During the twentieth century, maternal mortality has decreased drastically from 900 deaths per 100,000 live births in the early 1900s to 7.5 deaths per 100,000 live births in the 1980s.1 This decline was due mostly to medical and technological advances; however, health systems surveillance programs, such as the Confidential Enquires into Maternal Deaths program in the United Kingdom, have also played a role in identifying causes of maternal deaths, and subsequently reducing maternal mortality.2 These ongoing surveillance programs have led to systematic patient care improvements and encouraged the use of protocol-driven patient care.2
Primary postpartum hemorrhage (PPH), classified as hemorrhage that occurs within 24 hours of delivery, occurs in 4% to 6% of pregnancies.3 Most commonly due to uterine atony, PPH is the single most significant cause of maternal death worldwide and an important contributor to maternal deaths in the United States.3–5 More than half of all maternal deaths from hemorrhage occur within 24 hours of delivery leading to an estimated 140,000 worldwide deaths and a cause-specific maternal mortality rate of 1:50,000 annually within the United States.6,7 Multiple reviews suggest that a percentage of PPH-related deaths may be preventable through improvements in care.8,9 Although the incidence of hemorrhage-related morbidity is higher than hemorrhage-related mortality,10 the preventability of PPH-related morbidity has not been studied. It is likely that improvements in care would decrease hemorrhage-related morbidities such as anemia, exposure to blood products, and myocardial ischemia11 as well as decrease postpartum intensive care unit admission.12
Diagnosis and timely treatment are crucial to reduce PPH-related morbidity and mortality.13 Unfortunately, late recognition of PPH is common due not only to inaccurate estimation of blood loss but also because young healthy parturients often do not become symptomatic until significant blood loss has occurred, at which point coagulopathy may complicate clinical management.14–17 In general, massive PPH necessitates supportive measures such as large-bore IV access, fluid, and possibly blood product resuscitation, as well as communication and coordination among hospital laboratories, blood bank, and multispecialty teams.
The Joint Commission on the Accreditation of Healthcare Organizations recommended the adoption of protocols to reduce maternal morbidity and mortality associated with PPH.18 In May 2013, the American Congress of Obstetricians and Gynecologists and the Society for Maternal Fetal Medicine convened the National Partnership for Maternal Safety (NPMS) for the “National Maternal Health Initiative: Strategies to Improve Maternal Health and Safety” consensus conference.a The workgroup recommended patient “safety bundles” that consist of protocols and necessary equipment for managing obstetric emergencies. The number one priority in the obstetric hemorrhage bundle was the presence of a unit-standard obstetric hemorrhage protocol. The availability of PPH protocols in obstetric units is currently unknown; however, given the importance of such protocols, we hypothesized that 80% of all academic obstetric anesthesia units would have such a protocol in place.
In this IRB-approved study, a literature review was conducted, and a survey was developed by 2 of the investigators. The survey was then reviewed by an expert panel of 2 obstetric anesthesiologists. The final survey was reviewed by all of the authors for face validity. The survey is available as a Web supplement (Supplemental Digital Content 1, http://links.lww.com/AA/A982).
The survey consisted of 2 domains: obstetric unit characteristics (delivery volume, cesarean delivery [CD] rate, and PPH rate) and the existence of a PPH protocol. If there was no PPH protocol, the respondent was asked whether there were plans to develop a PPH protocol. Respondents with a PPH protocol were asked about specific components of the protocol. All respondents were asked about the existence of other NPMS patient safety bundle components such as a hospital-wide massive transfusion protocol (MTP), PPH hemorrhage cart, and assessment of blood loss.
The contact information for United States obstetric anesthesia directors was obtained from a list created for a previous study.19 The names and contact information were updated and verified before use in this study. Delivery volume for nonresponders with an obstetric anesthesia fellowship was obtained separately by review of the Society for Obstetric Anesthesia and Perinatology Obstetric Anesthesia Fellowship Directory.
An electronic invitation to complete the survey was mailed to all of the directors with a valid e-mail address (N = 104). Nonresponders received 3 reminder emails at 2-week intervals. Survey completion implied informed consent for study participation. The survey was conducted between October and December 2012.
The primary outcome was the percentage of obstetric anesthesia units that had a PPH protocol in place. A 1-sample t test was used to compare the percentage of responding units with a hemorrhage protocol to the hypothesized mean of 80%. Univariate statistics were used to characterize survey responses (counts, percentages, and medians). Delivery volume for respondents versus nonrespondents was compared using a 2-tailed t test. Delivery volume was dichotomized at the median, and the likelihood of having a PPH protocol was adjusted for delivery volume using logistic regression. Multiple imputations were used to impute the presence of a PPH protocol based on delivery volume in nonresponding hospitals using a logistic regression model. Probability distributions for PPH protocol availability and rapid response team availability were estimated using the binomial distribution. Two-sided 95% confidence intervals are reported. Obstetric units were then stratified by PPH protocol availability. Normal distribution was assessed and delivery volume and PPH rates were compared using a Mann-Whitney U test and a 2-tailed t test, respectively. A P value <0.05 was considered significant. Data were analyzed using Stata SE (version 10, StataCorp LP, College Station, TX).
Sixty directors of academic obstetric anesthesia units responded for a 58% response rate. There were no differences in delivery volume between survey responders and nonresponders (P = 0.06) (data not shown).
Unit Characteristics and PPH Protocol Availability
The percentage of units with a PPH protocol among responding units was lower than hypothesized (P = 0.03). Sixty-seven percent of responding U.S. academic obstetric anesthesia units have a PPH protocol (95% CI: 53%–78%). More than half of those units used a database to track PPH. Units with a PPH protocol had a higher median annual delivery volume compared to units without PPH protocol; however, there were no differences in the annual CD or overall PPH rates between the 2 groups (Table 1). High-delivery volume hospitals were more likely than smaller volume hospitals to have a PPH protocol in place (odds ratio 3.16, 95% CI: 1.01–9.90). Adjusting for delivery volume among nonresponding hospitals, we estimate that 67% (95% CI: 55%–77%) of all academic obstetric anesthesia units had a PPH protocol in place.
In the 20 responding units that did not currently have a PPH protocol, 10 of the 18 responding units were either currently developing a protocol, or planning to develop one in the future. The median reported rate of PPH among all responding units was 5% (interquartile range [IQR]: 3%–7%).
Blood Loss Estimation
Peripartum blood loss is estimated visually in 98% of responding units. Some units also combine visual estimation with gravimetric techniques (20% units) and/or calculations based on starting and final hematocrit (12% units). Obstetricians estimate blood loss for vaginal delivery in 92% of centers compared with 52% for CDs. In contrast, anesthesiologists contribute to estimation of blood loss for the CDs in the majority of centers (87%), but participate in vaginal delivery blood loss estimation in only 13% of centers (Fig. 1).
PPH Protocol Usage
Seventy-five percent of units with PPH protocols include provision within the protocol for staged escalation of care based on severity of hemorrhage. These include increasing venous and arterial access, upgrading blood status, consultation of multispecialty care teams, including interventional radiology and gynecology oncology, blood salvage, and postoperative intensive care. Timing of such measures depends most commonly on the discretion of the care team.
Massive Transfusion Protocol
There was an MTP in 95% of units with a PPH protocol, and in 90% of units without one (95% CI of difference: −7% to 7%). Initiation criteria for MTP were used in 43% of responding units. Of units that described these criteria, estimated blood loss of more than 1500 mL with ongoing bleeding was the most common trigger to initiate the MTP.
The median number of units of packed red blood cells (PRBC), fresh frozen plasma (FFP), cryoprecipitate and platelets (PLT) included in the MTPs were 6 (IQR 4–6), 4 (IQR 4–5), 1 (IQR 0–1), and 1 (IQR 1–1), respectively. For the purpose of the survey, 1 “unit” of cryoprecipitate or PLT was considered to be 1 bag of product. The median number of donors in 1 bag of product is 5 (IQR 4–6) for cryoprecipitate and 6 (IQR 5–6) for PLT.
A fixed blood component transfusion ratio was in place in 79% of the units, with 48% using a 1:1 PRBC:FFP ratio and 35% using a 1:1:1 PRBC:FFP:PLT ratio. The decision to transfuse cryoprecipitate was most commonly based on clinical judgment and clinical signs of hypofibrinoginemia. The most common laboratory evaluation-based transfusion threshold was fibrinogen less than 150 mg/dL. Only 1 unit reported transfusion based on thromboelastography or thromboelastometry (Fig. 2).
Maternal Code/Rapid Response Team
A code team or rapid response team for severe obstetric hemorrhage was available in 57% of units, with no difference between units with or without a PPH protocol (mean difference 4%, 95% CI: −24%–32%).
There was a dedicated hemorrhage cart in 18% of responding units. The most common cart items are supplies for initiating venous or arterial access, and materials for obtaining/sending labs (Fig. 3).
The important finding of this study is that only 67% of responding obstetric anesthesia units had a PPH protocol, below our hypothesized percentage. At least 20% of all academic obstetric units lacked a PPH protocol at the time of survey completion based on 20 responding units without a protocol in place. The lack of universal hemorrhage protocol availability is of concern because both the Joint Commission and a consensus conference on maternal safety recommend that protocols be developed for high-risk obstetric conditions, such as PPH.18 Although a nationwide epidemiological study showed PPH occurs in only 4%–6% of all deliveries,3 death from PPH remains a leading cause of maternal death in the United States and worldwide.6,7 Thus, the establishment of protocols is a key patient safety priority, because this could ensure suggested care pathways or minimal standards of care.
The NPMS patient safety bundle for maternal hemorrhage mandates development of PPH protocols, including thresholds for escalation of care, in all obstetric units. It also calls for hospital-wide MTPs including fixed transfusion ratios, set methods of blood loss estimation, and maintenance of hemorrhage carts.
More than 90% of responding units have a hospital-wide protocol for management of massive transfusion. Regimented use of MTPs and set transfusion ratios are heavily supported in the trauma literature with noted decreased incidence of sepsis, organ failure, and death.20 Although the optimal ratio of blood products to transfuse during PPH is unknown, a recent large retrospective study of transfusion in PPH found an association between higher FFP:red blood cell (RBC) ratio and lower odds of requiring an advanced interventional procedure.21 Our results indicate that nearly 80% of responding academic obstetric anesthesia units use a low RBC:FFP and/or RBC:FFP:PLT ratio during massive transfusion, but use of a 1:1 or 1:1:1 ratio is split. Additional randomized controlled studies are needed to determine the optimal transfusion ratio during massive hemorrhage due to PPH.
Although the majority of PPH protocols of surveyed units include measures for escalation in monitoring, or treatment, or both, few specify the blood loss threshold at which specific actions should occur. Responses suggest that while protocols may provide a list of potential interventions, the actual combination of executed actions remains at anesthesiologist and care team discretion. The NPMS safety bundle acknowledges that individual protocols will vary based on institutional and unit needs and resources; however, the committee also stressed that staged intervention including a nurse checklist is crucial to ensuring best care. The use of such a staged protocol led to earlier resolution of hemorrhage, reduced blood product utilization, and improved physician and staff perception of patient safety.22 The most effective combination of protocol or checklist-driven care versus physician discretion-driven care in PPH is unknown; however, additional outcomes will likely become available as obstetric units implement the NPMS-recommended staged PPH protocols.
Only a small percentage of responding units maintained a PPH cart, and the reported content of carts was heterogeneous. We did not solicit information regarding obstetric supplies (i.e., sutures, surgical instruments, or Bakri balloons) in hemorrhage carts, and such tools are featured in NPMS safety bundle recommendations.
We acknowledge that our study has limitations. First, our sample size was limited by the response rate of 58%. There is the possibility of responder bias, and responders may have been more interested in responding if there was a hemorrhage protocol in their institution. In addition, we elicited responses only from directors of academic obstetric anesthesia units. Although these directors could be considered opinion leaders in obstetric anesthesia, their responses do not represent a true cross section of PPH protocol use nationally. Furthermore, because only 1 individual at each institution was surveyed, it is possible that there may have been variability among providers in knowledge or awareness of PPH protocol components. If there are no hemorrhage protocols universally in academic obstetric anesthesia units, it is likely that these protocols do not exist in all community hospitals either, yet community hospitals were not surveyed as part of this study.
Protocol development is time-consuming, and successful implementation requires considerable resources, multidisciplinary cooperation, and education. Our results suggest there may remain opportunities for improvement and education on development and implementation of such protocols at academic obstetric anesthesia units to best meet the expectations of the NPMS patient safety bundle and the Joint Commission recommendation regarding protocol-driven treatment of PPH.
Name: Rachel M. Kacmar, MD.
Contribution: This author helped design the study, conduct the study, analyze the data, and write the manuscript.
Attestation: Rachel M. Kacmar has seen the original study data, reviewed the analysis of the data, approved the final manuscript, and is the author responsible for archiving the study files.
Name: Jill M. Mhyre, MD.
Contribution: This author helped design the study, conduct the study, and write the manuscript.
Attestation: Jill M. Mhyre approved the final manuscript.
Name: Barbara M. Scavone, MD.
Contribution: This author helped design the study, conduct the study, and write the manuscript.
Attestation: Barbara M. Scavone approved the final manuscript.
Name: Andrea J. Fuller, MD.
Contribution: This author helped write the manuscript.
Attestation: Andrea J. Fuller approved the final manuscript.
Name: Paloma Toledo, MD, MPH.
Contribution: This author helped design the study, conduct the study, analyze the data, and write the manuscript.
Attestation: Paloma Toledo has seen the original study data, re viewed the analysis of the data, and approved the final manuscript.
This manuscript was handled by: Steven L. Shafer, MD.
a SMFM/ACOG Maternal Safety Consensus Meeting, May 5, 2013. Maternal Safety Bundle Obstetric Hemorrhage. Available at: https://www.dropbox.com/sh/glb9k2379lhh5nw/MwWD9RjYvJ/Obstetric%20Hemorrhage%20Bundle/Obstetric%20Hemorrhage%20Safety%20Bundle%20Key%20Elements.pdf. Accessed October 1, 2013.
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