The Doctor’s Advocate | Fourth Quarter 2015
New Early Warning Criteria Could Reduce Maternal Mortality
This quarter, Director’s Forum features a report by Susan Mann, MD, about an important maternal safety initiative to implement early warning criteria for the recognition, diagnosis, and treatment of hemorrhage, hypertension, infection, and venous thrombosis in pregnancy. Dr. Mann, a board certified obstetrician-gynecologist and a fellow of the American College of Obstetricians and Gynecologists (ACOG), practices at Beth Israel Deaconess Medical Center in Boston. She is also assistant professor, part time, Harvard Medical School; a national consultant in patient safety and quality improvement in the field of obstetrics; and a member of our OB Advisory Board.
—David B. Troxel, MD, Medical Director, Board of Governors
Childbirth is the most frequent reason for hospitalization in the United States according to the Centers for Disease Control and Prevention.1 Fortunately, maternal and neonatal outcomes are, for the most part, uneventful and life enriching. Severe adverse maternal or neonatal outcomes can have drastic, long-term effects on patients, their families, and healthcare providers. The reality is that in the United States, maternal mortality has increased from 7.2 deaths per 100,000 live births in 1987 to a high of 17.8 deaths per 100,000 live births in 2009 and 2011.2 While we do not totally understand the cause of the increased rate of maternal mortality, we are obligated to identify and mitigate these risks.
The National Partnership for Maternal Safety—a unique multidisciplinary consortium of over a dozen professional organizations representing obstetrics, nursing, midwifery, anesthesia, and public health and safety organizations—was formed to attack this problem at its core. In September 2014, the partnership proposed a set of Maternal Early Warning Criteria to better recognize, diagnose, and treat hemorrhage, hypertension, infection, and venous thrombosis—all of which account for a large number of maternal deaths in the United States.3
The criteria identify a list of abnormal clinical parameters requiring urgent evaluation and escalation of care when necessary. They include the following:
- Heart rate below 50 or above 150 beats per minute.
- Systolic blood pressure below 90 or above 160 mm Hg.
- Diastolic blood pressure above 100 mm Hg.
- Respiratory rate below 10 or above 30 breaths per minute.
- Oxygen saturation on room air at sea level below 95 percent.
- Urine output below 35 mL per hour for two or more hours.
- Maternal agitation, confusion, or unresponsiveness.
- Patients with preeclampsia who report unremitting headache or shortness of breath.
Because healthy patients dominate obstetrics, these criteria can provide a safety net for the rare decompensating patient and offer a concrete way for clinicians to communicate their concerns and receive an urgent response. The implementation of these defined communication opportunities among care providers will require that hospitals develop protocols regarding the expected response to the bedside of these potentially critically ill patients and procedures to escalate concerns for a lack of appropriate response.
Communication problems among providers are a factor in 17 percent of all malpractice claims against obstetricians, according to a study of 882 obstetrical claims closed from 2007–2014 by The Doctors Company.4 Assumptions made by physicians and nurses about these severely ill patients regarding available resources, diagnosis, and treatment may not be accurate without appropriate bedside response and collaboration of care.
Standardized early warning criteria would take the guesswork out of this process, ideally without reprimand for providers who request bedside evaluation when they are uncertain of a patient’s status. Beth Israel Deaconess Medical Center, where I practice, implemented a similar initiative about five years ago. Known as the Trigger Program, it activates a rapid response process on the hospital’s postpartum floor to attend to any woman exhibiting triggers similar to these criteria. The program requires a physician at bedside within 15 minutes of activation and uses a combined charting tool for both physicians and nurses to ensure they have a shared vision for the patient’s care. A multidisciplinary committee reviews these trigger events. If necessary, preventive measures are developed and shared with the staff.
Encouraged by my experience and the new proposed Maternal Early Warning Criteria, experts discussed this topic at a recent OB Advisory Board meeting sponsored by The Doctors Company. The select group of practitioners and patient safety leaders discussed how the criteria could be implemented in various hospital settings. Some clinicians expressed concern about implementing the parameters in hospitals of different sizes.
In 2010, The Joint Commission suggested that hospitals identify specific triggers for responding to changes in the mother’s vital signs and use protocols and drills for responding to changes.5 This area of identifying specific changes in vital signs has not yet been widely studied, and much remains unknown, including the burden such criteria will place on hospital staff. The increasing maternal mortality rate in the United States is a call to arms to address this problem with any interventions possible.
Doctors can be slow to adopt new behaviors, and comprehensive change often takes years to achieve. Implementing the Maternal Early Warning Criteria at every birthing facility in the United States would ensure a shared vision between nurses and physicians to appropriately respond to acutely ill obstetric patients that could potentially save lives.
Comment by David B. Troxel, MD
In follow-up to Dr. Mann’s report on the Maternal Early Warning Criteria, our recent claims analysis of 882 obstetrical claims closed from 2007–2014 showed that 17 percent of patient allegations involved improper management of pregnancy—which included preeclampsia leading to stroke.
In identifying factors that contributed to patient injury, we found that 34 percent of claims involved the selection and management of therapy. Physician reviewers identified management problems that included failure to address pregnancy-induced hypertension and failure to diagnose and treat preeclampsia.
In February 2015, the ACOG Committee on Obstetric Practice published an opinion titled Emergent Therapy for Acute-Onset, Severe Hypertension During Pregnancy and the Postpartum Period. The essential points include the following:
- Integrate standardized, evidence-based guidelines for the management of acute onset, severe systolic or diastolic hypertension to reduce the incidence of adverse maternal outcomes.
- Guidelines should include mechanisms (e.g., checklists) to initiate the prompt administration of medication when a patient presents with a hypertensive emergency—regardless of its cause (preeclampsia, gestational hypertension, HELLP syndrome, endotracheal intubation, etc.).
- A hypertensive emergency is defined as acute-onset systolic hypertension equal to or above 160 mm Hg or severe diastolic hypertension equal to or above 110 mm Hg—or both—that persists for 15 minutes or more.
- The goal is to lower pressure to a range of 140–150/90–100 mm Hg to prevent prolonged exposure to severe systolic hypertension with loss of cerebral vascular autoregulation and the risk of cerebral hemorrhage or infarction.
- When a hypertensive emergency is diagnosed in the office setting, the patient should be sent to the hospital for treatment.
- The opinion presents protocols for intravenous labetalol and hydralazine and for oral nifedipine.
- Evaluation of maternal and fetal well-being should be initiated after the hypertensive emergency has been treated.
I recommend that all physicians who practice obstetrics read this ACOG Committee Opinion (Number 623, February 2015) in its entirety.