Maternal safety blueprint outlined

SAN FRANCISCO – Every birthing facility in the United States should have specific practices and equipment to optimize maternal safety in pregnancy, according to a recent consensus meeting of national medical organizations.

These include so-called "safety bundles," or safety initiatives, of protocols and equipment for preventing and managing obstetric hemorrhage, venous thromboembolism, and severe hypertension, as well as for supporting patients, families, and staff. Specific early-warning criteria should trigger a maternal evaluation, and facilities should regularly review severe maternal morbidity from a systems perspective.

Motivated by climbing maternal mortality rates in the United States in recent decades, the recommendations build on preliminary success from California efforts to improve maternal safety, said Dr. Elliott K. Main, who cochaired the "National Maternal Health Initiative: Strategies to Improve Maternal Health and Safety" consensus meeting in New Orleans in May 2013.

Maternal mortality rates declined in California since 1970, but started increasing again around 2000, so that by 2005, the rate of 17 maternal deaths/100,000 live births was similar to rates in the early 1970s. Nationally, U.S. maternal mortality rates increased from 1980 to 2008, in contrast with decreases in many other developed countries, he said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

The U.S. rates of pregnancy-related deaths from hemorrhage or hypertensive disorders of pregnancy decreased from the periods of 1987-1990 to 1998-2005, but increased for deaths associated with cardiomyopathy or other cardiovascular conditions, one study showed (Obstet. Gynecol. 2010;116:1302-9). Other data suggest that hemorrhage and preeclampsia cause the lion’s share of morbidity.

The Joint Commission in 2010 issued Sentinel Alert #44 to suggest ways that birthing centers might better improve maternal morbidity and mortality, and Dr. Main directed ongoing work by the California Maternal Quality Care Collaborative (CMQCC) to identify and address common causes of pregnancy-related deaths that have a good chance of being altered to improve outcomes.Free "toolkits" of best practices with guidelines, protocols, sample policies, and more are available on the CMQCC website .

Representatives of more than 30 organizations participated in the May consensus meeting, including the American College of Obstetricians and Gynecologists (ACOG), the American Academy of Family Physicians, the Society for Maternal-Fetal Medicine, the American Hospital Association, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Main, director of maternal-fetal medicine at California Pacific Medical Center, San Francisco, described some of the "safety bundles" that emerged from the consensus meeting and will be recommended nationally. "We’re not expecting you to implement all of these at once, but these are what you want to be working toward," he said.

• Hemorrhage: Be ready for obstetric hemorrhage by having a hemorrhage cart of equipment with instructions for newer procedures such as intrauterine balloons and compression sutures. Partner with your local blood bank to make sure that blood products at the right ratios are available rapidly and reliably, he said. Hold hemorrhage-response drills regularly with post-drill debriefs or "huddles." Ensure rapid availability of medications, establish easy availability of special care resources, and educate the unit staff about hemorrhage protocols.

To better recognize obstetric hemorrhage, assess a patient’s risk on admission and late in labor. Use the Early Warning Tool (see below) for vital signs and symptoms, and get semiquantitative assessments of cumulative blood loss, with the emphasis on cumulative, Dr. Main said.

Response to obstetric hemorrhage should rely on a protocol standardized for your unit with checklists. Universal use of active management in the third stage of labor is important for hemorrhage prevention. To promote learning, establish a culture of post-hemorrhage debrief/huddles, and review all serious cases for systems issues.

In an informal poll of the physicians and nurses in the audience, 58% said they have a comprehensive, standardized protocol for obstetric hemorrhage in their hospital, 23% have one that could be improved, 11% don’t have one, and 8% had no clue.

• Hypertension: Debate continues about the definition of severe preeclampsia, and ACOG should be issuing a presidential task force statement later this year on the topic, Dr. Main said.

Meanwhile, key elements of a "safety bundle" for hypertension in pregnancy include having unit-standard protocols and policies for the treatment of severe hypertension and eclampsia, safe use of magnesium therapy, and managing magnesium overdose, he said. The birthing unit also should have an agreed-upon definition of severe preeclampsia, early warning tools employing vital signs and symptoms, and regular review of all hypertension cases with severe morbidity to look for systems issues.

The CMQCC is expected soon to publish a California Preeclampsia QI Toolkit for quality improvement, which will be tested in 26 hospitals, he added.

A poll of the audience found that 31% have a comprehensive, standardized protocol for severe pregnancy hypertension in their hospital, 22% have one that could be improved, 35% don’t have one, and 11% had not a clue.(The percentages added up to 99% rather than 100% when the survey results were displayed at the meeting.)

• Thromboembolism: The keys to preventing venous thromboembolism are to have protocols for use of a sequential compression device, pharmacologic prophylaxis for higher-risk mothers, and antenatal prophylaxis, Dr. Main said.

A draft safety bundle for prevention of venous thromboembolism during cesarean section calls for applying a sequential compression device prior to delivery. Add chemoprophylaxis to all who already are receiving prophylaxis or full anticoagulation, patients with a history of thromboembolism who are not already on chemoprophylaxis, mothers with a family history of venous thromboembolism and any thrombophilia, mothers who are morbidly obese, or any patients with a score of two or more for other, more minor risk factors.

Obesity is "the big risk factor in California," he said. Two-thirds of pregnant Californians who die from thomboembolism have a body mass index greater then 40 kg/m².

An unexpectedly high proportion of the audience – 29% said that their hospital has a standardized protocol for using Lovenox (enoxaparin) for obstetric patients at higher risk for venous thromboembolism. Few local hospitals will have such protocols, Dr. Main noted, and if they have them, they’re usually very complicated. Another 18% at the meeting said they have such a protocol but it could be improved; 38% said they don’t have a protocol, and 15% had no clue.

• Warnings: Draft criteria for an Early Warning Tool that should trigger an evaluation of maternal safety include specific vital signs and important symptoms. Troubling vital signs include a systolic blood pressure below 90 mm Hg or above 160 mm Hg; diastolic blood pressure higher than 100 mm Hg; sustained heart rate below 50 or above 120 beats per minute; respiratory rate slower than 10 or faster than 30 breaths/minute; oxygen saturation less than 95% room air (at sea level); or oliguria less than 30 mL/hour for 2 hours.

Among symptoms, maternal agitation, confusion or unresponsiveness often is a sign of low oxygen saturation, Dr. Main said. A patient with hypertension who reports an unremitting headache is a red flag. Shortness of breath in a patient with preeclampsia or hypertension should raise big concerns about the development of pulmonary edema and cardiovascular problems.

As a core safety principal, however, the bedside clinician should always feel comfortable escalating concern at any point, because these criteria can’t address all scenarios, he added. These warning criteria are being rolled out in New York State hospitals for a trial, he said.

• Cardiovascular: There are not enough data yet to identify opportunities for safety improvements related to cardiovascular or cardiomyopathy risks in pregnancy, so instead of a safety bundle Dr. Main presented three clinical pearls from California’s work on maternal safety.

Morbid obesity plus hypertension equals high risk for cardiomyopathy, especially if the patient is African American and older than 35 years, he said. There are not many pregnant women with known underlying cardiovascular disease, but this group should be followed closely by a multidisciplinary team, perhaps in a tertiary care center. The third pearl was new to Dr. Main: the onset of wheezing in the third trimester, which is not likely to be asthma but cardiac in origin and deserves a patient referral for evaluation.

Dr. Main reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Every birthing facility in the United States should have specific practices and equipment to optimize maternal safety in pregnancy, according to a recent consensus meeting of national medical organizations.

These include so-called "safety bundles," or safety initiatives, of protocols and equipment for preventing and managing obstetric hemorrhage, venous thromboembolism, and severe hypertension, as well as for supporting patients, families, and staff. Specific early-warning criteria should trigger a maternal evaluation, and facilities should regularly review severe maternal morbidity from a systems perspective.

Motivated by climbing maternal mortality rates in the United States in recent decades, the recommendations build on preliminary success from California efforts to improve maternal safety, said Dr. Elliott K. Main, who cochaired the "National Maternal Health Initiative: Strategies to Improve Maternal Health and Safety" consensus meeting in New Orleans in May 2013.

Maternal mortality rates declined in California since 1970, but started increasing again around 2000, so that by 2005, the rate of 17 maternal deaths/100,000 live births was similar to rates in the early 1970s. Nationally, U.S. maternal mortality rates increased from 1980 to 2008, in contrast with decreases in many other developed countries, he said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

The U.S. rates of pregnancy-related deaths from hemorrhage or hypertensive disorders of pregnancy decreased from the periods of 1987-1990 to 1998-2005, but increased for deaths associated with cardiomyopathy or other cardiovascular conditions, one study showed (Obstet. Gynecol. 2010;116:1302-9). Other data suggest that hemorrhage and preeclampsia cause the lion’s share of morbidity.

The Joint Commission in 2010 issued Sentinel Alert #44 to suggest ways that birthing centers might better improve maternal morbidity and mortality, and Dr. Main directed ongoing work by the California Maternal Quality Care Collaborative (CMQCC) to identify and address common causes of pregnancy-related deaths that have a good chance of being altered to improve outcomes.Free "toolkits" of best practices with guidelines, protocols, sample policies, and more are available on the CMQCC website .

Representatives of more than 30 organizations participated in the May consensus meeting, including the American College of Obstetricians and Gynecologists (ACOG), the American Academy of Family Physicians, the Society for Maternal-Fetal Medicine, the American Hospital Association, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Main, director of maternal-fetal medicine at California Pacific Medical Center, San Francisco, described some of the "safety bundles" that emerged from the consensus meeting and will be recommended nationally. "We’re not expecting you to implement all of these at once, but these are what you want to be working toward," he said.

• Hemorrhage: Be ready for obstetric hemorrhage by having a hemorrhage cart of equipment with instructions for newer procedures such as intrauterine balloons and compression sutures. Partner with your local blood bank to make sure that blood products at the right ratios are available rapidly and reliably, he said. Hold hemorrhage-response drills regularly with post-drill debriefs or "huddles." Ensure rapid availability of medications, establish easy availability of special care resources, and educate the unit staff about hemorrhage protocols.

To better recognize obstetric hemorrhage, assess a patient’s risk on admission and late in labor. Use the Early Warning Tool (see below) for vital signs and symptoms, and get semiquantitative assessments of cumulative blood loss, with the emphasis on cumulative, Dr. Main said.

Response to obstetric hemorrhage should rely on a protocol standardized for your unit with checklists. Universal use of active management in the third stage of labor is important for hemorrhage prevention. To promote learning, establish a culture of post-hemorrhage debrief/huddles, and review all serious cases for systems issues.

In an informal poll of the physicians and nurses in the audience, 58% said they have a comprehensive, standardized protocol for obstetric hemorrhage in their hospital, 23% have one that could be improved, 11% don’t have one, and 8% had no clue.

• Hypertension: Debate continues about the definition of severe preeclampsia, and ACOG should be issuing a presidential task force statement later this year on the topic, Dr. Main said.

Meanwhile, key elements of a "safety bundle" for hypertension in pregnancy include having unit-standard protocols and policies for the treatment of severe hypertension and eclampsia, safe use of magnesium therapy, and managing magnesium overdose, he said. The birthing unit also should have an agreed-upon definition of severe preeclampsia, early warning tools employing vital signs and symptoms, and regular review of all hypertension cases with severe morbidity to look for systems issues.

The CMQCC is expected soon to publish a California Preeclampsia QI Toolkit for quality improvement, which will be tested in 26 hospitals, he added.

A poll of the audience found that 31% have a comprehensive, standardized protocol for severe pregnancy hypertension in their hospital, 22% have one that could be improved, 35% don’t have one, and 11% had not a clue.(The percentages added up to 99% rather than 100% when the survey results were displayed at the meeting.)

• Thromboembolism: The keys to preventing venous thromboembolism are to have protocols for use of a sequential compression device, pharmacologic prophylaxis for higher-risk mothers, and antenatal prophylaxis, Dr. Main said.

A draft safety bundle for prevention of venous thromboembolism during cesarean section calls for applying a sequential compression device prior to delivery. Add chemoprophylaxis to all who already are receiving prophylaxis or full anticoagulation, patients with a history of thromboembolism who are not already on chemoprophylaxis, mothers with a family history of venous thromboembolism and any thrombophilia, mothers who are morbidly obese, or any patients with a score of two or more for other, more minor risk factors.

Obesity is "the big risk factor in California," he said. Two-thirds of pregnant Californians who die from thomboembolism have a body mass index greater then 40 kg/m².

An unexpectedly high proportion of the audience – 29% said that their hospital has a standardized protocol for using Lovenox (enoxaparin) for obstetric patients at higher risk for venous thromboembolism. Few local hospitals will have such protocols, Dr. Main noted, and if they have them, they’re usually very complicated. Another 18% at the meeting said they have such a protocol but it could be improved; 38% said they don’t have a protocol, and 15% had no clue.

• Warnings: Draft criteria for an Early Warning Tool that should trigger an evaluation of maternal safety include specific vital signs and important symptoms. Troubling vital signs include a systolic blood pressure below 90 mm Hg or above 160 mm Hg; diastolic blood pressure higher than 100 mm Hg; sustained heart rate below 50 or above 120 beats per minute; respiratory rate slower than 10 or faster than 30 breaths/minute; oxygen saturation less than 95% room air (at sea level); or oliguria less than 30 mL/hour for 2 hours.

Among symptoms, maternal agitation, confusion or unresponsiveness often is a sign of low oxygen saturation, Dr. Main said. A patient with hypertension who reports an unremitting headache is a red flag. Shortness of breath in a patient with preeclampsia or hypertension should raise big concerns about the development of pulmonary edema and cardiovascular problems.

As a core safety principal, however, the bedside clinician should always feel comfortable escalating concern at any point, because these criteria can’t address all scenarios, he added. These warning criteria are being rolled out in New York State hospitals for a trial, he said.

• Cardiovascular: There are not enough data yet to identify opportunities for safety improvements related to cardiovascular or cardiomyopathy risks in pregnancy, so instead of a safety bundle Dr. Main presented three clinical pearls from California’s work on maternal safety.

Morbid obesity plus hypertension equals high risk for cardiomyopathy, especially if the patient is African American and older than 35 years, he said. There are not many pregnant women with known underlying cardiovascular disease, but this group should be followed closely by a multidisciplinary team, perhaps in a tertiary care center. The third pearl was new to Dr. Main: the onset of wheezing in the third trimester, which is not likely to be asthma but cardiac in origin and deserves a patient referral for evaluation.

Dr. Main reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Every birthing facility in the United States should have specific practices and equipment to optimize maternal safety in pregnancy, according to a recent consensus meeting of national medical organizations.

These include so-called "safety bundles," or safety initiatives, of protocols and equipment for preventing and managing obstetric hemorrhage, venous thromboembolism, and severe hypertension, as well as for supporting patients, families, and staff. Specific early-warning criteria should trigger a maternal evaluation, and facilities should regularly review severe maternal morbidity from a systems perspective.

Motivated by climbing maternal mortality rates in the United States in recent decades, the recommendations build on preliminary success from California efforts to improve maternal safety, said Dr. Elliott K. Main, who cochaired the "National Maternal Health Initiative: Strategies to Improve Maternal Health and Safety" consensus meeting in New Orleans in May 2013.

Maternal mortality rates declined in California since 1970, but started increasing again around 2000, so that by 2005, the rate of 17 maternal deaths/100,000 live births was similar to rates in the early 1970s. Nationally, U.S. maternal mortality rates increased from 1980 to 2008, in contrast with decreases in many other developed countries, he said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

The U.S. rates of pregnancy-related deaths from hemorrhage or hypertensive disorders of pregnancy decreased from the periods of 1987-1990 to 1998-2005, but increased for deaths associated with cardiomyopathy or other cardiovascular conditions, one study showed (Obstet. Gynecol. 2010;116:1302-9). Other data suggest that hemorrhage and preeclampsia cause the lion’s share of morbidity.

The Joint Commission in 2010 issued Sentinel Alert #44 to suggest ways that birthing centers might better improve maternal morbidity and mortality, and Dr. Main directed ongoing work by the California Maternal Quality Care Collaborative (CMQCC) to identify and address common causes of pregnancy-related deaths that have a good chance of being altered to improve outcomes.Free "toolkits" of best practices with guidelines, protocols, sample policies, and more are available on the CMQCC website .

Representatives of more than 30 organizations participated in the May consensus meeting, including the American College of Obstetricians and Gynecologists (ACOG), the American Academy of Family Physicians, the Society for Maternal-Fetal Medicine, the American Hospital Association, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Main, director of maternal-fetal medicine at California Pacific Medical Center, San Francisco, described some of the "safety bundles" that emerged from the consensus meeting and will be recommended nationally. "We’re not expecting you to implement all of these at once, but these are what you want to be working toward," he said.

• Hemorrhage: Be ready for obstetric hemorrhage by having a hemorrhage cart of equipment with instructions for newer procedures such as intrauterine balloons and compression sutures. Partner with your local blood bank to make sure that blood products at the right ratios are available rapidly and reliably, he said. Hold hemorrhage-response drills regularly with post-drill debriefs or "huddles." Ensure rapid availability of medications, establish easy availability of special care resources, and educate the unit staff about hemorrhage protocols.

To better recognize obstetric hemorrhage, assess a patient’s risk on admission and late in labor. Use the Early Warning Tool (see below) for vital signs and symptoms, and get semiquantitative assessments of cumulative blood loss, with the emphasis on cumulative, Dr. Main said.

Response to obstetric hemorrhage should rely on a protocol standardized for your unit with checklists. Universal use of active management in the third stage of labor is important for hemorrhage prevention. To promote learning, establish a culture of post-hemorrhage debrief/huddles, and review all serious cases for systems issues.

In an informal poll of the physicians and nurses in the audience, 58% said they have a comprehensive, standardized protocol for obstetric hemorrhage in their hospital, 23% have one that could be improved, 11% don’t have one, and 8% had no clue.

• Hypertension: Debate continues about the definition of severe preeclampsia, and ACOG should be issuing a presidential task force statement later this year on the topic, Dr. Main said.

Meanwhile, key elements of a "safety bundle" for hypertension in pregnancy include having unit-standard protocols and policies for the treatment of severe hypertension and eclampsia, safe use of magnesium therapy, and managing magnesium overdose, he said. The birthing unit also should have an agreed-upon definition of severe preeclampsia, early warning tools employing vital signs and symptoms, and regular review of all hypertension cases with severe morbidity to look for systems issues.

The CMQCC is expected soon to publish a California Preeclampsia QI Toolkit for quality improvement, which will be tested in 26 hospitals, he added.

A poll of the audience found that 31% have a comprehensive, standardized protocol for severe pregnancy hypertension in their hospital, 22% have one that could be improved, 35% don’t have one, and 11% had not a clue.(The percentages added up to 99% rather than 100% when the survey results were displayed at the meeting.)

• Thromboembolism: The keys to preventing venous thromboembolism are to have protocols for use of a sequential compression device, pharmacologic prophylaxis for higher-risk mothers, and antenatal prophylaxis, Dr. Main said.

A draft safety bundle for prevention of venous thromboembolism during cesarean section calls for applying a sequential compression device prior to delivery. Add chemoprophylaxis to all who already are receiving prophylaxis or full anticoagulation, patients with a history of thromboembolism who are not already on chemoprophylaxis, mothers with a family history of venous thromboembolism and any thrombophilia, mothers who are morbidly obese, or any patients with a score of two or more for other, more minor risk factors.

Obesity is "the big risk factor in California," he said. Two-thirds of pregnant Californians who die from thomboembolism have a body mass index greater then 40 kg/m².

An unexpectedly high proportion of the audience – 29% said that their hospital has a standardized protocol for using Lovenox (enoxaparin) for obstetric patients at higher risk for venous thromboembolism. Few local hospitals will have such protocols, Dr. Main noted, and if they have them, they’re usually very complicated. Another 18% at the meeting said they have such a protocol but it could be improved; 38% said they don’t have a protocol, and 15% had no clue.

• Warnings: Draft criteria for an Early Warning Tool that should trigger an evaluation of maternal safety include specific vital signs and important symptoms. Troubling vital signs include a systolic blood pressure below 90 mm Hg or above 160 mm Hg; diastolic blood pressure higher than 100 mm Hg; sustained heart rate below 50 or above 120 beats per minute; respiratory rate slower than 10 or faster than 30 breaths/minute; oxygen saturation less than 95% room air (at sea level); or oliguria less than 30 mL/hour for 2 hours.

Among symptoms, maternal agitation, confusion or unresponsiveness often is a sign of low oxygen saturation, Dr. Main said. A patient with hypertension who reports an unremitting headache is a red flag. Shortness of breath in a patient with preeclampsia or hypertension should raise big concerns about the development of pulmonary edema and cardiovascular problems.

As a core safety principal, however, the bedside clinician should always feel comfortable escalating concern at any point, because these criteria can’t address all scenarios, he added. These warning criteria are being rolled out in New York State hospitals for a trial, he said.

• Cardiovascular: There are not enough data yet to identify opportunities for safety improvements related to cardiovascular or cardiomyopathy risks in pregnancy, so instead of a safety bundle Dr. Main presented three clinical pearls from California’s work on maternal safety.

Morbid obesity plus hypertension equals high risk for cardiomyopathy, especially if the patient is African American and older than 35 years, he said. There are not many pregnant women with known underlying cardiovascular disease, but this group should be followed closely by a multidisciplinary team, perhaps in a tertiary care center. The third pearl was new to Dr. Main: the onset of wheezing in the third trimester, which is not likely to be asthma but cardiac in origin and deserves a patient referral for evaluation.

Dr. Main reported having no financial disclosures.

[email protected]

On Twitter @sherryboschert