and birth such individuals, whether these claims shall be asserted urgencies and emergencies, which standardizes the skills by a physician, or any other person. Every effort has been of practicing maternity care providers. made to ensure the accuracy of the data presented at this Demonstrate content and skill acquisition as evidenced course. Physicians may care to check specific details, such by successful completion of course examination, skills as drug doses and contraindications, etc, in standard workstations, and group testing stations. sources prior to clinical application. The AAFP does not Provide safe team leadership through various emergency certify competence upon completion of the ALSO Pro- obstetric scenarios. vider Course, nor does it intend this course to serve as a Demonstrate effective team communication strategies basis for requesting new or expanded privileges. focusing on patient safety. The American Academy of Family Physicians (AAFP) under the leadership of Dr Damos and John W. Beasley, wishes to acknowledge the initial development of the ALSO MD. The AAFP acquired the ALSO Program in 1993. Program by the University of Wisconsin Department of The curriculum demonstrates the evidence, and quality Family Medicine and the original national ALSO Develop- of that evidence, on which any recommendations of care ment Group of family physicians, obstetricians, and nurses, are based. which formed in 1991. The ALSO Program, originally The current ALSO Provider Manual continues to be an conceptualized by James R. Damos, MD, was developed ongoing process and is reviewed on a 3-year cycle. © 2020 American Academy of Family Physicians 11400 Tomahawk Creek Parkway, Leawood, Kansas 66211-2672 1-800-274-2237 913-906-6000 ii Provider Manual —  Advanced Life Support in Obstetrics (ALSO®) Status Life Cycle ALSO Instructor ALSO Approved ALSO Provider Candidate Instructor ALSO Advisory 3-year status Successfully complete 3-year status Faculty Successfully an ALSO Instructor Instruct in two courses Maintain Approved complete an ALSO Course and be (ALSO and/or BLSO) Instructor status to Provider Course evaluated at a Provider and complete the maintain Advisory Course (ALSO or BLSO) Online Instructor Faculty status within one year Renewal Course every three years ALSO Providers and Approved Instructors are responsible for maintaining their own status. Wallet Cards include status start and expiration dates and can be accessed in AAFP accounts/transcripts. Please review the ALSO Guidelines document at www.aafp.org/also for further details. To find out more about the ALSO program and upcoming courses, please visit www.aafp.org/also. — Provider Manual iii  Advanced Life Support in Obstetrics Table of Contents November 2020 Safety in Maternity Care...................................................................... 1 Intrapartum Fetal Surveillance............................................................... 19 Preterm Labor and Prelabor Rupture of Membranes............................................ 51 Hypertensive Disorders of Pregnancy......................................................... 73 Late Pregnancy Bleeding................................................................... 95 Labor Dystocia............................................................................ 111 Malpresentations, Malpositions, and Multiple Gestation........................................ 129 Shoulder Dystocia........................................................................ 157 Assisted Vaginal Delivery.................................................................. 173 Postpartum Hemorrhage................................................................... 187 Maternal Resuscitation and Trauma......................................................... 205 Cardiac Complications of Pregnancy........................................................ 229 Venous Thromboembolism in Pregnancy..................................................... 255 Maternal Sepsis.......................................................................... 275 Third- and Fourth-Degree Perineal Laceration................................................. 297 Diagnostic Ultrasound in Labor and Delivery.................................................. 307 First-Trimester Pregnancy Complications..................................................... 323 Cesarean Delivery........................................................................ 341 Birth Crisis............................................................................... 377 iv Provider Manual —  Safety in Maternity Care Learning Objectives 1. Discuss need for a patient safety focus and team-based approach to maternity care 2. Demonstrate teamwork tools that improve safety, including closed loop communication and application of the steps of evidence-based mnemonics 3. Explain risk management issues in obstetrics and possible solutions (The Five Cs) Introduction ticipants from different disciplines and settings, which On January 15, 2009, US Airways flight 1549 lost may provide a more realistic approach to team-based thrust in both engines. The plane landed on the Hud- training. Attending physicians (family medicine, son River near New York City, and all 155 individuals obstetrics/gynecology, and emergency medicine), mid- aboard survived. Teamwork and communication were wives, nurses, residents, and students have participated cited as key factors in the excellent outcome. Preflight in ALSO courses. Providers from rural and urban, and training and simulations prepared airline personnel academic and community programs can learn from for their roles when the accident occurred. Commu- each others’ experiences and perspectives. nication was effective between pilots, crew members, ALSO added a Safety in Maternity Care chapter to its passengers, ground control, and rescuers. Everyone curriculum in 2002. The chapter highlights the impor- contributed to the successful outcome. tance of addressing teamwork and systems issues in the The odds of being killed in an airline crash has provision of quality medical care. ALSO transitioned decreased to just 1 in 4.7 million flights.1 Much of this to a flipped classroom model in 2017 and eliminated success has been attributed to Crew Resource Man- all lectures from the in-person portion of the course, agement (CRM), which focuses on safety, protocols, except the Safety in Maternity Care lecture. Even before excellent communication, checklists, and other tools.1 the transition, courses began with the Safety in Mater- A 1979 National Aeronautics and Space Administra- nity Care lecture to emphasize the importance of the tion workshop introduced CRM to aviation in response teamwork, communication, and systems lessons that to a 1978 crash of a United Airlines DC-8 in Portland, are taught throughout the course’s content. where a pilot was unable to maintain awareness of criti- ALSO promotes safety by teaching a standardized cal aspects of flying under stressful conditions.2 approach to obstetric emergency situations. Standard- Successful aviation safety strategies, such as CRM, ization is a key patient safety element that can reduce can be applied to medical care. The focus on saving variation in practice and duplication of time and lives and improving outcomes through teamwork, com- resources, and provide reliability of patient care proce- munication, and system improvement is referred to as dures. Knowledge of the content, practice of manual patient safety. The Institute of Medicine defines patient skills, and use of mnemonics reduce the likelihood of safety as “the prevention of harm to patients.”3 error and the incidence of maternal and fetal morbidity and mortality. Advanced Life Support in Obstetrics and Patient Safety Importance of Safety in Maternity Care The mission of the Advanced Life Support in Obstet- Approximately 303,000 women died from childbirth rics (ALSO) program is strongly focused on patient related causes worldwide in 2015.4 A United Nations safety. From its inception in 1991, ALSO courses have Sustainable Development Goal is to reduce global promoted interdisciplinary teamwork and brought maternal mortality from 216 per 100,000 live births in together maternity care providers in the US and over 2015 to less than 70 per 100,000 by 2030.4 Childbirth 60 other countries. The courses ideally include par- is the most common reason for hospital admission, — Safety in Maternity Care 1 Safety in Maternity Care accounting for 11%, and cesarean delivery is the serious medication error; more Americans die each most common operative procedure performed year due to medical errors than of breast cancer, in the United States.5 With more than 4 million AIDS, or vehicle collisions.11 The cost associated births occurring in the United States annually,5 with medical errors is estimated at $17 billion to this equates to more than 80,000 adverse obstetric $29 billion annually.11 events. Public health and hygiene improvements, “We cannot change the human condition, but advancements in technology, development of we can change the conditions under which humans targeted drugs, increased training of nurses and work.”14 physicians, and the development of a regional- Assessment of human factors has become a ized approach to perinatal care have combined core process in the review of preventable errors. to reduce the overall risk of death and disability According to The Joint Commission, human fail- related to childbirth in the past century. ures cause 80% to 90% of errors.15 The ability to However, as discussed later in this chapter, recognize the integral connections that procedures, maternal mortality has increased in the United technology, and humans form within health care States, even though it has decreased in most is essential in the reduction of preventable errors. low- and high-resource countries since 1990.6 An A component of this strategy is the use of simula- exception is California, where maternal mortality tion and team-based training. decreased during this period. California’s success Team training has been a requirement of The often is attributed to its patient safety bundles, Joint Commission since the National Safety which are being implemented nationwide with the Patient Goals became effective in 2003; these goals hope of achieving similar improved outcomes.6,7 require hospitals to “incorporate(s) methods of According to The Joint Commission, between team training to foster an interdisciplinary, collab- 2004 and 2014, communication was the root orative approach to the delivery of patient care.”16 cause in 48% of maternal and 70% of perinatal In addition, staff must participate in education sentinel events.8 A root cause is the fundamental and training that incorporate team communica- reason for an adverse event and a point where tion, collaboration, and coordination of care.17 an intervention may have avoided the adverse Although some adverse outcomes cannot be pre- outcome. Technology and medical knowledge vented, even with exemplary care provided under continue to advance, but women and infants the best of circumstances, a significant proportion continue to die or experience adverse outcomes. of these outcomes result from communication and When this occurs, poor communication often is system problems. One study showed that 87% of the root cause. If the communication and actions adverse events and potential adverse events were of maternity care providers can be improved, lives preventable, and that poor teamwork, protocol can be saved. Communication and teamwork violation, and staff unavailability were the most skills are taught at the start of the live portion of common problems.9 the ALSO course and practiced throughout the “A team of experts does not make an expert team.”18 required workstations, where clinicians address Most maternity care units involve so many obstetric emergencies as cohesive teams in a simu- providers that a patient care team rarely involves lated in-situ patient care setting. the same people. For example, a maternity care Even highly trained and dedicated medical unit with 81 obstetricians, 50 registered nurses, professionals make mistakes. Fortunately, most 16 anesthesiologists, 12 neonatal nurse practi- errors do not result in harm, and fatal errors are tioners, 14 surgical technologists, and 35 nurse relatively rare.9 Nonetheless, an estimated 44,000 anesthetists could result in 381 million different to 98,000 Americans die each year of prevent- teams.19 This high variability in team member- able medical errors.10,11 A 2013 study showed this ship is a key threat to patient safety. Even the number to be between 210,000 and 400,000, most knowledgeable and skilled specialist cannot with nonlethal errors being 10 to 20 times more function to the best of his or her ability without common.12 This means that preventable medical support from a wide array of colleagues. Because errors are the third leading cause of death in the working with the exact same team is such a rar- United States, after heart disease and cancer.13 ity, it is not effective to train a particular team Seven percent of hospital patients experience a to work well together. Instead, all members of a 2 Safety in Maternity Care —  Safety in Maternity Care health care team should be trained in effective, ability of spontaneous vaginal delivery and reduce standardized communication techniques, so that the need for drugs and instrument delivery.25 every clinician is prepared to function within each Clinician strategies for supporting pregnant of the many teams with which they will interact. women include listening, anticipating potential problems, discussing options, reviewing birth Evidence for Teamwork Improving Outcomes plans, conferring at each decision point, and assess- A growing body of evidence shows that improv- ing for entrenched health beliefs, expectations, and ing teamwork improves outcomes. The University concerns. Patient-centered interviewing, caring of Minnesota and the Fairview Health System communication skills, and shared decision-making in Minneapolis have provided an evidence-based will promote effective patient-provider communi- framework for the dissemination of in-situ simula- cation.26 Involving women in their own care can tions to enhance interdisciplinary communication improve outcomes, satisfaction, and adherence.27 and teamwork.19,20 A 2011 study documented a Provider strategies for working with a woman’s persistent and statistically significant 37% decrease family and support network include develop- in perinatal morbidity at a hospital with stan- ing relationships with a woman’s partner and/ dardized teamwork training and regular in-situ or family, encouraging or expecting the woman simulations compared with no change at a hospital and her family to be part of the perinatal team, with standardized teamwork training alone and a assessing cultural norms and expectations, assess- control hospital where neither were taught.21 The ing family dynamics, encouraging attendance at Weighted Adverse Outcome Score (WAOS) and childbirth classes, and acknowledging existing maternal severity index improved 50% after the anger or anxiety. implementation of teamwork training on a mater- The health care team can improve patient safety nity care unit at the Harvard-affiliated Beth Israel and satisfaction through effective communication, Deaconess Medical Center.22 a readily available birth attendant, care teams, and A randomized controlled trial comparing the consultants who are willing to assist in a timely American Academy of Pediatrics Neonatal Resusci- manner. All team member contributions should tation Program course with and without additional be respected and encouraged. Characteristics of teamwork training showed that individuals who effective teams include having shared mental mod- underwent standardized teamwork training in con- els; having clear roles and responsibilities; having junction with the course demonstrated improved a clear, valued, and shared vision; optimizing teamwork behavior at the end of the course.23 resources; giving and receiving assistance; manag- Standardized team training may not be enough, ing and optimizing performance outcomes; having however. “The best team training in the world strong team leadership; engaging in a regular will not yield the desired outcomes unless the discipline of feedback; developing a powerful sense organization is aligned to support it. The next of collective trust and confidence; and creating frontier lies in making effective teamwork, as seen mechanisms for cooperation and coordination.28 in high-performance teams, an essential element in Impediments to team function include personality high-reliability organizations.”24 conflicts, competitive pressures, fixed beliefs about abilities or roles, biases regarding management, Essential Elements of a Strong and inadequate resources. Maternity Care Team Occasionally, the provider and woman do not Childbirth is an intense physical and emotional agree on the care plan. If this conflict cannot be experience. As such, the maternity care team, with resolved to both parties’ satisfaction, transfer of its focus on the pregnant woman, plays a vital role care may be the preferred option. Documentation in well-being and outcomes. A woman’s fam- is always important, especially in cases of conflict. ily members and support network often have an Providers should document that they explained important and integral role. The health care team the implications of the patient’s decisions to the includes the birth attendant, nurses, support person- patient. In addition, frequent conversations with nel (eg, nursing assistants), and consultants. The the care team with the patient present are impor- presence of a doula or professional support person tant to continue development of transparency and continuous labor support can increase the prob- and clarity regarding the care plan and anticipat- — Safety in Maternity Care 3 Safety in Maternity Care ing subsequent steps that might be necessary to by cross monitoring. Early briefings followed by promote a positive outcome. huddles when new issues arise can ensure that When conflict occurs, several strategies can help. all team members have the same understanding First, separate the people from the problem: be of the situation. Situational monitoring is an hard on the problem, soft on the people. Focus important patient safety tool that facilitates situ- on what is right for the patient, not who is right; ational awareness. this includes focusing on interests, not positions, The acronym STEP (Status of patient, Team and focusing on concerns and desired outcomes. members, Environment, Progress towards goal) Create options for mutual gain by brainstorming can be used to remember important components to yield win-win solutions. Insisting on the use of situational monitoring. of objective criteria provides the basis for further improvement.29 Standardized Language At a system level, a rapid response team can be Inadequate communication at shift change can created to quickly assemble people with essential compromise patient safety. For example, failing skills to respond to emergencies. An important to mention the presence of meconium at a sign- part of developing an effective response team out that occurs just prior to delivery may result in involves identifying appropriate triggers for inadequate newborn resuscitation preparation. activating the team. Early activation can improve Call-outs. Call-outs are a strategy used to quickly outcomes.30 Protocol should designate the role inform all team members simultaneously when new of different team members. Team function can critical events occur, particularly during an emer- be optimized through simulations, feedback, and gency when several caregivers are at the bedside. quality review when activation occurs. When managing a postpartum hemorrhage, a call- out of high blood pressure can alert the managing Teamwork Tools provider that methylergonovine is contraindicated. Like the medical management and technical A call-out addressing the insertion of a Foley skills taught in the ALSO course, teamwork can catheter may alert another team member to halt the be taught and learned. Important concepts and process knowing the patient has a latex allergy. tools that can improve teamwork and patient SBAR. An acronym for Situation, Background, safety include situational awareness, standardized Assessment, and Recommendation, SBAR is a language, closed-loop communication, mutual standard communication technique for conveying respect, and a shared mental model. It is impor- critical information.31,32 Use of SBAR in one insti- tant to have a standardized approach to teamwork tution resulted in a 72% to 88% improvement in tools within each hospital or health care organiza- updating patient medication lists on admission, tion that is supported by all levels of leadership. and a 53% to 89% improvement in having a corrected medication list on discharge.32 The rate Situational Awareness of adverse events decreased from 89.9 per 1,000 In an emergency, it is easy to fixate on one par- patient days to 39.96 per 1,000 patient days.32 ticular task and lose sight of the overall situation. SBAR can be an effective tool for communicating For example, a clinician may fixate on fetal heart critical patient care information to any new team rate decelerations and overlook elevated maternal member who enters a room, a nurse calling out to blood pressure levels, headache, and hyperreflexia a secretary to phone someone to come to a room, prior to an eclamptic seizure. Another clinician physician-nurse communication at shift changes, may focus on stopping preterm contractions, but and between different specialty care providers.33 miss signs and symptoms of an abruption and Situation – What is going on with the patient? worsen the condition by administering a tocolytic. Background – What is the clinical background A clinician may focus on difficult family dynamics or context? and fail to prepare the team to manage a shoulder Assessment – What do I think the problem is? dystocia despite a large estimated fetal weight and Recommendation – What would I do to cor- prolonged second stage of labor. rect it? Team members can help each other remain Miscommunications in the transfer of care from aware of active issues and potential complications one provider or care team to another can result in 4 Safety in Maternity Care —  Safety in Maternity Care life-threatening errors. Effective patient handoffs Consider Episiotomy, and R4: Removal of the should include interactive communications, lim- posterior arm, use of the Rotatory internal maneu- ited interactions, a process for verification, and an vers (Rubin II, Woods screw, and reverse Woods opportunity to review relevant historical data.34 screw), Roll the patient (Gaskin maneuver), and Handoffs. Handoffs occur not only between Repeat all maneuvers. This R4 portion of the mne- providers, but also between levels of care or dif- monic allows the clinician to use the maneuver(s) ferent hospital units such as labor and delivery in the order they judge to be most effective and and postpartum. One of the significant chal- appropriate given the clinical circumstances. lenges in many countries is having an organized and respectful process for transferring a patient Mutual Respect from her community care provider to prehospital The ability to communicate clearly and effectively transport, and timely referral and transport to the is an essential element of teamwork. Circumstances appropriate level of hospital care. may require escalation of care strategies to ensure the best outcomes for the woman, the infant, and Closed-Loop Communication the care team. The ability to state a concern, offer Closed-loop communication means that the indi- a solution, and agree on next steps in the care plan vidual receiving a message confirms or repeats back is a critical component of patient safety. Intimidat- what they have heard from the individual sending ing and disruptive behavior undermine patient the message, so that he/she can affirm that the safety and should not be tolerated.35 message is correct or offer a correction. This is a The Two-Challenge Rule and CUS Words are three-step process that ensures clarity and account- two communication strategies designed to give ability. Closed-loop communication also allows for voice to all team members. a clear, shared mental model of the care plan and Two-Challenge Rule. The Two-Challenge the assurance that someone is handling the request. Rule36 allows a team member to clearly articulate a For example, a physician may request 10 units concern regarding a perceived or real patient safety of oxytocin intramuscularly after delivery of the breach. The first challenge is made in the form anterior shoulder. The nurse would repeat back of a question. The second challenge is made in that the physician requested 10 units of oxyto- the form of a statement and can be offered by the cin intramuscularly after delivery of the anterior same clinician or by another member of the care shoulder as confirmation that the message was team. The second challenge is focused on advocat- understood. The physician then closes the loop by ing for the needs of the woman. confirming that, yes, this is what they requested. For example, a senior resident may be preparing Without closed-loop communication, messages to perform a non-emergent manual extraction of may be missed or misinterpreted. In this example, a placenta in a woman without epidural analgesia. the oxytocin may not have been administered or An accompanying medical student may say, “I an incorrect dose may have been administered. don’t think the patient has adequate anesthesia.” If the resident proceeds, a second statement from the Shared Mental Model medical student regarding the need for better pain Situational awareness, standardized language, and control should signal the senior resident and care closed-loop communication can allow a team to team to suspend the procedure and administer have a shared mental model. Without a shared men- additional anesthesia or explain to the student why tal model, teamwork and patient safety can be com- additional anesthesia is not indicated or feasible. promised. For example, the HELPER4 mnemonic CUS Words. CUS Words is a communication for shoulder dystocia taught in the ALSO course strategy, where every individual in a care unit is can create a shared mental model, where nurses and trained to listen when the specific words are spo- physicians work together via the McRoberts maneu- ken, as follows: ver, suprapubic pressure, and other interventions to 1. “I’m Concerned” avoid fetal injury or mortality. 2. “I’m Uncomfortable” HELPER4 is an acronym for Call for Help, 3. “This is a Safety issue”28 Evaluate and Explain for Episiotomy, Legs— This strategy may benefit any clinician who McRoberts Maneuver, Suprapubic Pressure, requires additional support when caring for a — Safety in Maternity Care 5 Safety in Maternity Care patient. For example, if a nurse on a care team harm is defined as receiving 4 or more units of says they are concerned about a fetal heart rate, blood products (subsequently revised to 4 or more that it makes them uncomfortable, and that it is a units of red blood cells) and/or admission to an safety issue, the team should respond by evaluating intensive care unit.37 whether a change in management is indicated. Near Misses and Positive Outcomes Briefings, Huddles, and Debriefings Debriefings and root cause analysis are also Briefings. Briefings are held before any patient encouraged for near misses and severe maternal care episode to allow team members to review risk mortality that do not constitute a sentinel event. factors, designate roles, and ensure that every- There is a much more frequent opportunity for one has a shared mental model regarding how quality improvement if debriefings and system to proceed. Briefings are a way to plan ahead. analysis occurs with near misses and not only Briefing prior to labor admission of a woman with when outcomes are poor. The introduction of gestational diabetes and an apparently large fetus, ALSO training to a Colombian hospital in 2007 for example, can prepare the team for who will led to an increase in the near miss incidence ratio perform which task if a shoulder dystocia occurs. (10.5 in 2005 to 2006, to 11.3 in 2008 to 2009) Huddles. Huddles are brief gatherings of care and severe maternal mortality cases (83 in 2005 team members to discuss patient status and the to 2006, to 161 in 2008 to 2009). However, the management plan when issues arise during patient maternal mortality ratio (MMR) decreased (114 care. Examples of events that should precipitate a deaths per 100,000 live births in 2005 to 2006, huddle are development of high blood pressure lev- to 28 in 2008 to 2009) along with the mortality els, fever, and concerning fetal heart tracings dur- index (9.8% [9/92] in 2005 to 2006, to 2.4% ing labor. A huddle may take place in person or via [4/165] in 2008 to 2009).38 The increase in near teleconference, if a key team member is not physi- misses could be due to the lives saved of laboring cally present when the huddle is needed. Huddles women with obstetric emergencies, who might are a way to solve problems in the moment. have otherwise died. Debriefings. Debriefings allow team members Debriefings can also be useful for reinforcing to learn from patient care episodes, regardless of positive practices after deliveries in which every- the outcome. Team members can quickly answer thing went well. Team members can be congratu- the questions: lated for communicating and acting effectively. A 1. What went well, and why? new positive practice, such as skin-to-skin time for 2. What could have gone better, and why? a woman and infant after delivery, can be noted 3. What would you do differently next time? and replicated on a system-wide level. Debriefings During debriefings, it can be helpful to discuss can be part of creating a culture of safety. When three levels of emergency care management: all team members cannot debrief, available team 1. Medical management members can still meet. Absent team members 2. Teamwork (eg, anesthesiologist, neonatal resuscitation staff) 3. System or process/protocol issues can be debriefed afterward via telephone. Discussion may naturally drift toward medi- cal management. Team leaders can guide the Fatigue discussion back to teamwork and system issues. Fatigue can affect patient safety factors including Debriefings can allow the team to perform pro- memory, speed, and mood.39 Fatigue has been cess improvement. cited as a root cause of maternal and neonatal Debriefing can include root cause analysis after injury.8 With standardized testing, adults with a sentinel event. A 2015 statement by The Joint fewer than 5 hours of sleep per night have dif- Commission defines a sentinel event as “a patient ficulty with short-term memory, retention, and safety event (not primarily related to the natural concentration.39 Federal Railroad Administration course of the patient’s illness or underlying condi- data indicates that fatigue is causative in approxi- tion) that reaches a patient and results in any of mately 29% of train crashes.40 Resident work-hour the following: death, permanent harm, severe requirements are an attempt to prevent fatigue- temporary harm.” In obstetrics, severe temporary related medical errors. 6 Safety in Maternity Care —  Safety in Maternity Care Individuals can ensure they are fit for work by Health Information Technology reviewing the I’M SAFE (Illness, Medication, Health information technology (IT) can be a Stress, Alcohol and Drugs, Fatigue, Eating and valuable patient safety tool beyond its role in Elimination) checklist.28 the safe prescribing of medications. Examples Systems and colleagues can monitor to ensure include: facilitating provider communication, work conditions allow for self-care. Employee tracking and reporting data, providing point- assistance programs should be high-quality and of-care reading material, promoting adherence accessible. Work-hour limits, such as those to practice guidelines, and increasing patient introduced for medical residents, may prevent engagement.45 Use of EMR problem lists can the fatigue often involved with medical errors.41 improve interconception care by alerting primary Work hours and facilities can facilitate employees care providers to conditions such as hypertensive eating and eliminating, so they will be performing disorders of pregnancy and gestational diabetes, optimally while working. which place a woman at higher lifetime risk of hypertension and diabetes, respectively. Medication Errors For data to be useful, it must be interpreted and On average, US patients experience one medica- acted on appropriately. Use of health IT has risks, tion error per patient per hospitalization day.42 including the possible compromise of patient pri- Some can result in mortalities. This happened in vacy as well as the use of documentation templates 2006 when a healthy, 16-year-old woman, who that may introduce and duplicate information that was in active labor, was admitted to a hospital is inaccurate or not reviewed. in Madison, Wisconsin.43 She tested positive Larger databases can produce more powerful for group B streptococcus and requested epi- research and recommendations. Two organizations dural analgesia. The anesthesiologist placed the promoting safety in maternity care using IT are epidural infusion bag on the counter and left the California Maternal Quality Care Collabora- the room. A nurse entered the room and hung tive (CMQCC) (https://www.cmqcc.org) and the the epidural bag, thinking it contained penicil- Family Medicine Education Consortium (FMEC) lin. Despite efforts to resuscitate her, the young IMPLICIT: Interventions to Minimize Preterm woman died. Her infant survived after a resusci- and Low birth weight Infants through Continuous tative hysterotomy. Improvement Techniques network (https://fmec. Electronic medical records (EMRs) are help- memberclicks.net/implicit). ful in reducing errors due to poor legibility and can identify drug allergies and drug interactions. System-Level Change Versus Blaming Prescribing errors can be reduced by avoiding Individuals nonstandard abbreviations and using the “always Reducing medical errors to improve patient safety lead, never follow” rule of placing a zero before is a high priority in the United States and other numbers less than one and not placing a zero after countries. Traditionally, medical culture expects a decimal point.42 EMR alerts can prevent errors perfection. The typical tactic to fix errors is to such as unrecognized drug interactions. However, ascribe individual blame. too many alerts may lead to desensitization: 49% Although there is a tendency to scapegoat an to 96% of alerts are overridden.44 individual when things go wrong, there usually are Medication errors are common after transi- numerous factors and system issues that lead to the tions in care. These errors can be reduced through adverse outcome. Blaming the individual does not systematic, careful medication reconciliation on address those other factors and allows the error to admission, transfer, and discharge. be perpetuated. For example, firing an employee Distraction can lead to errors. Areas for dispens- who makes an error at the end of a double shift ing medications can be established as noise-free, does not fix the work-hour structure that will likely distraction-free zones. result in fatigue and errors occurring again. As with other aspects of patient safety, com- Examples of ways to effect change at a system munication problems often are at the root of level include using checklists and protocols, which errors. Using closed-loop communication can be have been documented to improve outcomes lifesaving. through standardization of practice.46 One health — Safety in Maternity Care 7 Safety in Maternity Care care system incorporated a mandatory field into Community Birthing its EMR requiring a sponge count after obstetric One example where system-level interventions are procedures when a patient was found to have a needed to improve patient safety is community retained laparotomy sponge 1 week after normal birthing, including home and free-standing birth vaginal delivery.47 Other health care systems are center deliveries. A 2012 Cochrane review showed using vaginal wanding to avoid retained sponges. there is no strong evidence from randomized trials This method involves scanning individual to favor planned hospital birth or planned home sponges, which are equipped with radiofrequency birth for low-risk pregnant women; however, the tags, to account for all internal gauze or laparot- study notes that observational studies increas- omy sponges used during a delivery. ingly suggest that in countries where home birth In the early days of aviation, plane crashes is integrated into the health system, home birth often were blamed on pilot error without much for low-risk women results in fewer interven- further analysis. Blaming the faulty, and usu- tions and complications.52 Lack of role clarity and ally deceased, pilot did not do much to prevent poor communication are the biggest predictors further crashes from happening. The aviation of preventable maternal and neonatal outcomes, industry made minimal progress in safety and including death. Seamless coordination of care and reliability until they developed a broader notion interprofessional communication results in better of safety and considered the multiplicity of fac- maternal and child outcomes.53 tors underlying airplane crashes and pilot errors. Aviation safety improved through a “collective Maternal Mortality sense of urgency for maintaining safety and a As mentioned previously, although maternal mor- mutual understanding that all team members will tality has decreased in most low- and high-resource state their observations, opinions, and recom- countries since the 1990 United Nations Millen- mendations, and actively solicit and consider nium Development Goals were issued, maternal input from other team members.”48 mortality in the United States has increased.56 Efforts to reduce non-medically indicated, From 1990 to 2015, the world’s maternal mortal- early-term labor inductions and cesarean deliveries ity ratio (MMR) decreased from 385 to 216 per are an example of a successful system-level patient 100,000 live births. In the least developed coun- safety intervention. Delivery before 39 weeks’ tries, the ratio decreased from 903 to 436.54 In gestation is associated with increased respiratory contrast, between 2000 and 2014, the US MMR distress syndrome, transient tachypnea of the for 48 states (excluding California and Texas) and newborn, ventilator use, pneumonia, respiratory Washington, DC increased from 18.8 to 23.8.6 failure, newborn intensive care unit admission, Reasons for the increase are complex and hypoglycemia, 5-minute Apgar score less than 7, include many factors, one of which is improve- and neonatal mortality.49 A hospital hard-stop ments in reporting strategies. In 2003, a preg- where elective deliveries are not allowed by hospi- nancy question was added to the US standard tal personnel was the most effective approach to death certificate. US states gradually adopted reducing non-indicated near-term deliveries.50 the revised certificate and by 2014, 44 states and An important tenet of aviation safety is empow- Washington, DC were using it.6 This question ering each member of the flight team to identify ascertains whether maternal mortality occurred and correct potential errors.51 Teams are trained within 42 days after delivery, which is consistent to speak up if they feel any member is at risk of with the World Health Organization’s definition error. The aviation industry has found that this of maternal mortality; many states did not previ- helps overcome the effects of its traditionally ously report deaths after delivery.6 hierarchical organization, which otherwise tends The increase in US MMR is not only due to to discourage error reporting by subordinates. increased reporting, because some states had The medical profession has a similarly hierarchi- increases in MMR during periods when no cal organization and must overcome this tendency changes were made to reporting systems. Rural toward silence. CUS Words and the Two-Chal- access, poverty, immigration, cesarean delivery, lenge Rule are tools for overcoming hierarchy and obesity, diabetes, advanced maternal age, sub- improving communication. stance abuse, cardiac-related conditions, and 8 Safety in Maternity Care —  Safety in Maternity Care racial disparities are other possible causes of the eted approach to resolving what is perceived as a increase in US MMR.55-57 Defunding of women’s current malpractice crisis.63 health also has been associated with the increase The cost of malpractice insurance can affect the in maternal mortality in certain states, including ability to provide maternity care and the satisfac- Indiana, Alabama, Arkansas, Arizona, Florida, tion of physicians who pay high insurance premi- Louisiana, Kansas, Missouri, Oklahoma, Texas, ums. Multivariate regression analysis of a survey and Wisconsin.58 of obstetricians and gynecologists practicing in Despite the increasing US MMR, California’s Michigan, with 365 respondents, showed paying rate decreased from 21.5 to 15.1 from 2003 more than $50,000 per year for liability insurance to 2014.6 Some have attributed the improved was associated with lower career satisfaction (odds outcomes in California to systems changes intro- ratio = 0.35; 95% confidence interval = 0.13 to duced by the CMQCC patient safety bundles.7 0.93) compared with insurance coverage provided A 2017 study of 99 hospitals (256,541 annual by an employer.64 births) showed that the use of a standardized Pregnancy is unique from a liability standpoint postpartum hemorrhage (PPH) bundle resulted in several ways: 1) two patients are involved: the in a 20.8% reduction in severe maternal mor- woman and her fetus, 2) the woman usually is bidity compared with 48 comparison hospitals healthy when she presents for care, and 3) she and (81,089 annual births) with a 1.2% reduction her family often have expectations of a perfect (P 25 BPM Acceleration Visually apparent abrupt increase in FHR. An abrupt increase is defined as an increase from the onset of acceleration to the peak in 160 BPM lasting or the baseline for that period is >160 BPM more than 10 minutes 161-180 BPM moderate indeterminate. In which case, refer to the prior 10-minute window Bradycardia 160 BPM that persists 25 BPM Increased (saltatory pattern): Nonreassuring: a bandwidth value >25 BPM 25 BPM for 15-25 minutes Abnormal: 50 minutes >25 BPM >25 minutes Sinusoidal continues AAFP = American Academy of Family Physicians; ACNM = American College of Nurse-Midwives; ACOG = The American College of Obstetricians and Gynecologists; AWHONN = Association of Women’s Health, Obstetric and Neonatal Nurses; BPM = beats per minute; FHR = fetal heart rate; RCOG Royal College of Obstetricians and Gynaecologists; SMFM = Society for Maternal-Fetal Medicine.; 40 Intrapartum Fetal Surveillance —  Intrapartum Fetal Surveillance Table 16. Comparison of Guideline Definitions of Fetal Heart Rate (continued) National Institute of Child Health and Human Development (NICHD) International Federation of National Institute for Health (Endorsed by ACOG, AAFP, SMFM, Gynecology and Obstetrics and Care Excellence (NICE) Definition AWHONN, and ACNM) (FIGO) (Endorsed by RCOG) Accelerations Visually apparent abrupt increase in Transient increase in FHR of Transient increase in FHR of FHR defines as increase from the ≥15 BPM last ≥15 seconds but ≥15 BPM last ≥15 seconds onset of the acceleration to the 5 contractions in 10 minutes in 2 successive in 10 minutes averaged over a 10-minute periods or averaged 30-minute window. Term applies to over a 30-minute period spontaneous and stimulated labor Hyperstimulation and hypercontractility are not defined and should be abandoned AAFP = American Academy of Family Physicians; ACNM = American College of Nurse-Midwives; ACOG = The American College of Obstetricians and Gynecologists; AWHONN = Association of Women’s Health, Obstetric and Neonatal Nurses; BPM = beats per minute; FHR = fetal heart rate; RCOG Royal College of Obstetricians and Gynaecologists; SMFM = Society for Maternal-Fetal Medicine. Information from National Collaborating Centre for Women’s and Children’s Health commissioned by the National Institute for Health and Care Excellence (NICE). Intrapartum care for healthy women and babies. 2017 Retrieved from https://www.nice.org.uk/guidance/cg190/chapter/Rec- ommendations; Ayres-de-Campos D, Spong CY, Chandraharan E. FIGO consensus guidelines on intrapartum fetal monitoring: Cardiotocography. Int J of Gyn Obst. 2015;131:13-24; Santo S, Ayres-de-Campos A, Costa-Santos C, et al. Agreement and accuracy using the FIGO, ACOG, and NICE cardiotocography interpretation guidelines. Acta Obst Gyn Scand. 2017. 96:166-175; Macones GA, Hankins GD, Spong CY, et al. The 2008 National Institute of Child Health and Human Development workshop report on electronic fetal monitoring: update on definitions, interpretation, and research guidelines. Obstet Gynecol. 2008;112(3):661-666. Federation of Gynecology and Obstetrics (FIGO) the prediction of fetal acidemia and showed the guidelines were introduced in 1987 and last best agreement among Category II classifications. updated in 2015, and are the only international With the FIGO and NICE guidelines, there is consensus classification.74 higher reliability, a trend toward higher sensitiv- No general recommendation has been made ity, and lower specificity in the prediction of fetal that any one nomenclature or classification acidemia. Reliability of any of the guidelines was system is preferable to another. One comparative only slight to fair.75 study evaluated the accuracy and agreement of Another study compared the five-tier and the FIGO, NICE, and NICHD classifications. FIGO classification systems. The FIGO system Overall, the NICHD guidelines were less reli- showed a greater sensitivity and lower specificity able and sensitive, but had higher specificity for to detect neonatal acidemia and severe metabolic 42 Intrapartum Fetal Surveillance —  Intrapartum Fetal Surveillance acidemia compared with the five-tier system. case of acidemia. In addition, acceleration was an Interobserver agreement was moderate for both independent factor for normal pH levels with a systems, but the five-tier system performed better sensitivity of 63.4% and specificity of 67.2%.77 in each specific category.32,75 Research is being conducted to enhance the effi- In addition, use of the five-tier system has been cacy of EFM by using computerized interpretation shown to result in improved team communication and to develop newer methodologies to monitor compared with use of the NICHD system alone. fetal well-being during labor. Specifically, one study showed that it was a more Fetal hypoxemia results in biphasic changes in effective tool for communicating nonreassuring the ST segment of the fetal electrocardiogram fetal status and increased interobserver agreement (FECG) waveform and an increase in the T/QRS on tracing interpretation (Table 18).76 ratio. ST segment automated analysis software can Although there are some overall similarities record the frequency of ST events and, when com- among these EFM nomenclatures and classifica- bined with changes in EFM, has the potential to tion systems, important differences exist. Providers determine whether intervention during the labor should familiarize themselves with these differ- process is warranted. The need for membrane ences in order to communicate effectively with rupture and internal fetal scalp monitoring is one other team members and provide appropriate care drawback to this technique. Several studies have in international settings. Table 16 and Figure 5 evaluated the effect of FECG analysis on reducing summarize the differences between the NICHD, operative vaginal deliveries, fetal scalp sampling, NICE, FIGO, and five-tier systems. Providers neonatal encephalopathy, perinatal or neonatal who plan to practice in international settings are death, seizures, 5-minute Apgar scores less than 7, encouraged to familiarize themselves with the ter- neonatal intubation, NICU admission, and fetal minology and classification systems used in their acidosis (pH levels less than 7.05).78-81 To date, particular venue. RCTs and meta-analyses of over 26,500 women Notably, in some international settings, SIA using FECG waveform analysis have failed to may be the preferred method of monitoring the show an improvement in neonatal outcomes or fetus during labor. In many low-resource set- operative delivery rates. There appears to be a tings, it may be the only option available for fetal modest reduction in metabolic acidosis; however, assessment. In addition, SIA may be performed this decrease may be primarily due to the differ- with a fetoscope rather than a handheld Doppler. ences in the methodology and quality of these Therefore, skills in SIA should be obtained before studies. The clinical significance of this observed accepting an international assignment. More modest reduction in metabolic acidosis is contro- information on intrapartum fetal surveillance and versial, and further research is needed to confirm other topics relevant to low-resource settings are this finding.82-85 available at www.aafp.org/globalalso. Another area of research is the use of computer analysis of key components of the fetal tracing,86-88 Areas of Current Research or decision analysis, for the interpretation of the A prospective trial of 8,580 births conducted EFM tracing.88 These studies have not been shown between 2010 and 2015 showed that women to improve clinical outcomes using computerized whose newborns had acidemia were more likely to analysis.86,87,89 be nulliparous and older, have higher body mass Fetal pulse oximetry was developed using an indexes and/or pregestational diabetes, and were internal monitoring device, which requires the more likely to have labor induced with prostaglan- rupture of membranes, to continuously monitor din or a Foley catheter bulb. The total decelera- fetal oxygenation saturation during labor. Trials tion area (area of FHR tracing monitored during have not shown significant differences in cesarean decelerations [Figure 2]) for the 120 minutes delivery rates or neonatal outcomes (Apgar scores, preceding delivery was the most predictive of fetal cord pH levels less than 7.0, seizures, intubation in acidemia. The Youden maximal cut point for this the delivery room, stillbirth, death, NICU admis- study was 42,152, with a sensitivity of 63.4% and sion), and a recent Cochrane review noted that specificity of 67.2%, resulting in a number needed current data provided little support for use of fetal to treat of five cesarean deliveries to prevent one pulse oximetry.83,90-92 — Intrapartum Fetal Surveillance 43  Figure 4. Comparison of Fetal Heart Rate Classification Systems NICHD (Endorsed by ACOG, AAFP AWHONN, CNM, SMFM) Category I (FHR tracings including Category II (includes all FHR tracings not categorized as Category I or III. They include any of the following) all the following) Baseline Accelerations Baseline rate: 110-160 BPM Baseline bradycardia not accompanied Absence of induced accelerations after fetal stimulation Baseline variability: 6-25 BPM by absent variability Periodic or sporadic decelerations LD and VD absent Baseline tachycardia Recurrent VD with minimal or moderate variability ED present or absent Variability PD (2-10 minutes) Accelerations present or absent Minimal variability Recurrent LD with moderate variability Absent variability with no recurrent VD with other characteristics such as slow return to decelerations baseline, overshoots, or shoulders Marked variability FIGO Normal pattern Suspicious pattern Baseline heart rate between Baseline rate 150-170 BPM OR 100-110 BPM 110-150 BPM Amplitude of variability 5-10 BPM for more Amplitude of variability 5-25 BPM than 40 minutes Increased variability above 25 BPM VD NICE (Endorsed by RCOG) Normal (CTG including all Suspicious (CTG where one of the following features is present and all others fall into the reassur- 4 features) ing category) Baseline rate 110-160 BPM Baseline rate Decelerations Accelerations Variability ≥5 BPM 100-109 BPM Typical VD with >50% of The absence of accelerations No decelerations 161-180 BPM contractions occurring with an otherwise normal trace Accelerations present Baseline variability for >90 minutes is of uncertain significance 50% contractions ize the definitions, interpretation, and general Sinusoidal pattern for >30 minutes management of FHR tracings. DR C BRAVADO ≥10 minutes LD for >30 minutes is a helpful mnemonic for defining risk and EFM Baseline variability PD >3 minutes interpretation. It is critical that institutions and 1%, especially for women admitted for from 0.28% to 33.46%.78 A larger study (ideally a bedrest RCT) would be needed to determine whether an Antenatal: Prophylactic dose of LMWH or UFH increase in heparin prophylaxis affected VTE rates Postpartum: At least 1 to 2 weeks postpartum or wound complications. Indication 8: Assisted reproductive technology The Council on Patient Safety in Women’s Antenatal: Prophylactic dose of LMWH or UFH Health Care and the Alliance for Innovation Postpartum: 6 weeks of LMWH or warfarin on Maternal Health (AIM) have developed the Maternal Venous Thromboembolism Preven- Risk factors: Obesity (BMI >30 kg/m2); age >35 years; parity ≥3; tobacco use; tion patient safety bundle that facilities may use gross varicose veins; current preeclampsia; immobility (eg, paraplegia, pelvic girdle pain with reduced mobility); family history of unprovoked or estrogen-pro- as a tool to manage VTE in a standardized and voked VTE in first-degree relative; low-risk thrombophilia; multiple pregnancy; in evidence-based manner (http://safehealthcarefor- vitro fertilization/assisted reproductive technology. everywoman.org/patient-safety-bundles/maternal- BMI = body mass index; LMWH = low-molecular-weight heparin; UHF = unfrac- venous-thromboembolism/).79 The bundle has tionated heparin; VTE = venous thromboembolism. four domains (readiness, recognition, response, Information from Chan WS, Rey E, Kent NE, et al; VTE in Pregnancy Guideline Working Group. Society of Obstetricians and Gynecologists of Canada. Venous and reporting/systems learning), which can be thromboembolism and antithrombotic therapy in pregnancy. J Obstet Gynaecol used to guide the development of local standards Can. 2014;36(6):527-553. of practice for managing VTE. — Venous Thromboembolism in Pregnancy 267 Venous Thromboembolism in Pregnancy Table 8. Comparison of Recommendations for Postcesarean Delivery Thromboembolism Pharmacotherapy Prophylaxis Organization Indication for pharmacotherapy prophylaxis ACCP Criteria: one major or two or more minor risk factors Major risk factors (one needed for prophylaxis) Minor risk factors (two needed for prophylaxis) Immobility BMI >30 kg/m2 PPH 1,000 mL with surgery Multiple pregnancy Previous VTE Emergency cesarean delivery Preeclampsia with fetal growth restriction Tobacco use >10 cigarettes/day Thrombophilia Fetal growth restriction Antithrombin deficiency Thrombophilia Factor V Leiden (homozygous or heterozygous) Protein C deficiency Prothrombin G20210A (homozygous or heterozygous) Protein S deficiency Medical conditions Preeclampsia SLE Heart disease Sickle cell disease Blood transfusion Postpartum infection ACOG Criteria: Each institution should adopt a risk assessment protocol and implement it in a systematic way RCOG Criteria: High risk (at least 6 weeks postnatal prophylactic LMWH) Two or more of following: (consider longer Any previous VTE prophylaxis if >3 risk factors) Anyone requiring antenatal LMWH Age >35 years High-risk thrombophilia Current preeclampsia Low-risk thrombophilia + family history Current systemic infection Intermediate risk (at least 10 days postnatal prophylaxis LMWH) Elective cesarean delivery Any surgical procedure in the postpartum period except Family history of VTE immediate repair of the perineum Gross varicose veins BMI ≥40 kg/m2 Immobility (eg, paraplegia, pelvic girdle pain Cesarean delivery in labor with reduced mobility, long distance travel) Medical comorbidities (eg, cancer, heart failure, active SLE, Low-risk thrombophilia IBD or inflammatory polyarthropathy, nephrotic syndrome, Mid-cavity rotational or assisted delivery type 1 diabetes with nephropathy, sickle cell disease, Multiple pregnancy current intravenous drug user) Obesity (BMI ≥30 kg/m2) Readmission or prolonged hospitalization (≥3 days) in the Parity ≥3 postpartum period PPH >1 L or blood transfusion Preterm delivery in this pregnancy (24 hours) Tobacco use Stillbirth in this pregnancy continues who may benefit from pharmacotherapy prophy- Summary laxis for VTE.80 This bundle classifies women This chapter aims to improve learner understand- as low, medium, or high risk of VTE and gives ing of the risk factors, diagnosis, and management recommendations based on ACOG and ACCP of VTE. Pregnancy is a relatively prothrombotic guidelines.80 state, but routine screening for thrombophilia is 268 Venous Thromboembolism in Pregnancy —  Venous Thromboembolism in Pregnancy Table 8. Comparison of Recommendations for Postcesarean Delivery Thromboembolism Pharmacotherapy Prophylaxis (continued) Organization Indication for pharmacotherapy prophylaxis SOGC Criteria: At least one risk factor At least three risk factors History of any prior VTE Age >35 years Any high-risk thrombophilia: antiphospholipid syndrome, Parity ≥2 antithrombin deficiency, homozygous factor V Leiden or Any assisted reproductive technology prothrombin gene mutation 20210A, combined thrombophilia Multiple pregnancy Strict bed rest prior to delivery for 7 days or more Placental abruption Peripartum or postpartum blood loss of >1 L or blood product Prelabor rupture of membranes replacement, and concurrent postpartum surgery Elective cesarean delivery Peripartum/postpartum infection Maternal cancer At least two risk factors BMI ≥30 kg/m2 at first antepartum visit Tobacco use (>10 cigarettes/day antepartum) Preeclampsia Intrauterine growth restriction Placenta previa Emergency cesarean delivery Peripartum or postpartum blood loss of >1 L or blood product replacement Any low-risk thrombophilia (protein C or protein S deficiency, heterozygous factor V Leiden, or prothrombin gene mutation 20210A) Maternal cardiac disease, SLE, sickle cell disease, IBD, varicose veins, gestational diabetes Preterm delivery Stillbirth ACCP = American College of Chest Physicians; ACOG = American College of Obstetricians and Gynecologists; BMI = body mass index; IBD = inflammatory bowel disease; IV = intravenous; LMWH = low-molecular-weight heparin; PPH = postpartum hemorrhage; RCOG = Royal College of Obstetricians and Gynaecologists; SLE = systemic lupus erythematosus; VTE = venous thromboembolism. Information from Palmerola KL, D’Alton ME, Brock CO, Friedman AM. A comparison of recommendations for pharmacologic thromboembolism prophylaxis after caesarean delivery from three major guidelines. BJOG. 2016;123(13):2157-2162; Chan WS, Rey E, Kent NE, et al; VTE in Preg- nancy Guideline Working Group; Society of Obstetricians and Gynecologists of Canada. Venous thromboembolism and antithrombotic therapy in pregnancy. J Obstet Gynaecol Can. 2014;36(6):527-553. not recommended. Providers must maintain a American College of Chest Physicians, ACOG, high level of suspicion in women presenting with SOGC, and RCOG guidelines provide recom- symptoms suggestive of VTE in any trimester. mendations for treating and preventing VTE; local Doppler ultrasound is the initial diagnostic test of practice should be well-established based on the choice for DVT or PE in women who are stable, best available evidence. Regional anesthesia is not and treatment for DVT or suspected PE should contraindicated in women receiving prophylactic be initiated with positive ultrasound findings. or therapeutic anticoagulation; however, guide- High clinical suspicion in the absence of positive lines should be followed regarding safe timing. diagnostic studies should not delay treatment, Recommendations about postcesarean delivery and follow-up testing can be pursued even after VTE prophylaxis vary. The key to diagnosing therapy is initiated. Priority should be placed on these conditions is clinical vigilance coupled with stabilizing women who are unstable, with close appropriate laboratory or imaging studies, while consultation as indicated. LMWH is the agent of balancing maternal and fetal well-being in diag- choice for treatment and prophylaxis. nostic and treatment decisions. — Venous Thromboembolism in Pregnancy 269 Venous Thromboembolism in Pregnancy Nursing Considerations: Venous Thromboembolism in Pregnancy Identify women with risk factors for VTE, including pregnancy/postpartum, mode of delivery, and history Be familiar with signs and symptoms of and diagnostic tests for DVT and PE Advocate for early ambulation postdelivery Champion efforts to implement the Maternal Venous Thromboembolism Prevention Patient Safety Bundle DVT = deep vein thrombosis; PE = pulmonary embo- lism; VTE = venous thromboembolism. 270 Venous Thromboembolism in Pregnancy —  PATIENT COUNCIL ON PATIENT SAFETY IN WOMEN’S HEALTH CARE SAFETY safe health care for every woman BUNDLE Thromboembolism Prevention Maternal Venous READINESS Every Unit Use a standardized thromboembolism risk assessment tool for VTE during: Outpatient prenatal care Antepartum hospitalization Hospitalization after cesarean or vaginal deliveries Postpartum period (up to 6 weeks after delivery) RECOGNITION & PREVENTION Every Patient Apply standardized tool to all patients to assess VTE risk at time points designated under “Readiness” Apply standardized tool to identify appropriate patients for thromboprophylaxis Provide patient education Provide all healthcare providers education regarding risk assessment tools and recommended thromboprophylaxis RESPONSE Every Unit Use standardized recommendations for mechanical thromboprophylaxis Use standardized recommendations for dosing of prophylactic and therapeutic pharmacologic anticoagulation Use standardized recommendations for appropriate timing of pharmacologic prophylaxis with neuraxial anesthesia REPORTING/SYSTEMS LEARNING Every Unit Review all thromboembolism events for systems issues and compliance with protocols Monitor process metrics and outcomes in a standardized fashion Assess for complications of pharmacologic thromboprophylaxis © 2015 American College of Obstetricians and Gynecologists. Permission is hereby granted for duplication and distribution of this document, in its entirety and without modification, for solely non-commercial activities that are for educational, quality improvement, and patient safety purposes. All other uses require written permission from ACOG. Standardization of health care processes and reduced variation has been shown to improve outcomes and quality of care. The Council on Patient Safety in Women’s Health Care disseminates patient safety bundles to help facilitate the standardization process. This bundle reflects emerging clinical, scientific, and patient safety advances as of the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed. Although the components of a particular bundle may be adapted to local resources, standardization within an institution is strongly encouraged. The Council on Patient Safety in Women’s Health Care is a broad consortium of organizations across the spectrum of women’s health for the promotion of safe health care for every woman. October 2015 For more information visit the Council’s website at www.safehealthcareforeverywoman.org Reprinted from Council on Patient Safety in Women’s Health Care. AIM-Supported Patient Safety Bundles. Maternal Venous Thromboembolism Preven- tion. Available at https:​//safehealthcareforeverywoman.org. — Venous Thromboembolism in Pregnancy 271 Venous Thromboembolism in Pregnancy References 17. Bates S, Jaeschke R, Stevens S, et al. Diagnosis of DVT:​antithrombotic therapy and prevention of Throm- 1. ACOG Practice Bulletin no. 196:​thromboembolism in bosis, 9th ed:​American College of Chest Physicians pregnancy. Obstet Gynecol. 2018;​132(1):​e1-e17. Evidence-Based Clinical Practice Guidelines. Chest. 2. Heit JA, Kobbervig CE, James AH, et al. Trends in the 2012;​141(2 Suppl):​e351S-e418S. incidence of venous thromboembolism during preg- 18. Chan WS, Spencer FA, Ginsberg JS. Anatomic distribu- nancy or postpartum:​a 30-year population-based study. tion of deep vein thrombosis in pregnancy. CMAJ. 2010;​ Ann Intern Med. 2005;​143(10):​697-706. 182(7):​657-660. 3. Kourlaba G, Relakis J, Kontodimas S, et al. A system- 19. Chan WS, Lee A, Spencer FA, et al. Predicting deep atic review and meta-analysis of the epidemiology and venous thrombosis in pregnancy:​out in “LEFt” field? burden of venous thromboembolism among pregnant Ann Intern Med. 2009;​151(2):​8 5-92. women. Int J Gynaecol Obstet. 2016;​132(1):​4 -10. 20. Righini M, Jobic C, Boehlen F, et al;​EDVIGE study 4. Doyle NM, Ramirez MM, Mastrobattista JM, et al. Diag- group. Predicting deep venous thrombosis in preg- nosis of pulmonary embolism:​a cost-effectiveness nancy:​external validation of the LEFT clinical prediction analysis. Am J Obstet Gynecol. 2004;​191(3):​1019-1023. rule. Haematologica. 2013;​98(4):​5 45-548. 5. Kreidy R. Pathophysiology of post-thrombotic syndrome:​ 21. Nijkeuter M, Ginsberg JS, Huisman MV. Diagnosis of the effect of recurrent venous thrombosis and inherited deep vein thrombosis and pulmonary embolism in preg- thrombophilia. ISRN Vascular Med. 2011;​513503. nancy:​a systematic review. J Thromb Haemost. 2006;​ 6. Gerhardt A, Scharf RE, Zotz RB. Effect of hemostatic 4(3):​496-500. risk factors on the individual probability of thrombosis 22. Kearon C, Akl EA, Comerota AJ, et al. Antithrombotic during pregnancy and the puerperium. Thromb Hae- therapy for VTE disease:​antithrombotic therapy and most. 2003;​90(1):​7 7-85. prevention of thrombosis, 9th ed:​American College