Mary Ann Moon

Couples who try to conceive shortly after an early pregnancy loss have a higher likelihood of a subsequent live birth than those who wait 3 months or longer to try again, according to a report published online Jan. 11 in Obstetrics & Gynecology.

“Our results indicate that there is no physiological basis for delaying pregnancy attempt after a nonectopic, nonmolar, less-than-20-week gestational age pregnancy loss. Recommendations to delay pregnancy attempts for at least 3-6 months among couples who are psychologically ready to begin trying may be unwarranted and should be revisited,” wrote Karen C. Schliep, Ph.D., of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md., and her associates.

©Sunlight19/thinkstockphotos.com

Couples who experience an early pregnancy loss often seek counseling about how long to wait before attempting to conceive again. Even though the optimal timing after a pregnancy loss that was nonectopic, nonmolar, and less than 20 weeks’ gestation has never been well studied, “many clinicians recommend waiting at least 3 months, with the World Health Organization recommending a minimum of 6 months,” the researchers wrote.

To assess pregnancy outcomes after a variety of such time intervals, they performed a secondary analysis of data from a multicenter randomized trial involving women with a history of pregnancy loss. For their analysis, the investigators focused on 1,083 women who had experienced pregnancy loss at 20 weeks or earlier.

Most women in the study (76.6%) tried again to conceive within 0-3 months, while 23.4% waited more than 3 months.

Compared with women who waited longer than 3 months to attempt to conceive again, those who didn’t wait were more likely to achieve pregnancy (68.6% vs 51.1%) and more likely to have a live birth (53.2% vs. 36.1%). Yet they were no more likely to develop pregnancy complications, including pregnancy loss, preterm birth, preeclampsia, or gestational diabetes (Obstet Gynecol. 2016;127:205-13. doi: 10.1097/AOG.0000000000001159).

While the study finds no physiological reason for couples to delay attempting to conceive after early pregnancy loss, emotional readiness is another matter. However, the researchers noted that previous studies have shown that “a speedy new pregnancy and birth of a living child lessens grief among couples who are suffering from a pregnancy loss.”

The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Schliep and her associates reported having no relevant financial disclosures.

Couples who try to conceive shortly after an early pregnancy loss have a higher likelihood of a subsequent live birth than those who wait 3 months or longer to try again, according to a report published online Jan. 11 in Obstetrics & Gynecology.

“Our results indicate that there is no physiological basis for delaying pregnancy attempt after a nonectopic, nonmolar, less-than-20-week gestational age pregnancy loss. Recommendations to delay pregnancy attempts for at least 3-6 months among couples who are psychologically ready to begin trying may be unwarranted and should be revisited,” wrote Karen C. Schliep, Ph.D., of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md., and her associates.

©Sunlight19/thinkstockphotos.com

Couples who experience an early pregnancy loss often seek counseling about how long to wait before attempting to conceive again. Even though the optimal timing after a pregnancy loss that was nonectopic, nonmolar, and less than 20 weeks’ gestation has never been well studied, “many clinicians recommend waiting at least 3 months, with the World Health Organization recommending a minimum of 6 months,” the researchers wrote.

To assess pregnancy outcomes after a variety of such time intervals, they performed a secondary analysis of data from a multicenter randomized trial involving women with a history of pregnancy loss. For their analysis, the investigators focused on 1,083 women who had experienced pregnancy loss at 20 weeks or earlier.

Most women in the study (76.6%) tried again to conceive within 0-3 months, while 23.4% waited more than 3 months.

Compared with women who waited longer than 3 months to attempt to conceive again, those who didn’t wait were more likely to achieve pregnancy (68.6% vs 51.1%) and more likely to have a live birth (53.2% vs. 36.1%). Yet they were no more likely to develop pregnancy complications, including pregnancy loss, preterm birth, preeclampsia, or gestational diabetes (Obstet Gynecol. 2016;127:205-13. doi: 10.1097/AOG.0000000000001159).

While the study finds no physiological reason for couples to delay attempting to conceive after early pregnancy loss, emotional readiness is another matter. However, the researchers noted that previous studies have shown that “a speedy new pregnancy and birth of a living child lessens grief among couples who are suffering from a pregnancy loss.”

The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Schliep and her associates reported having no relevant financial disclosures.

Couples who try to conceive shortly after an early pregnancy loss have a higher likelihood of a subsequent live birth than those who wait 3 months or longer to try again, according to a report published online Jan. 11 in Obstetrics & Gynecology.

“Our results indicate that there is no physiological basis for delaying pregnancy attempt after a nonectopic, nonmolar, less-than-20-week gestational age pregnancy loss. Recommendations to delay pregnancy attempts for at least 3-6 months among couples who are psychologically ready to begin trying may be unwarranted and should be revisited,” wrote Karen C. Schliep, Ph.D., of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md., and her associates.

©Sunlight19/thinkstockphotos.com

Couples who experience an early pregnancy loss often seek counseling about how long to wait before attempting to conceive again. Even though the optimal timing after a pregnancy loss that was nonectopic, nonmolar, and less than 20 weeks’ gestation has never been well studied, “many clinicians recommend waiting at least 3 months, with the World Health Organization recommending a minimum of 6 months,” the researchers wrote.

To assess pregnancy outcomes after a variety of such time intervals, they performed a secondary analysis of data from a multicenter randomized trial involving women with a history of pregnancy loss. For their analysis, the investigators focused on 1,083 women who had experienced pregnancy loss at 20 weeks or earlier.

Most women in the study (76.6%) tried again to conceive within 0-3 months, while 23.4% waited more than 3 months.

Compared with women who waited longer than 3 months to attempt to conceive again, those who didn’t wait were more likely to achieve pregnancy (68.6% vs 51.1%) and more likely to have a live birth (53.2% vs. 36.1%). Yet they were no more likely to develop pregnancy complications, including pregnancy loss, preterm birth, preeclampsia, or gestational diabetes (Obstet Gynecol. 2016;127:205-13. doi: 10.1097/AOG.0000000000001159).

While the study finds no physiological reason for couples to delay attempting to conceive after early pregnancy loss, emotional readiness is another matter. However, the researchers noted that previous studies have shown that “a speedy new pregnancy and birth of a living child lessens grief among couples who are suffering from a pregnancy loss.”

The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Schliep and her associates reported having no relevant financial disclosures.

Separate groups of researchers supported by nonprofit and government agencies have assessed two novel Ebola virus disease treatments in the midst of the recent outbreak in West Africa.

The first study was a “natural experiment” that occurred when one Liberian treatment center temporarily ran out of first-line antimalarial drugs. This allowed investigators to discover that a second-line regimen may actually be more effective in reducing mortality from Ebola infection. (N Engl J Med. 2016 Jan 7;374:23-32. doi: 10.1056/NEJMoa1504605).

Courtesy Wikimedia Commons/Thomas W. Geisbert/Creative Commons License

The lack of effective therapies against the Ebola virus spurred the U.S. Food and Drug Administration to identify several potential candidate treatments among compounds that are already used to treat other diseases, including malaria. However, there is little or no evidence to date concerning the real-world efficacy of these agents that have shown in-vitro activity against Ebola, said Etienne Gignoux of Epicentre, an epidemiologic research group headquartered in Paris, and of Médecins sans Frontières in Paris and Geneva, and his associates.

At the treatment center in Foya, Liberia, infected patients were routinely prescribed prophylactic antibiotics and a 3-day course of the antimalarial combination therapy artemether-lumefantrine, along with supportive treatment such as intravenous fluids. A 2-week shortage of this first-line antimalarial occurred during a sudden surge in admissions, and patients were instead prescribed artesunate-amodiaquine. Mr. Gignoux and his associates assessed outcomes in 194 patients prescribed artemether-lumefantrine, 71 prescribed artesunate-amodiaquine, 63 prescribed no antimalarials, and 53 for whom prescription data were missing.

They found that mortality risk was 31% lower with artesunate-amodiaquine than with the first-line antimalarials (risk ratio, 0.69). This mortality benefit persisted across several subgroups of patients, as well as in an analysis that specifically adjusted for the effects of potential confounding factors.

The results suggest that artesunate-amodiaquine may be preferable for the treatment of Ebola infection, but more research is needed to confirm this and to establish the safest, most effective therapeutic dose in these patients, the investigators said.They noted that their study had several limitations. The patient records included only prescribing information, so it was impossible to assess whether patients completed the full course of treatment. And all the antimalarials were oral formulations, so severely ill patients may not have been able to swallow or to keep down all doses.

In addition, artesunate-amodiaquine is known to cause more gastrointestinal adverse effects than the other antimalarials, so it’s possible that patients in that group were less likely to complete the full course of treatment. And many patients were concomitantly given the antiemetic metoclopramide, but data on possible adverse effects of this drug or possible drug interactions were not recorded.

The Liberian study was largely supported by Médecins sans Frontières, and the researchers reported no relevant financial disclosures.

Efficacy of convalescent plasma

In the second study, researchers at an Ebola treatment center in Guinea examined whether transfusion of convalescent plasma – plasma derived from patients who recovered from Ebola infection, which presumably carries helpful antibodies to the virus – was safe and effective. Their 6-month nonrandomized study involved 84 patients given two consecutive transfusions of 200-250 mL ABO-compatible plasma plus routine supportive care and 418 historical control subjects who had been treated before the plasma transfusions became available (N Engl J Med. 2016 Jan 7;374:33-42. doi: 10.1056/NEJMoa15118212).

The primary outcome – the risk of death during the 3-16 days after diagnosis – was 31% in the intervention group and 38% in the control group, a nonsignificant difference. This indicates that convalescent plasma transfusions do not exert a marked survival effect, at least at this dosage, said Dr. Johan van Griensven of the Institute of Tropical Medicine, Antwerp (Belgium), and his associates.

There were no serious adverse effects from the transfusions, and the procedure was acceptable to donors, patients, and caregivers.

The main limitation of this study was that actual levels of neutralizing antibodies in the transfused plasma could not be assessed. Such assays require biosafety level-4 laboratories, which are not available in the affected countries. “It is possible that high-titer convalescent plasma or hyperimmune globulin might be more potent” than the plasma used in this study, or that more frequent administration and higher total volumes could be more effective, Dr. van Griensven and his associates said.

They added that they “cannot exclude the possibility that some patients will benefit more than others from treatment with convalescent plasma.” For example, children younger than 5 years are known to be at high risk of death from the Ebola virus and had the highest risk of death in this study’s control group. However, four of the five patients in this age group who received convalescent plasma survived. Similarly, pregnant women infected with Ebola virus also are at high risk of death, but six of the eight in this study who received convalescent plasma survived.

The Guinea study was supported by the European Union’s Horizon 2020 Research and Innovation Program, the Flemish Department of Economy, Science, and Innovation, the Bill and Melinda Gates Foundation, the U.K. National Institute for Health Research’s Unit on Emerging and Zoonotic Infections at the University of Liverpool, the Medical Research Council, and the Department for International Development. Dr. van Griensven and his associates reported having no relevant financial disclosures.

Separate groups of researchers supported by nonprofit and government agencies have assessed two novel Ebola virus disease treatments in the midst of the recent outbreak in West Africa.

The first study was a “natural experiment” that occurred when one Liberian treatment center temporarily ran out of first-line antimalarial drugs. This allowed investigators to discover that a second-line regimen may actually be more effective in reducing mortality from Ebola infection. (N Engl J Med. 2016 Jan 7;374:23-32. doi: 10.1056/NEJMoa1504605).

Courtesy Wikimedia Commons/Thomas W. Geisbert/Creative Commons License

The lack of effective therapies against the Ebola virus spurred the U.S. Food and Drug Administration to identify several potential candidate treatments among compounds that are already used to treat other diseases, including malaria. However, there is little or no evidence to date concerning the real-world efficacy of these agents that have shown in-vitro activity against Ebola, said Etienne Gignoux of Epicentre, an epidemiologic research group headquartered in Paris, and of Médecins sans Frontières in Paris and Geneva, and his associates.

At the treatment center in Foya, Liberia, infected patients were routinely prescribed prophylactic antibiotics and a 3-day course of the antimalarial combination therapy artemether-lumefantrine, along with supportive treatment such as intravenous fluids. A 2-week shortage of this first-line antimalarial occurred during a sudden surge in admissions, and patients were instead prescribed artesunate-amodiaquine. Mr. Gignoux and his associates assessed outcomes in 194 patients prescribed artemether-lumefantrine, 71 prescribed artesunate-amodiaquine, 63 prescribed no antimalarials, and 53 for whom prescription data were missing.

They found that mortality risk was 31% lower with artesunate-amodiaquine than with the first-line antimalarials (risk ratio, 0.69). This mortality benefit persisted across several subgroups of patients, as well as in an analysis that specifically adjusted for the effects of potential confounding factors.

The results suggest that artesunate-amodiaquine may be preferable for the treatment of Ebola infection, but more research is needed to confirm this and to establish the safest, most effective therapeutic dose in these patients, the investigators said.They noted that their study had several limitations. The patient records included only prescribing information, so it was impossible to assess whether patients completed the full course of treatment. And all the antimalarials were oral formulations, so severely ill patients may not have been able to swallow or to keep down all doses.

In addition, artesunate-amodiaquine is known to cause more gastrointestinal adverse effects than the other antimalarials, so it’s possible that patients in that group were less likely to complete the full course of treatment. And many patients were concomitantly given the antiemetic metoclopramide, but data on possible adverse effects of this drug or possible drug interactions were not recorded.

The Liberian study was largely supported by Médecins sans Frontières, and the researchers reported no relevant financial disclosures.

Efficacy of convalescent plasma

In the second study, researchers at an Ebola treatment center in Guinea examined whether transfusion of convalescent plasma – plasma derived from patients who recovered from Ebola infection, which presumably carries helpful antibodies to the virus – was safe and effective. Their 6-month nonrandomized study involved 84 patients given two consecutive transfusions of 200-250 mL ABO-compatible plasma plus routine supportive care and 418 historical control subjects who had been treated before the plasma transfusions became available (N Engl J Med. 2016 Jan 7;374:33-42. doi: 10.1056/NEJMoa15118212).

The primary outcome – the risk of death during the 3-16 days after diagnosis – was 31% in the intervention group and 38% in the control group, a nonsignificant difference. This indicates that convalescent plasma transfusions do not exert a marked survival effect, at least at this dosage, said Dr. Johan van Griensven of the Institute of Tropical Medicine, Antwerp (Belgium), and his associates.

There were no serious adverse effects from the transfusions, and the procedure was acceptable to donors, patients, and caregivers.

The main limitation of this study was that actual levels of neutralizing antibodies in the transfused plasma could not be assessed. Such assays require biosafety level-4 laboratories, which are not available in the affected countries. “It is possible that high-titer convalescent plasma or hyperimmune globulin might be more potent” than the plasma used in this study, or that more frequent administration and higher total volumes could be more effective, Dr. van Griensven and his associates said.

They added that they “cannot exclude the possibility that some patients will benefit more than others from treatment with convalescent plasma.” For example, children younger than 5 years are known to be at high risk of death from the Ebola virus and had the highest risk of death in this study’s control group. However, four of the five patients in this age group who received convalescent plasma survived. Similarly, pregnant women infected with Ebola virus also are at high risk of death, but six of the eight in this study who received convalescent plasma survived.

The Guinea study was supported by the European Union’s Horizon 2020 Research and Innovation Program, the Flemish Department of Economy, Science, and Innovation, the Bill and Melinda Gates Foundation, the U.K. National Institute for Health Research’s Unit on Emerging and Zoonotic Infections at the University of Liverpool, the Medical Research Council, and the Department for International Development. Dr. van Griensven and his associates reported having no relevant financial disclosures.

Separate groups of researchers supported by nonprofit and government agencies have assessed two novel Ebola virus disease treatments in the midst of the recent outbreak in West Africa.

The first study was a “natural experiment” that occurred when one Liberian treatment center temporarily ran out of first-line antimalarial drugs. This allowed investigators to discover that a second-line regimen may actually be more effective in reducing mortality from Ebola infection. (N Engl J Med. 2016 Jan 7;374:23-32. doi: 10.1056/NEJMoa1504605).

Courtesy Wikimedia Commons/Thomas W. Geisbert/Creative Commons License

The lack of effective therapies against the Ebola virus spurred the U.S. Food and Drug Administration to identify several potential candidate treatments among compounds that are already used to treat other diseases, including malaria. However, there is little or no evidence to date concerning the real-world efficacy of these agents that have shown in-vitro activity against Ebola, said Etienne Gignoux of Epicentre, an epidemiologic research group headquartered in Paris, and of Médecins sans Frontières in Paris and Geneva, and his associates.

At the treatment center in Foya, Liberia, infected patients were routinely prescribed prophylactic antibiotics and a 3-day course of the antimalarial combination therapy artemether-lumefantrine, along with supportive treatment such as intravenous fluids. A 2-week shortage of this first-line antimalarial occurred during a sudden surge in admissions, and patients were instead prescribed artesunate-amodiaquine. Mr. Gignoux and his associates assessed outcomes in 194 patients prescribed artemether-lumefantrine, 71 prescribed artesunate-amodiaquine, 63 prescribed no antimalarials, and 53 for whom prescription data were missing.

They found that mortality risk was 31% lower with artesunate-amodiaquine than with the first-line antimalarials (risk ratio, 0.69). This mortality benefit persisted across several subgroups of patients, as well as in an analysis that specifically adjusted for the effects of potential confounding factors.

The results suggest that artesunate-amodiaquine may be preferable for the treatment of Ebola infection, but more research is needed to confirm this and to establish the safest, most effective therapeutic dose in these patients, the investigators said.They noted that their study had several limitations. The patient records included only prescribing information, so it was impossible to assess whether patients completed the full course of treatment. And all the antimalarials were oral formulations, so severely ill patients may not have been able to swallow or to keep down all doses.

In addition, artesunate-amodiaquine is known to cause more gastrointestinal adverse effects than the other antimalarials, so it’s possible that patients in that group were less likely to complete the full course of treatment. And many patients were concomitantly given the antiemetic metoclopramide, but data on possible adverse effects of this drug or possible drug interactions were not recorded.

The Liberian study was largely supported by Médecins sans Frontières, and the researchers reported no relevant financial disclosures.

Efficacy of convalescent plasma

In the second study, researchers at an Ebola treatment center in Guinea examined whether transfusion of convalescent plasma – plasma derived from patients who recovered from Ebola infection, which presumably carries helpful antibodies to the virus – was safe and effective. Their 6-month nonrandomized study involved 84 patients given two consecutive transfusions of 200-250 mL ABO-compatible plasma plus routine supportive care and 418 historical control subjects who had been treated before the plasma transfusions became available (N Engl J Med. 2016 Jan 7;374:33-42. doi: 10.1056/NEJMoa15118212).

The primary outcome – the risk of death during the 3-16 days after diagnosis – was 31% in the intervention group and 38% in the control group, a nonsignificant difference. This indicates that convalescent plasma transfusions do not exert a marked survival effect, at least at this dosage, said Dr. Johan van Griensven of the Institute of Tropical Medicine, Antwerp (Belgium), and his associates.

There were no serious adverse effects from the transfusions, and the procedure was acceptable to donors, patients, and caregivers.

The main limitation of this study was that actual levels of neutralizing antibodies in the transfused plasma could not be assessed. Such assays require biosafety level-4 laboratories, which are not available in the affected countries. “It is possible that high-titer convalescent plasma or hyperimmune globulin might be more potent” than the plasma used in this study, or that more frequent administration and higher total volumes could be more effective, Dr. van Griensven and his associates said.

They added that they “cannot exclude the possibility that some patients will benefit more than others from treatment with convalescent plasma.” For example, children younger than 5 years are known to be at high risk of death from the Ebola virus and had the highest risk of death in this study’s control group. However, four of the five patients in this age group who received convalescent plasma survived. Similarly, pregnant women infected with Ebola virus also are at high risk of death, but six of the eight in this study who received convalescent plasma survived.

The Guinea study was supported by the European Union’s Horizon 2020 Research and Innovation Program, the Flemish Department of Economy, Science, and Innovation, the Bill and Melinda Gates Foundation, the U.K. National Institute for Health Research’s Unit on Emerging and Zoonotic Infections at the University of Liverpool, the Medical Research Council, and the Department for International Development. Dr. van Griensven and his associates reported having no relevant financial disclosures.

Could a better method for ruling out preeclampsia in the short term be on the way?

Using one brand of serum immunoassays measuring soluble fms-like tyrosine kinase 1 (sFlt-1) and placental growth factor (PlGF) in maternal serum, a ratio of 38 or lower appears to rule out preeclampsia among women suspected of having the disorder, with a negative predictive value of 99.3%, according to a report published online Jan. 6 in the New England Journal of Medicine.

A reliable predictor of preeclampsia is needed because women with suggestive signs or symptoms usually must be hospitalized until the disorder can be ruled out, which can take days or weeks. Circulating maternal levels of sFlt-1 are increased and those of PlGF are decreased in preeclampsia, and assessing the ratio of these two biomarkers may serve as a better risk predictor than measuring either one alone, according to Dr. Harald Zeisler of the Medical University of Vienna and his associates.

They performed a 3-year industry-sponsored prospective observational study at 30 sites in 14 countries involving women with singleton pregnancies with suspected preeclampsia.

In the first phase, involving 500 women suspected of having preeclampsia, the investigators established that a ratio cut-off point of 38 reliably distinguished the 79.8% of women who did not develop preeclampsia within 1 week from the 20.2% who did develop the condition. The second phase, involving 550 additional women suspected of having preeclampsia, validated that a ratio of 38 or lower reliably distinguished the 82.2% of women who did not develop preeclampsia from the 17.8% who did develop the condition.

In the validation cohort, the median sFlt:PlGF ratio was 87.8 in women who developed preeclampsia within 1 week and 59.4 among those who developed preeclampsia within 4 weeks. In contrast, these ratios were 8.0 and 6.3, respectively, in women who did not develop preeclampsia. The negative predictive value of an sFlt:PlGF ratio of 38 or lower was 99.3% in this cohort, while the positive predictive value – a diagnosis of preeclampsia, eclampsia, or the HELLP syndrome within 4 weeks – was 36.7% (N Engl J Med 2016 Jan 6;374:13-22. doi: 10.1056/NEJMoa1414838.).

Adding the sFlt:PlGF ratio to proteinuria and blood pressure assessments will likely help clinicians decide whether hospitalization or outpatient monitoring is the better course for such patients, the investigators wrote.

“In clinical practice, a very high negative predictive value is crucial in the evaluation of a patient with suspected preeclampsia, since failure to detect imminent disease could have devastating consequences for the fetus or the mother,” Dr. Zeisler and his associates wrote.

They noted that 38 is the optimal cutoff point only for the specific immunoassays used in this study – Elecsys, manufactured by Roche Diagnostics. Other brands of assays may have different ratio cutoffs. The findings of this observational study must also be confirmed in randomized trials to establish whether use of this ratio in clinical practice could reduce unnecessary hospitalizations and costs.

This study was funded by Roche Diagnostics, maker of the Elecsys sFlt-1 and PlGF immunoassays assessed in the study. The manufacturer also designed the study, analyzed the data, and funded a medical writer to provide assistance to the authors. Dr. Zeisler reported receiving lecture fees from Ferring and Roche Diagnostics, and his associates reported numerous ties to Roche and other industry sources.

Could a better method for ruling out preeclampsia in the short term be on the way?

Using one brand of serum immunoassays measuring soluble fms-like tyrosine kinase 1 (sFlt-1) and placental growth factor (PlGF) in maternal serum, a ratio of 38 or lower appears to rule out preeclampsia among women suspected of having the disorder, with a negative predictive value of 99.3%, according to a report published online Jan. 6 in the New England Journal of Medicine.

A reliable predictor of preeclampsia is needed because women with suggestive signs or symptoms usually must be hospitalized until the disorder can be ruled out, which can take days or weeks. Circulating maternal levels of sFlt-1 are increased and those of PlGF are decreased in preeclampsia, and assessing the ratio of these two biomarkers may serve as a better risk predictor than measuring either one alone, according to Dr. Harald Zeisler of the Medical University of Vienna and his associates.

They performed a 3-year industry-sponsored prospective observational study at 30 sites in 14 countries involving women with singleton pregnancies with suspected preeclampsia.

In the first phase, involving 500 women suspected of having preeclampsia, the investigators established that a ratio cut-off point of 38 reliably distinguished the 79.8% of women who did not develop preeclampsia within 1 week from the 20.2% who did develop the condition. The second phase, involving 550 additional women suspected of having preeclampsia, validated that a ratio of 38 or lower reliably distinguished the 82.2% of women who did not develop preeclampsia from the 17.8% who did develop the condition.

In the validation cohort, the median sFlt:PlGF ratio was 87.8 in women who developed preeclampsia within 1 week and 59.4 among those who developed preeclampsia within 4 weeks. In contrast, these ratios were 8.0 and 6.3, respectively, in women who did not develop preeclampsia. The negative predictive value of an sFlt:PlGF ratio of 38 or lower was 99.3% in this cohort, while the positive predictive value – a diagnosis of preeclampsia, eclampsia, or the HELLP syndrome within 4 weeks – was 36.7% (N Engl J Med 2016 Jan 6;374:13-22. doi: 10.1056/NEJMoa1414838.).

Adding the sFlt:PlGF ratio to proteinuria and blood pressure assessments will likely help clinicians decide whether hospitalization or outpatient monitoring is the better course for such patients, the investigators wrote.

“In clinical practice, a very high negative predictive value is crucial in the evaluation of a patient with suspected preeclampsia, since failure to detect imminent disease could have devastating consequences for the fetus or the mother,” Dr. Zeisler and his associates wrote.

They noted that 38 is the optimal cutoff point only for the specific immunoassays used in this study – Elecsys, manufactured by Roche Diagnostics. Other brands of assays may have different ratio cutoffs. The findings of this observational study must also be confirmed in randomized trials to establish whether use of this ratio in clinical practice could reduce unnecessary hospitalizations and costs.

This study was funded by Roche Diagnostics, maker of the Elecsys sFlt-1 and PlGF immunoassays assessed in the study. The manufacturer also designed the study, analyzed the data, and funded a medical writer to provide assistance to the authors. Dr. Zeisler reported receiving lecture fees from Ferring and Roche Diagnostics, and his associates reported numerous ties to Roche and other industry sources.

Could a better method for ruling out preeclampsia in the short term be on the way?

Using one brand of serum immunoassays measuring soluble fms-like tyrosine kinase 1 (sFlt-1) and placental growth factor (PlGF) in maternal serum, a ratio of 38 or lower appears to rule out preeclampsia among women suspected of having the disorder, with a negative predictive value of 99.3%, according to a report published online Jan. 6 in the New England Journal of Medicine.

A reliable predictor of preeclampsia is needed because women with suggestive signs or symptoms usually must be hospitalized until the disorder can be ruled out, which can take days or weeks. Circulating maternal levels of sFlt-1 are increased and those of PlGF are decreased in preeclampsia, and assessing the ratio of these two biomarkers may serve as a better risk predictor than measuring either one alone, according to Dr. Harald Zeisler of the Medical University of Vienna and his associates.

They performed a 3-year industry-sponsored prospective observational study at 30 sites in 14 countries involving women with singleton pregnancies with suspected preeclampsia.

In the first phase, involving 500 women suspected of having preeclampsia, the investigators established that a ratio cut-off point of 38 reliably distinguished the 79.8% of women who did not develop preeclampsia within 1 week from the 20.2% who did develop the condition. The second phase, involving 550 additional women suspected of having preeclampsia, validated that a ratio of 38 or lower reliably distinguished the 82.2% of women who did not develop preeclampsia from the 17.8% who did develop the condition.

In the validation cohort, the median sFlt:PlGF ratio was 87.8 in women who developed preeclampsia within 1 week and 59.4 among those who developed preeclampsia within 4 weeks. In contrast, these ratios were 8.0 and 6.3, respectively, in women who did not develop preeclampsia. The negative predictive value of an sFlt:PlGF ratio of 38 or lower was 99.3% in this cohort, while the positive predictive value – a diagnosis of preeclampsia, eclampsia, or the HELLP syndrome within 4 weeks – was 36.7% (N Engl J Med 2016 Jan 6;374:13-22. doi: 10.1056/NEJMoa1414838.).

Adding the sFlt:PlGF ratio to proteinuria and blood pressure assessments will likely help clinicians decide whether hospitalization or outpatient monitoring is the better course for such patients, the investigators wrote.

“In clinical practice, a very high negative predictive value is crucial in the evaluation of a patient with suspected preeclampsia, since failure to detect imminent disease could have devastating consequences for the fetus or the mother,” Dr. Zeisler and his associates wrote.

They noted that 38 is the optimal cutoff point only for the specific immunoassays used in this study – Elecsys, manufactured by Roche Diagnostics. Other brands of assays may have different ratio cutoffs. The findings of this observational study must also be confirmed in randomized trials to establish whether use of this ratio in clinical practice could reduce unnecessary hospitalizations and costs.

This study was funded by Roche Diagnostics, maker of the Elecsys sFlt-1 and PlGF immunoassays assessed in the study. The manufacturer also designed the study, analyzed the data, and funded a medical writer to provide assistance to the authors. Dr. Zeisler reported receiving lecture fees from Ferring and Roche Diagnostics, and his associates reported numerous ties to Roche and other industry sources.

Screening young-adult survivors of childhood cancer revealed “considerable” subclinical cardiovascular disease, including valvular regurgitation or stenosis in 28%, cardiomyopathy in 7.4%, conduction or rhythm abnormalities in 4.4%, and coronary artery disease in 3.8%, according to a report published online Jan. 4 in Annals of Internal Medicine.

Most of the 1,853 study participants (median age, 31 years) were asymptomatic, with only 4 reporting occasional chest pain and only 1 reporting occasional palpitations. Yet, on careful examination, many showed significantly impaired physical performance. For example, “asymptomatic” young-adult survivors found to have cardiomyopathy and CAD were twice as likely as others to perform poorly on the 6-minute walk test, said Dr. Daniel A. Mulrooney of St. Jude Children’s Research Hospital, Memphis, and his associates.

The number of adult survivors of childhood cancer is predicted to exceed 500,000 by 2020, and the late effects of cancer treatment, primarily on the heart, are the chief cause of death among those who survive to 30 years. Few studies, however, have directly examined cardiac outcomes among survivors “because of the rarity of childhood cancer and the challenges of following patients across the life spectrum,” the investigators noted.

They were able to do so using data from the St. Jude Lifetime Cohort Study, focusing on patients aged 18 years and older from 44 states and 28 countries who had been treated with cardiotoxic therapy (anthracycline or chest irradiation) at St. Jude and survived 10 years or more after diagnosis. The participants’ median age was 8 years (range, 0-24) at diagnosis and 31 years (range, 18-60) at the time of the study. The median time since diagnosis was 23 years.

The study participants had been treated for leukemia or lymphoma (67%), sarcoma (14%), Wilms tumor (7%), neuroblastoma (5%), CNS tumors (4%), or other cancers (3%). They underwent a full medical evaluation plus echocardiography and electrocardiography.

Of particular concern was the finding that so many study participants had asymptomatic cardiomyopathy and were at high risk for heart failure. “At a median age of 31 years, we identified 7.4% of survivors with evidence of decreased systolic function, an estimate expected in a much older population,” they wrote. By comparison, in one study the rate of cardiomyopathy among healthy adults was less than 3% at ages 45-54 years, and it didn’t rise to 7% until ages 65-74 years, Dr. Mulrooney and his associates said (Ann Intern Med. 2016 Jan 4. doi: 10.7326/M15-0424).

The high (28%) frequency of valvular abnormalities – mitral or aortal regurgitation, stenosis, thickening, and calcification – also was of particular concern.

The prevalence of CV abnormalities increased with increasing patient age and with increasing doses of anthracycline and/or radiation exposure. Yet nearly 5% of the youngest patients – those aged 30 years or younger – showed evidence of cardiomyopathy.

Overall, the study findings suggest that CV disease represents “a substantial future health care burden” in this patient population. “Clinically, these data may guide stratification of risk factors, screening practices, health counseling, and potential therapeutic measures aimed at changing the disease trajectory in” these patients, the investigators said.

This study was funded by the National Cancer Institute and the American Lebanese Syrian Associated Charities. Dr. Mulrooney and his associates reported having no relevant conflicts of interest; their financial disclosures are available at acponline.org.

Screening young-adult survivors of childhood cancer revealed “considerable” subclinical cardiovascular disease, including valvular regurgitation or stenosis in 28%, cardiomyopathy in 7.4%, conduction or rhythm abnormalities in 4.4%, and coronary artery disease in 3.8%, according to a report published online Jan. 4 in Annals of Internal Medicine.

Most of the 1,853 study participants (median age, 31 years) were asymptomatic, with only 4 reporting occasional chest pain and only 1 reporting occasional palpitations. Yet, on careful examination, many showed significantly impaired physical performance. For example, “asymptomatic” young-adult survivors found to have cardiomyopathy and CAD were twice as likely as others to perform poorly on the 6-minute walk test, said Dr. Daniel A. Mulrooney of St. Jude Children’s Research Hospital, Memphis, and his associates.

The number of adult survivors of childhood cancer is predicted to exceed 500,000 by 2020, and the late effects of cancer treatment, primarily on the heart, are the chief cause of death among those who survive to 30 years. Few studies, however, have directly examined cardiac outcomes among survivors “because of the rarity of childhood cancer and the challenges of following patients across the life spectrum,” the investigators noted.

They were able to do so using data from the St. Jude Lifetime Cohort Study, focusing on patients aged 18 years and older from 44 states and 28 countries who had been treated with cardiotoxic therapy (anthracycline or chest irradiation) at St. Jude and survived 10 years or more after diagnosis. The participants’ median age was 8 years (range, 0-24) at diagnosis and 31 years (range, 18-60) at the time of the study. The median time since diagnosis was 23 years.

The study participants had been treated for leukemia or lymphoma (67%), sarcoma (14%), Wilms tumor (7%), neuroblastoma (5%), CNS tumors (4%), or other cancers (3%). They underwent a full medical evaluation plus echocardiography and electrocardiography.

Of particular concern was the finding that so many study participants had asymptomatic cardiomyopathy and were at high risk for heart failure. “At a median age of 31 years, we identified 7.4% of survivors with evidence of decreased systolic function, an estimate expected in a much older population,” they wrote. By comparison, in one study the rate of cardiomyopathy among healthy adults was less than 3% at ages 45-54 years, and it didn’t rise to 7% until ages 65-74 years, Dr. Mulrooney and his associates said (Ann Intern Med. 2016 Jan 4. doi: 10.7326/M15-0424).

The high (28%) frequency of valvular abnormalities – mitral or aortal regurgitation, stenosis, thickening, and calcification – also was of particular concern.

The prevalence of CV abnormalities increased with increasing patient age and with increasing doses of anthracycline and/or radiation exposure. Yet nearly 5% of the youngest patients – those aged 30 years or younger – showed evidence of cardiomyopathy.

Overall, the study findings suggest that CV disease represents “a substantial future health care burden” in this patient population. “Clinically, these data may guide stratification of risk factors, screening practices, health counseling, and potential therapeutic measures aimed at changing the disease trajectory in” these patients, the investigators said.

This study was funded by the National Cancer Institute and the American Lebanese Syrian Associated Charities. Dr. Mulrooney and his associates reported having no relevant conflicts of interest; their financial disclosures are available at acponline.org.

Screening young-adult survivors of childhood cancer revealed “considerable” subclinical cardiovascular disease, including valvular regurgitation or stenosis in 28%, cardiomyopathy in 7.4%, conduction or rhythm abnormalities in 4.4%, and coronary artery disease in 3.8%, according to a report published online Jan. 4 in Annals of Internal Medicine.

Most of the 1,853 study participants (median age, 31 years) were asymptomatic, with only 4 reporting occasional chest pain and only 1 reporting occasional palpitations. Yet, on careful examination, many showed significantly impaired physical performance. For example, “asymptomatic” young-adult survivors found to have cardiomyopathy and CAD were twice as likely as others to perform poorly on the 6-minute walk test, said Dr. Daniel A. Mulrooney of St. Jude Children’s Research Hospital, Memphis, and his associates.

The number of adult survivors of childhood cancer is predicted to exceed 500,000 by 2020, and the late effects of cancer treatment, primarily on the heart, are the chief cause of death among those who survive to 30 years. Few studies, however, have directly examined cardiac outcomes among survivors “because of the rarity of childhood cancer and the challenges of following patients across the life spectrum,” the investigators noted.

They were able to do so using data from the St. Jude Lifetime Cohort Study, focusing on patients aged 18 years and older from 44 states and 28 countries who had been treated with cardiotoxic therapy (anthracycline or chest irradiation) at St. Jude and survived 10 years or more after diagnosis. The participants’ median age was 8 years (range, 0-24) at diagnosis and 31 years (range, 18-60) at the time of the study. The median time since diagnosis was 23 years.

The study participants had been treated for leukemia or lymphoma (67%), sarcoma (14%), Wilms tumor (7%), neuroblastoma (5%), CNS tumors (4%), or other cancers (3%). They underwent a full medical evaluation plus echocardiography and electrocardiography.

Of particular concern was the finding that so many study participants had asymptomatic cardiomyopathy and were at high risk for heart failure. “At a median age of 31 years, we identified 7.4% of survivors with evidence of decreased systolic function, an estimate expected in a much older population,” they wrote. By comparison, in one study the rate of cardiomyopathy among healthy adults was less than 3% at ages 45-54 years, and it didn’t rise to 7% until ages 65-74 years, Dr. Mulrooney and his associates said (Ann Intern Med. 2016 Jan 4. doi: 10.7326/M15-0424).

The high (28%) frequency of valvular abnormalities – mitral or aortal regurgitation, stenosis, thickening, and calcification – also was of particular concern.

The prevalence of CV abnormalities increased with increasing patient age and with increasing doses of anthracycline and/or radiation exposure. Yet nearly 5% of the youngest patients – those aged 30 years or younger – showed evidence of cardiomyopathy.

Overall, the study findings suggest that CV disease represents “a substantial future health care burden” in this patient population. “Clinically, these data may guide stratification of risk factors, screening practices, health counseling, and potential therapeutic measures aimed at changing the disease trajectory in” these patients, the investigators said.

This study was funded by the National Cancer Institute and the American Lebanese Syrian Associated Charities. Dr. Mulrooney and his associates reported having no relevant conflicts of interest; their financial disclosures are available at acponline.org.

After attending specialized centers for severe, refractory asthma, British patients had improved asthma control, decreased use of emergency health care services, reduced medication usage, and improved quality-of-life measures, according to a report published in Chest.

British researchers recently established a national registry for the approximately 5% of asthma patients who attended dedicated Difficult Asthma Services centers because of severe, refractory disease. These specialized centers perform multiple assessments to determine the cause of persistent symptoms and develop a targeted treatment approach for each patient. Alternative diagnoses are ruled out, and comorbid conditions such as allergies are identified and treated. Treatment adherence is addressed, and medications, including novel biologic agents, are tailored to each patient’s needs, said Dr. David Gibeon of Royal Brompton Hospital and the National Heart and Lung Institute, Imperial College, both in London, and his associates.

To assess the usefulness of this approach, 346 patients who were referred to these centers and enrolled in the national registry were followed for a median of 286 days (range, 100-833). More than half were found to have a contributing disorder requiring treatment, such as gastroesophageal reflux (55%) or allergies (71%).

Significantly fewer patients required an unscheduled emergency dept. or primary care visit after attending the specialized centers (66%) than they had in the preceding year (88%). Also, the average number of such visits decreased from four to one, and the percentage of patients requiring hospitalization declined significantly from 48% to 38% (Chest. 2015;148[4]:870-6).

At the same time, serum total IgE levels significantly dropped, forced expiratory volume in 1 second measures improved, and the number of courses and doses of oral corticosteroids declined. In addition, scores on two measures of asthma-related quality of life significantly improved.

This study could not address the specific reasons why the use of Difficult Asthma Services produced these improvements, and it is possible that patients’ multiple contacts with health care professionals may have exerted a placebo-type effect. Future research should examine how different components of such programs – including the treatment of comorbidities, weight loss, clinical psychological support, and asthma education – contribute to improved outcomes, Dr. Gibeon and his associates added.

The study received no funding. Dr. Gibeon reported having no relevant financial disclosures.

After attending specialized centers for severe, refractory asthma, British patients had improved asthma control, decreased use of emergency health care services, reduced medication usage, and improved quality-of-life measures, according to a report published in Chest.

British researchers recently established a national registry for the approximately 5% of asthma patients who attended dedicated Difficult Asthma Services centers because of severe, refractory disease. These specialized centers perform multiple assessments to determine the cause of persistent symptoms and develop a targeted treatment approach for each patient. Alternative diagnoses are ruled out, and comorbid conditions such as allergies are identified and treated. Treatment adherence is addressed, and medications, including novel biologic agents, are tailored to each patient’s needs, said Dr. David Gibeon of Royal Brompton Hospital and the National Heart and Lung Institute, Imperial College, both in London, and his associates.

To assess the usefulness of this approach, 346 patients who were referred to these centers and enrolled in the national registry were followed for a median of 286 days (range, 100-833). More than half were found to have a contributing disorder requiring treatment, such as gastroesophageal reflux (55%) or allergies (71%).

Significantly fewer patients required an unscheduled emergency dept. or primary care visit after attending the specialized centers (66%) than they had in the preceding year (88%). Also, the average number of such visits decreased from four to one, and the percentage of patients requiring hospitalization declined significantly from 48% to 38% (Chest. 2015;148[4]:870-6).

At the same time, serum total IgE levels significantly dropped, forced expiratory volume in 1 second measures improved, and the number of courses and doses of oral corticosteroids declined. In addition, scores on two measures of asthma-related quality of life significantly improved.

This study could not address the specific reasons why the use of Difficult Asthma Services produced these improvements, and it is possible that patients’ multiple contacts with health care professionals may have exerted a placebo-type effect. Future research should examine how different components of such programs – including the treatment of comorbidities, weight loss, clinical psychological support, and asthma education – contribute to improved outcomes, Dr. Gibeon and his associates added.

The study received no funding. Dr. Gibeon reported having no relevant financial disclosures.

After attending specialized centers for severe, refractory asthma, British patients had improved asthma control, decreased use of emergency health care services, reduced medication usage, and improved quality-of-life measures, according to a report published in Chest.

British researchers recently established a national registry for the approximately 5% of asthma patients who attended dedicated Difficult Asthma Services centers because of severe, refractory disease. These specialized centers perform multiple assessments to determine the cause of persistent symptoms and develop a targeted treatment approach for each patient. Alternative diagnoses are ruled out, and comorbid conditions such as allergies are identified and treated. Treatment adherence is addressed, and medications, including novel biologic agents, are tailored to each patient’s needs, said Dr. David Gibeon of Royal Brompton Hospital and the National Heart and Lung Institute, Imperial College, both in London, and his associates.

To assess the usefulness of this approach, 346 patients who were referred to these centers and enrolled in the national registry were followed for a median of 286 days (range, 100-833). More than half were found to have a contributing disorder requiring treatment, such as gastroesophageal reflux (55%) or allergies (71%).

Significantly fewer patients required an unscheduled emergency dept. or primary care visit after attending the specialized centers (66%) than they had in the preceding year (88%). Also, the average number of such visits decreased from four to one, and the percentage of patients requiring hospitalization declined significantly from 48% to 38% (Chest. 2015;148[4]:870-6).

At the same time, serum total IgE levels significantly dropped, forced expiratory volume in 1 second measures improved, and the number of courses and doses of oral corticosteroids declined. In addition, scores on two measures of asthma-related quality of life significantly improved.

This study could not address the specific reasons why the use of Difficult Asthma Services produced these improvements, and it is possible that patients’ multiple contacts with health care professionals may have exerted a placebo-type effect. Future research should examine how different components of such programs – including the treatment of comorbidities, weight loss, clinical psychological support, and asthma education – contribute to improved outcomes, Dr. Gibeon and his associates added.

The study received no funding. Dr. Gibeon reported having no relevant financial disclosures.

The rates of several adverse outcomes appear to be twice as high among planned out-of-hospital births than planned in-hospital births, based on a study in Oregon that relied on more accurate statistical information about planned birth location.

Out-of-hospital births also were associated with fewer obstetrical procedures, and with increased odds of unassisted vaginal delivery.

Nationally, and in most individual states, data for births that were intended to occur in a hospital can not be separated from data for births that were intended to occur at home or at another nonhospital location such as a birth center but required transfer to a hospital. In effect, intrapartum home-to-hospital transfers were inaccurately counted as in-hospital births, said Dr. Jonathan M. Snowden of the departments of ob.gyn. and public health and preventive medicine, Oregon Health and Science University, Portland, and his associates.

©Cameron Whitman/Thinkstock

In 2012, Oregon began requiring that birth certificates document both the planned place of delivery at the onset of labor and the actual site of delivery. This change allowed researchers to use birth certificate data to assess more accurately maternal and neonatal outcomes by birth plan.

Dr. Snowden and his associates analyzed data from Oregon birth and death certificates during 2012-2013. They focused on 79,727 singleton term deliveries in which 95.2% of the mothers planned to deliver in hospital and did so, 4% planned and completed an out-of-hospital delivery (1,968 at home and 1,235 at a birth center), and 601 women (0.8%) planned an out-of-hospital delivery but ended up delivering in hospital after an intrapartum transfer.

Of mothers who planned an out-of-hospital delivery, 16.5% actually required transfer to a hospital and gave birth there. Misclassifying these births as simply “in-hospital” according to the previous statistical methods “caused rates of adverse outcomes among planned out-of-hospital births to be underestimated (in some cases, substantially),” the investigators said in a study published online Dec. 31 in the New England Journal of Medicine (doi: 10.1056/NEJMsa1501738).

Before intrapartum transfers were classified more accurately, rates of fetal, perinatal, and neonatal death did not differ significantly between in-hospital and out-of-hospital deliveries. After reclassification, death rates were higher for out-of-hospital than for in-hospital births: the fetal death rate was 2.4 vs. 1.2/1,000 deliveries, the perinatal death rate was 3.9 vs. 1.8 deaths/1,000 deliveries, and the neonatal death rate was 1.6 vs. 0.6/1,000 deliveries.

Using the more accurate data, rates of depressed 5-minute Apgar scores, neonatal seizures, and maternal blood transfusions were significantly higher for out-of-hospital than for in-hospital deliveries.

It is important to note that rates of all serious adverse outcomes were very low across the study groups, and that the absolute differences in risk between in-hospital and out-of-hospital delivery were correspondingly small, Dr. Snowden and his associates said.

Alternatively, the odds of NICU admission were lower with planned out-of-hospital births (adjusted odds ratio, 0.71; 95% confidence interval, 0.55-0.92).

Also, planned out-of-hospital birth remained strongly associated with decreased odds of induced labor (adjusted OR, 0.11; 95% CI, 0.09-0.12), cesarean delivery (adjusted OR, 0.18; 95% CI, 0.16-0.22), and other obstetrical procedures, and with increased odds of unassisted vaginal delivery (adjusted OR, 5.63; 95% CI, 4.84-6.55), the researchers wrote.

The rates of several adverse outcomes appear to be twice as high among planned out-of-hospital births than planned in-hospital births, based on a study in Oregon that relied on more accurate statistical information about planned birth location.

Out-of-hospital births also were associated with fewer obstetrical procedures, and with increased odds of unassisted vaginal delivery.

Nationally, and in most individual states, data for births that were intended to occur in a hospital can not be separated from data for births that were intended to occur at home or at another nonhospital location such as a birth center but required transfer to a hospital. In effect, intrapartum home-to-hospital transfers were inaccurately counted as in-hospital births, said Dr. Jonathan M. Snowden of the departments of ob.gyn. and public health and preventive medicine, Oregon Health and Science University, Portland, and his associates.

©Cameron Whitman/Thinkstock

In 2012, Oregon began requiring that birth certificates document both the planned place of delivery at the onset of labor and the actual site of delivery. This change allowed researchers to use birth certificate data to assess more accurately maternal and neonatal outcomes by birth plan.

Dr. Snowden and his associates analyzed data from Oregon birth and death certificates during 2012-2013. They focused on 79,727 singleton term deliveries in which 95.2% of the mothers planned to deliver in hospital and did so, 4% planned and completed an out-of-hospital delivery (1,968 at home and 1,235 at a birth center), and 601 women (0.8%) planned an out-of-hospital delivery but ended up delivering in hospital after an intrapartum transfer.

Of mothers who planned an out-of-hospital delivery, 16.5% actually required transfer to a hospital and gave birth there. Misclassifying these births as simply “in-hospital” according to the previous statistical methods “caused rates of adverse outcomes among planned out-of-hospital births to be underestimated (in some cases, substantially),” the investigators said in a study published online Dec. 31 in the New England Journal of Medicine (doi: 10.1056/NEJMsa1501738).

Before intrapartum transfers were classified more accurately, rates of fetal, perinatal, and neonatal death did not differ significantly between in-hospital and out-of-hospital deliveries. After reclassification, death rates were higher for out-of-hospital than for in-hospital births: the fetal death rate was 2.4 vs. 1.2/1,000 deliveries, the perinatal death rate was 3.9 vs. 1.8 deaths/1,000 deliveries, and the neonatal death rate was 1.6 vs. 0.6/1,000 deliveries.

Using the more accurate data, rates of depressed 5-minute Apgar scores, neonatal seizures, and maternal blood transfusions were significantly higher for out-of-hospital than for in-hospital deliveries.

It is important to note that rates of all serious adverse outcomes were very low across the study groups, and that the absolute differences in risk between in-hospital and out-of-hospital delivery were correspondingly small, Dr. Snowden and his associates said.

Alternatively, the odds of NICU admission were lower with planned out-of-hospital births (adjusted odds ratio, 0.71; 95% confidence interval, 0.55-0.92).

Also, planned out-of-hospital birth remained strongly associated with decreased odds of induced labor (adjusted OR, 0.11; 95% CI, 0.09-0.12), cesarean delivery (adjusted OR, 0.18; 95% CI, 0.16-0.22), and other obstetrical procedures, and with increased odds of unassisted vaginal delivery (adjusted OR, 5.63; 95% CI, 4.84-6.55), the researchers wrote.

The rates of several adverse outcomes appear to be twice as high among planned out-of-hospital births than planned in-hospital births, based on a study in Oregon that relied on more accurate statistical information about planned birth location.

Out-of-hospital births also were associated with fewer obstetrical procedures, and with increased odds of unassisted vaginal delivery.

Nationally, and in most individual states, data for births that were intended to occur in a hospital can not be separated from data for births that were intended to occur at home or at another nonhospital location such as a birth center but required transfer to a hospital. In effect, intrapartum home-to-hospital transfers were inaccurately counted as in-hospital births, said Dr. Jonathan M. Snowden of the departments of ob.gyn. and public health and preventive medicine, Oregon Health and Science University, Portland, and his associates.

©Cameron Whitman/Thinkstock

In 2012, Oregon began requiring that birth certificates document both the planned place of delivery at the onset of labor and the actual site of delivery. This change allowed researchers to use birth certificate data to assess more accurately maternal and neonatal outcomes by birth plan.

Dr. Snowden and his associates analyzed data from Oregon birth and death certificates during 2012-2013. They focused on 79,727 singleton term deliveries in which 95.2% of the mothers planned to deliver in hospital and did so, 4% planned and completed an out-of-hospital delivery (1,968 at home and 1,235 at a birth center), and 601 women (0.8%) planned an out-of-hospital delivery but ended up delivering in hospital after an intrapartum transfer.

Of mothers who planned an out-of-hospital delivery, 16.5% actually required transfer to a hospital and gave birth there. Misclassifying these births as simply “in-hospital” according to the previous statistical methods “caused rates of adverse outcomes among planned out-of-hospital births to be underestimated (in some cases, substantially),” the investigators said in a study published online Dec. 31 in the New England Journal of Medicine (doi: 10.1056/NEJMsa1501738).

Before intrapartum transfers were classified more accurately, rates of fetal, perinatal, and neonatal death did not differ significantly between in-hospital and out-of-hospital deliveries. After reclassification, death rates were higher for out-of-hospital than for in-hospital births: the fetal death rate was 2.4 vs. 1.2/1,000 deliveries, the perinatal death rate was 3.9 vs. 1.8 deaths/1,000 deliveries, and the neonatal death rate was 1.6 vs. 0.6/1,000 deliveries.

Using the more accurate data, rates of depressed 5-minute Apgar scores, neonatal seizures, and maternal blood transfusions were significantly higher for out-of-hospital than for in-hospital deliveries.

It is important to note that rates of all serious adverse outcomes were very low across the study groups, and that the absolute differences in risk between in-hospital and out-of-hospital delivery were correspondingly small, Dr. Snowden and his associates said.

Alternatively, the odds of NICU admission were lower with planned out-of-hospital births (adjusted odds ratio, 0.71; 95% confidence interval, 0.55-0.92).

Also, planned out-of-hospital birth remained strongly associated with decreased odds of induced labor (adjusted OR, 0.11; 95% CI, 0.09-0.12), cesarean delivery (adjusted OR, 0.18; 95% CI, 0.16-0.22), and other obstetrical procedures, and with increased odds of unassisted vaginal delivery (adjusted OR, 5.63; 95% CI, 4.84-6.55), the researchers wrote.

Massive ventral hernias should be defined as those with a length or width of at least 15 cm and/or an overall area of 150 cm², according to a report published in the Journal of American Surgery.

Until now, there has been no standardized definition of these defects. Defining massive ventral hernias is the first step in collecting and analyzing data on outcomes so that the best-practice methods for managing these cases can be determined, said Dr. Samuel W. Ross and his associates in the division of gastrointestinal and minimally invasive surgery, Carolinas Medical Center, Charlotte, N.C.

Their results suggest that patients with a massive ventral hernias “can be expected to stay in hospital for approximately 8 days, have an approximately 25% wound complication rate, have an 80% rate of activity limitation, and have a 100% rate of symptomatic pain at 1 month after surgery. This not only requires a long hospital course, with incumbent morbidity, but also the subsequent follow-up and management of wound and other complications,” the investigators said.

As expected, patients with massive ventral hernias had more complications and lower postop quality of life in terms of pain, activity limitation, and “mesh sensation,” compared with patients having regular hernia.

Large hernia defects are defined in the literature as up to 10 cm in size, but Dr. Ross and his colleagues hypothesized that massive hernia needed a more accurate cutoff size. The goal of this study was to define massive ventral hernia as 15 cm or more intraoperative defect size in any dimension or area 150 cm² or more, and validate it by comparing ventral hernia repair patients’ outcomes using an international, multicenter, prospectively collected database.

To validate that their definition correlated with patient outcomes, the investigators analyzed information in the International Hernia Mesh Registry, a prospectively collected database covering consecutive inguinal, umbilical, and ventral hernia repairs at 45 medical centers in 10 countries. They focused on 878 cases of ventral hernia treated during a 6-year period. A total of 158 cases (18%) met their criteria for massive ventral hernia.

Hernia repairs were nearly equally divided between laparoscopic (50.3%) and open (49.7%) surgeries. Approximately 18% of each group were massive ventral hernias.

Overall, there were 118 wound complications, including seromas (affecting 9.6% of patients), hematomas (2%), and superficial and deep surgical site infections (2%). Other complications included deep vein thrombosis (0.5%), pneumonia (1%), cardiac events (0.5%), and problems requiring reoperation (4.2%). At 2-year follow-up, 1.5% of the study participants had died and 5.1% had ventral hernia recurrences.

As expected, compared with patients who had regular-sized hernias, those with massive hernias were significantly more obese, had a higher percentage of previous hernia surgeries, and had larger defect sizes. In general, their outcomes were not as good as those of patients with regular-sized hernias.

In the laparoscopic group, patients with massive hernias required a longer length of hospital stay than did those with regular-sized hernias (4.8 vs. 2.6 days), but their rates of wound complications, deep vein thrombosis, cardiac events, reoperation, and recurrence were similar. They had significantly increased pain and limitation of activity for the first postoperative month, but thereafter these factors were comparable.

In the open-surgery group, patients with massive hernias required a longer length of stay and had significantly more hematomas, deep infections at the surgical site, other wound complications, and cases of pneumonia. But their rates of superficial surgical site infection, seroma, cardiac events, hernia recurrence, and death were comparable with those in patients with regular-size hernias. They had significantly increased pain and limitation of activity during the first postoperative month, but thereafter, these factors were comparable (Amer J Surg. 2015;210[5]:801-13).

Interestingly, massive hernias were associated with “increased mesh sensation” at both 1-year and 2-year follow-up only in the laparoscopic cohort. “This finding may be due to the lack of closure of the musculofascial abdominal wall during these laparoscopic repairs, which may allow the patients to directly appreciate the mesh underneath their subcutaneous tissue.” In contrast, open surgery allowed more complete closure of the abdominal wall, “which may have impacted the patients’ perception of the mesh in their abdomens,” Dr. Ross and his associates wrote.

The study had no outside funding. Dr. Ross reported having no relevant financial disclosures. His associates reported ties to W.L. Gore, Ethicon, Novadaq, Bard/Davol, and LifeCell; one associate reported holding a patent for a free mobile app predicting the rate and cost of wound complications after ventral hernia repair, for which he receives no financial gain.

Massive ventral hernias should be defined as those with a length or width of at least 15 cm and/or an overall area of 150 cm², according to a report published in the Journal of American Surgery.

Until now, there has been no standardized definition of these defects. Defining massive ventral hernias is the first step in collecting and analyzing data on outcomes so that the best-practice methods for managing these cases can be determined, said Dr. Samuel W. Ross and his associates in the division of gastrointestinal and minimally invasive surgery, Carolinas Medical Center, Charlotte, N.C.

Their results suggest that patients with a massive ventral hernias “can be expected to stay in hospital for approximately 8 days, have an approximately 25% wound complication rate, have an 80% rate of activity limitation, and have a 100% rate of symptomatic pain at 1 month after surgery. This not only requires a long hospital course, with incumbent morbidity, but also the subsequent follow-up and management of wound and other complications,” the investigators said.

As expected, patients with massive ventral hernias had more complications and lower postop quality of life in terms of pain, activity limitation, and “mesh sensation,” compared with patients having regular hernia.

Large hernia defects are defined in the literature as up to 10 cm in size, but Dr. Ross and his colleagues hypothesized that massive hernia needed a more accurate cutoff size. The goal of this study was to define massive ventral hernia as 15 cm or more intraoperative defect size in any dimension or area 150 cm² or more, and validate it by comparing ventral hernia repair patients’ outcomes using an international, multicenter, prospectively collected database.

To validate that their definition correlated with patient outcomes, the investigators analyzed information in the International Hernia Mesh Registry, a prospectively collected database covering consecutive inguinal, umbilical, and ventral hernia repairs at 45 medical centers in 10 countries. They focused on 878 cases of ventral hernia treated during a 6-year period. A total of 158 cases (18%) met their criteria for massive ventral hernia.

Hernia repairs were nearly equally divided between laparoscopic (50.3%) and open (49.7%) surgeries. Approximately 18% of each group were massive ventral hernias.

Overall, there were 118 wound complications, including seromas (affecting 9.6% of patients), hematomas (2%), and superficial and deep surgical site infections (2%). Other complications included deep vein thrombosis (0.5%), pneumonia (1%), cardiac events (0.5%), and problems requiring reoperation (4.2%). At 2-year follow-up, 1.5% of the study participants had died and 5.1% had ventral hernia recurrences.

As expected, compared with patients who had regular-sized hernias, those with massive hernias were significantly more obese, had a higher percentage of previous hernia surgeries, and had larger defect sizes. In general, their outcomes were not as good as those of patients with regular-sized hernias.

In the laparoscopic group, patients with massive hernias required a longer length of hospital stay than did those with regular-sized hernias (4.8 vs. 2.6 days), but their rates of wound complications, deep vein thrombosis, cardiac events, reoperation, and recurrence were similar. They had significantly increased pain and limitation of activity for the first postoperative month, but thereafter these factors were comparable.

In the open-surgery group, patients with massive hernias required a longer length of stay and had significantly more hematomas, deep infections at the surgical site, other wound complications, and cases of pneumonia. But their rates of superficial surgical site infection, seroma, cardiac events, hernia recurrence, and death were comparable with those in patients with regular-size hernias. They had significantly increased pain and limitation of activity during the first postoperative month, but thereafter, these factors were comparable (Amer J Surg. 2015;210[5]:801-13).

Interestingly, massive hernias were associated with “increased mesh sensation” at both 1-year and 2-year follow-up only in the laparoscopic cohort. “This finding may be due to the lack of closure of the musculofascial abdominal wall during these laparoscopic repairs, which may allow the patients to directly appreciate the mesh underneath their subcutaneous tissue.” In contrast, open surgery allowed more complete closure of the abdominal wall, “which may have impacted the patients’ perception of the mesh in their abdomens,” Dr. Ross and his associates wrote.

The study had no outside funding. Dr. Ross reported having no relevant financial disclosures. His associates reported ties to W.L. Gore, Ethicon, Novadaq, Bard/Davol, and LifeCell; one associate reported holding a patent for a free mobile app predicting the rate and cost of wound complications after ventral hernia repair, for which he receives no financial gain.

Massive ventral hernias should be defined as those with a length or width of at least 15 cm and/or an overall area of 150 cm², according to a report published in the Journal of American Surgery.

Until now, there has been no standardized definition of these defects. Defining massive ventral hernias is the first step in collecting and analyzing data on outcomes so that the best-practice methods for managing these cases can be determined, said Dr. Samuel W. Ross and his associates in the division of gastrointestinal and minimally invasive surgery, Carolinas Medical Center, Charlotte, N.C.

Their results suggest that patients with a massive ventral hernias “can be expected to stay in hospital for approximately 8 days, have an approximately 25% wound complication rate, have an 80% rate of activity limitation, and have a 100% rate of symptomatic pain at 1 month after surgery. This not only requires a long hospital course, with incumbent morbidity, but also the subsequent follow-up and management of wound and other complications,” the investigators said.

As expected, patients with massive ventral hernias had more complications and lower postop quality of life in terms of pain, activity limitation, and “mesh sensation,” compared with patients having regular hernia.

Large hernia defects are defined in the literature as up to 10 cm in size, but Dr. Ross and his colleagues hypothesized that massive hernia needed a more accurate cutoff size. The goal of this study was to define massive ventral hernia as 15 cm or more intraoperative defect size in any dimension or area 150 cm² or more, and validate it by comparing ventral hernia repair patients’ outcomes using an international, multicenter, prospectively collected database.

To validate that their definition correlated with patient outcomes, the investigators analyzed information in the International Hernia Mesh Registry, a prospectively collected database covering consecutive inguinal, umbilical, and ventral hernia repairs at 45 medical centers in 10 countries. They focused on 878 cases of ventral hernia treated during a 6-year period. A total of 158 cases (18%) met their criteria for massive ventral hernia.

Hernia repairs were nearly equally divided between laparoscopic (50.3%) and open (49.7%) surgeries. Approximately 18% of each group were massive ventral hernias.

Overall, there were 118 wound complications, including seromas (affecting 9.6% of patients), hematomas (2%), and superficial and deep surgical site infections (2%). Other complications included deep vein thrombosis (0.5%), pneumonia (1%), cardiac events (0.5%), and problems requiring reoperation (4.2%). At 2-year follow-up, 1.5% of the study participants had died and 5.1% had ventral hernia recurrences.

As expected, compared with patients who had regular-sized hernias, those with massive hernias were significantly more obese, had a higher percentage of previous hernia surgeries, and had larger defect sizes. In general, their outcomes were not as good as those of patients with regular-sized hernias.

In the laparoscopic group, patients with massive hernias required a longer length of hospital stay than did those with regular-sized hernias (4.8 vs. 2.6 days), but their rates of wound complications, deep vein thrombosis, cardiac events, reoperation, and recurrence were similar. They had significantly increased pain and limitation of activity for the first postoperative month, but thereafter these factors were comparable.

In the open-surgery group, patients with massive hernias required a longer length of stay and had significantly more hematomas, deep infections at the surgical site, other wound complications, and cases of pneumonia. But their rates of superficial surgical site infection, seroma, cardiac events, hernia recurrence, and death were comparable with those in patients with regular-size hernias. They had significantly increased pain and limitation of activity during the first postoperative month, but thereafter, these factors were comparable (Amer J Surg. 2015;210[5]:801-13).

Interestingly, massive hernias were associated with “increased mesh sensation” at both 1-year and 2-year follow-up only in the laparoscopic cohort. “This finding may be due to the lack of closure of the musculofascial abdominal wall during these laparoscopic repairs, which may allow the patients to directly appreciate the mesh underneath their subcutaneous tissue.” In contrast, open surgery allowed more complete closure of the abdominal wall, “which may have impacted the patients’ perception of the mesh in their abdomens,” Dr. Ross and his associates wrote.

The study had no outside funding. Dr. Ross reported having no relevant financial disclosures. His associates reported ties to W.L. Gore, Ethicon, Novadaq, Bard/Davol, and LifeCell; one associate reported holding a patent for a free mobile app predicting the rate and cost of wound complications after ventral hernia repair, for which he receives no financial gain.