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HPV Vaccine Gaining Ground for Use in Pregnancy

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HPV Vaccine Gaining Ground for Use in Pregnancy

'There is not [yet] enough information to recommend HPV vaccination in pregnancy.' DR. LAWRENCE

LA JOLLA, CALIF. — The human papillomavirus vaccine, although still not recommended for use in pregnancy, was no longer listed as contraindicated by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices as of early last year.

“This may lessen the concern when a woman inadvertently receives a dose before learning she is pregnant,” Dr. Hal Lawrence said at Perspectives in Women's Health sponsored by FAMILY PRACTICE NEWS, OB.GYN. NEWS, and INTERNAL MEDICINE NEWS.

“Given time and more data, multiple doses of the vaccine may prove to be safe during pregnancy, offering clinicians an opportunity to initiate or complete the three-dose series during a period of routine office visits,” added Dr. Lawrence, vice president for practice activities, American College of Obstetricians and Gynecologists, and a member of the editorial advisory board of OB.GYN. NEWS.

For now, however, neither intentional initiation of the vaccine series nor delivery of doses two and three during pregnancy is recommended, according to updated vaccine information from the CDC's Guidelines for Vaccinating Pregnant Women, available online at www.cdc.gov/vaccines/pubs/preg-guide.htm

The HPV vaccine contains neither live nor attenuated viral particles; instead, it contains viruslike particles engineered to resemble the L1 protein on the outer capsule of the virus.

Although it provokes a robust immune response, “it does not have any actual viral activity,” said Dr. Lawrence. This mechanism is reassuring, and to date no adverse events related to mothers or developing fetuses have been associated with administering the HPV vaccine during pregnancy.

In an interview following the meeting, however, Dr. Lawrence emphasized that the data are limited. “What we are really saying is that while no adverse events have been reported, there is not enough information to recommend HPV vaccination in pregnancy,” he said.

Dr. Lawrence said that clinicians with patients who received the HPV vaccine during pregnancy are encouraged to call the HPV Vaccine Pregnancy Registry at 800-986-8999 to add to the information base. As HPV vaccinations during pregnancy are identified and pregnancy outcomes are tracked, the CDC and other organizations may reevaluate use of the vaccine during pregnancy.

In other news regarding HPV vaccines, Dr. Lawrence cited recent data showing partial blocking of 10 additional HPV strains, in addition to HPV 6, 11, 16, and 18, the four covered by the quadrivalent vaccine. “This may boost protection [against cervical cancer] to 90%,” he said at the meeting.

HPV is also responsible for the majority of anal and vulvar cancers in young women and for head, neck, and oral cancers as well, any of which could potentially be prevented with the HPV vaccine, according to Dr. Lawrence. For additional information, see ACOG Committee Opinion No. 344 and ACOG Practice Bulletin No. 61.

OB.GYN. NEWS, FAMILY PRACTICE NEWS, and INTERNAL MEDICINE NEWS are published by the International Medical News Group, a division of Elsevier.

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'There is not [yet] enough information to recommend HPV vaccination in pregnancy.' DR. LAWRENCE

LA JOLLA, CALIF. — The human papillomavirus vaccine, although still not recommended for use in pregnancy, was no longer listed as contraindicated by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices as of early last year.

“This may lessen the concern when a woman inadvertently receives a dose before learning she is pregnant,” Dr. Hal Lawrence said at Perspectives in Women's Health sponsored by FAMILY PRACTICE NEWS, OB.GYN. NEWS, and INTERNAL MEDICINE NEWS.

“Given time and more data, multiple doses of the vaccine may prove to be safe during pregnancy, offering clinicians an opportunity to initiate or complete the three-dose series during a period of routine office visits,” added Dr. Lawrence, vice president for practice activities, American College of Obstetricians and Gynecologists, and a member of the editorial advisory board of OB.GYN. NEWS.

For now, however, neither intentional initiation of the vaccine series nor delivery of doses two and three during pregnancy is recommended, according to updated vaccine information from the CDC's Guidelines for Vaccinating Pregnant Women, available online at www.cdc.gov/vaccines/pubs/preg-guide.htm

The HPV vaccine contains neither live nor attenuated viral particles; instead, it contains viruslike particles engineered to resemble the L1 protein on the outer capsule of the virus.

Although it provokes a robust immune response, “it does not have any actual viral activity,” said Dr. Lawrence. This mechanism is reassuring, and to date no adverse events related to mothers or developing fetuses have been associated with administering the HPV vaccine during pregnancy.

In an interview following the meeting, however, Dr. Lawrence emphasized that the data are limited. “What we are really saying is that while no adverse events have been reported, there is not enough information to recommend HPV vaccination in pregnancy,” he said.

Dr. Lawrence said that clinicians with patients who received the HPV vaccine during pregnancy are encouraged to call the HPV Vaccine Pregnancy Registry at 800-986-8999 to add to the information base. As HPV vaccinations during pregnancy are identified and pregnancy outcomes are tracked, the CDC and other organizations may reevaluate use of the vaccine during pregnancy.

In other news regarding HPV vaccines, Dr. Lawrence cited recent data showing partial blocking of 10 additional HPV strains, in addition to HPV 6, 11, 16, and 18, the four covered by the quadrivalent vaccine. “This may boost protection [against cervical cancer] to 90%,” he said at the meeting.

HPV is also responsible for the majority of anal and vulvar cancers in young women and for head, neck, and oral cancers as well, any of which could potentially be prevented with the HPV vaccine, according to Dr. Lawrence. For additional information, see ACOG Committee Opinion No. 344 and ACOG Practice Bulletin No. 61.

OB.GYN. NEWS, FAMILY PRACTICE NEWS, and INTERNAL MEDICINE NEWS are published by the International Medical News Group, a division of Elsevier.

'There is not [yet] enough information to recommend HPV vaccination in pregnancy.' DR. LAWRENCE

LA JOLLA, CALIF. — The human papillomavirus vaccine, although still not recommended for use in pregnancy, was no longer listed as contraindicated by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices as of early last year.

“This may lessen the concern when a woman inadvertently receives a dose before learning she is pregnant,” Dr. Hal Lawrence said at Perspectives in Women's Health sponsored by FAMILY PRACTICE NEWS, OB.GYN. NEWS, and INTERNAL MEDICINE NEWS.

“Given time and more data, multiple doses of the vaccine may prove to be safe during pregnancy, offering clinicians an opportunity to initiate or complete the three-dose series during a period of routine office visits,” added Dr. Lawrence, vice president for practice activities, American College of Obstetricians and Gynecologists, and a member of the editorial advisory board of OB.GYN. NEWS.

For now, however, neither intentional initiation of the vaccine series nor delivery of doses two and three during pregnancy is recommended, according to updated vaccine information from the CDC's Guidelines for Vaccinating Pregnant Women, available online at www.cdc.gov/vaccines/pubs/preg-guide.htm

The HPV vaccine contains neither live nor attenuated viral particles; instead, it contains viruslike particles engineered to resemble the L1 protein on the outer capsule of the virus.

Although it provokes a robust immune response, “it does not have any actual viral activity,” said Dr. Lawrence. This mechanism is reassuring, and to date no adverse events related to mothers or developing fetuses have been associated with administering the HPV vaccine during pregnancy.

In an interview following the meeting, however, Dr. Lawrence emphasized that the data are limited. “What we are really saying is that while no adverse events have been reported, there is not enough information to recommend HPV vaccination in pregnancy,” he said.

Dr. Lawrence said that clinicians with patients who received the HPV vaccine during pregnancy are encouraged to call the HPV Vaccine Pregnancy Registry at 800-986-8999 to add to the information base. As HPV vaccinations during pregnancy are identified and pregnancy outcomes are tracked, the CDC and other organizations may reevaluate use of the vaccine during pregnancy.

In other news regarding HPV vaccines, Dr. Lawrence cited recent data showing partial blocking of 10 additional HPV strains, in addition to HPV 6, 11, 16, and 18, the four covered by the quadrivalent vaccine. “This may boost protection [against cervical cancer] to 90%,” he said at the meeting.

HPV is also responsible for the majority of anal and vulvar cancers in young women and for head, neck, and oral cancers as well, any of which could potentially be prevented with the HPV vaccine, according to Dr. Lawrence. For additional information, see ACOG Committee Opinion No. 344 and ACOG Practice Bulletin No. 61.

OB.GYN. NEWS, FAMILY PRACTICE NEWS, and INTERNAL MEDICINE NEWS are published by the International Medical News Group, a division of Elsevier.

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Vulvar, Vaginal Pain Is Common In Pregnancy

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CHICAGO — Many women report vulvar and vaginal symptoms during pregnancy, but little is known about the frequency, severity, and timing of complaints such as vulvar pain, burning, itching, and dyspareunia, said Dr. Colleen M. Kennedy of the University of Iowa, Iowa City, in a poster presentation at the annual meeting of the Central Association of Obstetricians and Gynecologists.

Vulvar and vaginal symptoms account for more than 10 million office visits annually and represent the most common gynecologic complaint.

To identify the prevalence rates of burning, itching, pain, and dyspareunia during pregnancy and in the 3 months post partum, and to determine how rates of vulvar and vaginal symptoms compare in pregnant and nonpregnant women, Dr. Kennedy and her colleagues evaluated 103 pregnant women recruited from the University of Iowa obstetrics clinics. Sixty-three of these participants completed the final postpartum survey. The study also included 122 nonpregnant women in a control group.

The participants had a mean age of 28 years and were mostly white (92%) and married or living with a partner (81%); most had completed some education beyond high school (86%).

The results showed that both vulvar and vaginal symptoms commonly occur in pregnancy. Pregnant women reported vulvar pain more frequently in their second and third trimesters than in the first trimester, but pregnant women and their nonpregnant controls reported the same level of severity. Vaginal discharge increased in frequency and severity in the second and third trimesters. Dyspareunia was less common in the first trimester than in subsequent trimesters, but reached its peak in the postpartum period, particularly in those women who gave birth vaginally. All other symptoms decreased during the postpartum period.

“Symptoms are dynamic and change [during pregnancy],” said Dr. Kennedy. Compared with nonpregnant controls, the pregnant women in the study did not have higher rates of vulvar pruritus and burning.

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CHICAGO — Many women report vulvar and vaginal symptoms during pregnancy, but little is known about the frequency, severity, and timing of complaints such as vulvar pain, burning, itching, and dyspareunia, said Dr. Colleen M. Kennedy of the University of Iowa, Iowa City, in a poster presentation at the annual meeting of the Central Association of Obstetricians and Gynecologists.

Vulvar and vaginal symptoms account for more than 10 million office visits annually and represent the most common gynecologic complaint.

To identify the prevalence rates of burning, itching, pain, and dyspareunia during pregnancy and in the 3 months post partum, and to determine how rates of vulvar and vaginal symptoms compare in pregnant and nonpregnant women, Dr. Kennedy and her colleagues evaluated 103 pregnant women recruited from the University of Iowa obstetrics clinics. Sixty-three of these participants completed the final postpartum survey. The study also included 122 nonpregnant women in a control group.

The participants had a mean age of 28 years and were mostly white (92%) and married or living with a partner (81%); most had completed some education beyond high school (86%).

The results showed that both vulvar and vaginal symptoms commonly occur in pregnancy. Pregnant women reported vulvar pain more frequently in their second and third trimesters than in the first trimester, but pregnant women and their nonpregnant controls reported the same level of severity. Vaginal discharge increased in frequency and severity in the second and third trimesters. Dyspareunia was less common in the first trimester than in subsequent trimesters, but reached its peak in the postpartum period, particularly in those women who gave birth vaginally. All other symptoms decreased during the postpartum period.

“Symptoms are dynamic and change [during pregnancy],” said Dr. Kennedy. Compared with nonpregnant controls, the pregnant women in the study did not have higher rates of vulvar pruritus and burning.

CHICAGO — Many women report vulvar and vaginal symptoms during pregnancy, but little is known about the frequency, severity, and timing of complaints such as vulvar pain, burning, itching, and dyspareunia, said Dr. Colleen M. Kennedy of the University of Iowa, Iowa City, in a poster presentation at the annual meeting of the Central Association of Obstetricians and Gynecologists.

Vulvar and vaginal symptoms account for more than 10 million office visits annually and represent the most common gynecologic complaint.

To identify the prevalence rates of burning, itching, pain, and dyspareunia during pregnancy and in the 3 months post partum, and to determine how rates of vulvar and vaginal symptoms compare in pregnant and nonpregnant women, Dr. Kennedy and her colleagues evaluated 103 pregnant women recruited from the University of Iowa obstetrics clinics. Sixty-three of these participants completed the final postpartum survey. The study also included 122 nonpregnant women in a control group.

The participants had a mean age of 28 years and were mostly white (92%) and married or living with a partner (81%); most had completed some education beyond high school (86%).

The results showed that both vulvar and vaginal symptoms commonly occur in pregnancy. Pregnant women reported vulvar pain more frequently in their second and third trimesters than in the first trimester, but pregnant women and their nonpregnant controls reported the same level of severity. Vaginal discharge increased in frequency and severity in the second and third trimesters. Dyspareunia was less common in the first trimester than in subsequent trimesters, but reached its peak in the postpartum period, particularly in those women who gave birth vaginally. All other symptoms decreased during the postpartum period.

“Symptoms are dynamic and change [during pregnancy],” said Dr. Kennedy. Compared with nonpregnant controls, the pregnant women in the study did not have higher rates of vulvar pruritus and burning.

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Poor Outcomes Seen in Pregnancy-Tied Breast Ca

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Poor Outcomes Seen in Pregnancy-Tied Breast Ca

SAN ANTONIO — Survival outcomes in women with pregnancy-associated breast cancer were significantly worse than in nonpregnant controls matched for age and tumor stage in a relatively large single-center study.

This finding is at odds with most prior series, which have found no difference in 5-year survival depending upon whether a breast cancer patient was pregnant, study investigator Dr. Rajesh Sehgal said at the San Antonio Breast Cancer Symposium.

“We don't know why our results were different. We could not explain it on any basis,” he said in an interview.

Breast cancer is the most frequently diagnosed malignancy in pregnancy, with an incidence of roughly three cases per 10,000 live births.

Dr. Sehgal presented a retrospective study involving 40 women with pregnancy-associated breast cancer (defined as breast cancer diagnosed during pregnancy, within 1 year of delivery, or at any time during lactation) and 40 matched nonpregnant controls, all treated at University of Pittsburgh Medical Center.

Median overall survival was 4.9 years in the pregnancy-associated breast cancer group, significantly less than the 6.0 years in controls. Median disease-free survival was 2.7 years in women with pregnancy-associated breast cancer, compared with 5.1 years in controls. The most common site of relapse in the pregnancy-associated breast cancer group was bone. In controls, recurrences were most commonly local.

Pregnancy remained an independent predictor of worse outcomes in breast cancer patients after adjusting for key variables including hormone receptor status, family history, tumor stage, human epidermal growth factor receptor 2 (HER2) status, and the use of radiotherapy and/or chemotherapy.

None of the studies reported to date is large enough to be definitive, and a national registry is warranted, Dr. Sehgal said.

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SAN ANTONIO — Survival outcomes in women with pregnancy-associated breast cancer were significantly worse than in nonpregnant controls matched for age and tumor stage in a relatively large single-center study.

This finding is at odds with most prior series, which have found no difference in 5-year survival depending upon whether a breast cancer patient was pregnant, study investigator Dr. Rajesh Sehgal said at the San Antonio Breast Cancer Symposium.

“We don't know why our results were different. We could not explain it on any basis,” he said in an interview.

Breast cancer is the most frequently diagnosed malignancy in pregnancy, with an incidence of roughly three cases per 10,000 live births.

Dr. Sehgal presented a retrospective study involving 40 women with pregnancy-associated breast cancer (defined as breast cancer diagnosed during pregnancy, within 1 year of delivery, or at any time during lactation) and 40 matched nonpregnant controls, all treated at University of Pittsburgh Medical Center.

Median overall survival was 4.9 years in the pregnancy-associated breast cancer group, significantly less than the 6.0 years in controls. Median disease-free survival was 2.7 years in women with pregnancy-associated breast cancer, compared with 5.1 years in controls. The most common site of relapse in the pregnancy-associated breast cancer group was bone. In controls, recurrences were most commonly local.

Pregnancy remained an independent predictor of worse outcomes in breast cancer patients after adjusting for key variables including hormone receptor status, family history, tumor stage, human epidermal growth factor receptor 2 (HER2) status, and the use of radiotherapy and/or chemotherapy.

None of the studies reported to date is large enough to be definitive, and a national registry is warranted, Dr. Sehgal said.

SAN ANTONIO — Survival outcomes in women with pregnancy-associated breast cancer were significantly worse than in nonpregnant controls matched for age and tumor stage in a relatively large single-center study.

This finding is at odds with most prior series, which have found no difference in 5-year survival depending upon whether a breast cancer patient was pregnant, study investigator Dr. Rajesh Sehgal said at the San Antonio Breast Cancer Symposium.

“We don't know why our results were different. We could not explain it on any basis,” he said in an interview.

Breast cancer is the most frequently diagnosed malignancy in pregnancy, with an incidence of roughly three cases per 10,000 live births.

Dr. Sehgal presented a retrospective study involving 40 women with pregnancy-associated breast cancer (defined as breast cancer diagnosed during pregnancy, within 1 year of delivery, or at any time during lactation) and 40 matched nonpregnant controls, all treated at University of Pittsburgh Medical Center.

Median overall survival was 4.9 years in the pregnancy-associated breast cancer group, significantly less than the 6.0 years in controls. Median disease-free survival was 2.7 years in women with pregnancy-associated breast cancer, compared with 5.1 years in controls. The most common site of relapse in the pregnancy-associated breast cancer group was bone. In controls, recurrences were most commonly local.

Pregnancy remained an independent predictor of worse outcomes in breast cancer patients after adjusting for key variables including hormone receptor status, family history, tumor stage, human epidermal growth factor receptor 2 (HER2) status, and the use of radiotherapy and/or chemotherapy.

None of the studies reported to date is large enough to be definitive, and a national registry is warranted, Dr. Sehgal said.

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Neonatal Lupus Study Seeks Pregnant Women

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Intravenous immune globulin has been suggested as a possible therapy for preventing congenital heart block caused by neonatal lupus, and early data from a study of the treatment indicate that further study is warranted.

Of five women with a previous fetus affected by neonatal lupus—who thus are at increased risk of having a baby with congenital heart block—who were enrolled at press time in the Preventive IVIG Therapy for Congenital Heart Block (PITCH) study, three had given birth to babies without congenital heart block following IVIG treatment, one was still undergoing treatment but showed no fetal echocardiographic evidence of congenital heart block, and one had not reached 12 weeks' gestation and therefore had not begun treatment, principal investigator Dr. Jill Buyon said during an informational teleconference on the study. At least 19 total patients are needed to adequately power this open-label first- phase of the PITCH study, which is sponsored by New York University and the Alliance for Lupus Research, said Dr. Buyon, professor of medicine and vice chair of the department of rheumatology at New York University.

An additional 35 patients will be needed for the second phase of the study, which will proceed if fewer than 3 of the 19 women in the first phase have children with second- or third-degree heart block.

Neonatal lupus can affect babies of mothers with SSA/Ro and SSB/La autoantibodies, and can appear as a transient rash that disappears by the time the baby is about 6 months old, or, in rare cases, as a transient abnormal blood or liver condition. In some cases, however, congenital heart block occurs in affected fetuses, causing permanent heart damage and fetal death.

The risk of congenital heart block is about 2% in a first pregnancy for women with anti-Ro and anti-La antibodies, but the risk jumps to 20% in subsequent pregnancies in women who have had a previous child with congenital heart block or neonatal lupus-related rash, coinvestigator Dr. Deborah Friedman of St. Barnabas Medical Center in Livingston, N.J., said.

Since no therapy has been successful for the treatment of complete heart block, the focus has shifted to prevention of the condition, which appears to occur because of scarring of the conduction system that results from inflammation triggered by the mother's antibodies.

The scarred heart beats extremely slowly, and 20% of affected babies die—most of them within 2 weeks and in utero. Surviving babies almost always require permanent implantation of a pacemaker.

Giving IVIG to at-risk mothers was suggested as a potential preventative therapy because it has the potential to lower maternal antibody levels, thereby reducing fetal exposure, and also to influence effector mechanisms in the fetus itself. Furthermore, IVIG has been shown to be safe in pregnancy, Dr. Buyon noted.

Having a total of 19 women enrolled in the first phase of PITCH will provide adequate power to demonstrate a reduction of risk from 20% to 5% in women with a previously affected child. Patients will receive 400 mg/kg IVIG every 3 weeks for a total of five treatments from weeks 12–24 of pregnancy.

IVIG will be considered efficacious and worthy of further study if fewer than six women in phase II of PITCH have a child with advanced heart block.

Participants should be aged 18–50 years, have a current intrauterine pregnancy of less than 12 weeks, and have circulating SSA/Ro and/or SSB/La antibodies. Participants also should have a previous child with congenital heart block of any degree, which has been documented by EKG and/or echocardiogram; with confirmed characteristic lupus rash; or with congenital heart block and rash.

Women with rheumatic disease can participate if they aren't taking more than 20 mg/day of prednisone. Other exclusion criteria include conditions that would contraindicate the use of IVIG such as a prior serious IVIG infusion reaction, known IgA deficiency, intolerance of volume load, and nephrotic syndrome. Those with a fetus with structural lesions that could cause congenital heart block also are excluded.

Those interested in enrolling patients in PITCH should refer to ClinicalTrials.gov identifier NCT00460928, and should contact research administrator, Lena Geffrard, by calling 212-263-2255 or sending an e-mail to [email protected]

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Intravenous immune globulin has been suggested as a possible therapy for preventing congenital heart block caused by neonatal lupus, and early data from a study of the treatment indicate that further study is warranted.

Of five women with a previous fetus affected by neonatal lupus—who thus are at increased risk of having a baby with congenital heart block—who were enrolled at press time in the Preventive IVIG Therapy for Congenital Heart Block (PITCH) study, three had given birth to babies without congenital heart block following IVIG treatment, one was still undergoing treatment but showed no fetal echocardiographic evidence of congenital heart block, and one had not reached 12 weeks' gestation and therefore had not begun treatment, principal investigator Dr. Jill Buyon said during an informational teleconference on the study. At least 19 total patients are needed to adequately power this open-label first- phase of the PITCH study, which is sponsored by New York University and the Alliance for Lupus Research, said Dr. Buyon, professor of medicine and vice chair of the department of rheumatology at New York University.

An additional 35 patients will be needed for the second phase of the study, which will proceed if fewer than 3 of the 19 women in the first phase have children with second- or third-degree heart block.

Neonatal lupus can affect babies of mothers with SSA/Ro and SSB/La autoantibodies, and can appear as a transient rash that disappears by the time the baby is about 6 months old, or, in rare cases, as a transient abnormal blood or liver condition. In some cases, however, congenital heart block occurs in affected fetuses, causing permanent heart damage and fetal death.

The risk of congenital heart block is about 2% in a first pregnancy for women with anti-Ro and anti-La antibodies, but the risk jumps to 20% in subsequent pregnancies in women who have had a previous child with congenital heart block or neonatal lupus-related rash, coinvestigator Dr. Deborah Friedman of St. Barnabas Medical Center in Livingston, N.J., said.

Since no therapy has been successful for the treatment of complete heart block, the focus has shifted to prevention of the condition, which appears to occur because of scarring of the conduction system that results from inflammation triggered by the mother's antibodies.

The scarred heart beats extremely slowly, and 20% of affected babies die—most of them within 2 weeks and in utero. Surviving babies almost always require permanent implantation of a pacemaker.

Giving IVIG to at-risk mothers was suggested as a potential preventative therapy because it has the potential to lower maternal antibody levels, thereby reducing fetal exposure, and also to influence effector mechanisms in the fetus itself. Furthermore, IVIG has been shown to be safe in pregnancy, Dr. Buyon noted.

Having a total of 19 women enrolled in the first phase of PITCH will provide adequate power to demonstrate a reduction of risk from 20% to 5% in women with a previously affected child. Patients will receive 400 mg/kg IVIG every 3 weeks for a total of five treatments from weeks 12–24 of pregnancy.

IVIG will be considered efficacious and worthy of further study if fewer than six women in phase II of PITCH have a child with advanced heart block.

Participants should be aged 18–50 years, have a current intrauterine pregnancy of less than 12 weeks, and have circulating SSA/Ro and/or SSB/La antibodies. Participants also should have a previous child with congenital heart block of any degree, which has been documented by EKG and/or echocardiogram; with confirmed characteristic lupus rash; or with congenital heart block and rash.

Women with rheumatic disease can participate if they aren't taking more than 20 mg/day of prednisone. Other exclusion criteria include conditions that would contraindicate the use of IVIG such as a prior serious IVIG infusion reaction, known IgA deficiency, intolerance of volume load, and nephrotic syndrome. Those with a fetus with structural lesions that could cause congenital heart block also are excluded.

Those interested in enrolling patients in PITCH should refer to ClinicalTrials.gov identifier NCT00460928, and should contact research administrator, Lena Geffrard, by calling 212-263-2255 or sending an e-mail to [email protected]

Intravenous immune globulin has been suggested as a possible therapy for preventing congenital heart block caused by neonatal lupus, and early data from a study of the treatment indicate that further study is warranted.

Of five women with a previous fetus affected by neonatal lupus—who thus are at increased risk of having a baby with congenital heart block—who were enrolled at press time in the Preventive IVIG Therapy for Congenital Heart Block (PITCH) study, three had given birth to babies without congenital heart block following IVIG treatment, one was still undergoing treatment but showed no fetal echocardiographic evidence of congenital heart block, and one had not reached 12 weeks' gestation and therefore had not begun treatment, principal investigator Dr. Jill Buyon said during an informational teleconference on the study. At least 19 total patients are needed to adequately power this open-label first- phase of the PITCH study, which is sponsored by New York University and the Alliance for Lupus Research, said Dr. Buyon, professor of medicine and vice chair of the department of rheumatology at New York University.

An additional 35 patients will be needed for the second phase of the study, which will proceed if fewer than 3 of the 19 women in the first phase have children with second- or third-degree heart block.

Neonatal lupus can affect babies of mothers with SSA/Ro and SSB/La autoantibodies, and can appear as a transient rash that disappears by the time the baby is about 6 months old, or, in rare cases, as a transient abnormal blood or liver condition. In some cases, however, congenital heart block occurs in affected fetuses, causing permanent heart damage and fetal death.

The risk of congenital heart block is about 2% in a first pregnancy for women with anti-Ro and anti-La antibodies, but the risk jumps to 20% in subsequent pregnancies in women who have had a previous child with congenital heart block or neonatal lupus-related rash, coinvestigator Dr. Deborah Friedman of St. Barnabas Medical Center in Livingston, N.J., said.

Since no therapy has been successful for the treatment of complete heart block, the focus has shifted to prevention of the condition, which appears to occur because of scarring of the conduction system that results from inflammation triggered by the mother's antibodies.

The scarred heart beats extremely slowly, and 20% of affected babies die—most of them within 2 weeks and in utero. Surviving babies almost always require permanent implantation of a pacemaker.

Giving IVIG to at-risk mothers was suggested as a potential preventative therapy because it has the potential to lower maternal antibody levels, thereby reducing fetal exposure, and also to influence effector mechanisms in the fetus itself. Furthermore, IVIG has been shown to be safe in pregnancy, Dr. Buyon noted.

Having a total of 19 women enrolled in the first phase of PITCH will provide adequate power to demonstrate a reduction of risk from 20% to 5% in women with a previously affected child. Patients will receive 400 mg/kg IVIG every 3 weeks for a total of five treatments from weeks 12–24 of pregnancy.

IVIG will be considered efficacious and worthy of further study if fewer than six women in phase II of PITCH have a child with advanced heart block.

Participants should be aged 18–50 years, have a current intrauterine pregnancy of less than 12 weeks, and have circulating SSA/Ro and/or SSB/La antibodies. Participants also should have a previous child with congenital heart block of any degree, which has been documented by EKG and/or echocardiogram; with confirmed characteristic lupus rash; or with congenital heart block and rash.

Women with rheumatic disease can participate if they aren't taking more than 20 mg/day of prednisone. Other exclusion criteria include conditions that would contraindicate the use of IVIG such as a prior serious IVIG infusion reaction, known IgA deficiency, intolerance of volume load, and nephrotic syndrome. Those with a fetus with structural lesions that could cause congenital heart block also are excluded.

Those interested in enrolling patients in PITCH should refer to ClinicalTrials.gov identifier NCT00460928, and should contact research administrator, Lena Geffrard, by calling 212-263-2255 or sending an e-mail to [email protected]

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Elective C-Section Linked to Infant Respiratory Problems

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Elective C-Section Linked to Infant Respiratory Problems

Elective C-section increases by up to fourfold the risk of respiratory morbidity in babies who were delivered at 37–39 weeks of gestation, compared with babies who were delivered vaginally or by emergency C-section at the same gestational age.

That finding—from a Danish cohort study of 34,458 singleton deliveries—suggests that elective C-section should wait until after the 39th week, the study investigators wrote online in BMJ.

“Carrying out elective caesarean sections at greater gestational ages may, however, result in higher rates of intrapartum caesarean sections because some women would go into spontaneous labour (in our population, 25% of spontaneous intended vaginal deliveries started before 39 weeks' gestation),” wrote Anne Kirkeby Hansen of the Aarhus (Denmark) University Hospital and associates.

“Compared with elective caesarean sections, intrapartum caesarean sections may carry an increased risk of complications such as uterine rupture in women with previous caesarean section, infections, or even maternal mortality,”

The risk of respiratory morbidity (transitory tachypnea of the newborn, respiratory distress syndrome, persistent pulmonary hypertension of the newborn) was increased in babies delivered by elective C-section at 37 weeks (odds ratio 3.9), 38 weeks (OR 3.0), and 39 weeks (OR 1.9), compared with newborns intended for vaginal delivery.

Risk was not increased at 40 weeks (OR 0.9).

The data were adjusted for factors such as smoking and parity, the study authors reported (doi:10.1136/bmj.39405.539282.BE).

The analysis included all liveborn singletons born without malformation between 37 and 41 weeks' gestation at one institution between 1998 and 2006.

In all, 2,687 liveborn babies were delivered by elective C-section and 2,877 were delivered by emergency C-section. The remaining babies were born vaginally.

A total of 1.8% of all babies had a respiratory problem, with 0.2% of them having serious respiratory morbidity (a condition requiring treatment for at least 3 days with continuous oxygen supplementation, nasal continuous positive airway pressure, or any period of mechanical ventilation).

The relative risk for serious respiratory morbidity was increased in those delivered by elective C-section at 37 weeks (OR 5.0) and 38 weeks (OR 4.2), compared with intended vaginal delivery.

At 39 weeks, the odds ratio was 2.4, but this increase in risk was not statistically significant.

The authors said hormones released during normal vaginal delivery may help prevent respiratory problems.

Catecholamines are present in the fetus during normal vaginal delivery in response to the rupture of membranes and labor, a phenomenon that may decrease the secretion of fetal lung liquid, increase its absorption, and stimulate the release of surfactants.

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Elective C-section increases by up to fourfold the risk of respiratory morbidity in babies who were delivered at 37–39 weeks of gestation, compared with babies who were delivered vaginally or by emergency C-section at the same gestational age.

That finding—from a Danish cohort study of 34,458 singleton deliveries—suggests that elective C-section should wait until after the 39th week, the study investigators wrote online in BMJ.

“Carrying out elective caesarean sections at greater gestational ages may, however, result in higher rates of intrapartum caesarean sections because some women would go into spontaneous labour (in our population, 25% of spontaneous intended vaginal deliveries started before 39 weeks' gestation),” wrote Anne Kirkeby Hansen of the Aarhus (Denmark) University Hospital and associates.

“Compared with elective caesarean sections, intrapartum caesarean sections may carry an increased risk of complications such as uterine rupture in women with previous caesarean section, infections, or even maternal mortality,”

The risk of respiratory morbidity (transitory tachypnea of the newborn, respiratory distress syndrome, persistent pulmonary hypertension of the newborn) was increased in babies delivered by elective C-section at 37 weeks (odds ratio 3.9), 38 weeks (OR 3.0), and 39 weeks (OR 1.9), compared with newborns intended for vaginal delivery.

Risk was not increased at 40 weeks (OR 0.9).

The data were adjusted for factors such as smoking and parity, the study authors reported (doi:10.1136/bmj.39405.539282.BE).

The analysis included all liveborn singletons born without malformation between 37 and 41 weeks' gestation at one institution between 1998 and 2006.

In all, 2,687 liveborn babies were delivered by elective C-section and 2,877 were delivered by emergency C-section. The remaining babies were born vaginally.

A total of 1.8% of all babies had a respiratory problem, with 0.2% of them having serious respiratory morbidity (a condition requiring treatment for at least 3 days with continuous oxygen supplementation, nasal continuous positive airway pressure, or any period of mechanical ventilation).

The relative risk for serious respiratory morbidity was increased in those delivered by elective C-section at 37 weeks (OR 5.0) and 38 weeks (OR 4.2), compared with intended vaginal delivery.

At 39 weeks, the odds ratio was 2.4, but this increase in risk was not statistically significant.

The authors said hormones released during normal vaginal delivery may help prevent respiratory problems.

Catecholamines are present in the fetus during normal vaginal delivery in response to the rupture of membranes and labor, a phenomenon that may decrease the secretion of fetal lung liquid, increase its absorption, and stimulate the release of surfactants.

Elective C-section increases by up to fourfold the risk of respiratory morbidity in babies who were delivered at 37–39 weeks of gestation, compared with babies who were delivered vaginally or by emergency C-section at the same gestational age.

That finding—from a Danish cohort study of 34,458 singleton deliveries—suggests that elective C-section should wait until after the 39th week, the study investigators wrote online in BMJ.

“Carrying out elective caesarean sections at greater gestational ages may, however, result in higher rates of intrapartum caesarean sections because some women would go into spontaneous labour (in our population, 25% of spontaneous intended vaginal deliveries started before 39 weeks' gestation),” wrote Anne Kirkeby Hansen of the Aarhus (Denmark) University Hospital and associates.

“Compared with elective caesarean sections, intrapartum caesarean sections may carry an increased risk of complications such as uterine rupture in women with previous caesarean section, infections, or even maternal mortality,”

The risk of respiratory morbidity (transitory tachypnea of the newborn, respiratory distress syndrome, persistent pulmonary hypertension of the newborn) was increased in babies delivered by elective C-section at 37 weeks (odds ratio 3.9), 38 weeks (OR 3.0), and 39 weeks (OR 1.9), compared with newborns intended for vaginal delivery.

Risk was not increased at 40 weeks (OR 0.9).

The data were adjusted for factors such as smoking and parity, the study authors reported (doi:10.1136/bmj.39405.539282.BE).

The analysis included all liveborn singletons born without malformation between 37 and 41 weeks' gestation at one institution between 1998 and 2006.

In all, 2,687 liveborn babies were delivered by elective C-section and 2,877 were delivered by emergency C-section. The remaining babies were born vaginally.

A total of 1.8% of all babies had a respiratory problem, with 0.2% of them having serious respiratory morbidity (a condition requiring treatment for at least 3 days with continuous oxygen supplementation, nasal continuous positive airway pressure, or any period of mechanical ventilation).

The relative risk for serious respiratory morbidity was increased in those delivered by elective C-section at 37 weeks (OR 5.0) and 38 weeks (OR 4.2), compared with intended vaginal delivery.

At 39 weeks, the odds ratio was 2.4, but this increase in risk was not statistically significant.

The authors said hormones released during normal vaginal delivery may help prevent respiratory problems.

Catecholamines are present in the fetus during normal vaginal delivery in response to the rupture of membranes and labor, a phenomenon that may decrease the secretion of fetal lung liquid, increase its absorption, and stimulate the release of surfactants.

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Some Risks Lower in Planned C-Section vs. Vaginal Delivery

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HOLLYWOOD, FLA. — Planned cesarean deliveries are associated with a lower risk for chorioamnionitis and postpartum hemorrhage, compared with planned vaginal births, and are not associated with a higher risk for transfusion, venous thromboembolism, or wound infection, according to a retrospective study of low-risk women.

Perhaps not surprisingly, however, planned cesarean delivery is associated with a longer average stay in the hospital, Dr. Elizabeth J. Geller said at the annual meeting of the American Urogynecologic Society.

Dr. Geller presented results of a review of deliveries by healthy, primiparous women. Planned cesarean was associated with significantly lower risk of prolonged rupture of the membranes (2% vs. 18% in the planned vaginal group); chorioamnionitis (2% vs. 17%), and postpartum hemorrhage (1% vs. 6%).

However, the women in the planned cesarean group had a significantly longer stay in the hospital (3.2 days vs. 2.6 days).

After controlling for age, race, obesity, gestational age, and prolonged rupture of the membranes, the risk of chorioamnionitis (odds ratio, 0.2) and postpartum hemorrhage (OR, 0.2) were significantly lower in the planned cesarean group, said Dr. Geller of the University of North Carolina at Chapel Hill.

Transfusion, cesarean hysterectomy, venous thromboembolism, and wound infection rates were not significantly different between groups.

There were no maternal deaths or pulmonary emboli in either group.

Dr. Geller and her associates at the university reviewed 26,356 deliveries by healthy, primiparous women from 1995 to 2005 in their institution's perinatal database. They excluded high-risk deliveries, including multiparous women, multiple gestations, and premature births.

“This left us with a low-risk population,” said Dr. Geller, a clinical fellow in female pelvic medicine in the division of urogynecology and reconstructive pelvic surgery.

The researchers compared rates of chorioamnionitis, postpartum hemorrhage, and transfusion between 3,868 planned vaginal deliveries and 180 planned cesarean deliveries.

The women in the vaginal group were more likely to be younger (25 years vs. 28 years), but “the absolute values were close so this difference is not clinically relevant,” Dr. Geller said.

In addition, women in the planned cesarean group delivered earlier, at a gestational age of 38.7 weeks, compared with 39.4 weeks in the planned vaginal group.

Although there were no differences between groups in terms of obesity or black race, women in the planned cesarean group were more likely to be white (59% vs. 43%) or Asian (10% vs. 5%), and less likely to be Hispanic (21% vs. 37%).

The intent-to-treat study design and inclusion of a decade's worth of data for a large hospital database are strengths of the research, Dr. Geller said.

Possible limitations include its retrospective nature, inclusion of only low-risk women, and a lack of outcomes data following hospital discharge.

A meeting attendee pointed out that all the findings addressed maternal and not newborn outcomes.

“Stay tuned,” Dr. Geller replied.

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HOLLYWOOD, FLA. — Planned cesarean deliveries are associated with a lower risk for chorioamnionitis and postpartum hemorrhage, compared with planned vaginal births, and are not associated with a higher risk for transfusion, venous thromboembolism, or wound infection, according to a retrospective study of low-risk women.

Perhaps not surprisingly, however, planned cesarean delivery is associated with a longer average stay in the hospital, Dr. Elizabeth J. Geller said at the annual meeting of the American Urogynecologic Society.

Dr. Geller presented results of a review of deliveries by healthy, primiparous women. Planned cesarean was associated with significantly lower risk of prolonged rupture of the membranes (2% vs. 18% in the planned vaginal group); chorioamnionitis (2% vs. 17%), and postpartum hemorrhage (1% vs. 6%).

However, the women in the planned cesarean group had a significantly longer stay in the hospital (3.2 days vs. 2.6 days).

After controlling for age, race, obesity, gestational age, and prolonged rupture of the membranes, the risk of chorioamnionitis (odds ratio, 0.2) and postpartum hemorrhage (OR, 0.2) were significantly lower in the planned cesarean group, said Dr. Geller of the University of North Carolina at Chapel Hill.

Transfusion, cesarean hysterectomy, venous thromboembolism, and wound infection rates were not significantly different between groups.

There were no maternal deaths or pulmonary emboli in either group.

Dr. Geller and her associates at the university reviewed 26,356 deliveries by healthy, primiparous women from 1995 to 2005 in their institution's perinatal database. They excluded high-risk deliveries, including multiparous women, multiple gestations, and premature births.

“This left us with a low-risk population,” said Dr. Geller, a clinical fellow in female pelvic medicine in the division of urogynecology and reconstructive pelvic surgery.

The researchers compared rates of chorioamnionitis, postpartum hemorrhage, and transfusion between 3,868 planned vaginal deliveries and 180 planned cesarean deliveries.

The women in the vaginal group were more likely to be younger (25 years vs. 28 years), but “the absolute values were close so this difference is not clinically relevant,” Dr. Geller said.

In addition, women in the planned cesarean group delivered earlier, at a gestational age of 38.7 weeks, compared with 39.4 weeks in the planned vaginal group.

Although there were no differences between groups in terms of obesity or black race, women in the planned cesarean group were more likely to be white (59% vs. 43%) or Asian (10% vs. 5%), and less likely to be Hispanic (21% vs. 37%).

The intent-to-treat study design and inclusion of a decade's worth of data for a large hospital database are strengths of the research, Dr. Geller said.

Possible limitations include its retrospective nature, inclusion of only low-risk women, and a lack of outcomes data following hospital discharge.

A meeting attendee pointed out that all the findings addressed maternal and not newborn outcomes.

“Stay tuned,” Dr. Geller replied.

HOLLYWOOD, FLA. — Planned cesarean deliveries are associated with a lower risk for chorioamnionitis and postpartum hemorrhage, compared with planned vaginal births, and are not associated with a higher risk for transfusion, venous thromboembolism, or wound infection, according to a retrospective study of low-risk women.

Perhaps not surprisingly, however, planned cesarean delivery is associated with a longer average stay in the hospital, Dr. Elizabeth J. Geller said at the annual meeting of the American Urogynecologic Society.

Dr. Geller presented results of a review of deliveries by healthy, primiparous women. Planned cesarean was associated with significantly lower risk of prolonged rupture of the membranes (2% vs. 18% in the planned vaginal group); chorioamnionitis (2% vs. 17%), and postpartum hemorrhage (1% vs. 6%).

However, the women in the planned cesarean group had a significantly longer stay in the hospital (3.2 days vs. 2.6 days).

After controlling for age, race, obesity, gestational age, and prolonged rupture of the membranes, the risk of chorioamnionitis (odds ratio, 0.2) and postpartum hemorrhage (OR, 0.2) were significantly lower in the planned cesarean group, said Dr. Geller of the University of North Carolina at Chapel Hill.

Transfusion, cesarean hysterectomy, venous thromboembolism, and wound infection rates were not significantly different between groups.

There were no maternal deaths or pulmonary emboli in either group.

Dr. Geller and her associates at the university reviewed 26,356 deliveries by healthy, primiparous women from 1995 to 2005 in their institution's perinatal database. They excluded high-risk deliveries, including multiparous women, multiple gestations, and premature births.

“This left us with a low-risk population,” said Dr. Geller, a clinical fellow in female pelvic medicine in the division of urogynecology and reconstructive pelvic surgery.

The researchers compared rates of chorioamnionitis, postpartum hemorrhage, and transfusion between 3,868 planned vaginal deliveries and 180 planned cesarean deliveries.

The women in the vaginal group were more likely to be younger (25 years vs. 28 years), but “the absolute values were close so this difference is not clinically relevant,” Dr. Geller said.

In addition, women in the planned cesarean group delivered earlier, at a gestational age of 38.7 weeks, compared with 39.4 weeks in the planned vaginal group.

Although there were no differences between groups in terms of obesity or black race, women in the planned cesarean group were more likely to be white (59% vs. 43%) or Asian (10% vs. 5%), and less likely to be Hispanic (21% vs. 37%).

The intent-to-treat study design and inclusion of a decade's worth of data for a large hospital database are strengths of the research, Dr. Geller said.

Possible limitations include its retrospective nature, inclusion of only low-risk women, and a lack of outcomes data following hospital discharge.

A meeting attendee pointed out that all the findings addressed maternal and not newborn outcomes.

“Stay tuned,” Dr. Geller replied.

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Calibrated Drapes May Aid Blood-Loss Estimates : Estimate error was reduced from more than 30% to less than 10% in one study.

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Calibrated Drapes May Aid Blood-Loss Estimates : Estimate error was reduced from more than 30% to less than 10% in one study.

SAN FRANCISCO — There's a product niche waiting to be filled, one that might save a life during postpartum hemorrhage.

Health care providers consistently underestimate the amount of postpartum blood loss, and adding calibrations to vaginal delivery drapes could improve blood loss estimates, results of a randomized crossover study suggest.

Participants who viewed calibrated delivery drapes and then were asked to estimate the amount of blood in uncalibrated drapes reduced the error in their estimates from more than 30% to less than 10% for the highest volumes of blood, Robert J. McCarthy, Pharm.D., said in a poster presentation at the annual meeting of the American Society of Anesthesiologists.

There are no vaginal delivery drapes on the market calibrated to indicate the amount of blood loss, added Dr. McCarthy of Northwestern University, Chicago. “It's time consuming to go through and set these up [individually],” he said. If such a product became available, it “could prevent delay in diagnosis and treatment of postpartum hemorrhage.”

The investigators asked 42 obstetricians, 21 nurses, and 43 anesthesiologists to estimate blood loss at eight mock vaginal delivery stations, four with uncalibrated delivery drapes and four with drapes that were marked at 500-mL increments up to 2,500 mL.

Each set of delivery drapes contained expired packed red blood cells diluted to a hematocrit of 33%, in volumes of 300, 500, 1,000, or 2,000 mL, plus 100 mL of urine and 5, 10, or 15 surgical sponges.

Subjects were randomized to view the calibrated or uncalibrated drapes first, then crossed over to the other group of stations.

Viewing the uncalibrated drapes first produced greater underestimates of blood loss that worsened with larger volumes of blood loss, reported Dr. McCarthy, lead investigator Dr. Paloma Toledo, and their associates. All the authors are from Northwestern University.

Errors by those who first viewed uncalibrated drapes ranged from a 16% underestimate of the 300-mL blood volume to a 41% underestimate of the 2000-mL volume.

Subjects who first viewed the calibrated drapes underestimated volumes in the uncalibrated drapes by less than 15%.

The results did not differ by the type of health care provider, the level of training, or number of years of experience.

A previous study reported that estimates of postpartum blood loss based on visual assessment underestimated blood loss by 33%–50% compared with photospectrometry, “which is the gold standard for this,” Dr. McCarthy said (Int. J. Gynecol. Obstet. 2006;93:220–4).

“They used smaller amounts of blood loss—300 mL as their top volume—while we used volumes that were more likely to be clinically important and need some kind of intervention.”

Another previous study reported that estimates of blood loss worsen with increasing volumes of blood loss (Int. J. Gynecol. Obstet. 2000;71:69–70).

Blood loss greater than 500 mL after vaginal delivery (postpartum hemorrhage) is a major cause of maternal morbidity and mortality.

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SAN FRANCISCO — There's a product niche waiting to be filled, one that might save a life during postpartum hemorrhage.

Health care providers consistently underestimate the amount of postpartum blood loss, and adding calibrations to vaginal delivery drapes could improve blood loss estimates, results of a randomized crossover study suggest.

Participants who viewed calibrated delivery drapes and then were asked to estimate the amount of blood in uncalibrated drapes reduced the error in their estimates from more than 30% to less than 10% for the highest volumes of blood, Robert J. McCarthy, Pharm.D., said in a poster presentation at the annual meeting of the American Society of Anesthesiologists.

There are no vaginal delivery drapes on the market calibrated to indicate the amount of blood loss, added Dr. McCarthy of Northwestern University, Chicago. “It's time consuming to go through and set these up [individually],” he said. If such a product became available, it “could prevent delay in diagnosis and treatment of postpartum hemorrhage.”

The investigators asked 42 obstetricians, 21 nurses, and 43 anesthesiologists to estimate blood loss at eight mock vaginal delivery stations, four with uncalibrated delivery drapes and four with drapes that were marked at 500-mL increments up to 2,500 mL.

Each set of delivery drapes contained expired packed red blood cells diluted to a hematocrit of 33%, in volumes of 300, 500, 1,000, or 2,000 mL, plus 100 mL of urine and 5, 10, or 15 surgical sponges.

Subjects were randomized to view the calibrated or uncalibrated drapes first, then crossed over to the other group of stations.

Viewing the uncalibrated drapes first produced greater underestimates of blood loss that worsened with larger volumes of blood loss, reported Dr. McCarthy, lead investigator Dr. Paloma Toledo, and their associates. All the authors are from Northwestern University.

Errors by those who first viewed uncalibrated drapes ranged from a 16% underestimate of the 300-mL blood volume to a 41% underestimate of the 2000-mL volume.

Subjects who first viewed the calibrated drapes underestimated volumes in the uncalibrated drapes by less than 15%.

The results did not differ by the type of health care provider, the level of training, or number of years of experience.

A previous study reported that estimates of postpartum blood loss based on visual assessment underestimated blood loss by 33%–50% compared with photospectrometry, “which is the gold standard for this,” Dr. McCarthy said (Int. J. Gynecol. Obstet. 2006;93:220–4).

“They used smaller amounts of blood loss—300 mL as their top volume—while we used volumes that were more likely to be clinically important and need some kind of intervention.”

Another previous study reported that estimates of blood loss worsen with increasing volumes of blood loss (Int. J. Gynecol. Obstet. 2000;71:69–70).

Blood loss greater than 500 mL after vaginal delivery (postpartum hemorrhage) is a major cause of maternal morbidity and mortality.

SAN FRANCISCO — There's a product niche waiting to be filled, one that might save a life during postpartum hemorrhage.

Health care providers consistently underestimate the amount of postpartum blood loss, and adding calibrations to vaginal delivery drapes could improve blood loss estimates, results of a randomized crossover study suggest.

Participants who viewed calibrated delivery drapes and then were asked to estimate the amount of blood in uncalibrated drapes reduced the error in their estimates from more than 30% to less than 10% for the highest volumes of blood, Robert J. McCarthy, Pharm.D., said in a poster presentation at the annual meeting of the American Society of Anesthesiologists.

There are no vaginal delivery drapes on the market calibrated to indicate the amount of blood loss, added Dr. McCarthy of Northwestern University, Chicago. “It's time consuming to go through and set these up [individually],” he said. If such a product became available, it “could prevent delay in diagnosis and treatment of postpartum hemorrhage.”

The investigators asked 42 obstetricians, 21 nurses, and 43 anesthesiologists to estimate blood loss at eight mock vaginal delivery stations, four with uncalibrated delivery drapes and four with drapes that were marked at 500-mL increments up to 2,500 mL.

Each set of delivery drapes contained expired packed red blood cells diluted to a hematocrit of 33%, in volumes of 300, 500, 1,000, or 2,000 mL, plus 100 mL of urine and 5, 10, or 15 surgical sponges.

Subjects were randomized to view the calibrated or uncalibrated drapes first, then crossed over to the other group of stations.

Viewing the uncalibrated drapes first produced greater underestimates of blood loss that worsened with larger volumes of blood loss, reported Dr. McCarthy, lead investigator Dr. Paloma Toledo, and their associates. All the authors are from Northwestern University.

Errors by those who first viewed uncalibrated drapes ranged from a 16% underestimate of the 300-mL blood volume to a 41% underestimate of the 2000-mL volume.

Subjects who first viewed the calibrated drapes underestimated volumes in the uncalibrated drapes by less than 15%.

The results did not differ by the type of health care provider, the level of training, or number of years of experience.

A previous study reported that estimates of postpartum blood loss based on visual assessment underestimated blood loss by 33%–50% compared with photospectrometry, “which is the gold standard for this,” Dr. McCarthy said (Int. J. Gynecol. Obstet. 2006;93:220–4).

“They used smaller amounts of blood loss—300 mL as their top volume—while we used volumes that were more likely to be clinically important and need some kind of intervention.”

Another previous study reported that estimates of blood loss worsen with increasing volumes of blood loss (Int. J. Gynecol. Obstet. 2000;71:69–70).

Blood loss greater than 500 mL after vaginal delivery (postpartum hemorrhage) is a major cause of maternal morbidity and mortality.

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Angiogenic Imbalances Predict Preeclampsia in SLE

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BOSTON — Alterations in circulating antiangiogenic protein levels in pregnant women with lupus and antiphospholipid antibody syndrome may predict preeclampsia, a pregnancy complication for which they are at increased risk, according to data presented at the annual meeting of the American College of Rheumatology.

The findings suggest that identification of angiogenic imbalances early in gestation and subsequent interventions targeting the inflammatory pathways that trigger the imbalances could potentially reduce the incidence of preeclampsia in women with these autoimmune conditions, reported Dr. Jane E. Salmon of the Hospital for Special Surgery in New York.

In a nested case-control study of pregnant women with systemic lupus erythematosus (SLE) and/or antiphospholipid antibody (APLA) syndrome, women with elevated levels of circulating soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin (sEng) at midpregnancy were at significantly increased risk for preeclampsia later in pregnancy, compared with age- and ethnicity-matched disease control patients who had SLE and/or APLA but not preeclampsia, reported Dr. Salmon.

Subjects for the investigation were enrolled in the multicenter observational PROMISSE (Predictors of Pregnancy Outcome BioMarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus) study. In the larger study, 211 women with SLE and/or APLA who were less than 12 weeks pregnant at enrollment were followed throughout their pregnancy to determine the association between alterations in antiangiogenic factors and the later development of preeclampsia. In the nested case-control study, each of the 16 women with SLE and/or APLA syndrome from the larger cohort who developed preeclampsia was matched to both another SLE woman and/or an APLA-positive woman who didn't develop preeclampsia and to a healthy control who had neither autoimmune disease or pregnancy complications, Dr. Salmon explained.

Compared with the healthy controls, elevations in levels of circulating sFlt-1 were observed in all of the autoimmune patients as early as 12–15 weeks' gestation. Additionally, the rate of increase in levels of that protein throughout pregnancy was significantly higher in patients who went on to develop preeclampsia, and it was higher in all patients with autoimmune disorders, compared with healthy controls, reported Dr. Salmon. Among the patients with autoimmune disorders, elevated levels of sFlt-1 and sEng at 20–23 weeks' gestation were independently associated with increased risk of developing preeclampsia, she noted.

The findings indicate that sFlt-1 and sEng are biomarkers predictive of preeclampsia in patients with lupus and/or APLA and that “imbalances [in the levels of these biomarkers] early in pregnancy increase the vulnerability of these patients to preeclampsia,” said Dr. Salmon. “Because inflammatory mediators trigger production of antiangiogenic factors, early intervention to block specific pathways of inflammation could prevent angiogenic imbalance in lupus pregnancies at risk for preeclampsia.”

Dr. Salmon reported having no financial disclosures relative to this presentation.

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BOSTON — Alterations in circulating antiangiogenic protein levels in pregnant women with lupus and antiphospholipid antibody syndrome may predict preeclampsia, a pregnancy complication for which they are at increased risk, according to data presented at the annual meeting of the American College of Rheumatology.

The findings suggest that identification of angiogenic imbalances early in gestation and subsequent interventions targeting the inflammatory pathways that trigger the imbalances could potentially reduce the incidence of preeclampsia in women with these autoimmune conditions, reported Dr. Jane E. Salmon of the Hospital for Special Surgery in New York.

In a nested case-control study of pregnant women with systemic lupus erythematosus (SLE) and/or antiphospholipid antibody (APLA) syndrome, women with elevated levels of circulating soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin (sEng) at midpregnancy were at significantly increased risk for preeclampsia later in pregnancy, compared with age- and ethnicity-matched disease control patients who had SLE and/or APLA but not preeclampsia, reported Dr. Salmon.

Subjects for the investigation were enrolled in the multicenter observational PROMISSE (Predictors of Pregnancy Outcome BioMarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus) study. In the larger study, 211 women with SLE and/or APLA who were less than 12 weeks pregnant at enrollment were followed throughout their pregnancy to determine the association between alterations in antiangiogenic factors and the later development of preeclampsia. In the nested case-control study, each of the 16 women with SLE and/or APLA syndrome from the larger cohort who developed preeclampsia was matched to both another SLE woman and/or an APLA-positive woman who didn't develop preeclampsia and to a healthy control who had neither autoimmune disease or pregnancy complications, Dr. Salmon explained.

Compared with the healthy controls, elevations in levels of circulating sFlt-1 were observed in all of the autoimmune patients as early as 12–15 weeks' gestation. Additionally, the rate of increase in levels of that protein throughout pregnancy was significantly higher in patients who went on to develop preeclampsia, and it was higher in all patients with autoimmune disorders, compared with healthy controls, reported Dr. Salmon. Among the patients with autoimmune disorders, elevated levels of sFlt-1 and sEng at 20–23 weeks' gestation were independently associated with increased risk of developing preeclampsia, she noted.

The findings indicate that sFlt-1 and sEng are biomarkers predictive of preeclampsia in patients with lupus and/or APLA and that “imbalances [in the levels of these biomarkers] early in pregnancy increase the vulnerability of these patients to preeclampsia,” said Dr. Salmon. “Because inflammatory mediators trigger production of antiangiogenic factors, early intervention to block specific pathways of inflammation could prevent angiogenic imbalance in lupus pregnancies at risk for preeclampsia.”

Dr. Salmon reported having no financial disclosures relative to this presentation.

BOSTON — Alterations in circulating antiangiogenic protein levels in pregnant women with lupus and antiphospholipid antibody syndrome may predict preeclampsia, a pregnancy complication for which they are at increased risk, according to data presented at the annual meeting of the American College of Rheumatology.

The findings suggest that identification of angiogenic imbalances early in gestation and subsequent interventions targeting the inflammatory pathways that trigger the imbalances could potentially reduce the incidence of preeclampsia in women with these autoimmune conditions, reported Dr. Jane E. Salmon of the Hospital for Special Surgery in New York.

In a nested case-control study of pregnant women with systemic lupus erythematosus (SLE) and/or antiphospholipid antibody (APLA) syndrome, women with elevated levels of circulating soluble fms-like tyrosine kinase 1 (sFlt-1) and soluble endoglin (sEng) at midpregnancy were at significantly increased risk for preeclampsia later in pregnancy, compared with age- and ethnicity-matched disease control patients who had SLE and/or APLA but not preeclampsia, reported Dr. Salmon.

Subjects for the investigation were enrolled in the multicenter observational PROMISSE (Predictors of Pregnancy Outcome BioMarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus) study. In the larger study, 211 women with SLE and/or APLA who were less than 12 weeks pregnant at enrollment were followed throughout their pregnancy to determine the association between alterations in antiangiogenic factors and the later development of preeclampsia. In the nested case-control study, each of the 16 women with SLE and/or APLA syndrome from the larger cohort who developed preeclampsia was matched to both another SLE woman and/or an APLA-positive woman who didn't develop preeclampsia and to a healthy control who had neither autoimmune disease or pregnancy complications, Dr. Salmon explained.

Compared with the healthy controls, elevations in levels of circulating sFlt-1 were observed in all of the autoimmune patients as early as 12–15 weeks' gestation. Additionally, the rate of increase in levels of that protein throughout pregnancy was significantly higher in patients who went on to develop preeclampsia, and it was higher in all patients with autoimmune disorders, compared with healthy controls, reported Dr. Salmon. Among the patients with autoimmune disorders, elevated levels of sFlt-1 and sEng at 20–23 weeks' gestation were independently associated with increased risk of developing preeclampsia, she noted.

The findings indicate that sFlt-1 and sEng are biomarkers predictive of preeclampsia in patients with lupus and/or APLA and that “imbalances [in the levels of these biomarkers] early in pregnancy increase the vulnerability of these patients to preeclampsia,” said Dr. Salmon. “Because inflammatory mediators trigger production of antiangiogenic factors, early intervention to block specific pathways of inflammation could prevent angiogenic imbalance in lupus pregnancies at risk for preeclampsia.”

Dr. Salmon reported having no financial disclosures relative to this presentation.

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Check Pattern Variability First in Fetal Heart Rate Monitoring

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Check Pattern Variability First in Fetal Heart Rate Monitoring

SAN FRANCISCO — The first and most important thing to look for in a fetal heart rate pattern is variability, Michael D. Fox, R.N., said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

Pattern recognition is the key. Is the heart rate pattern jagged and unpredictable? That's a sign of moderate variability, which nearly guarantees that the fetus is sufficiently oxygenated. Is the pattern smooth, round, blunted, and flat? That loss of variability, when combined with recurrent heart rate decelerations, flags a baby who may be getting asphyxiated, said Mr. Fox, director of the perinatal resource group at the university.

The conventional method of assessing fetal heart rate-monitoring strips starts with drawing an arbitrary line that the clinician designates as the baseline heart rate, so that everything above it is considered accelerations and everything below it is thought to be decelerations. “I would argue that [the conventional method] is fraught with peril” because it employs the wrong interpretive construct and the wrong cues, he said.

Clinicians get into trouble by focusing too much on various methods to measure the height of the variability complexes on the fetal heart rate-monitoring strip. “It's not just the height of the variability complexes that are important, but the way they look,” he added.

A jagged and unpredictable pattern on the heart rate-monitoring strip is good: It's a visual representation of an intact neurologic pathway in the fetus. A progressively smooth, round, blunted and flat pattern is bad: This is a pattern that every baby who dies of asphyxia develops, even if the height of the heart rate oscillations meets previous definitions for moderate variability. A common mistake is to consider smooth, round, blunted oscillations to be moderate variability if they have enough height in the pattern.

Because heart rate accelerations usually occur in association with moderate variability, they are typically jagged and unpredictable in both appearance and timing. Rarely are accelerations regular, rhythmic, or occurring with each contraction.

Recurrent decelerations that get deeper and deeper as labor progresses are no cause for immediate delivery, so long as moderate variability remains present. “These are tracings that we traditionally called nonreassuring,” yet 98% of fetuses with this pattern will be free of asphyxia and 99% will have no morbidities, he noted.

That doesn't mean clinicians needn't be alert. If you see recurrent decelerations in the presence of moderate variability, then be sure a physician or nurse-midwife is managing the patient at the bedside, prepare the patient for delivery, and notify the rest of the obstetric and neonatal team. “Once you have the capacity to rescue this fetus, these are tracings that can continue to be observed,” he said.

The timing of decelerations in relation to uterine activity may tell the clinician something about the underlying physiology “but it does not tell you what to do in most circumstances,” Mr. Fox added. “Variability always trumps timing.”

He teaches a four-step process of evaluating a fetal heart rate strip. First, ask if variability is absent, minimal, moderate, or marked. Second, look for decelerations. Third, consider the baseline fetal heart rate. Finally, sum up the evolution of the tracing. Babies with asphyxia don't regain variability; they continue to lose it over time in association with deeper decelerations.

Video Teaches Pattern Recognition

A free video that teaches recognition of variability and other signs of fetal health on heart rate-monitoring tracings is available to clinicians who “commit to interdisciplinary education”—meaning it will be used to train doctors, nurses, midwives, and anyone else involved in monitoring fetal heart rates, Mr. Fox said.

Funded by Kaiser Permanente, the video “Situational Awareness in Fetal Heart Rate Monitoring” features four 27-minute segments with cases and tracings presented by Mr. Fox, Dr. Julian (“Bill”) Parer, professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, and other faculty members.

A small shipping and handling fee is charged for each order. Mr. Fox is the distributor. To request a copy, contact him at

[email protected]

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SAN FRANCISCO — The first and most important thing to look for in a fetal heart rate pattern is variability, Michael D. Fox, R.N., said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

Pattern recognition is the key. Is the heart rate pattern jagged and unpredictable? That's a sign of moderate variability, which nearly guarantees that the fetus is sufficiently oxygenated. Is the pattern smooth, round, blunted, and flat? That loss of variability, when combined with recurrent heart rate decelerations, flags a baby who may be getting asphyxiated, said Mr. Fox, director of the perinatal resource group at the university.

The conventional method of assessing fetal heart rate-monitoring strips starts with drawing an arbitrary line that the clinician designates as the baseline heart rate, so that everything above it is considered accelerations and everything below it is thought to be decelerations. “I would argue that [the conventional method] is fraught with peril” because it employs the wrong interpretive construct and the wrong cues, he said.

Clinicians get into trouble by focusing too much on various methods to measure the height of the variability complexes on the fetal heart rate-monitoring strip. “It's not just the height of the variability complexes that are important, but the way they look,” he added.

A jagged and unpredictable pattern on the heart rate-monitoring strip is good: It's a visual representation of an intact neurologic pathway in the fetus. A progressively smooth, round, blunted and flat pattern is bad: This is a pattern that every baby who dies of asphyxia develops, even if the height of the heart rate oscillations meets previous definitions for moderate variability. A common mistake is to consider smooth, round, blunted oscillations to be moderate variability if they have enough height in the pattern.

Because heart rate accelerations usually occur in association with moderate variability, they are typically jagged and unpredictable in both appearance and timing. Rarely are accelerations regular, rhythmic, or occurring with each contraction.

Recurrent decelerations that get deeper and deeper as labor progresses are no cause for immediate delivery, so long as moderate variability remains present. “These are tracings that we traditionally called nonreassuring,” yet 98% of fetuses with this pattern will be free of asphyxia and 99% will have no morbidities, he noted.

That doesn't mean clinicians needn't be alert. If you see recurrent decelerations in the presence of moderate variability, then be sure a physician or nurse-midwife is managing the patient at the bedside, prepare the patient for delivery, and notify the rest of the obstetric and neonatal team. “Once you have the capacity to rescue this fetus, these are tracings that can continue to be observed,” he said.

The timing of decelerations in relation to uterine activity may tell the clinician something about the underlying physiology “but it does not tell you what to do in most circumstances,” Mr. Fox added. “Variability always trumps timing.”

He teaches a four-step process of evaluating a fetal heart rate strip. First, ask if variability is absent, minimal, moderate, or marked. Second, look for decelerations. Third, consider the baseline fetal heart rate. Finally, sum up the evolution of the tracing. Babies with asphyxia don't regain variability; they continue to lose it over time in association with deeper decelerations.

Video Teaches Pattern Recognition

A free video that teaches recognition of variability and other signs of fetal health on heart rate-monitoring tracings is available to clinicians who “commit to interdisciplinary education”—meaning it will be used to train doctors, nurses, midwives, and anyone else involved in monitoring fetal heart rates, Mr. Fox said.

Funded by Kaiser Permanente, the video “Situational Awareness in Fetal Heart Rate Monitoring” features four 27-minute segments with cases and tracings presented by Mr. Fox, Dr. Julian (“Bill”) Parer, professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, and other faculty members.

A small shipping and handling fee is charged for each order. Mr. Fox is the distributor. To request a copy, contact him at

[email protected]

SAN FRANCISCO — The first and most important thing to look for in a fetal heart rate pattern is variability, Michael D. Fox, R.N., said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

Pattern recognition is the key. Is the heart rate pattern jagged and unpredictable? That's a sign of moderate variability, which nearly guarantees that the fetus is sufficiently oxygenated. Is the pattern smooth, round, blunted, and flat? That loss of variability, when combined with recurrent heart rate decelerations, flags a baby who may be getting asphyxiated, said Mr. Fox, director of the perinatal resource group at the university.

The conventional method of assessing fetal heart rate-monitoring strips starts with drawing an arbitrary line that the clinician designates as the baseline heart rate, so that everything above it is considered accelerations and everything below it is thought to be decelerations. “I would argue that [the conventional method] is fraught with peril” because it employs the wrong interpretive construct and the wrong cues, he said.

Clinicians get into trouble by focusing too much on various methods to measure the height of the variability complexes on the fetal heart rate-monitoring strip. “It's not just the height of the variability complexes that are important, but the way they look,” he added.

A jagged and unpredictable pattern on the heart rate-monitoring strip is good: It's a visual representation of an intact neurologic pathway in the fetus. A progressively smooth, round, blunted and flat pattern is bad: This is a pattern that every baby who dies of asphyxia develops, even if the height of the heart rate oscillations meets previous definitions for moderate variability. A common mistake is to consider smooth, round, blunted oscillations to be moderate variability if they have enough height in the pattern.

Because heart rate accelerations usually occur in association with moderate variability, they are typically jagged and unpredictable in both appearance and timing. Rarely are accelerations regular, rhythmic, or occurring with each contraction.

Recurrent decelerations that get deeper and deeper as labor progresses are no cause for immediate delivery, so long as moderate variability remains present. “These are tracings that we traditionally called nonreassuring,” yet 98% of fetuses with this pattern will be free of asphyxia and 99% will have no morbidities, he noted.

That doesn't mean clinicians needn't be alert. If you see recurrent decelerations in the presence of moderate variability, then be sure a physician or nurse-midwife is managing the patient at the bedside, prepare the patient for delivery, and notify the rest of the obstetric and neonatal team. “Once you have the capacity to rescue this fetus, these are tracings that can continue to be observed,” he said.

The timing of decelerations in relation to uterine activity may tell the clinician something about the underlying physiology “but it does not tell you what to do in most circumstances,” Mr. Fox added. “Variability always trumps timing.”

He teaches a four-step process of evaluating a fetal heart rate strip. First, ask if variability is absent, minimal, moderate, or marked. Second, look for decelerations. Third, consider the baseline fetal heart rate. Finally, sum up the evolution of the tracing. Babies with asphyxia don't regain variability; they continue to lose it over time in association with deeper decelerations.

Video Teaches Pattern Recognition

A free video that teaches recognition of variability and other signs of fetal health on heart rate-monitoring tracings is available to clinicians who “commit to interdisciplinary education”—meaning it will be used to train doctors, nurses, midwives, and anyone else involved in monitoring fetal heart rates, Mr. Fox said.

Funded by Kaiser Permanente, the video “Situational Awareness in Fetal Heart Rate Monitoring” features four 27-minute segments with cases and tracings presented by Mr. Fox, Dr. Julian (“Bill”) Parer, professor of obstetrics, gynecology, and reproductive sciences at the University of California, San Francisco, and other faculty members.

A small shipping and handling fee is charged for each order. Mr. Fox is the distributor. To request a copy, contact him at

[email protected]

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Prenatal Alcohol Exposure Tied to Conduct Problems

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Prenatal Alcohol Exposure Tied to Conduct Problems

Prenatal alcohol exposure appears to cause later conduct problems in childhood, reported Dr. Brian M. D'Onofrio of Indiana University, Bloomington, and his associates.

In contrast, the later attention and impulsivity problems seen in children who were exposed to alcohol in utero appear to be caused by other factors correlated with maternal drinking rather than to the alcohol exposure itself, the researchers said.

Dr. D'Onofrio and his associates used data from a large longitudinal study of adolescents and young adults to examine the relation between drinking in young women and behavior in their offspring. The survey, funded by the U. S. Bureau of Labor Statistics, covered a racially diverse sample of over 6,000 subjects assessed annually from 1979 through 1994 and then biannually since then (Arch. Gen. Psychiatry 2007;64:1296–304).

Dr. D'Onofrio and his associates analyzed data on a subsample of 4,912 young female subjects who had at least one child aged 4–11 years by the 2004 assessment. The women had furnished information on their substance use both before they had become pregnant and during their pregnancies. They then reported on their children's conduct problems and attention/impulsivity problems using the Behavior Problem Index.

Prenatal exposure strongly correlated with conduct problems, and children with exposure to higher levels of alcohol had more such problems than those exposed to less alcohol. Compared with children who were not exposed to alcohol in utero, those who were exposed to alcohol every day had an increase of 0.35 standard deviations in conduct problems.

This link persisted after the data were adjusted to account for potentially confounding factors such as prenatal exposure to nicotine and other drugs, maternal traits, and genetic and environmental factors. It also persisted in comparisons with siblings and cousins, and in a number of statistical models.

“The results of all models are consistent with a causal association between prenatal alcohol exposure and offspring conduct problems,” the authors said. In contrast, prenatal alcohol exposure did not appear to be causally related to attention/impulsivity problems, although these problems were highly prevalent in exposed children.

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Prenatal alcohol exposure appears to cause later conduct problems in childhood, reported Dr. Brian M. D'Onofrio of Indiana University, Bloomington, and his associates.

In contrast, the later attention and impulsivity problems seen in children who were exposed to alcohol in utero appear to be caused by other factors correlated with maternal drinking rather than to the alcohol exposure itself, the researchers said.

Dr. D'Onofrio and his associates used data from a large longitudinal study of adolescents and young adults to examine the relation between drinking in young women and behavior in their offspring. The survey, funded by the U. S. Bureau of Labor Statistics, covered a racially diverse sample of over 6,000 subjects assessed annually from 1979 through 1994 and then biannually since then (Arch. Gen. Psychiatry 2007;64:1296–304).

Dr. D'Onofrio and his associates analyzed data on a subsample of 4,912 young female subjects who had at least one child aged 4–11 years by the 2004 assessment. The women had furnished information on their substance use both before they had become pregnant and during their pregnancies. They then reported on their children's conduct problems and attention/impulsivity problems using the Behavior Problem Index.

Prenatal exposure strongly correlated with conduct problems, and children with exposure to higher levels of alcohol had more such problems than those exposed to less alcohol. Compared with children who were not exposed to alcohol in utero, those who were exposed to alcohol every day had an increase of 0.35 standard deviations in conduct problems.

This link persisted after the data were adjusted to account for potentially confounding factors such as prenatal exposure to nicotine and other drugs, maternal traits, and genetic and environmental factors. It also persisted in comparisons with siblings and cousins, and in a number of statistical models.

“The results of all models are consistent with a causal association between prenatal alcohol exposure and offspring conduct problems,” the authors said. In contrast, prenatal alcohol exposure did not appear to be causally related to attention/impulsivity problems, although these problems were highly prevalent in exposed children.

Prenatal alcohol exposure appears to cause later conduct problems in childhood, reported Dr. Brian M. D'Onofrio of Indiana University, Bloomington, and his associates.

In contrast, the later attention and impulsivity problems seen in children who were exposed to alcohol in utero appear to be caused by other factors correlated with maternal drinking rather than to the alcohol exposure itself, the researchers said.

Dr. D'Onofrio and his associates used data from a large longitudinal study of adolescents and young adults to examine the relation between drinking in young women and behavior in their offspring. The survey, funded by the U. S. Bureau of Labor Statistics, covered a racially diverse sample of over 6,000 subjects assessed annually from 1979 through 1994 and then biannually since then (Arch. Gen. Psychiatry 2007;64:1296–304).

Dr. D'Onofrio and his associates analyzed data on a subsample of 4,912 young female subjects who had at least one child aged 4–11 years by the 2004 assessment. The women had furnished information on their substance use both before they had become pregnant and during their pregnancies. They then reported on their children's conduct problems and attention/impulsivity problems using the Behavior Problem Index.

Prenatal exposure strongly correlated with conduct problems, and children with exposure to higher levels of alcohol had more such problems than those exposed to less alcohol. Compared with children who were not exposed to alcohol in utero, those who were exposed to alcohol every day had an increase of 0.35 standard deviations in conduct problems.

This link persisted after the data were adjusted to account for potentially confounding factors such as prenatal exposure to nicotine and other drugs, maternal traits, and genetic and environmental factors. It also persisted in comparisons with siblings and cousins, and in a number of statistical models.

“The results of all models are consistent with a causal association between prenatal alcohol exposure and offspring conduct problems,” the authors said. In contrast, prenatal alcohol exposure did not appear to be causally related to attention/impulsivity problems, although these problems were highly prevalent in exposed children.

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