Obstetrics

Women may be receiving unnecessary antibiotics for overdiagnosed urinary tract infections while their sexually transmitted infections go undetected, according to a recent study in an urban academic emergency department.

“Our study is a reflection of what happens in current clinical practice in an ED setting including adult women 18-65 years of age for whom UTI diagnoses and empiric therapy for UTI are often given even in the absence of any UTI-related symptoms and without a urine culture,” Dr. Michelle T. Hecker of MetroHealth Medical Center, Cleveland, and her colleagues wrote in the Journal of Clinical Microbiology (J. Clin. Microbiol. 2015 [doi:10.1128/JCM.00670-15]).

Overdiagnosis of UTI was not only a common cause of unnecessary antibiotic use, it also contributed to underdiagnosis of STI since 64% of the patients with a missed STI were diagnosed as having a UTI instead, they reported.

The researchers compared urinalysis, culture, and nucleic acid amplification testing for gonorrhea, chlamydia, and trichomoniasis among 264 women, aged 18-65 years, who presented to an urban academic emergency department over a 2-month period. Although providers diagnosed 66% of these women with UTIs, less than half these women (48%) had a positive urine culture and more than half (57%) received treatment without a urine culture.

Among the 23% of women overall who had at least one positive STI test, 37% (22 of 60 women) did not receive treatment for their STI within 7 days of their visit, and 14 of those 22 women (64%) received a UTI diagnosis instead of an STI diagnosis.

Urinalysis was abnormal for 92% of all the women in the study and did not predict positive urine cultures. The researchers determined the positive predictive value of abnormal urinalysis to be 41% and the negative predictive value to be 76%.

“Based on our data and others, we believe that alternative test and treat strategies for managing women with [genitourinary] and nonspecific abdominal pain in the ED should be evaluated,” Dr. Hecker and her associates wrote.

They specifically recommended decreasing urinalysis testing and increasing urine culture and STI testing.

The research was supported by a grant from the Centers for Disease Control and Prevention. One of the researchers reported that he is an R&D scientist employed by Hologic.

Women may be receiving unnecessary antibiotics for overdiagnosed urinary tract infections while their sexually transmitted infections go undetected, according to a recent study in an urban academic emergency department.

“Our study is a reflection of what happens in current clinical practice in an ED setting including adult women 18-65 years of age for whom UTI diagnoses and empiric therapy for UTI are often given even in the absence of any UTI-related symptoms and without a urine culture,” Dr. Michelle T. Hecker of MetroHealth Medical Center, Cleveland, and her colleagues wrote in the Journal of Clinical Microbiology (J. Clin. Microbiol. 2015 [doi:10.1128/JCM.00670-15]).

Overdiagnosis of UTI was not only a common cause of unnecessary antibiotic use, it also contributed to underdiagnosis of STI since 64% of the patients with a missed STI were diagnosed as having a UTI instead, they reported.

The researchers compared urinalysis, culture, and nucleic acid amplification testing for gonorrhea, chlamydia, and trichomoniasis among 264 women, aged 18-65 years, who presented to an urban academic emergency department over a 2-month period. Although providers diagnosed 66% of these women with UTIs, less than half these women (48%) had a positive urine culture and more than half (57%) received treatment without a urine culture.

Among the 23% of women overall who had at least one positive STI test, 37% (22 of 60 women) did not receive treatment for their STI within 7 days of their visit, and 14 of those 22 women (64%) received a UTI diagnosis instead of an STI diagnosis.

Urinalysis was abnormal for 92% of all the women in the study and did not predict positive urine cultures. The researchers determined the positive predictive value of abnormal urinalysis to be 41% and the negative predictive value to be 76%.

“Based on our data and others, we believe that alternative test and treat strategies for managing women with [genitourinary] and nonspecific abdominal pain in the ED should be evaluated,” Dr. Hecker and her associates wrote.

They specifically recommended decreasing urinalysis testing and increasing urine culture and STI testing.

The research was supported by a grant from the Centers for Disease Control and Prevention. One of the researchers reported that he is an R&D scientist employed by Hologic.

Women may be receiving unnecessary antibiotics for overdiagnosed urinary tract infections while their sexually transmitted infections go undetected, according to a recent study in an urban academic emergency department.

“Our study is a reflection of what happens in current clinical practice in an ED setting including adult women 18-65 years of age for whom UTI diagnoses and empiric therapy for UTI are often given even in the absence of any UTI-related symptoms and without a urine culture,” Dr. Michelle T. Hecker of MetroHealth Medical Center, Cleveland, and her colleagues wrote in the Journal of Clinical Microbiology (J. Clin. Microbiol. 2015 [doi:10.1128/JCM.00670-15]).

Overdiagnosis of UTI was not only a common cause of unnecessary antibiotic use, it also contributed to underdiagnosis of STI since 64% of the patients with a missed STI were diagnosed as having a UTI instead, they reported.

The researchers compared urinalysis, culture, and nucleic acid amplification testing for gonorrhea, chlamydia, and trichomoniasis among 264 women, aged 18-65 years, who presented to an urban academic emergency department over a 2-month period. Although providers diagnosed 66% of these women with UTIs, less than half these women (48%) had a positive urine culture and more than half (57%) received treatment without a urine culture.

Among the 23% of women overall who had at least one positive STI test, 37% (22 of 60 women) did not receive treatment for their STI within 7 days of their visit, and 14 of those 22 women (64%) received a UTI diagnosis instead of an STI diagnosis.

Urinalysis was abnormal for 92% of all the women in the study and did not predict positive urine cultures. The researchers determined the positive predictive value of abnormal urinalysis to be 41% and the negative predictive value to be 76%.

“Based on our data and others, we believe that alternative test and treat strategies for managing women with [genitourinary] and nonspecific abdominal pain in the ED should be evaluated,” Dr. Hecker and her associates wrote.

They specifically recommended decreasing urinalysis testing and increasing urine culture and STI testing.

The research was supported by a grant from the Centers for Disease Control and Prevention. One of the researchers reported that he is an R&D scientist employed by Hologic.

Based on the available evidence of the impact “cocooning” has on transmission of pertussis to infants, no changes are currently recommended in the use of Tdap vaccine for close contacts of infants, Jennifer Liang, D.V.M., said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

Presenting the conclusions of ACIP’s pertussis vaccines work group review on the impact of cocooning strategies, Dr. Liang, the CDC’s lead member of the work group, said that pertussis vaccination programs should be focused on vaccinating women during every pregnancy, maintaining high levels of DTap coverage, sustaining Tdap coverage in adolescents, and improving Tdap coverage in adults.

In 2005, ACIP recommended the “cocooning” strategy: vaccinating with Tdap for all close contacts of infants under age 12 months to reduce the risk of transmitting pertussis, including parents, siblings, grandparents, child care providers, and health care personnel, in addition to vaccinating pregnant women immediately post partum. In 2011, ACIP recommended Tdap during pregnancy for women who had not previously received the vaccine, or a postpartum dose for women who did not receive the vaccine during pregnancy and had not previously received the vaccine. In 2012, the recommendation was expanded to every pregnancy, whether or not the woman had received the vaccine before.

The optimal strategy to prevent the transmission of pertussis is vaccinating women during pregnancy, which has been shown to be highly effective in reducing transmission to infants, but rates of vaccination in pregnant women have not been high, said Dr. Liang, an epidemiologist in the CDC’s National Center for Immunization and Respiratory Diseases.

Rates of Tdap coverage, however, among pregnant women in the United States have ranged from 14% to 23% in studies using different sources, including a Michigan Medicaid study, she said.

Implementing and sustaining cocooning programs remain a challenge. Although uptake of Tdap has been highest in postpartum women, there has been limited success in vaccinating fathers or other family members, she said, noting that, in 2012, the rate of Tdap coverage among adults aged 19-64 years who reported living with an infant under age 1 year was 26%.

The effect of cocooning in preventing infant pertussis also is “unclear and inconclusive,” and evidence of the effectiveness of the postpartum dose in preventing infant pertussis is limited and the data are conflicting, Dr. Liang said. Another issue is that, over the past decade, the source of transmission to infants has shifted from parents (usually mothers) as the most common source to siblings, who have more recently been identified as the most common source, she said. A CDC study determined that, between 2006 and 2013, family members were the source of the infection in 66%-85% of infant pertussis cases in which the source of infection was known. Siblings were the most common source, linked to almost 40% of cases.

“Even if additional Tdap doses are recommended, this would not address the observed shift to siblings as the source of pertussis to infants and puts greater emphasis on the importance of providing newborns with antipertussis antibodies, and there is an optimal strategy in place – vaccinating women during pregnancy,” she said.

This message is emphasized in a recently launched CDC campaign to improve Tdap vaccination rates during pregnancy, which includes fact sheets for health care professionals that point out that Tdap during pregnancy provides the best protection for infants, postpartum Tdap administration is not optimal, and “cocooning alone may not be effective and is hard to implement.”

Several meeting participants pointed out that vaccine uptake during pregnancy is higher in settings where the vaccine is available on site, as high as 80%-90% of pregnancies, and that having to get the vaccine outside of the office, such as at a pharmacy, can markedly reduce the likelihood of vaccination. The CDC’s updated materials, including fact sheets and posters, are available for health care professionals at http://www.cdc.gov/pertussis/materials/hcp.html.

A single dose of Tdap is recommended for people aged 11-64 years: one dose is routinely administered at age 11 or 12 years and one dose of Tdap is recommended for pregnant women during every pregnancy. DTaP vaccine is used to vaccinate younger children starting at age 2 months and is not licensed for adolescents, adults, or children 7 years of age and older.

[email protected]

Based on the available evidence of the impact “cocooning” has on transmission of pertussis to infants, no changes are currently recommended in the use of Tdap vaccine for close contacts of infants, Jennifer Liang, D.V.M., said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

Presenting the conclusions of ACIP’s pertussis vaccines work group review on the impact of cocooning strategies, Dr. Liang, the CDC’s lead member of the work group, said that pertussis vaccination programs should be focused on vaccinating women during every pregnancy, maintaining high levels of DTap coverage, sustaining Tdap coverage in adolescents, and improving Tdap coverage in adults.

In 2005, ACIP recommended the “cocooning” strategy: vaccinating with Tdap for all close contacts of infants under age 12 months to reduce the risk of transmitting pertussis, including parents, siblings, grandparents, child care providers, and health care personnel, in addition to vaccinating pregnant women immediately post partum. In 2011, ACIP recommended Tdap during pregnancy for women who had not previously received the vaccine, or a postpartum dose for women who did not receive the vaccine during pregnancy and had not previously received the vaccine. In 2012, the recommendation was expanded to every pregnancy, whether or not the woman had received the vaccine before.

The optimal strategy to prevent the transmission of pertussis is vaccinating women during pregnancy, which has been shown to be highly effective in reducing transmission to infants, but rates of vaccination in pregnant women have not been high, said Dr. Liang, an epidemiologist in the CDC’s National Center for Immunization and Respiratory Diseases.

Rates of Tdap coverage, however, among pregnant women in the United States have ranged from 14% to 23% in studies using different sources, including a Michigan Medicaid study, she said.

Implementing and sustaining cocooning programs remain a challenge. Although uptake of Tdap has been highest in postpartum women, there has been limited success in vaccinating fathers or other family members, she said, noting that, in 2012, the rate of Tdap coverage among adults aged 19-64 years who reported living with an infant under age 1 year was 26%.

The effect of cocooning in preventing infant pertussis also is “unclear and inconclusive,” and evidence of the effectiveness of the postpartum dose in preventing infant pertussis is limited and the data are conflicting, Dr. Liang said. Another issue is that, over the past decade, the source of transmission to infants has shifted from parents (usually mothers) as the most common source to siblings, who have more recently been identified as the most common source, she said. A CDC study determined that, between 2006 and 2013, family members were the source of the infection in 66%-85% of infant pertussis cases in which the source of infection was known. Siblings were the most common source, linked to almost 40% of cases.

“Even if additional Tdap doses are recommended, this would not address the observed shift to siblings as the source of pertussis to infants and puts greater emphasis on the importance of providing newborns with antipertussis antibodies, and there is an optimal strategy in place – vaccinating women during pregnancy,” she said.

This message is emphasized in a recently launched CDC campaign to improve Tdap vaccination rates during pregnancy, which includes fact sheets for health care professionals that point out that Tdap during pregnancy provides the best protection for infants, postpartum Tdap administration is not optimal, and “cocooning alone may not be effective and is hard to implement.”

Several meeting participants pointed out that vaccine uptake during pregnancy is higher in settings where the vaccine is available on site, as high as 80%-90% of pregnancies, and that having to get the vaccine outside of the office, such as at a pharmacy, can markedly reduce the likelihood of vaccination. The CDC’s updated materials, including fact sheets and posters, are available for health care professionals at http://www.cdc.gov/pertussis/materials/hcp.html.

A single dose of Tdap is recommended for people aged 11-64 years: one dose is routinely administered at age 11 or 12 years and one dose of Tdap is recommended for pregnant women during every pregnancy. DTaP vaccine is used to vaccinate younger children starting at age 2 months and is not licensed for adolescents, adults, or children 7 years of age and older.

[email protected]

Based on the available evidence of the impact “cocooning” has on transmission of pertussis to infants, no changes are currently recommended in the use of Tdap vaccine for close contacts of infants, Jennifer Liang, D.V.M., said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

Presenting the conclusions of ACIP’s pertussis vaccines work group review on the impact of cocooning strategies, Dr. Liang, the CDC’s lead member of the work group, said that pertussis vaccination programs should be focused on vaccinating women during every pregnancy, maintaining high levels of DTap coverage, sustaining Tdap coverage in adolescents, and improving Tdap coverage in adults.

In 2005, ACIP recommended the “cocooning” strategy: vaccinating with Tdap for all close contacts of infants under age 12 months to reduce the risk of transmitting pertussis, including parents, siblings, grandparents, child care providers, and health care personnel, in addition to vaccinating pregnant women immediately post partum. In 2011, ACIP recommended Tdap during pregnancy for women who had not previously received the vaccine, or a postpartum dose for women who did not receive the vaccine during pregnancy and had not previously received the vaccine. In 2012, the recommendation was expanded to every pregnancy, whether or not the woman had received the vaccine before.

The optimal strategy to prevent the transmission of pertussis is vaccinating women during pregnancy, which has been shown to be highly effective in reducing transmission to infants, but rates of vaccination in pregnant women have not been high, said Dr. Liang, an epidemiologist in the CDC’s National Center for Immunization and Respiratory Diseases.

Rates of Tdap coverage, however, among pregnant women in the United States have ranged from 14% to 23% in studies using different sources, including a Michigan Medicaid study, she said.

Implementing and sustaining cocooning programs remain a challenge. Although uptake of Tdap has been highest in postpartum women, there has been limited success in vaccinating fathers or other family members, she said, noting that, in 2012, the rate of Tdap coverage among adults aged 19-64 years who reported living with an infant under age 1 year was 26%.

The effect of cocooning in preventing infant pertussis also is “unclear and inconclusive,” and evidence of the effectiveness of the postpartum dose in preventing infant pertussis is limited and the data are conflicting, Dr. Liang said. Another issue is that, over the past decade, the source of transmission to infants has shifted from parents (usually mothers) as the most common source to siblings, who have more recently been identified as the most common source, she said. A CDC study determined that, between 2006 and 2013, family members were the source of the infection in 66%-85% of infant pertussis cases in which the source of infection was known. Siblings were the most common source, linked to almost 40% of cases.

“Even if additional Tdap doses are recommended, this would not address the observed shift to siblings as the source of pertussis to infants and puts greater emphasis on the importance of providing newborns with antipertussis antibodies, and there is an optimal strategy in place – vaccinating women during pregnancy,” she said.

This message is emphasized in a recently launched CDC campaign to improve Tdap vaccination rates during pregnancy, which includes fact sheets for health care professionals that point out that Tdap during pregnancy provides the best protection for infants, postpartum Tdap administration is not optimal, and “cocooning alone may not be effective and is hard to implement.”

Several meeting participants pointed out that vaccine uptake during pregnancy is higher in settings where the vaccine is available on site, as high as 80%-90% of pregnancies, and that having to get the vaccine outside of the office, such as at a pharmacy, can markedly reduce the likelihood of vaccination. The CDC’s updated materials, including fact sheets and posters, are available for health care professionals at http://www.cdc.gov/pertussis/materials/hcp.html.

A single dose of Tdap is recommended for people aged 11-64 years: one dose is routinely administered at age 11 or 12 years and one dose of Tdap is recommended for pregnant women during every pregnancy. DTaP vaccine is used to vaccinate younger children starting at age 2 months and is not licensed for adolescents, adults, or children 7 years of age and older.

[email protected]

ROME – New therapies introduced over the past 15 years have vastly improved the lives of patients with rheumatic diseases but are also creating complex treatment scenarios as more female patients consider starting a family or become pregnant while taking medication. At the European Congress of Rheumatology, experts discussed the importance of contraceptive counseling, pregnancy planning, and how to treat pregnant women with rheumatic diseases.

“Nowadays we have such better treatments for our patients that sexuality and contraception is becoming more and more important,” said Dr. Eliza Chakravarty of the Oklahoma Medical Research Foundation in Oklahoma City. Yet contraception is “quite underused in our patients,” she observed.

©Jupiterimages/thinkstockphotos.com

Indeed, in one study looking at the risk of unintended pregnancy in women with lupus, over half (55%) of the 212 women surveyed admitted that they had unprotected sex at least once, with almost a quarter (23%) saying that this was usually in the preceding 3 months (Arthritis Care Res. 2008;59:863-6).

This underuse of contraception is not unique to lupus patients, and there are many reasons why women with rheumatic diseases who are sexually active may not always use adequate contraception. One of these reasons was the lack of time during consultations, which tend to focus on disease management rather than issues such as contraceptive counseling. Other reasons may be misconceptions on fertility or a lack of understanding of the teratogenicity of medications or the effect that hormones may have on disease activity. Women also may be reluctant to take additional medicines or feel uncomfortable discussing the topic with their rheumatologists.

“Patients see their rheumatologist more frequently than any other [health care] provider,” Dr. Chakravarty said, adding that continual follow-up appointments over time provide an opportunity to discuss fertility and changing contraception needs. “Contraception is a component of effective disease management for young women,” she said.

There are many contraceptive methods available, each with pros and cons and varying efficacy, so women have multiple options to choose from to suit their personal preferences and lifestyles. Dr. Chakravarty suggested that, of all the available methods, long-acting reversible contraceptive methods, such as the subdermal implant or intrauterine device, were perhaps the best choice for many women with rheumatic diseases since they are associated with a low rate of accidental pregnancy and after insertion there is little or nothing to do or remember until the devices needed replacing after 3-10 years.

Dr. Monika Østensen of the Norwegian National Advisory Unit on Pregnancy and Rheumatic Diseases at St. Olavs Hospital-Trondheim University Hospital, echoed the need for repeated family-planning advice. Of course, pregnancies occur even with the best planning, she said, and the question then is how to manage the rheumatic disease.

The need for treatment will depending on the type of disease, she said, noting that the need generally decreased during pregnancy in women with rheumatoid arthritis (RA) but increased in those with ankylosing spondylitis, most notably in the first and second trimesters (Ann. Rheum. Dis. 2004;63:1212-7). The ideal situation would be to adjust disease-directed therapy if needed before conception, although methotrexate is the only drug with proven teratogenicity that is used for RA and ankylosing spondylitis and that should definitely be stopped, she said.

There is a lot of evidence that methotrexate needs to be stopped before pregnancy. One recent prospective study (Arthritis Rheumatol. 2014;66:1101-10) looked at pregnancy outcomes and methotrexate use and found a high rate of spontaneous abortions if it was used within 10 weeks of conception (14.4%) or in the first trimester (42.5%). The rate of major birth defects was 6.6% if methotrexate was used in early pregnancy, versus 2.9% for women without rheumatic disease or 3.5% in women with rheumatic disease who were not taking the disease-modifying antirheumatic drug (DMARD).

Dr. Østensen advised that, when stopping methotrexate, women should be counseled to wait for one menstrual cycle before attempting to conceive and not to stop therapy without perhaps checking for fertility or switching to another pregnancy-compatible drug. She also stressed that patients who want to become pregnant or who do become pregnant should not immediately stop taking their medication without consulting a rheumatologist. Such an action could result in disease flares, and the aim of therapy should always be to keep the patient in remission or low disease activity and continue drugs that support remission while trying to minimize any likely effects on the fetus.

Leflunomide (Arava), rituximab (Rituxan), abatacept (Orencia), and newer biologics such as tocilizumab (Actemra), ustekinumab (Stelara), and tofacitinb (Xeljanz) are contraindicated because of lack of data on whether they are safe for the fetus. If a woman did become pregnant while taking any of these drugs or even methotrexate, then taking a careful history and performing fetal ultrasound and amniocentesis may be the best approach to determine what action to take and if pregnancy termination should be considered.

Tumor necrosis factor-alpha inhibitors (TNFi), the best-studied biologic DMARDs, can be given before conception and during the first and early second trimester; however, use in late pregnancy requires different considerations because transplacental passage varies based on differences related to their structure. Some TNFis, such as certolizumab pegol (Cimzia), have small affinity to the fetal Fc receptor or no Fc part and show low transplacental passage to the fetus. TNFis that possess an Fc part of immunoglobulin G1, however, allow high amounts of transfer and should be avoided in the third trimester whenever possible, Dr. Østensen said.

Data are sparse on human pregnancy exposure and fetal side effects and outcomes for most other biologics, so decisions to use biologics targeting B-cells, T-cell activation, or cytokines like interleukin (IL)-6, IL-23, IL-17, or IL-1beta must be based on the severity of maternal disease and reserved for cases in which no other safe options are available, Dr. Østensen cautioned.

So how can acute arthritis be treated during pregnancy? Options in RA include NSAIDs, short-term oral prednisone with rapid tapering or intramuscular injection of triamcinolone. Intra-articular steroid injection also might be considered, and TNFi in patients with severe polyarthritis. Spondyloarthritis might be treated with NSAIDs, intramuscular triamcinolone, or intra-articular steroid injection, with TNFi in severe cases.

Newer approaches to managing arthritis during pregnancy are to perhaps prescribe a TNFi with a low propensity for transplacental passage or to use a flexible regimen of TNFi by reducing the dose or prolonging the interval between administrations.

Continuing medications such as hydroxychloroquine, sulfasalazine, or azathioprine might be in some patients’ best interests to support remission and keep disease activity low, Dr. Østensen suggested. She noted that prednisone should be used at a low (5-7.5 mg) dose during pregnancy and that the aim should be to try to slowly reduce the use of pregnancy-compatible medications that are not necessary for continued remission, keeping a close eye on patients’ disease activity to ensure that no flares occur.

Dr. Chakravarty had no financial disclosures. Dr. Østensen reported receiving speaker fees and honoraria from UCB, Roche, AbbVie, MSD, Pfizer, and New Bridge.

ROME – New therapies introduced over the past 15 years have vastly improved the lives of patients with rheumatic diseases but are also creating complex treatment scenarios as more female patients consider starting a family or become pregnant while taking medication. At the European Congress of Rheumatology, experts discussed the importance of contraceptive counseling, pregnancy planning, and how to treat pregnant women with rheumatic diseases.

“Nowadays we have such better treatments for our patients that sexuality and contraception is becoming more and more important,” said Dr. Eliza Chakravarty of the Oklahoma Medical Research Foundation in Oklahoma City. Yet contraception is “quite underused in our patients,” she observed.

©Jupiterimages/thinkstockphotos.com

Indeed, in one study looking at the risk of unintended pregnancy in women with lupus, over half (55%) of the 212 women surveyed admitted that they had unprotected sex at least once, with almost a quarter (23%) saying that this was usually in the preceding 3 months (Arthritis Care Res. 2008;59:863-6).

This underuse of contraception is not unique to lupus patients, and there are many reasons why women with rheumatic diseases who are sexually active may not always use adequate contraception. One of these reasons was the lack of time during consultations, which tend to focus on disease management rather than issues such as contraceptive counseling. Other reasons may be misconceptions on fertility or a lack of understanding of the teratogenicity of medications or the effect that hormones may have on disease activity. Women also may be reluctant to take additional medicines or feel uncomfortable discussing the topic with their rheumatologists.

“Patients see their rheumatologist more frequently than any other [health care] provider,” Dr. Chakravarty said, adding that continual follow-up appointments over time provide an opportunity to discuss fertility and changing contraception needs. “Contraception is a component of effective disease management for young women,” she said.

There are many contraceptive methods available, each with pros and cons and varying efficacy, so women have multiple options to choose from to suit their personal preferences and lifestyles. Dr. Chakravarty suggested that, of all the available methods, long-acting reversible contraceptive methods, such as the subdermal implant or intrauterine device, were perhaps the best choice for many women with rheumatic diseases since they are associated with a low rate of accidental pregnancy and after insertion there is little or nothing to do or remember until the devices needed replacing after 3-10 years.

Dr. Monika Østensen of the Norwegian National Advisory Unit on Pregnancy and Rheumatic Diseases at St. Olavs Hospital-Trondheim University Hospital, echoed the need for repeated family-planning advice. Of course, pregnancies occur even with the best planning, she said, and the question then is how to manage the rheumatic disease.

The need for treatment will depending on the type of disease, she said, noting that the need generally decreased during pregnancy in women with rheumatoid arthritis (RA) but increased in those with ankylosing spondylitis, most notably in the first and second trimesters (Ann. Rheum. Dis. 2004;63:1212-7). The ideal situation would be to adjust disease-directed therapy if needed before conception, although methotrexate is the only drug with proven teratogenicity that is used for RA and ankylosing spondylitis and that should definitely be stopped, she said.

There is a lot of evidence that methotrexate needs to be stopped before pregnancy. One recent prospective study (Arthritis Rheumatol. 2014;66:1101-10) looked at pregnancy outcomes and methotrexate use and found a high rate of spontaneous abortions if it was used within 10 weeks of conception (14.4%) or in the first trimester (42.5%). The rate of major birth defects was 6.6% if methotrexate was used in early pregnancy, versus 2.9% for women without rheumatic disease or 3.5% in women with rheumatic disease who were not taking the disease-modifying antirheumatic drug (DMARD).

Dr. Østensen advised that, when stopping methotrexate, women should be counseled to wait for one menstrual cycle before attempting to conceive and not to stop therapy without perhaps checking for fertility or switching to another pregnancy-compatible drug. She also stressed that patients who want to become pregnant or who do become pregnant should not immediately stop taking their medication without consulting a rheumatologist. Such an action could result in disease flares, and the aim of therapy should always be to keep the patient in remission or low disease activity and continue drugs that support remission while trying to minimize any likely effects on the fetus.

Leflunomide (Arava), rituximab (Rituxan), abatacept (Orencia), and newer biologics such as tocilizumab (Actemra), ustekinumab (Stelara), and tofacitinb (Xeljanz) are contraindicated because of lack of data on whether they are safe for the fetus. If a woman did become pregnant while taking any of these drugs or even methotrexate, then taking a careful history and performing fetal ultrasound and amniocentesis may be the best approach to determine what action to take and if pregnancy termination should be considered.

Tumor necrosis factor-alpha inhibitors (TNFi), the best-studied biologic DMARDs, can be given before conception and during the first and early second trimester; however, use in late pregnancy requires different considerations because transplacental passage varies based on differences related to their structure. Some TNFis, such as certolizumab pegol (Cimzia), have small affinity to the fetal Fc receptor or no Fc part and show low transplacental passage to the fetus. TNFis that possess an Fc part of immunoglobulin G1, however, allow high amounts of transfer and should be avoided in the third trimester whenever possible, Dr. Østensen said.

Data are sparse on human pregnancy exposure and fetal side effects and outcomes for most other biologics, so decisions to use biologics targeting B-cells, T-cell activation, or cytokines like interleukin (IL)-6, IL-23, IL-17, or IL-1beta must be based on the severity of maternal disease and reserved for cases in which no other safe options are available, Dr. Østensen cautioned.

So how can acute arthritis be treated during pregnancy? Options in RA include NSAIDs, short-term oral prednisone with rapid tapering or intramuscular injection of triamcinolone. Intra-articular steroid injection also might be considered, and TNFi in patients with severe polyarthritis. Spondyloarthritis might be treated with NSAIDs, intramuscular triamcinolone, or intra-articular steroid injection, with TNFi in severe cases.

Newer approaches to managing arthritis during pregnancy are to perhaps prescribe a TNFi with a low propensity for transplacental passage or to use a flexible regimen of TNFi by reducing the dose or prolonging the interval between administrations.

Continuing medications such as hydroxychloroquine, sulfasalazine, or azathioprine might be in some patients’ best interests to support remission and keep disease activity low, Dr. Østensen suggested. She noted that prednisone should be used at a low (5-7.5 mg) dose during pregnancy and that the aim should be to try to slowly reduce the use of pregnancy-compatible medications that are not necessary for continued remission, keeping a close eye on patients’ disease activity to ensure that no flares occur.

Dr. Chakravarty had no financial disclosures. Dr. Østensen reported receiving speaker fees and honoraria from UCB, Roche, AbbVie, MSD, Pfizer, and New Bridge.

ROME – New therapies introduced over the past 15 years have vastly improved the lives of patients with rheumatic diseases but are also creating complex treatment scenarios as more female patients consider starting a family or become pregnant while taking medication. At the European Congress of Rheumatology, experts discussed the importance of contraceptive counseling, pregnancy planning, and how to treat pregnant women with rheumatic diseases.

“Nowadays we have such better treatments for our patients that sexuality and contraception is becoming more and more important,” said Dr. Eliza Chakravarty of the Oklahoma Medical Research Foundation in Oklahoma City. Yet contraception is “quite underused in our patients,” she observed.

©Jupiterimages/thinkstockphotos.com

Indeed, in one study looking at the risk of unintended pregnancy in women with lupus, over half (55%) of the 212 women surveyed admitted that they had unprotected sex at least once, with almost a quarter (23%) saying that this was usually in the preceding 3 months (Arthritis Care Res. 2008;59:863-6).

This underuse of contraception is not unique to lupus patients, and there are many reasons why women with rheumatic diseases who are sexually active may not always use adequate contraception. One of these reasons was the lack of time during consultations, which tend to focus on disease management rather than issues such as contraceptive counseling. Other reasons may be misconceptions on fertility or a lack of understanding of the teratogenicity of medications or the effect that hormones may have on disease activity. Women also may be reluctant to take additional medicines or feel uncomfortable discussing the topic with their rheumatologists.

“Patients see their rheumatologist more frequently than any other [health care] provider,” Dr. Chakravarty said, adding that continual follow-up appointments over time provide an opportunity to discuss fertility and changing contraception needs. “Contraception is a component of effective disease management for young women,” she said.

There are many contraceptive methods available, each with pros and cons and varying efficacy, so women have multiple options to choose from to suit their personal preferences and lifestyles. Dr. Chakravarty suggested that, of all the available methods, long-acting reversible contraceptive methods, such as the subdermal implant or intrauterine device, were perhaps the best choice for many women with rheumatic diseases since they are associated with a low rate of accidental pregnancy and after insertion there is little or nothing to do or remember until the devices needed replacing after 3-10 years.

Dr. Monika Østensen of the Norwegian National Advisory Unit on Pregnancy and Rheumatic Diseases at St. Olavs Hospital-Trondheim University Hospital, echoed the need for repeated family-planning advice. Of course, pregnancies occur even with the best planning, she said, and the question then is how to manage the rheumatic disease.

The need for treatment will depending on the type of disease, she said, noting that the need generally decreased during pregnancy in women with rheumatoid arthritis (RA) but increased in those with ankylosing spondylitis, most notably in the first and second trimesters (Ann. Rheum. Dis. 2004;63:1212-7). The ideal situation would be to adjust disease-directed therapy if needed before conception, although methotrexate is the only drug with proven teratogenicity that is used for RA and ankylosing spondylitis and that should definitely be stopped, she said.

There is a lot of evidence that methotrexate needs to be stopped before pregnancy. One recent prospective study (Arthritis Rheumatol. 2014;66:1101-10) looked at pregnancy outcomes and methotrexate use and found a high rate of spontaneous abortions if it was used within 10 weeks of conception (14.4%) or in the first trimester (42.5%). The rate of major birth defects was 6.6% if methotrexate was used in early pregnancy, versus 2.9% for women without rheumatic disease or 3.5% in women with rheumatic disease who were not taking the disease-modifying antirheumatic drug (DMARD).

Dr. Østensen advised that, when stopping methotrexate, women should be counseled to wait for one menstrual cycle before attempting to conceive and not to stop therapy without perhaps checking for fertility or switching to another pregnancy-compatible drug. She also stressed that patients who want to become pregnant or who do become pregnant should not immediately stop taking their medication without consulting a rheumatologist. Such an action could result in disease flares, and the aim of therapy should always be to keep the patient in remission or low disease activity and continue drugs that support remission while trying to minimize any likely effects on the fetus.

Leflunomide (Arava), rituximab (Rituxan), abatacept (Orencia), and newer biologics such as tocilizumab (Actemra), ustekinumab (Stelara), and tofacitinb (Xeljanz) are contraindicated because of lack of data on whether they are safe for the fetus. If a woman did become pregnant while taking any of these drugs or even methotrexate, then taking a careful history and performing fetal ultrasound and amniocentesis may be the best approach to determine what action to take and if pregnancy termination should be considered.

Tumor necrosis factor-alpha inhibitors (TNFi), the best-studied biologic DMARDs, can be given before conception and during the first and early second trimester; however, use in late pregnancy requires different considerations because transplacental passage varies based on differences related to their structure. Some TNFis, such as certolizumab pegol (Cimzia), have small affinity to the fetal Fc receptor or no Fc part and show low transplacental passage to the fetus. TNFis that possess an Fc part of immunoglobulin G1, however, allow high amounts of transfer and should be avoided in the third trimester whenever possible, Dr. Østensen said.

Data are sparse on human pregnancy exposure and fetal side effects and outcomes for most other biologics, so decisions to use biologics targeting B-cells, T-cell activation, or cytokines like interleukin (IL)-6, IL-23, IL-17, or IL-1beta must be based on the severity of maternal disease and reserved for cases in which no other safe options are available, Dr. Østensen cautioned.

So how can acute arthritis be treated during pregnancy? Options in RA include NSAIDs, short-term oral prednisone with rapid tapering or intramuscular injection of triamcinolone. Intra-articular steroid injection also might be considered, and TNFi in patients with severe polyarthritis. Spondyloarthritis might be treated with NSAIDs, intramuscular triamcinolone, or intra-articular steroid injection, with TNFi in severe cases.

Newer approaches to managing arthritis during pregnancy are to perhaps prescribe a TNFi with a low propensity for transplacental passage or to use a flexible regimen of TNFi by reducing the dose or prolonging the interval between administrations.

Continuing medications such as hydroxychloroquine, sulfasalazine, or azathioprine might be in some patients’ best interests to support remission and keep disease activity low, Dr. Østensen suggested. She noted that prednisone should be used at a low (5-7.5 mg) dose during pregnancy and that the aim should be to try to slowly reduce the use of pregnancy-compatible medications that are not necessary for continued remission, keeping a close eye on patients’ disease activity to ensure that no flares occur.

Dr. Chakravarty had no financial disclosures. Dr. Østensen reported receiving speaker fees and honoraria from UCB, Roche, AbbVie, MSD, Pfizer, and New Bridge.

ROME – Reassuring new data from the German biologics registry RABBIT presented at the European Congress of Rheumatology indicate that exposure to biologic therapies around the time of conception does not increase the risk of malformations or other harmful neonatal consequences.

Observational studies suggest that biologic disease-modifying antirheumatic drugs (DMARDs) are safe to use in patients with rheumatoid arthritis until conception, but questions remain about their influence on birth outcomes, Dr. Anja Strangfeld of the German Rheumatism Research Center, Berlin, and one of the principal investigators for RABBIT (Rheumatoid Arthritis Observation of Biologic Therapy), said in a precongress interview. Dr. Strangfeld also noted that questions remained on the course of RA during pregnancy in women who stopped biologic therapy in the first trimester, and how to treat high disease activity, including the use of glucocorticoids.

Her coprincipal investigator, Dr. Angela Zink, also of the German Rheumatism Research Center, presented the new findings during the scientific sessions, which considered 106 pregnancies in 88 women aged 45 years or younger that had occurred between 2001 and the end of 2014. Of these, 42 had occurred in the preceding 3 years.

Among the 38 women who stopped biologics before conception, therapies included rituximab (n = 13), etanercept (n = 12), adalimumab (n = 9), tocilizumab (n = 2), and infliximab (n = 2). Etanercept and adalimumab were the most common therapies among those using biologics at conception, administered in 29 and 11 patients, respectively.

The study identified five spontaneous abortions in 38 pregnancies (13%) in which biologic DMARD infusions or injections were stopped at least 4 weeks before conception and 11 spontaneous abortions among 57 pregnancies (19%) exposed to biologic DMARDs at conception. A total of 11 patients were biologic naive, and no spontaneous abortions were observed. Reassuringly, the rates of spontaneous abortions were within the range of about 15%-20% observed in the general public.

Induced abortions were decided on in 4 of the 106 pregnancies. Three occurred in the 38 women who stopped biologic therapy before conception, including one abortion due to trisomy 21, and the other one was in a women who had been taking biologic DMARD therapy at conception.

The live birth rate was 100% for the biologic-naive women, and 79% for both women who stopped biologic DMARDs before conception and those who had been taking them at conception.

Four congenital defects were reported in live-born children: one anal atresia with urogenital malformation (last adalimumab injection 4 weeks before conception), one congenital nystagmus after preterm birth (last adalimumab injection > 6 months before conception), and one case of spina bifida (last etanercept injection > 9 months before conception). There was also one case of talipes in a child whose mother reported also having talipes and had been taking adalimumab at time of conception.

Although the analysis includes a limited sample of pregnancies, these data confirm previous reports and show no increased risk of major malformations or other harmful consequences in patients exposed to biologic therapy around conception.

“We found that, in patients with long-standing rheumatic disease, remission during pregnancy is rarely reached,” Dr. Zink observed. In fact, “disease activity increased during pregnancy in a considerable proportion of the patients,” she added. This is in contrast to other studies and experience, however, she acknowledged, where disease activity has been shown to reduce during pregnancy.

Of 23 patients who were in already in remission before conception, 10 (43%) remained in remission during their pregnancies. Of the 49 patients who had not been in remission before pregnancy, only seven (14%) went into remission during pregnancy.

Dr. Zink noted that a new German pregnancy registry, RHEKISS, will start recruitment in July 2015 to observe treatment needs from the first desire to conceive or early pregnancy (first trimester) until the child’s second birthday. This register will initially include women with any inflammatory rheumatic disease but will later also include male patients whose partner is pregnant.

In a separate presentation, Dr. John J. Cush of Baylor Research Institute and Baylor University Medical Center in Dallas reported other data on the safety of tumor necrosis factor inhibitors (TNFis) in pregnancy. He presented prospectively collected data on pregnancy outcomes in 78 women with rheumatic disease and 148 women with other inflammatory diseases, such as Crohn’s disease, who were exposed to certolizumab pegol (Cimzia) from the manufacturer UCB Pharma’s global safety database.

He observed that because certolizumab’s structure lacks an Fc region, it was potentially a more favorable anti-TNF therapy to use during pregnancy than etanercept, infliximab, adalimumab, or golimumab because it was thought to be less likely to cross the placental barrier and affect the developing fetus.

“Live births were reported for the majority of pregnancies of women with rheumatic diseases following maternal certolizumab exposure,” Dr. Cush said.

Almost three-quarters (73.1%) of the 78 women with rheumatic disease had a live birth with no congenital malformations. Around 5% of live births were associated with congenital malformations, and the rates of spontaneous and induced abortions were a respective 11.5% and 14.1%.

In the 132 women with nonrheumatic inflammatory diseases, there were 86.6% live births without and 4.4% with congenital abnormalities and 9.1% and 5.3% spontaneous and induced abortions.

For all indications, there were 12 congenital malformations from 254 live births. These included anal fistula, polydactyl left hand, posterior ankyloglossia, renal cyst for which no treatment was needed, pyloric stenosis, club foot, and left-sided vesicoureteral reflux.

Dr. Cush noted that one neonate in a set of premature twins delivered at 26 weeks died due to brain damage and pneumoperitoneum.

Importantly, the data were “encouraging” he said and “suggest that certolizumab exposure in utero, including the first trimester of exposure, does not adversely affect pregnancy outcome.”

The German biologics registry RABBIT is supported by grants from AbbVie, BMS, Celltrion, Hospira, MSD, Pfizer, Roche, and UCB. Dr. Strangfeld reported having no disclosures. Dr. Zink has received speaker fees from AbbVie, BMS, MSD, Pfizer, Sanofi Aventis, Roche and USB. Dr. Cush disclosed receiving research grants from Pfizer, Celgene, CORRONA, Amgen, the National Institutes of Health, Novartis, and UCB.

*Correction, 6/24/2015: An earlier version of this article contained a misspelled word in the headline.

ROME – Reassuring new data from the German biologics registry RABBIT presented at the European Congress of Rheumatology indicate that exposure to biologic therapies around the time of conception does not increase the risk of malformations or other harmful neonatal consequences.

Observational studies suggest that biologic disease-modifying antirheumatic drugs (DMARDs) are safe to use in patients with rheumatoid arthritis until conception, but questions remain about their influence on birth outcomes, Dr. Anja Strangfeld of the German Rheumatism Research Center, Berlin, and one of the principal investigators for RABBIT (Rheumatoid Arthritis Observation of Biologic Therapy), said in a precongress interview. Dr. Strangfeld also noted that questions remained on the course of RA during pregnancy in women who stopped biologic therapy in the first trimester, and how to treat high disease activity, including the use of glucocorticoids.

Her coprincipal investigator, Dr. Angela Zink, also of the German Rheumatism Research Center, presented the new findings during the scientific sessions, which considered 106 pregnancies in 88 women aged 45 years or younger that had occurred between 2001 and the end of 2014. Of these, 42 had occurred in the preceding 3 years.

Among the 38 women who stopped biologics before conception, therapies included rituximab (n = 13), etanercept (n = 12), adalimumab (n = 9), tocilizumab (n = 2), and infliximab (n = 2). Etanercept and adalimumab were the most common therapies among those using biologics at conception, administered in 29 and 11 patients, respectively.

The study identified five spontaneous abortions in 38 pregnancies (13%) in which biologic DMARD infusions or injections were stopped at least 4 weeks before conception and 11 spontaneous abortions among 57 pregnancies (19%) exposed to biologic DMARDs at conception. A total of 11 patients were biologic naive, and no spontaneous abortions were observed. Reassuringly, the rates of spontaneous abortions were within the range of about 15%-20% observed in the general public.

Induced abortions were decided on in 4 of the 106 pregnancies. Three occurred in the 38 women who stopped biologic therapy before conception, including one abortion due to trisomy 21, and the other one was in a women who had been taking biologic DMARD therapy at conception.

The live birth rate was 100% for the biologic-naive women, and 79% for both women who stopped biologic DMARDs before conception and those who had been taking them at conception.

Four congenital defects were reported in live-born children: one anal atresia with urogenital malformation (last adalimumab injection 4 weeks before conception), one congenital nystagmus after preterm birth (last adalimumab injection > 6 months before conception), and one case of spina bifida (last etanercept injection > 9 months before conception). There was also one case of talipes in a child whose mother reported also having talipes and had been taking adalimumab at time of conception.

Although the analysis includes a limited sample of pregnancies, these data confirm previous reports and show no increased risk of major malformations or other harmful consequences in patients exposed to biologic therapy around conception.

“We found that, in patients with long-standing rheumatic disease, remission during pregnancy is rarely reached,” Dr. Zink observed. In fact, “disease activity increased during pregnancy in a considerable proportion of the patients,” she added. This is in contrast to other studies and experience, however, she acknowledged, where disease activity has been shown to reduce during pregnancy.

Of 23 patients who were in already in remission before conception, 10 (43%) remained in remission during their pregnancies. Of the 49 patients who had not been in remission before pregnancy, only seven (14%) went into remission during pregnancy.

Dr. Zink noted that a new German pregnancy registry, RHEKISS, will start recruitment in July 2015 to observe treatment needs from the first desire to conceive or early pregnancy (first trimester) until the child’s second birthday. This register will initially include women with any inflammatory rheumatic disease but will later also include male patients whose partner is pregnant.

In a separate presentation, Dr. John J. Cush of Baylor Research Institute and Baylor University Medical Center in Dallas reported other data on the safety of tumor necrosis factor inhibitors (TNFis) in pregnancy. He presented prospectively collected data on pregnancy outcomes in 78 women with rheumatic disease and 148 women with other inflammatory diseases, such as Crohn’s disease, who were exposed to certolizumab pegol (Cimzia) from the manufacturer UCB Pharma’s global safety database.

He observed that because certolizumab’s structure lacks an Fc region, it was potentially a more favorable anti-TNF therapy to use during pregnancy than etanercept, infliximab, adalimumab, or golimumab because it was thought to be less likely to cross the placental barrier and affect the developing fetus.

“Live births were reported for the majority of pregnancies of women with rheumatic diseases following maternal certolizumab exposure,” Dr. Cush said.

Almost three-quarters (73.1%) of the 78 women with rheumatic disease had a live birth with no congenital malformations. Around 5% of live births were associated with congenital malformations, and the rates of spontaneous and induced abortions were a respective 11.5% and 14.1%.

In the 132 women with nonrheumatic inflammatory diseases, there were 86.6% live births without and 4.4% with congenital abnormalities and 9.1% and 5.3% spontaneous and induced abortions.

For all indications, there were 12 congenital malformations from 254 live births. These included anal fistula, polydactyl left hand, posterior ankyloglossia, renal cyst for which no treatment was needed, pyloric stenosis, club foot, and left-sided vesicoureteral reflux.

Dr. Cush noted that one neonate in a set of premature twins delivered at 26 weeks died due to brain damage and pneumoperitoneum.

Importantly, the data were “encouraging” he said and “suggest that certolizumab exposure in utero, including the first trimester of exposure, does not adversely affect pregnancy outcome.”

The German biologics registry RABBIT is supported by grants from AbbVie, BMS, Celltrion, Hospira, MSD, Pfizer, Roche, and UCB. Dr. Strangfeld reported having no disclosures. Dr. Zink has received speaker fees from AbbVie, BMS, MSD, Pfizer, Sanofi Aventis, Roche and USB. Dr. Cush disclosed receiving research grants from Pfizer, Celgene, CORRONA, Amgen, the National Institutes of Health, Novartis, and UCB.

*Correction, 6/24/2015: An earlier version of this article contained a misspelled word in the headline.

ROME – Reassuring new data from the German biologics registry RABBIT presented at the European Congress of Rheumatology indicate that exposure to biologic therapies around the time of conception does not increase the risk of malformations or other harmful neonatal consequences.

Observational studies suggest that biologic disease-modifying antirheumatic drugs (DMARDs) are safe to use in patients with rheumatoid arthritis until conception, but questions remain about their influence on birth outcomes, Dr. Anja Strangfeld of the German Rheumatism Research Center, Berlin, and one of the principal investigators for RABBIT (Rheumatoid Arthritis Observation of Biologic Therapy), said in a precongress interview. Dr. Strangfeld also noted that questions remained on the course of RA during pregnancy in women who stopped biologic therapy in the first trimester, and how to treat high disease activity, including the use of glucocorticoids.

Her coprincipal investigator, Dr. Angela Zink, also of the German Rheumatism Research Center, presented the new findings during the scientific sessions, which considered 106 pregnancies in 88 women aged 45 years or younger that had occurred between 2001 and the end of 2014. Of these, 42 had occurred in the preceding 3 years.

Among the 38 women who stopped biologics before conception, therapies included rituximab (n = 13), etanercept (n = 12), adalimumab (n = 9), tocilizumab (n = 2), and infliximab (n = 2). Etanercept and adalimumab were the most common therapies among those using biologics at conception, administered in 29 and 11 patients, respectively.

The study identified five spontaneous abortions in 38 pregnancies (13%) in which biologic DMARD infusions or injections were stopped at least 4 weeks before conception and 11 spontaneous abortions among 57 pregnancies (19%) exposed to biologic DMARDs at conception. A total of 11 patients were biologic naive, and no spontaneous abortions were observed. Reassuringly, the rates of spontaneous abortions were within the range of about 15%-20% observed in the general public.

Induced abortions were decided on in 4 of the 106 pregnancies. Three occurred in the 38 women who stopped biologic therapy before conception, including one abortion due to trisomy 21, and the other one was in a women who had been taking biologic DMARD therapy at conception.

The live birth rate was 100% for the biologic-naive women, and 79% for both women who stopped biologic DMARDs before conception and those who had been taking them at conception.

Four congenital defects were reported in live-born children: one anal atresia with urogenital malformation (last adalimumab injection 4 weeks before conception), one congenital nystagmus after preterm birth (last adalimumab injection > 6 months before conception), and one case of spina bifida (last etanercept injection > 9 months before conception). There was also one case of talipes in a child whose mother reported also having talipes and had been taking adalimumab at time of conception.

Although the analysis includes a limited sample of pregnancies, these data confirm previous reports and show no increased risk of major malformations or other harmful consequences in patients exposed to biologic therapy around conception.

“We found that, in patients with long-standing rheumatic disease, remission during pregnancy is rarely reached,” Dr. Zink observed. In fact, “disease activity increased during pregnancy in a considerable proportion of the patients,” she added. This is in contrast to other studies and experience, however, she acknowledged, where disease activity has been shown to reduce during pregnancy.

Of 23 patients who were in already in remission before conception, 10 (43%) remained in remission during their pregnancies. Of the 49 patients who had not been in remission before pregnancy, only seven (14%) went into remission during pregnancy.

Dr. Zink noted that a new German pregnancy registry, RHEKISS, will start recruitment in July 2015 to observe treatment needs from the first desire to conceive or early pregnancy (first trimester) until the child’s second birthday. This register will initially include women with any inflammatory rheumatic disease but will later also include male patients whose partner is pregnant.

In a separate presentation, Dr. John J. Cush of Baylor Research Institute and Baylor University Medical Center in Dallas reported other data on the safety of tumor necrosis factor inhibitors (TNFis) in pregnancy. He presented prospectively collected data on pregnancy outcomes in 78 women with rheumatic disease and 148 women with other inflammatory diseases, such as Crohn’s disease, who were exposed to certolizumab pegol (Cimzia) from the manufacturer UCB Pharma’s global safety database.

He observed that because certolizumab’s structure lacks an Fc region, it was potentially a more favorable anti-TNF therapy to use during pregnancy than etanercept, infliximab, adalimumab, or golimumab because it was thought to be less likely to cross the placental barrier and affect the developing fetus.

“Live births were reported for the majority of pregnancies of women with rheumatic diseases following maternal certolizumab exposure,” Dr. Cush said.

Almost three-quarters (73.1%) of the 78 women with rheumatic disease had a live birth with no congenital malformations. Around 5% of live births were associated with congenital malformations, and the rates of spontaneous and induced abortions were a respective 11.5% and 14.1%.

In the 132 women with nonrheumatic inflammatory diseases, there were 86.6% live births without and 4.4% with congenital abnormalities and 9.1% and 5.3% spontaneous and induced abortions.

For all indications, there were 12 congenital malformations from 254 live births. These included anal fistula, polydactyl left hand, posterior ankyloglossia, renal cyst for which no treatment was needed, pyloric stenosis, club foot, and left-sided vesicoureteral reflux.

Dr. Cush noted that one neonate in a set of premature twins delivered at 26 weeks died due to brain damage and pneumoperitoneum.

Importantly, the data were “encouraging” he said and “suggest that certolizumab exposure in utero, including the first trimester of exposure, does not adversely affect pregnancy outcome.”

The German biologics registry RABBIT is supported by grants from AbbVie, BMS, Celltrion, Hospira, MSD, Pfizer, Roche, and UCB. Dr. Strangfeld reported having no disclosures. Dr. Zink has received speaker fees from AbbVie, BMS, MSD, Pfizer, Sanofi Aventis, Roche and USB. Dr. Cush disclosed receiving research grants from Pfizer, Celgene, CORRONA, Amgen, the National Institutes of Health, Novartis, and UCB.

*Correction, 6/24/2015: An earlier version of this article contained a misspelled word in the headline.

Pregnancy outcomes in women with systemic lupus erythematosus were better than expected in the largest study of the issue to date, according to a report published online June 22 in Annals of Internal Medicine.

Until now, research examining pregnancy outcomes in systemic lupus erythematosus (SLE) has comprised retrospective or single-center studies with few patients. These studies have failed to include women of diverse ethnic backgrounds and have drawn “controversial” conclusions, Dr. Jill P. Buyon of New York University/Langone Medical Center, New York, and her associates wrote in their report.

Dr. Buyon and her colleagues examined pregnancy outcomes in SLE by analyzing data in the prospective PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and SLE) study. They focused on 385 women who conceived singleton pregnancies while their SLE was inactive or mildly to moderately active during the 8-year study period. The women (48% non-Hispanic white, 15% Hispanic white, 20% African American, 11% Asian American, 3% other, and 3% unknown ethnicity) were enrolled after attaining at least 12 weeks’ gestation, and were followed at eight sites in the United States and one in Canada.

The adverse outcomes of interest in this study were fetal or neonatal death; birth before 36 weeks due to placental insufficiency, maternal hypertension, or preeclampsia; and small-for-gestational-age neonates. Overall, 81% of these pregnancies had none of these complications, and 3% of the women experienced severe SLE flares during pregnancy. “In patients with inactive disease or stable mild or moderate activity, pregnancy is safer for mother and child than it was previously believed to be,” the investigators wrote (Ann. Intern, Med. 2015 June 22 [doi:10.7326/M14-2235]).

One or more adverse outcomes occurred in 19% of the pregnancies, including fetal death (4%), neonatal death (1%), preterm delivery due to placental insufficiency or preeclampsia (9%), and small-for-gestational-age neonates (10%). The rate of adverse pregnancy outcomes was highest among both African Americans and Hispanic whites (26% in each), followed by non-Hispanic whites (15%) and Asian Americans (14%).

Risk factors that predicted adverse pregnancy outcomes included nonwhite ethnicity, the presence of antiphospholipid antibodies, the presence of lupus anticoagulant, higher scores on the Physician’s Global Assessment (PGA) or Systemic Lupus Erythematosus Pregnancy Disease Activity Index, the use of antihypertensive drugs, a low platelet count, and the development of a severe SLE flare during pregnancy.

The rate of adverse pregnancy outcomes was remarkably low – less than 8% – in the large subgroup of women at lowest risk for adverse pregnancy outcomes, which includes those who were white, negative for lupus anticoagulant, had a PGA score of 1 or lower, were not taking antihypertensive medication, had adequate platelet counts, and did not experience a severe SLE flare during the pregnancy, Dr. Buyon and her associates added.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institutes of Health, the Mary Kirkland Center for Lupus Research, and Rheuminations supported the study. Dr. Buyon and her associates reported having no conflicts of interest.

Pregnancy outcomes in women with systemic lupus erythematosus were better than expected in the largest study of the issue to date, according to a report published online June 22 in Annals of Internal Medicine.

Until now, research examining pregnancy outcomes in systemic lupus erythematosus (SLE) has comprised retrospective or single-center studies with few patients. These studies have failed to include women of diverse ethnic backgrounds and have drawn “controversial” conclusions, Dr. Jill P. Buyon of New York University/Langone Medical Center, New York, and her associates wrote in their report.

Dr. Buyon and her colleagues examined pregnancy outcomes in SLE by analyzing data in the prospective PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and SLE) study. They focused on 385 women who conceived singleton pregnancies while their SLE was inactive or mildly to moderately active during the 8-year study period. The women (48% non-Hispanic white, 15% Hispanic white, 20% African American, 11% Asian American, 3% other, and 3% unknown ethnicity) were enrolled after attaining at least 12 weeks’ gestation, and were followed at eight sites in the United States and one in Canada.

The adverse outcomes of interest in this study were fetal or neonatal death; birth before 36 weeks due to placental insufficiency, maternal hypertension, or preeclampsia; and small-for-gestational-age neonates. Overall, 81% of these pregnancies had none of these complications, and 3% of the women experienced severe SLE flares during pregnancy. “In patients with inactive disease or stable mild or moderate activity, pregnancy is safer for mother and child than it was previously believed to be,” the investigators wrote (Ann. Intern, Med. 2015 June 22 [doi:10.7326/M14-2235]).

One or more adverse outcomes occurred in 19% of the pregnancies, including fetal death (4%), neonatal death (1%), preterm delivery due to placental insufficiency or preeclampsia (9%), and small-for-gestational-age neonates (10%). The rate of adverse pregnancy outcomes was highest among both African Americans and Hispanic whites (26% in each), followed by non-Hispanic whites (15%) and Asian Americans (14%).

Risk factors that predicted adverse pregnancy outcomes included nonwhite ethnicity, the presence of antiphospholipid antibodies, the presence of lupus anticoagulant, higher scores on the Physician’s Global Assessment (PGA) or Systemic Lupus Erythematosus Pregnancy Disease Activity Index, the use of antihypertensive drugs, a low platelet count, and the development of a severe SLE flare during pregnancy.

The rate of adverse pregnancy outcomes was remarkably low – less than 8% – in the large subgroup of women at lowest risk for adverse pregnancy outcomes, which includes those who were white, negative for lupus anticoagulant, had a PGA score of 1 or lower, were not taking antihypertensive medication, had adequate platelet counts, and did not experience a severe SLE flare during the pregnancy, Dr. Buyon and her associates added.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institutes of Health, the Mary Kirkland Center for Lupus Research, and Rheuminations supported the study. Dr. Buyon and her associates reported having no conflicts of interest.

Pregnancy outcomes in women with systemic lupus erythematosus were better than expected in the largest study of the issue to date, according to a report published online June 22 in Annals of Internal Medicine.

Until now, research examining pregnancy outcomes in systemic lupus erythematosus (SLE) has comprised retrospective or single-center studies with few patients. These studies have failed to include women of diverse ethnic backgrounds and have drawn “controversial” conclusions, Dr. Jill P. Buyon of New York University/Langone Medical Center, New York, and her associates wrote in their report.

Dr. Buyon and her colleagues examined pregnancy outcomes in SLE by analyzing data in the prospective PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and SLE) study. They focused on 385 women who conceived singleton pregnancies while their SLE was inactive or mildly to moderately active during the 8-year study period. The women (48% non-Hispanic white, 15% Hispanic white, 20% African American, 11% Asian American, 3% other, and 3% unknown ethnicity) were enrolled after attaining at least 12 weeks’ gestation, and were followed at eight sites in the United States and one in Canada.

The adverse outcomes of interest in this study were fetal or neonatal death; birth before 36 weeks due to placental insufficiency, maternal hypertension, or preeclampsia; and small-for-gestational-age neonates. Overall, 81% of these pregnancies had none of these complications, and 3% of the women experienced severe SLE flares during pregnancy. “In patients with inactive disease or stable mild or moderate activity, pregnancy is safer for mother and child than it was previously believed to be,” the investigators wrote (Ann. Intern, Med. 2015 June 22 [doi:10.7326/M14-2235]).

One or more adverse outcomes occurred in 19% of the pregnancies, including fetal death (4%), neonatal death (1%), preterm delivery due to placental insufficiency or preeclampsia (9%), and small-for-gestational-age neonates (10%). The rate of adverse pregnancy outcomes was highest among both African Americans and Hispanic whites (26% in each), followed by non-Hispanic whites (15%) and Asian Americans (14%).

Risk factors that predicted adverse pregnancy outcomes included nonwhite ethnicity, the presence of antiphospholipid antibodies, the presence of lupus anticoagulant, higher scores on the Physician’s Global Assessment (PGA) or Systemic Lupus Erythematosus Pregnancy Disease Activity Index, the use of antihypertensive drugs, a low platelet count, and the development of a severe SLE flare during pregnancy.

The rate of adverse pregnancy outcomes was remarkably low – less than 8% – in the large subgroup of women at lowest risk for adverse pregnancy outcomes, which includes those who were white, negative for lupus anticoagulant, had a PGA score of 1 or lower, were not taking antihypertensive medication, had adequate platelet counts, and did not experience a severe SLE flare during the pregnancy, Dr. Buyon and her associates added.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institutes of Health, the Mary Kirkland Center for Lupus Research, and Rheuminations supported the study. Dr. Buyon and her associates reported having no conflicts of interest.

A national group that includes ob.gyns., nurse-midwives, anesthesiologists, and other providers has released a safety bundle with 13 steps that hospitals can use to prevent, recognize, and better manage obstetric hemorrhage.

The new safety bundle draws on evidence from several existing evidence-based guidelines and the work of safety collaboratives in California and New York. The idea behind the bundle’s release is to standardize the response to obstetric hemorrhage across hospitals, whether they deliver hundreds of babies a year or thousands. Not every hospital will have the same approach, but they should all have a standardized response that is triggered by excessive bleeding during delivery.

“Our goal with this bundle is to make any hospital in the country that does obstetric care understand the basic elements that they should have considered and thought through and dealt with, with their own multidisciplinary team,” said Dr. Dena Goffman, director of maternal safety and simulation at Montefiore Medical Center in New York City.

Courtesy Helene Guss/ Montefiore Medical Center

The hemorrhage bundle is the first national maternity patient safety bundle released by a multidisciplinary workgroup of the National Partnership for Maternal Safety, part of the Council on Patient Safety in Women’s Health Care. Future safety bundles will focus on severe hypertension and venous thromboembolism.

These efforts come as the United States ranks worst among developed nations, and 60th overall, in maternal mortality, according to the Health Resources and Services Administration. Obstetric hemorrhage is a good first target, the workgroup members said, because it is both the most common serious complication of childbirth and the most preventable cause of maternal mortality.

The hemorrhage safety bundle calls on hospitals to implement 13 steps focused on readiness, recognition and prevention, response, and reporting and systems learning.

Readiness

1. Create a hemorrhage cart with medication and other supplies that might be needed immediately.

2. Create a kit (or equivalent) for immediate access to hemorrhage medications that may need refrigeration.

3. Establish a response team.

4. Establish protocols for massive transfusion and emergency release of blood products.

5. Perform unit education on protocols, including regular unit-based drills.

Recognition and Prevention

6. Assess hemorrhage risk at various times, including antepartum, on admission to labor and delivery, later in labor, and on transfer to postpartum care.

7. Measure cumulative blood loss.

8. Actively manage the third stage of labor.

Response

9. Create a stage-based obstetric hemorrhage emergency management plan similar to a “Code Blue” for cardiopulmonary arrest.

10. Provide a support program for patients, families, and staff for all significant hemorrhages.

Reporting and Systems Learning

11. Establish a culture of brief planning meetings, huddles for high-risk patients, and postevent debriefings.

12. Perform formal, multidisciplinary reviews of serious hemorrhages to identify systems issues.

13. Monitor outcomes and process metrics such as the number of women who receive four or more units of red blood cells or who require care in the intensive care unit.

The overall goal of the safety bundle is to eliminate the “denial and delay” that are commonly seen in obstetric emergencies, said Dr. Elliott K. Main, medical director of the California Maternal Quality Care Collaborative.

“It’s partly because we are spoiled in obstetrics by having essentially young, healthy women who can withstand a lot of bleeding, for example, and not have anything go wrong,” he said. “If you’re young and healthy, you do look good until suddenly you don’t.”

One of the main elements of the safety bundle is creating a hemorrhage cart – stocked with necessary supplies and medications – that is immediately available in the birthing unit, with similar materials available on the antepartum and postpartum floors. The safety bundle does not specify what should go in the cart, only that the materials should be determined with input from obstetric, anesthesiology, nursing, midwifery, and pharmacy providers.

It’s that communication among a multidisciplinary team of providers that is really the centerpiece of the safety bundle, according to physicians who worked on the document, which was published simultaneously in the Journal of Obstetric, Gynecologic, & Neonatal Nursing; the Journal of Midwifery & Women’s Health; Anesthesia & Analgesia; and Obstetrics & Gynecology (Obstet. Gynecol. 2015;126:155-62).

Along with the hemorrhage cart, the bundle calls on hospitals to establish a response team and protocols for the emergency release of blood products for massive transfusion.

The members of the team would vary depending on the severity of the hemorrhage and the resources at the hospital. But the team could include the primary obstetrician and nurse, as well as representatives from anesthesiology, the blood bank, the pharmacy, advanced gynecologic surgery, critical care medicine, and interventional radiology. Social services support, such as chaplains, should also be available as needed, according to the document.

It’s critical that all members of the multidisciplinary team are involved during the planning phase, otherwise the emergency response can be hindered, according to Dr. David C. Lagrew Jr., chief integration and accountability officer at MemorialCare Health System in California. For instance, he worked with a hospital that recounted to him having failed to inform the blood bank that they had renovated their operating room and renumbered the doors. The result was that the blood bank staff person was delayed in finding the correct operating room.

“When someone is bleeding to death, minutes matter,” said Dr. Lagrew.

Once protocols and supplies are in place, units need to educate their staff about the new procedures and run drills.

“I’m a proponent of drills for this kind of response,” said Dr. Main. While simulations are effective for technical work, drills are essential when dealing with emergency responses so that staff on the unit know whom to call, when to call, and what to do, he said.

But Dr. Main said he expects that drills will be a challenge for hospitals because they involve an investment of time and money. Another challenge, he said, is getting private practice physicians to participate in the hospital unit drills. “It’s about their time and money,” Dr. Main said.

As part of the response to hemorrhage, the safety bundle also calls for a more standardized approach to assessing blood loss, as well as “universal vigilance,” since about 40% of postpartum hemorrhages occur in low-risk women.

Physicians are encouraged to directly measure cumulative blood loss using methods such as collecting blood in calibrated, under-buttocks drapes during vaginal birth or in calibrated canisters during cesarean delivery. Another measurement approach is to weigh blood-soaked items, such as sponges.

This type of quantitative approach is superior to traditional methods of “eye balling” the amount of bleeding, waiting for lab results, or monitoring vital signs, said Dr. Lagrew. “We are absolutely miserable at estimating blood loss,” he said, noting that frequently the obstetrician will give one number for blood loss, while the anesthesiologist and the nurse offer different numbers.

And lab results often take too long, while vital signs don’t offer an early enough warning that blood loss is severe since women often have to lose 1.5 L of blood before there are any changes in their vital signs.

“The bottom line is, you don’t want to wait that long to intervene,” Dr. Lagrew said. “By doing this, it allows us to have a more timely response.”

The safety bundle also calls on hospital teams to engage in debriefings and monitor outcomes to improve their response to obstetric hemorrhage, said Dr. Goffman, who has been working with hospitals in New York as part of the American Congress of Obstetricians and Gynecologists District II Safe Motherhood Initiative.

“It’s this move to a culture of safety that may be the most difficult change for some hospitals,” she said. “That culture change takes time.”

[email protected]

On Twitter @maryellenny

A national group that includes ob.gyns., nurse-midwives, anesthesiologists, and other providers has released a safety bundle with 13 steps that hospitals can use to prevent, recognize, and better manage obstetric hemorrhage.

The new safety bundle draws on evidence from several existing evidence-based guidelines and the work of safety collaboratives in California and New York. The idea behind the bundle’s release is to standardize the response to obstetric hemorrhage across hospitals, whether they deliver hundreds of babies a year or thousands. Not every hospital will have the same approach, but they should all have a standardized response that is triggered by excessive bleeding during delivery.

“Our goal with this bundle is to make any hospital in the country that does obstetric care understand the basic elements that they should have considered and thought through and dealt with, with their own multidisciplinary team,” said Dr. Dena Goffman, director of maternal safety and simulation at Montefiore Medical Center in New York City.

Courtesy Helene Guss/ Montefiore Medical Center

The hemorrhage bundle is the first national maternity patient safety bundle released by a multidisciplinary workgroup of the National Partnership for Maternal Safety, part of the Council on Patient Safety in Women’s Health Care. Future safety bundles will focus on severe hypertension and venous thromboembolism.

These efforts come as the United States ranks worst among developed nations, and 60th overall, in maternal mortality, according to the Health Resources and Services Administration. Obstetric hemorrhage is a good first target, the workgroup members said, because it is both the most common serious complication of childbirth and the most preventable cause of maternal mortality.

The hemorrhage safety bundle calls on hospitals to implement 13 steps focused on readiness, recognition and prevention, response, and reporting and systems learning.

Readiness

1. Create a hemorrhage cart with medication and other supplies that might be needed immediately.

2. Create a kit (or equivalent) for immediate access to hemorrhage medications that may need refrigeration.

3. Establish a response team.

4. Establish protocols for massive transfusion and emergency release of blood products.

5. Perform unit education on protocols, including regular unit-based drills.

Recognition and Prevention

6. Assess hemorrhage risk at various times, including antepartum, on admission to labor and delivery, later in labor, and on transfer to postpartum care.

7. Measure cumulative blood loss.

8. Actively manage the third stage of labor.

Response

9. Create a stage-based obstetric hemorrhage emergency management plan similar to a “Code Blue” for cardiopulmonary arrest.

10. Provide a support program for patients, families, and staff for all significant hemorrhages.

Reporting and Systems Learning

11. Establish a culture of brief planning meetings, huddles for high-risk patients, and postevent debriefings.

12. Perform formal, multidisciplinary reviews of serious hemorrhages to identify systems issues.

13. Monitor outcomes and process metrics such as the number of women who receive four or more units of red blood cells or who require care in the intensive care unit.

The overall goal of the safety bundle is to eliminate the “denial and delay” that are commonly seen in obstetric emergencies, said Dr. Elliott K. Main, medical director of the California Maternal Quality Care Collaborative.

“It’s partly because we are spoiled in obstetrics by having essentially young, healthy women who can withstand a lot of bleeding, for example, and not have anything go wrong,” he said. “If you’re young and healthy, you do look good until suddenly you don’t.”

One of the main elements of the safety bundle is creating a hemorrhage cart – stocked with necessary supplies and medications – that is immediately available in the birthing unit, with similar materials available on the antepartum and postpartum floors. The safety bundle does not specify what should go in the cart, only that the materials should be determined with input from obstetric, anesthesiology, nursing, midwifery, and pharmacy providers.

It’s that communication among a multidisciplinary team of providers that is really the centerpiece of the safety bundle, according to physicians who worked on the document, which was published simultaneously in the Journal of Obstetric, Gynecologic, & Neonatal Nursing; the Journal of Midwifery & Women’s Health; Anesthesia & Analgesia; and Obstetrics & Gynecology (Obstet. Gynecol. 2015;126:155-62).

Along with the hemorrhage cart, the bundle calls on hospitals to establish a response team and protocols for the emergency release of blood products for massive transfusion.

The members of the team would vary depending on the severity of the hemorrhage and the resources at the hospital. But the team could include the primary obstetrician and nurse, as well as representatives from anesthesiology, the blood bank, the pharmacy, advanced gynecologic surgery, critical care medicine, and interventional radiology. Social services support, such as chaplains, should also be available as needed, according to the document.

It’s critical that all members of the multidisciplinary team are involved during the planning phase, otherwise the emergency response can be hindered, according to Dr. David C. Lagrew Jr., chief integration and accountability officer at MemorialCare Health System in California. For instance, he worked with a hospital that recounted to him having failed to inform the blood bank that they had renovated their operating room and renumbered the doors. The result was that the blood bank staff person was delayed in finding the correct operating room.

“When someone is bleeding to death, minutes matter,” said Dr. Lagrew.

Once protocols and supplies are in place, units need to educate their staff about the new procedures and run drills.

“I’m a proponent of drills for this kind of response,” said Dr. Main. While simulations are effective for technical work, drills are essential when dealing with emergency responses so that staff on the unit know whom to call, when to call, and what to do, he said.

But Dr. Main said he expects that drills will be a challenge for hospitals because they involve an investment of time and money. Another challenge, he said, is getting private practice physicians to participate in the hospital unit drills. “It’s about their time and money,” Dr. Main said.

As part of the response to hemorrhage, the safety bundle also calls for a more standardized approach to assessing blood loss, as well as “universal vigilance,” since about 40% of postpartum hemorrhages occur in low-risk women.

Physicians are encouraged to directly measure cumulative blood loss using methods such as collecting blood in calibrated, under-buttocks drapes during vaginal birth or in calibrated canisters during cesarean delivery. Another measurement approach is to weigh blood-soaked items, such as sponges.

This type of quantitative approach is superior to traditional methods of “eye balling” the amount of bleeding, waiting for lab results, or monitoring vital signs, said Dr. Lagrew. “We are absolutely miserable at estimating blood loss,” he said, noting that frequently the obstetrician will give one number for blood loss, while the anesthesiologist and the nurse offer different numbers.

And lab results often take too long, while vital signs don’t offer an early enough warning that blood loss is severe since women often have to lose 1.5 L of blood before there are any changes in their vital signs.

“The bottom line is, you don’t want to wait that long to intervene,” Dr. Lagrew said. “By doing this, it allows us to have a more timely response.”

The safety bundle also calls on hospital teams to engage in debriefings and monitor outcomes to improve their response to obstetric hemorrhage, said Dr. Goffman, who has been working with hospitals in New York as part of the American Congress of Obstetricians and Gynecologists District II Safe Motherhood Initiative.

“It’s this move to a culture of safety that may be the most difficult change for some hospitals,” she said. “That culture change takes time.”

[email protected]

On Twitter @maryellenny

A national group that includes ob.gyns., nurse-midwives, anesthesiologists, and other providers has released a safety bundle with 13 steps that hospitals can use to prevent, recognize, and better manage obstetric hemorrhage.

The new safety bundle draws on evidence from several existing evidence-based guidelines and the work of safety collaboratives in California and New York. The idea behind the bundle’s release is to standardize the response to obstetric hemorrhage across hospitals, whether they deliver hundreds of babies a year or thousands. Not every hospital will have the same approach, but they should all have a standardized response that is triggered by excessive bleeding during delivery.

“Our goal with this bundle is to make any hospital in the country that does obstetric care understand the basic elements that they should have considered and thought through and dealt with, with their own multidisciplinary team,” said Dr. Dena Goffman, director of maternal safety and simulation at Montefiore Medical Center in New York City.

Courtesy Helene Guss/ Montefiore Medical Center

The hemorrhage bundle is the first national maternity patient safety bundle released by a multidisciplinary workgroup of the National Partnership for Maternal Safety, part of the Council on Patient Safety in Women’s Health Care. Future safety bundles will focus on severe hypertension and venous thromboembolism.

These efforts come as the United States ranks worst among developed nations, and 60th overall, in maternal mortality, according to the Health Resources and Services Administration. Obstetric hemorrhage is a good first target, the workgroup members said, because it is both the most common serious complication of childbirth and the most preventable cause of maternal mortality.

The hemorrhage safety bundle calls on hospitals to implement 13 steps focused on readiness, recognition and prevention, response, and reporting and systems learning.

Readiness

1. Create a hemorrhage cart with medication and other supplies that might be needed immediately.

2. Create a kit (or equivalent) for immediate access to hemorrhage medications that may need refrigeration.

3. Establish a response team.

4. Establish protocols for massive transfusion and emergency release of blood products.

5. Perform unit education on protocols, including regular unit-based drills.

Recognition and Prevention

6. Assess hemorrhage risk at various times, including antepartum, on admission to labor and delivery, later in labor, and on transfer to postpartum care.

7. Measure cumulative blood loss.

8. Actively manage the third stage of labor.

Response

9. Create a stage-based obstetric hemorrhage emergency management plan similar to a “Code Blue” for cardiopulmonary arrest.

10. Provide a support program for patients, families, and staff for all significant hemorrhages.

Reporting and Systems Learning

11. Establish a culture of brief planning meetings, huddles for high-risk patients, and postevent debriefings.

12. Perform formal, multidisciplinary reviews of serious hemorrhages to identify systems issues.

13. Monitor outcomes and process metrics such as the number of women who receive four or more units of red blood cells or who require care in the intensive care unit.

The overall goal of the safety bundle is to eliminate the “denial and delay” that are commonly seen in obstetric emergencies, said Dr. Elliott K. Main, medical director of the California Maternal Quality Care Collaborative.

“It’s partly because we are spoiled in obstetrics by having essentially young, healthy women who can withstand a lot of bleeding, for example, and not have anything go wrong,” he said. “If you’re young and healthy, you do look good until suddenly you don’t.”

One of the main elements of the safety bundle is creating a hemorrhage cart – stocked with necessary supplies and medications – that is immediately available in the birthing unit, with similar materials available on the antepartum and postpartum floors. The safety bundle does not specify what should go in the cart, only that the materials should be determined with input from obstetric, anesthesiology, nursing, midwifery, and pharmacy providers.

It’s that communication among a multidisciplinary team of providers that is really the centerpiece of the safety bundle, according to physicians who worked on the document, which was published simultaneously in the Journal of Obstetric, Gynecologic, & Neonatal Nursing; the Journal of Midwifery & Women’s Health; Anesthesia & Analgesia; and Obstetrics & Gynecology (Obstet. Gynecol. 2015;126:155-62).

Along with the hemorrhage cart, the bundle calls on hospitals to establish a response team and protocols for the emergency release of blood products for massive transfusion.

The members of the team would vary depending on the severity of the hemorrhage and the resources at the hospital. But the team could include the primary obstetrician and nurse, as well as representatives from anesthesiology, the blood bank, the pharmacy, advanced gynecologic surgery, critical care medicine, and interventional radiology. Social services support, such as chaplains, should also be available as needed, according to the document.

It’s critical that all members of the multidisciplinary team are involved during the planning phase, otherwise the emergency response can be hindered, according to Dr. David C. Lagrew Jr., chief integration and accountability officer at MemorialCare Health System in California. For instance, he worked with a hospital that recounted to him having failed to inform the blood bank that they had renovated their operating room and renumbered the doors. The result was that the blood bank staff person was delayed in finding the correct operating room.

“When someone is bleeding to death, minutes matter,” said Dr. Lagrew.

Once protocols and supplies are in place, units need to educate their staff about the new procedures and run drills.

“I’m a proponent of drills for this kind of response,” said Dr. Main. While simulations are effective for technical work, drills are essential when dealing with emergency responses so that staff on the unit know whom to call, when to call, and what to do, he said.

But Dr. Main said he expects that drills will be a challenge for hospitals because they involve an investment of time and money. Another challenge, he said, is getting private practice physicians to participate in the hospital unit drills. “It’s about their time and money,” Dr. Main said.

As part of the response to hemorrhage, the safety bundle also calls for a more standardized approach to assessing blood loss, as well as “universal vigilance,” since about 40% of postpartum hemorrhages occur in low-risk women.

Physicians are encouraged to directly measure cumulative blood loss using methods such as collecting blood in calibrated, under-buttocks drapes during vaginal birth or in calibrated canisters during cesarean delivery. Another measurement approach is to weigh blood-soaked items, such as sponges.

This type of quantitative approach is superior to traditional methods of “eye balling” the amount of bleeding, waiting for lab results, or monitoring vital signs, said Dr. Lagrew. “We are absolutely miserable at estimating blood loss,” he said, noting that frequently the obstetrician will give one number for blood loss, while the anesthesiologist and the nurse offer different numbers.

And lab results often take too long, while vital signs don’t offer an early enough warning that blood loss is severe since women often have to lose 1.5 L of blood before there are any changes in their vital signs.

“The bottom line is, you don’t want to wait that long to intervene,” Dr. Lagrew said. “By doing this, it allows us to have a more timely response.”

The safety bundle also calls on hospital teams to engage in debriefings and monitor outcomes to improve their response to obstetric hemorrhage, said Dr. Goffman, who has been working with hospitals in New York as part of the American Congress of Obstetricians and Gynecologists District II Safe Motherhood Initiative.

“It’s this move to a culture of safety that may be the most difficult change for some hospitals,” she said. “That culture change takes time.”

[email protected]

On Twitter @maryellenny

LISBON – Advances in assisted reproductive technology (ART) have paid off, nearly halving the rate of ectopic pregnancy in the past 12 years.

The rate of ectopic pregnancy (EP) following ART progressively declined from 20 to 12 cases per thousand in a nationwide analysis of all ART pregnancies achieved in the United Kingdom between 2000 and 2012.

This trend appears to be related to a reduction in the incidence of tubal factor infertility, a lower number of embryos being transferred, and extended embryo culture, Dr. Nikolaos Polyzos said at the annual meeting of the European Society of Human Reproduction and Embryology.

Patrice Wendling/Frontline Medical News

Ectopic pregnancy (EP) is a rare event, occurring in only 2% of all spontaneous conceptions. ART has been consistently associated with higher rates of EP, which is the most common cause of mortality during the first trimester of pregnancy in the U.K., said Dr. Polyzos of the Centre for Reproductive Medicine at Vrije University Brussels.

Using the Human Fertilisation and Embryology Authority (HFEA) database, the investigators identified 684,247 ART cycles in the U.K. between 2000-2012, resulting in 212,877 pregnancies. After exclusion for various reasons including surrogacy, unspecified treatment, or missing data, 161,967 pregnancies were included in the analysis. Of these, 153,115 pregnancies occurred following in-vitro fertilization or intracytoplasmic sperm injection and 8,852 following intrauterine insemination.

The incidence of ectopic pregnancy was 1.4% over the 12-year study period.

In adjusted analyses, the most important independent risk factor for an ectopic pregnancy was tubal factor infertility, which more than doubled the risk (odds ratio, 2.23), Dr. Polyzos said.

Also significant was the number of embryos transferred (two vs. one; OR, 1.28; ≥ three vs. one; OR, 1.67) and extended embryo culture (day 3 vs. day 2; OR, 0.85; day 5 vs. day 2; OR, 0.73).

What this means in everyday clinical practice is that the probability of having an ectopic pregnancy is 29% per 1,000 pregnancies in a patient with tubal infertility if more than one embryo is transferred, he said. In contrast, the risk is more than three times lower at only 8.2% per 1,000 pregnancies in a patient who has a partner with male infertility and a single blastocyst transferred.

Details from the HFEA database showed that the proportion of infertile patients with tubal disease having ART progressively declined from 24% in 2000 to 12% in 2012. Tubal factor infertility accounts for about 14% of all infertility and is typically the result of Chlamydia trachomatis infection.

“Future efforts should promote national screening programs like the U.K.’s National Chlamydia Screening Programme. Although there is a discussion on how effective it is, I think it is very important we increase the uptake of these programs,” Dr. Polyzos said.

Efforts to promote widespread introduction of single-embryo transfer, which have been widely adopted in his own country, but less so in the United States, would lower the risk of EP even further, he added.

A recent U.S. analysis looking at the risk of EP associated with ART found that the rate of ectopic pregnancy was 1.6% when one embryo was transferred and 1.7%, 2.2%, and 2.5% when two, three, or four or more embryos were transferred, respectively. Overall, the EP rate declined from 2% in 2001 to 1.6% in 2011 based on 553,577 pregnancies reported during those years to the U.S. National ART Surveillance System (Obstet. Gynecol. 2015;125:70-8).

ESHRE did not require reports of financial disclosures.

[email protected]

On Twitter @pwendl

LISBON – Advances in assisted reproductive technology (ART) have paid off, nearly halving the rate of ectopic pregnancy in the past 12 years.

The rate of ectopic pregnancy (EP) following ART progressively declined from 20 to 12 cases per thousand in a nationwide analysis of all ART pregnancies achieved in the United Kingdom between 2000 and 2012.

This trend appears to be related to a reduction in the incidence of tubal factor infertility, a lower number of embryos being transferred, and extended embryo culture, Dr. Nikolaos Polyzos said at the annual meeting of the European Society of Human Reproduction and Embryology.

Patrice Wendling/Frontline Medical News

Ectopic pregnancy (EP) is a rare event, occurring in only 2% of all spontaneous conceptions. ART has been consistently associated with higher rates of EP, which is the most common cause of mortality during the first trimester of pregnancy in the U.K., said Dr. Polyzos of the Centre for Reproductive Medicine at Vrije University Brussels.

Using the Human Fertilisation and Embryology Authority (HFEA) database, the investigators identified 684,247 ART cycles in the U.K. between 2000-2012, resulting in 212,877 pregnancies. After exclusion for various reasons including surrogacy, unspecified treatment, or missing data, 161,967 pregnancies were included in the analysis. Of these, 153,115 pregnancies occurred following in-vitro fertilization or intracytoplasmic sperm injection and 8,852 following intrauterine insemination.

The incidence of ectopic pregnancy was 1.4% over the 12-year study period.

In adjusted analyses, the most important independent risk factor for an ectopic pregnancy was tubal factor infertility, which more than doubled the risk (odds ratio, 2.23), Dr. Polyzos said.

Also significant was the number of embryos transferred (two vs. one; OR, 1.28; ≥ three vs. one; OR, 1.67) and extended embryo culture (day 3 vs. day 2; OR, 0.85; day 5 vs. day 2; OR, 0.73).

What this means in everyday clinical practice is that the probability of having an ectopic pregnancy is 29% per 1,000 pregnancies in a patient with tubal infertility if more than one embryo is transferred, he said. In contrast, the risk is more than three times lower at only 8.2% per 1,000 pregnancies in a patient who has a partner with male infertility and a single blastocyst transferred.

Details from the HFEA database showed that the proportion of infertile patients with tubal disease having ART progressively declined from 24% in 2000 to 12% in 2012. Tubal factor infertility accounts for about 14% of all infertility and is typically the result of Chlamydia trachomatis infection.

“Future efforts should promote national screening programs like the U.K.’s National Chlamydia Screening Programme. Although there is a discussion on how effective it is, I think it is very important we increase the uptake of these programs,” Dr. Polyzos said.

Efforts to promote widespread introduction of single-embryo transfer, which have been widely adopted in his own country, but less so in the United States, would lower the risk of EP even further, he added.

A recent U.S. analysis looking at the risk of EP associated with ART found that the rate of ectopic pregnancy was 1.6% when one embryo was transferred and 1.7%, 2.2%, and 2.5% when two, three, or four or more embryos were transferred, respectively. Overall, the EP rate declined from 2% in 2001 to 1.6% in 2011 based on 553,577 pregnancies reported during those years to the U.S. National ART Surveillance System (Obstet. Gynecol. 2015;125:70-8).

ESHRE did not require reports of financial disclosures.

[email protected]

On Twitter @pwendl

LISBON – Advances in assisted reproductive technology (ART) have paid off, nearly halving the rate of ectopic pregnancy in the past 12 years.

The rate of ectopic pregnancy (EP) following ART progressively declined from 20 to 12 cases per thousand in a nationwide analysis of all ART pregnancies achieved in the United Kingdom between 2000 and 2012.

This trend appears to be related to a reduction in the incidence of tubal factor infertility, a lower number of embryos being transferred, and extended embryo culture, Dr. Nikolaos Polyzos said at the annual meeting of the European Society of Human Reproduction and Embryology.

Patrice Wendling/Frontline Medical News

Ectopic pregnancy (EP) is a rare event, occurring in only 2% of all spontaneous conceptions. ART has been consistently associated with higher rates of EP, which is the most common cause of mortality during the first trimester of pregnancy in the U.K., said Dr. Polyzos of the Centre for Reproductive Medicine at Vrije University Brussels.

Using the Human Fertilisation and Embryology Authority (HFEA) database, the investigators identified 684,247 ART cycles in the U.K. between 2000-2012, resulting in 212,877 pregnancies. After exclusion for various reasons including surrogacy, unspecified treatment, or missing data, 161,967 pregnancies were included in the analysis. Of these, 153,115 pregnancies occurred following in-vitro fertilization or intracytoplasmic sperm injection and 8,852 following intrauterine insemination.

The incidence of ectopic pregnancy was 1.4% over the 12-year study period.

In adjusted analyses, the most important independent risk factor for an ectopic pregnancy was tubal factor infertility, which more than doubled the risk (odds ratio, 2.23), Dr. Polyzos said.

Also significant was the number of embryos transferred (two vs. one; OR, 1.28; ≥ three vs. one; OR, 1.67) and extended embryo culture (day 3 vs. day 2; OR, 0.85; day 5 vs. day 2; OR, 0.73).

What this means in everyday clinical practice is that the probability of having an ectopic pregnancy is 29% per 1,000 pregnancies in a patient with tubal infertility if more than one embryo is transferred, he said. In contrast, the risk is more than three times lower at only 8.2% per 1,000 pregnancies in a patient who has a partner with male infertility and a single blastocyst transferred.

Details from the HFEA database showed that the proportion of infertile patients with tubal disease having ART progressively declined from 24% in 2000 to 12% in 2012. Tubal factor infertility accounts for about 14% of all infertility and is typically the result of Chlamydia trachomatis infection.

“Future efforts should promote national screening programs like the U.K.’s National Chlamydia Screening Programme. Although there is a discussion on how effective it is, I think it is very important we increase the uptake of these programs,” Dr. Polyzos said.

Efforts to promote widespread introduction of single-embryo transfer, which have been widely adopted in his own country, but less so in the United States, would lower the risk of EP even further, he added.

A recent U.S. analysis looking at the risk of EP associated with ART found that the rate of ectopic pregnancy was 1.6% when one embryo was transferred and 1.7%, 2.2%, and 2.5% when two, three, or four or more embryos were transferred, respectively. Overall, the EP rate declined from 2% in 2001 to 1.6% in 2011 based on 553,577 pregnancies reported during those years to the U.S. National ART Surveillance System (Obstet. Gynecol. 2015;125:70-8).

ESHRE did not require reports of financial disclosures.

[email protected]

On Twitter @pwendl