New Study Reveals Startling 28% Increase in Significant Bleeding of Mothers After Delivery

IRVINE, Calif., May 6 /PRNewswire-FirstCall/ -- A new study of U.S. maternal outcomes after vaginal and cesarean deliveries published in the May 2010 issue of Anesthesia & Analgesia, a peer-reviewed academic journal, shows that between 1995 and 2004, postpartum hemorrhage (excessive blood loss after delivery) increased 28% in prevalence(1).  Postpartum hemorrhage is one of today's most common complications for delivering mothers that according to the study, "markedly increases the odds of in-hospital mortality" and causes 19% of in-hospital maternal deaths.  In support of this and other recent data, earlier this year the Joint Commission issued a sentinel event alert calling for protocols and training to improve the ability to detect hemorrhage and other conditions that put mothers at high risk.  

In the study, researchers from the Massachusetts General Hospital, Harvard Medical School, and Columbia University College of Physicians and Surgeons used the largest U.S. database of hospitalizations to define and assess trends and risk factors in the incidence of postpartum hemorrhage.  Their analysis included discharge datasets from 876,641 hospital admissions for obstetric deliveries in 2004, revealing that postpartum hemorrhage occurred in 25,654 cases, at a rate of 3 per 100 deliveries.  Changes in both obstetric practice and maternal demographics in the U.S.—including the increased rate of cesarean delivery, larger proportion of multiple gestation births, and advanced maternal age—may be contributing factors for this deadly trend.  

The increase in postpartum hemorrhage was primarily due to an increase in uterine atony—accounting for 79% of all cases.  Uterine atony—failure of the uterus to contract maximally after delivery of the baby and placenta—results in heavy uterine (internal) bleeding that can be difficult to identify after delivery (postpartum).  Unlike other maternal and fetal risk factors that predispose high-risk deliveries, such as abnormal placentation, which can frequently be identified by predelivery imaging and triaged accordingly, uterine atony does not have identifiable antepartum risk factors and cannot be identified before delivery—making it more difficult to detect and treat.  Because of this, patients who hemorrhage from uterine atony (with severity significant enough to require transfusion) represent the greatest challenge to anesthesiologists and obstetricians.  

According to researchers:  "Because prompt recognition and resuscitation may limit the morbidity and mortality associated with postpartum hemorrhage(2,3), our results suggest that anesthesiologists practicing in all labor and delivery settings need to have systems in place to manage these patients."  Study findings also showed that "postpartum hemorrhage is more common among patients delivering at hospitals in the bottom quartile for delivery volume compared with those delivering at hospitals in the top quartile" and since both anesthesiologists and obstetricians often cover multiple hospitals, researchers cite a need for prudent establishment of "protocols to expedite access to blood products and additional trained personnel."

Based on the increasing risk and growing tragedy of preventable maternal deaths, industry standards and guidelines are also calling for the assessment of key indicators and early warnings signs of hemorrhage during and after delivery.  Earlier this year in a Sentinel Event Alert, The Joint Commission warned of this disturbing trend and the increasing rate of maternal mortality(4).  Citing the leading cause of maternal death as hemorrhage, the Joint Commission calls out its 2010 standards as a key opportunity for preventing maternal deaths.  The Joint Commission Provision of Care, Treatment and Services Standard PC.02.01.19 requires hospitals to: 1) Have a process for recognizing and responding as soon as a patient's condition appears to be worsening; 2) Develop written criteria describing early warning signs of a change or deterioration in a patient's condition and when to seek further assistance; 3) Based on the hospital's early warning criteria, have staff seek additional assistance when they have concerns about a patient's condition; 4) Inform the patient and family how to seek assistance when they have concerns about a patient's condition.  Additionally, last year the California Maternal Quality Care Collaborative (CMQCC) released the Obstetric Hemorrhage Care Guidelines Checklist recommending pre-screening, ongoing risk assessment for hemorrhage, and ongoing quantitative evaluation of blood loss on every birth(5).  

Brian Jones, M.D., Medical Director of OB Anesthesia at Sutter Medical Center in Sacramento and Assistant Professor of Anesthesiology at the University of California-Davis, says that: "This study provides strong evidence of a growing deadly trend—the frequency of serious maternal postpartum hemorrhage is increasing at an alarming rate.  Having established protocols in place, such as the CMQCC Obstetric Hemorrhage Care Guidelines, will help physicians and hospitals to have an organized approach for dealing with maternal hemorrhage.  And today, new technologies like Masimo noninvasive and continuous hemoglobin (SpHb) offer the opportunity to provide more vigilant and proactive care because it allows clinicians to quickly measure current hemoglobin levels and continuously track them in real-time to detect falling hemoglobin levels that represent an early sign of a potential hemorrhage.  With SpHb, clinicians have the ability to detect hemoglobin changes earlier, so they can intervene sooner to help protect delivering mothers from the disastrous consequences of postpartum hemorrhage."

Maternal bleeding is typically discovered after a significant change in vital signs, signs, and/or symptoms, and then confirmed with an invasive laboratory hemoglobin test.  This approach can result in late detection of bleeding that can affect patient outcome.  Masimo Rainbow SET Pulse CO-Oximeters provide the first-and-only continuous and noninvasive hemoglobin (SpHb) measurements, which can help clinicians quickly identify significant changes hemoglobin levels. When used with other clinical variables, Masimo SpHb may help clinicians assess anemic status and help determine treatment and additional test options.

Madhava Karunarathna, MD, an OB/GYN at Balangoda Hospital in Sri Lanka, stated: "In cases of severe hemorrhaging during and after childbirth, SpHb has enabled us to immediately identify and continuously assess blood loss severity to better manage internal bleeding, prevent overloading of fluid, and decrease maternal death."

Masimo Rainbow SET Pulse CO-Oximetry is a breakthrough noninvasive blood constituent monitoring platform measuring multiple blood constituents that previously required invasive procedures, including: total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI®, acoustic respiration rate (RRa™), oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI).  Masimo SpHb, PVI, and SpO2 have been shown in multiple clinical studies to provide accurate, reliable, real-time measurements that help clinicians to proactively monitor and manage hemoglobin, fluid, and oxygen saturation levels.

(1) Bateman BT, Berman MF, Riley LE, Leffert LR.  "The Epidemiology of Postpartum Hemorrhage in a Large, Nationwide Sample of Deliveries" Anesth Analg May 2010 110:1368-1373. Available online here.

(2) Mercier FJ, Van de Velde M. "Major Obstetric Hemorrhage."  Anesthesiol Clin 2008;26:53–66.

(3) Mahutte NG, Murphy-Kaulbeck L, Le Q, Solomon J, Benjamin A, Boyd ME. "Obstetric Admissions to the Intensive Care Unit." Obstet Gynecol 1999;94:263–6.

(4) The Joint Commission, "Sentinel Event Alert: Preventing Maternal Death" Issue 44, January 26, 2010. Available online here.

(5) California Maternal Quality Care Collaborative (CMQCC) "Obstetric Hemorrhage Care Guidelines Checklist." Available online here.

About Masimo

Masimo (NASDAQ: MASI) develops innovative monitoring technologies that significantly improve patient care—helping solve "unsolvable" problems.  In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events.  More than 100 independent and objective studies demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusion.  In 2005, Masimo introduced Masimo Rainbow SET® Pulse CO-Oximetry™, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and PVI®, in addition to SpO2, pulse rate, and perfusion index (PI).  In 2009, Masimo introduced Masimo Rainbow SET® Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa™).  Masimo's Rainbow platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options.  Founded in 1989, Masimo has the mission of "Improving Patient Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications." Additional information about Masimo and its products may be found at www.masimo.com.

Forward Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to risks related to our beliefs that Masimo Pulse CO-Oximeters provide the first-and-only commercially available and clinically-proven monitoring solutions for the ongoing, continuous, noninvasive measurement of hemoglobin levels; Masimo SpHb will help clinicians to immediately detect anemia, identify internal bleeding earlier, and maintain tighter transfusion management protocols and controls; and Masimo Rainbow SET Pulse CO-Oximetry noninvasive measurements (specifically SpHb, PVI, and SpO2) will provide sufficient sensitivity and specificity to help clinicians proactively monitor and manage hemoglobin, fluid and oxygen saturation levels more appropriately and conservatively for all patients, as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these forward-looking statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, RRa, Radical-7, Rad-87, Rad-57, Rad-9, Rad-8, Rad-5,Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.

SOURCE Masimo Corporation

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