Krening, Cynthia F. MS, RNC-OB, C-EFM; Rehling-Anthony, Kimberly MSN, RN, WHNP, IBCLC, C-EFM; Garko, Candace MSN, RNC-OB, C-EFM
The frequency of labor inductions increased 125% between 1989 and 2001.1 Some of the causes of this upward trend include the availability of cervical ripening agents, consumer pressure, provider convenience, and the obstetrical medicolegal practice environment. In many facilities across the United States, spontaneous labor is less frequently seen than scheduled labor induction. This development has led to an increase in obstetrical interventions to facilitate birth. These interventions include the utilization of oxytocin, artificial rupture of membranes, episiotomy, forceps or vacuum application, and cesarean delivery.2
Oxytocin is the most commonly used induction agent worldwide, and is utilized to stimulate or augment labor in 50% of all births in the United States2 Furthermore, one of the leading causes of obstetrical liability claims involves the administration of oxytocin leading to tachysystole.3 Healthcare providers have become accustomed to routinely administering this potent medication to pregnant women, most of whom would labor and deliver independently without the risks associated with the administration of oxytocin if allowed to do so.4
A collaborative of Perinatal Clinical Nurse Specialists and Obstetric Nurse Educators for a 9-hospital healthcare system throughout Colorado undertook a system-wide process-improvement project to increase safety for pregnant women receiving oxytocin. The goal of this initiative was to decrease risk exposure by successfully implementing a standardized evidence-based protocol and processes across the healthcare system. This included a standardized oxytocin mixture, low-dose administration guidelines, and utilization of safety checklists to assure fetal and maternal well-being before initiation of oxytocin and increases in oxytocin dosages. This article will outline the journey taken toward the successful transition in oxytocin administration and management and the associated outcomes.
Centura Health, in Colorado, is a private, nonprofit, healthcare system that includes 11 hospitals, 9 of which provide obstetric care (at the time of this project, only 10 hospitals were Centura Health facilities, and 9 had obstetric services). The facilities are located in a variety of settings ranging from small, rural communities to large urban areas. Delivery volumes range from less than 25 births per month to more than 200 births per month.
In 2006, the Centura Perinatal Council, a collaborative of Perinatal Clinical Nurse Specialists and Obstetric Nurse Educators from each facility began performing a perinatal safety analysis utilizing the Institute for Healthcare Improvement white paper—Idealized Design of Perinatal Care—as a framework.5 Because of the credibility of Institute for Healthcare Improvement within the Centura Health system, the council quickly gained support from leadership to evaluate and change practice to enhance perinatal safety. Beginning in 2007, Centura Health leadership committed to a more formal evaluation of perinatal safety and hired nationally recognized consultants to conduct a Perinatal Services Quality Review at each facility. At that time, various induction and augmentation protocols were in place throughout the 9 hospitals. The protocols varied in oxytocin concentration as well as the initial and incremental dose ranges and frequency of titration. The initial and incremental doses ranged from 0.5 to 6 mU/min. The frequency of titration ranged from 20 to 60 minutes. There was also variation in nursing practice. Some facilities utilized the philosophy of increasing or decreasing the oxytocin on the basis of labor progress and the physiological response to the medication. Other facilities continued to increase the oxytocin in a systematic fashion every 20 minutes with the common practice of “pitting to distress” or “pitting through” excessive uterine activity.
Upon the conclusion of the quality review, it was determined across the healthcare system that there was an increased incidence of “oxytocin-induced hyperstimulation (tachysystole) or oxytocin overdose.” Uterine tachysystole was defined according to the National Institute of Health and Human Development's guidelines for electronic fetal monitoring as greater than 5 contractions in 10 minutes averaged over a 30-minute window.6 The consultants recommended a reduction in the incidence of hyperstimulation (tachysystole) and concluded that by doing so, the healthcare system would have a reduction in associated medicolegal risk. The combination of the recommendations from the quality review as well as emerging literature provided the Perinatal Council with significant evidence to proceed forward with this process-improvement project.
The initial review of the literature revealed important information regarding oxytocin that was summarized and presented to key stakeholders as this project began. Oxytocin was designated as a high-alert medication in 2007 by the Institute for Safe Medical Practice.7 High-alert medications are recognized as those that require special considerations and precautions before and during administration and carry an increased risk of causing significant patient harm when used in error, and patient injury from administration is the most common type of adverse event that can occur.7 Specific to oxytocin, errors are usually dose related involving fetal heart rate (FHR) changes after a lack of timely recognition and inappropriate treatment of uterine tachysystole.7
It is evident by the frequent utilization and risk profile of oxytocin that a thorough understanding of safe administration and management of the drug is critical. The goal of oxytocin administration is stimulation of uterine contractions that are normal in intensity, duration, and frequency, and to avoid tachysystole and fetal compromise.8 Controversy has existed for years about dosage and rate increase intervals of oxytocin.4,8–13 Large variations in oxytocin protocols exist without clear demonstration of superiority of any specific regimen. Currently, preference for 2 administration protocols prevails: low-dose and high-dose oxytocin. Each protocol varies in the initial dose, incremental dose, dosage interval, and maximum dose administered.11,14
Oxytocin, whether endogenous or exogenous, works within the myometrium to stimulate oxytocin receptor cells that in turn stimulate contractions of the uterine muscle. Oxytocin receptor cells, similar to other receptor cells, once saturated are unable to absorb any more of the drug, thus increasing the potential for undesirable effects.10,11,15 With increasing levels of exogenous oxytocin, the receptor sites become desensitized and are unable to initiate a myometrial contraction.12,15
If the oxytocin receptor sites are not saturated, they continue to absorb oxytocin and to signal the myometrium to contract.12 The half-life of oxytocin is brief, between 10 and 12 minutes.12 Three to 5 half-lives are required to achieve steady state concentration and uterine response would be notable within 30 to 60 minutes after the steady state of oxytocin is achieved.12 With this knowledge, it becomes evident that high-dose protocols that saturate the receptor sites quickly without allowing a steady state to be achieved will increase the risk for tachysystole of the uterine muscle and the potential for category II and category III FHR tracings.11,14
Uterine activity has been shown to affect the fetus in a variety of ways. Fetal oxygen saturation levels are lower after a uterine contraction and require, on the average, 2 minutes to return to the precontraction value.16 Simpson and James17 demonstrated a steady decline in fetal oxygen saturation with persistent increased uterine activity. Additionally, increased uterine activity has been linked to lower pH values in the umbilical artery, indicating fetal acidemia.18 When oxytocin receptor sites are slowly saturated and the steady-state response of the drug is reached before increasing the titration, less uterine tachysystole occurs, thus reducing the risk of fetal acidemia.4
The Hospital Corporation of America published outcomes data after implementation of a conservative checklist-based protocol for oxytocin administration.19 The Hospital Corporation of America protocol was based on maternal and fetal responses to oxytocin rather than infusion rate. This approach led to lower oxytocin infusion rates without lengthening labor or increasing operative intervention.19 Implementation of a low-dose oxytocin protocol with safety checklists in place for the safest administration of this high-alert medication to minimize risks of adverse effects seems timely in this era increasingly focused on maternal-fetal safety.
The initiation of this project began by gathering preintervention data: the average length of labor for both primigravidas and multiparous women, and the incidence of hyperstimulation (now tachysystole). After presenting the evidence and preintervention data to key stakeholders, it was determined that the project would be more successful if a multidisciplinary subcommittee was developed to draft the new oxytocin policy and processes. Including providers in the process was essential to the success of the project. The providers could then serve as champions of the new process with their peers. The subcommittee represented 6 of the 9 hospitals and consisted of the 3 clinical nurse specialists, a perinatologist, and an obstetrics-gynecology physician.
The subcommittee reviewed the evidence and chose a conservative, safety-based approach to minimize error and risk. Although no specific regimen of oxytocin administration had conclusively proven to ensure superior outcomes for mother and infant, the fundamental principle of patient safety and the designation of oxytocin as a high-alert medication led to selection of a protocol that administered the lowest amount of medication without significantly lengthening labor or increased the incidence of cesarean delivery. Prerequisites for administration include: provider order, verification of vertex presentation, an available labor and delivery nurse, physician with cesarean delivery privileges readily available, Bishop score assessment (if score is <6, provider will be notified), reassuring FHR assessment for a minimum of 10 minutes of the previous 30 minutes (now category I FHR), terbutaline readily available, continuous electronic fetal monitoring, and confirmation that the woman has been educated by the obstetric provider about the purpose of, indication for, risks and benefits of, and alternatives to oxytocin administration.
The oxytocin preparation was converted at each facility to a standardized mixture of 30 units of oxytocin in 500 mL of intravenous fluid. This mixture enhances safety by creating a concentration of 1 mU of oxytocin equaling 1 mL/h via infusion pump. The policy outlines a standardized starting dose of 0.5 to 2 mU/min, incremental doses of 1 to 2 mU/min every 30 to 60 minutes, and a maximum oxytocin dose of 20 mU/min without bedside assessment and an additional order by the provider. The nurse at the bedside is expected to titrate the oxytocin to meet a contraction goal of 3 to 4 contractions in a 10-minute period that are moderate to strong per palpation or a minimum strength of 60 mm Hg via an intrauterine pressure catheter. The rate of oxytocin should not be increased after an adequate labor pattern is established with adequate cervical change. If cervical change does not occur, the nurse may continue to increase the rate of oxytocin every 30 to 60 minutes, providing the FHR is category I, and there is no evidence of tachysystole. However, labor arrest or protraction disorder must be evaluated and ruled out by the provider. The protocol assures administration of the lowest dose of oxytocin possible to achieve cervical change and labor progress.
The goal of the low-dose regimen is to avoid tachysystole and to treat it in a timely manner if it occurs. Treatment for tachysystole in the presence of a reassuring FHR tracing as well as during a nonreassuring FHR tracing was clearly outlined (see Figure 1). The policy delineates the expectation that interventions for tachysystole should not be delayed until changes in the FHR pattern are noted. Time frames for restarting oxytocin after discontinuation were also included in the policy (Figure 1). The policy has since been updated to replace the terms reassuring and nonreassuring with the FHR categories I–III (Figure 1).6
Signs and symptoms of complications associated with oxytocin administration were also addressed in the policy. The potential complication of water intoxication after extended administration of oxytocin requires monitoring for headache, nausea and vomiting, mental confusion, decreased urinary output, hypotension, tachycardia, cardiac arrhythmias, and/or convulsions. Assessing for signs and symptoms of impending or actual uterine rupture includes recognition of uterine tenderness, suprapubic pain, uterine tachysystole, abdominal rigidity, vaginal bleeding, indeterminate or abnormal FHR tracing, loss of station, loss of intrauterine pressure or sudden cessation of uterine contractions, hypotension, maternal tachycardia, and/or loss of consciousness.
A standardized order set was developed to reflect the new policy for induction and augmentation with oxytocin. This assisted in the reinforcement of a standardized approach for the initiation and management of oxytocin across the healthcare system.
The draft policy was shared with the members of the Perinatal Council for input and revisions. In response to concerns about the prerequisite of “education by the provider about oxytocin prior to its initiation,” the group created an educational handout for pregnant women titled “What You Should Know About Pitocin” (see Figure 2).
The handout was shared with providers to obtain input and approval for dissemination. Physicians and midwives were supportive of standardized oxytocin education and a way to assure education was accomplished for the pregnant woman when they were not at the bedside to provide it themselves.
Preuse and in-use oxytocin checklists
After review of the literature,5,19 it was concluded that Centura Health would utilize oxytocin checklists similar to those described in the publication by Clark et al19 (see Figures 3 and 4). The checklists described by Clark et al19 included components of the Institute for Healthcare Improvement induction/augmentation bundles,5 as well as oxytocin management criteria. The successful outcomes demonstrated by Hospital Corporation of America after implementation of checklists for oxytocin infusion provided strong evidence for their adoption in this project.19
The preuse oxytocin checklists are completed by the labor and delivery nurse after receiving an order to initiate oxytocin. If all items on the checklist cannot be completed, oxytocin cannot be started, and the provider is notified. Once oxytocin is running, the in-use oxytocin checklist is to be completed every 30 minutes during the infusion. If all elements of the in-use checklist are not present, the infusion must be decreased or discontinued.
The checklists have since been amended to incorporate the National Institute for Child Health and Human Development terminology6 for assessment of FHR tracings. They also have been built into the electronic documentation system utilized during labor at all Centura Health facilities. Thus, completion of the checklists is part of the routine documentation completed by all labor and delivery nurses during induction or augmentation of labor with oxytocin.
After approval of the policy and checklists by the Centura Perinatal Council, the processes of implementation were initiated. To gain understanding and support from the administration at each facility, the entire project with supporting data and literature was presented to the chief nursing officer/chief medical officer group for Centura Health. The chief nursing officer/chief medical officer group gave approval and their commitment to support the implementation of this project at their respective facilities.
The education sheet regarding oxytocin was made available at each hospital for women who needed additional information prior to initiation of oxytocin. Each Perinatal Council representative identified key physician stakeholders at their individual facility. This provided the council member with a physician counterpart to assist in championing the practice change. In the spring of 2009, physicians, certified nurse midwives, residents, and nurses at each facility were educated about the new policy, patient education sheet, and oxytocin checklists by their Perinatal Council representative and physician champion. Some facilities had more resistance to the change than others. The subcommittee physicians who had assisted in the development of the policy presented the literature as well as answered questions in an open forum at the facilities that were experiencing more resistance. Leadership supported a clear implementation timeline for transition to the new policy. The expectation was that each facility would adhere to the timeline and implement the practice change.
A quality improvement (QI) form to monitor the outcomes of the initiative was developed (see Figure 5). Education regarding the practice changes and criteria being evaluated was provided to the nursing staff before requesting them to complete the QI form. The QI tool was implemented for data collection 1 month prior to the practice changes. Each facility completed a concurrent review of a minimum of 30 charts, or 100% of the charts if 30 did not independently exist within the population. The QI form was continued for the duration of monitoring after the new policies were implemented. The form was initiated by the nurse who began the oxytocin infusion, and was completed after delivery by the delivering nurse. A spreadsheet was created for the Perinatal Council members to enter pertinent data by facility to track and trend outcomes of the safety initiative. The data on the spreadsheet are divided by primigravidas and multigravidas. Relevant data on the form include Bishop score when oxytocin initiated, length of time from initiation of oxytocin to delivery, type of delivery, maximum dose of oxytocin administered, and whether tachysystole was noted during oxytocin infusion.
Average length of labor prior to initiation of the new oxytocin policy with accompanying checklists was 10 hours for primigravidas and just under 8 hours for multigravidas. In 2009, after initiation of the changes, the average length of labor was 9 hours for primigravidas and 61/2 hours for multigravidas. In 2010, primigravidas averaged 91/2 hours of labor and multigravidas averaged just over 6 hours of labor on oxytocin. From January 2011 through May 2011, primigravidas averaged 91/2 hours of labor and multigravidas averaged 61/2 hours (see Figure 6).
On the basis of a 2-tailed t test comparing the mean of the months postimplementation to the preimplementation value, hours receiving oxytocin for both primigravida (P < .0005; 8.783 vs 9.9) and multigravida (P < .0005; 6.221 vs 7.8) women were significantly lower. By decreasing length of labor an average of 1 hour, and thereby length of stay by 1 hour, the theoretical financial impact to the healthcare system has been a savings of at least $173,000 per year if volume remains constant.
The baseline incidence of tachysystole was determined by a retrospective review of FHR tracings by the Perinatal Council member from each facility. The facility representative audited 30 charts from 1 month (or 100% of charts if there were less than 30 receiving oxytocin for induction or augmentation in 1 month). The entire FHR tracing was reviewed for the presence or absence of tachysystole. The overall incidence of tachysystole for all hospitals across the system, based on the review, was 54%. After implementation of the changes, the tachysystole incidence was 23% in 2009, 21% in 2010, and approximately 20% (19.8) in 2011 (January-May) (see Figure 7). When conducting a 1-sample t test comparing the mean of the months postimplementation to the mean value of preimplementation, the rate of tachysystole was significantly lower postimplementation (P < .0005; 19.187 vs 52.0).
The downward trend in tachysystole is promising; however, the hope is that the incidence of tachysystole will decrease further as staff continue to prudently administer this high-alert medication. The postimplementation tachysystole incidence was obtained through self-reporting from the staff nurses' completion of the QI tool. To account for the difference in data collection modalities, the council members periodically, randomly select cases to review and confirm the data reported on the QI tool.
In 2008, prior to implementation of the new oxytocin policy, nearly 61% of all cesarean deliveries were primary. In tracking this data point since then, the primary cesarean delivery rate dropped to 55.5% in 2009 and 56% in 2010 (see Figure 8).
The overall cesarean delivery rate has decreased by 5% since beginning this initiative, saving Centura Health approximately $286,000 per year. Since this was a process-improvement project and not a formal research study, we did not control for other variables. Concurrent to this project, there was another initiative driven by the Centura Perinatal Council to decrease the incidence of elective births prior to 39 weeks' gestation. It is likely that both initiatives contributed to the decrease in cesarean birth.
Barriers and limitations
Implementation of the system-wide oxytocin policy and checklists was met with little resistance at the facilities that had previously been administering oxytocin by a similar low-dose protocol. Some of the facilities struggled with the new standardized, low-dose, physiologic approach because it was a significant change from their previous high-dose regimen or multiple dosing options for providers to select from, that had been in place for a number of years. Providers voiced concern with changing practice when they had practiced this way for years and never experienced a “bad” outcome. Furthermore, they felt that women would have significantly longer labors, and that the incidence of primary cesarean deliveries would increase as well. To address these concerns, physician members of the subcommittee held follow-up meetings with concerned providers. They reviewed the evidence with the providers and provided clarification. They also requested that the providers trial the practice change to determine if their concerns were valid. A date for review of the data and possible policy revisions was set at that time.
The Perinatal Council members continued to provide education to both providers and nursing staff regarding the background of this initiative, as well as answered questions and served as a resource. Data were presented at obstetric department meetings to keep providers abreast of average length of labor, tachysystole incidence, and average Bishop score of women receiving oxytocin that ended up with a cesarean delivery for failure to progress. If the provider chose to deviate from the new oxytocin policy, the chart was sent to the facility's obstetrical peer review committee for consideration. Although percent compliance of providers with the new policy was not calculated, there were only occasional physicians who overrode the oxytocin titration parameters. Confidential follow-up with providers was done as necessary.
A barrier for nursing in the oxytocin process changes was that the preuse and in-use oxytocin checklists were initially available for documentation on paper only. This required the nurse to move from electronic documentation to paper charting with every change in the rate of oxytocin. This was addressed when the electronic documentation system was updated and the checklists were integrated into the labor charting. This change increased nurse satisfaction regarding the requirement of checklist completion for women receiving oxytocin.
At a few of the facilities, another barrier was noted when staff nurses failed to complete the oxytocin QI forms. This prohibited comprehensive data collection and analysis for those facilities. In an effort to increased compliance, the Perinatal Council members added the form to the preassembled chart packets. This served as a visual cue to the nurses and assisted them to collect the data required. Council members also performed chart reviews as necessary.
The primary concerns voiced by providers of longer labors and increased primary section rates with the changes in oxytocin administration were not supported by the data obtained after initiation of the policy and subsequent practice changes. Recently, some providers have raised concerns due to new literature that supports higher-dose protocols.13 However, one of the limitations of this recently published study was that data on tachysystole were not collected. The use of intrapartum tocolytics was utilized as a marker instead.13 It can be argued that this is not an adequate marker because intrauterine resuscitation measures do not always require the use of a tocolytic to resolve tachysystole. Typically, the response to tachysystole would be maternal repositioning, intravenous fluid boluses, decreasing or discontinuing the oxytocin infusion, careful evaluation to rule out placental abruption, and then administration of a tocolytic agent.20
As a system, it is felt that as long as oxytocin remains on the high-alert medication list6 and requires a heightened awareness to avoid possible negative consequences, it must be treated with respect. Processes must continue to be in place to prevent errors and harm to patients. Literature continues to support the practices changes that were implemented, which provide the infrastructure to deliver safe care.21–24
The primary limitation of the data collected for this project was that cofounding variables were not controlled for because this was a process-improvement initiative and not a research project. The incidence of additional adverse outcomes relative to this project were not initially collected but will be evaluated in the coming months. These may include Apgar scores, unexpected admissions to the neonatal intensive care unit, and cord gas values. The rationale for not collecting these data during initial analysis of the oxytocin project was that because pregnant women are usually healthy and even when practice deviates from what is safest for the patient and her unborn child, outcomes are usually favorable.3 On the basis of this knowledge, there will likely be little change in these metrics shown due to the population of healthy pregnant women served both before and after this process-improvement project.
In this era of attention to patient safety and maximizing outcomes, implementation of a low-dose oxytocin policy, which includes the use of checklists prior to and during administration of this common but dangerous medication has shown benefit. This low-dose regimen and the use of checklists should decrease risk exposure for mothers and their fetuses by decreasing length of labor, incidence of tachysystole, and primary cesarean birth. The system-wide approach provided the support necessary to implement a controversial practice change as well as provided resources to smaller, lower-volume facilities.
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