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Pregnancy in Former Breast Ca Patient 'High Risk'
SAN ANTONIO — Pregnancies in women with a history of breast cancer should be considered high risk on the basis of their increased rates of preterm birth, cesarean section, and congenital malformations, Dr. Kristina Dalberg said at a breast cancer symposium sponsored by the Cancer Therapy and Research Center.
One-fifth of women with breast cancer are diagnosed before age 50, and the incidence is increasing. So data on the reproductive impact of the malignancy and its adjuvant therapies are increasingly important, noted Dr. Dalberg of Uppsala (Sweden) University Hospital.
She and her coworkers conducted a Swedish national population-based cohort study in which they cross-checked the 2,870,932 singleton births entered into the Swedish Birth Registry during 1973–2002 against enrollees in the Swedish Cancer Registry database. In this way they identified 331 first births following treatment for invasive breast cancer. The mean time between breast cancer surgery and pregnancy was 37 months.
The former breast cancer patients were significantly older: a mean age of 34 years, compared with 27 years for pregnant women without such a history. Multiple logistic regression analysis adjusted for maternal age, parity, and year of delivery demonstrated that former breast cancer patients had a 3.2-fold increased risk of preterm delivery before 32 weeks, a 2.9-fold increased risk of low birth weight less than 1,500 g, and a 1.3-fold increased rate of C-section, compared with mothers without a history of breast cancer (see chart).
Moreover, women with a history of breast cancer who gave birth during 1988–2002 had a 2.1-fold greater risk of having a baby with congenital malformations than did matched controls. During 1973–1987, when the use of adjuvant chemotherapy in younger breast cancer patients was less common, there was a nonsignificant 1.3-fold increased risk.
There was no increase in stillbirths among women with prior breast cancer.
Dr. Dalberg said she and her coinvestigators had hypothesized wrongly that there would be no increased risk of adverse birth outcomes in Swedish women previously treated for breast cancer. This expectation was based in part on a reassuring recent Danish cohort study that showed no increase in preterm birth, low birth weight, congenital malformations, or stillbirth in 216 Danes with previously treated breast cancer (Br. J. Cancer 2006;94:142–6).
The discrepancy might be the result of different ways of classifying outcomes in the two national registries or differences in the use of adjuvant therapies. Additional studies in other countries are needed to resolve the discrepancy. Nonetheless, Dr. Dalberg continued, patients can be reassured that the great majority of births in women previously treated for breast cancer are uncomplicated.
ELSEVIER GLOBAL MEDICAL NEWS
SAN ANTONIO — Pregnancies in women with a history of breast cancer should be considered high risk on the basis of their increased rates of preterm birth, cesarean section, and congenital malformations, Dr. Kristina Dalberg said at a breast cancer symposium sponsored by the Cancer Therapy and Research Center.
One-fifth of women with breast cancer are diagnosed before age 50, and the incidence is increasing. So data on the reproductive impact of the malignancy and its adjuvant therapies are increasingly important, noted Dr. Dalberg of Uppsala (Sweden) University Hospital.
She and her coworkers conducted a Swedish national population-based cohort study in which they cross-checked the 2,870,932 singleton births entered into the Swedish Birth Registry during 1973–2002 against enrollees in the Swedish Cancer Registry database. In this way they identified 331 first births following treatment for invasive breast cancer. The mean time between breast cancer surgery and pregnancy was 37 months.
The former breast cancer patients were significantly older: a mean age of 34 years, compared with 27 years for pregnant women without such a history. Multiple logistic regression analysis adjusted for maternal age, parity, and year of delivery demonstrated that former breast cancer patients had a 3.2-fold increased risk of preterm delivery before 32 weeks, a 2.9-fold increased risk of low birth weight less than 1,500 g, and a 1.3-fold increased rate of C-section, compared with mothers without a history of breast cancer (see chart).
Moreover, women with a history of breast cancer who gave birth during 1988–2002 had a 2.1-fold greater risk of having a baby with congenital malformations than did matched controls. During 1973–1987, when the use of adjuvant chemotherapy in younger breast cancer patients was less common, there was a nonsignificant 1.3-fold increased risk.
There was no increase in stillbirths among women with prior breast cancer.
Dr. Dalberg said she and her coinvestigators had hypothesized wrongly that there would be no increased risk of adverse birth outcomes in Swedish women previously treated for breast cancer. This expectation was based in part on a reassuring recent Danish cohort study that showed no increase in preterm birth, low birth weight, congenital malformations, or stillbirth in 216 Danes with previously treated breast cancer (Br. J. Cancer 2006;94:142–6).
The discrepancy might be the result of different ways of classifying outcomes in the two national registries or differences in the use of adjuvant therapies. Additional studies in other countries are needed to resolve the discrepancy. Nonetheless, Dr. Dalberg continued, patients can be reassured that the great majority of births in women previously treated for breast cancer are uncomplicated.
ELSEVIER GLOBAL MEDICAL NEWS
SAN ANTONIO — Pregnancies in women with a history of breast cancer should be considered high risk on the basis of their increased rates of preterm birth, cesarean section, and congenital malformations, Dr. Kristina Dalberg said at a breast cancer symposium sponsored by the Cancer Therapy and Research Center.
One-fifth of women with breast cancer are diagnosed before age 50, and the incidence is increasing. So data on the reproductive impact of the malignancy and its adjuvant therapies are increasingly important, noted Dr. Dalberg of Uppsala (Sweden) University Hospital.
She and her coworkers conducted a Swedish national population-based cohort study in which they cross-checked the 2,870,932 singleton births entered into the Swedish Birth Registry during 1973–2002 against enrollees in the Swedish Cancer Registry database. In this way they identified 331 first births following treatment for invasive breast cancer. The mean time between breast cancer surgery and pregnancy was 37 months.
The former breast cancer patients were significantly older: a mean age of 34 years, compared with 27 years for pregnant women without such a history. Multiple logistic regression analysis adjusted for maternal age, parity, and year of delivery demonstrated that former breast cancer patients had a 3.2-fold increased risk of preterm delivery before 32 weeks, a 2.9-fold increased risk of low birth weight less than 1,500 g, and a 1.3-fold increased rate of C-section, compared with mothers without a history of breast cancer (see chart).
Moreover, women with a history of breast cancer who gave birth during 1988–2002 had a 2.1-fold greater risk of having a baby with congenital malformations than did matched controls. During 1973–1987, when the use of adjuvant chemotherapy in younger breast cancer patients was less common, there was a nonsignificant 1.3-fold increased risk.
There was no increase in stillbirths among women with prior breast cancer.
Dr. Dalberg said she and her coinvestigators had hypothesized wrongly that there would be no increased risk of adverse birth outcomes in Swedish women previously treated for breast cancer. This expectation was based in part on a reassuring recent Danish cohort study that showed no increase in preterm birth, low birth weight, congenital malformations, or stillbirth in 216 Danes with previously treated breast cancer (Br. J. Cancer 2006;94:142–6).
The discrepancy might be the result of different ways of classifying outcomes in the two national registries or differences in the use of adjuvant therapies. Additional studies in other countries are needed to resolve the discrepancy. Nonetheless, Dr. Dalberg continued, patients can be reassured that the great majority of births in women previously treated for breast cancer are uncomplicated.
ELSEVIER GLOBAL MEDICAL NEWS
Uterine Myomas in Pregnancy Increase Risk of Complications
LAS VEGAS — Uterine myomas that are present during pregnancy are significantly associated with pregnancy complications, including first- and second-trimester miscarriage, malpresentation of the baby at delivery, and preterm labor, Dr. Radwan Assad reported at the annual meeting of the American Association of Gynecologic Laparoscopists.
In addition, “a cesarean delivery in the presence of a low anterior myoma is associated with a high incidence of postpartum hemorrhage,” said Dr. Assad of Wayne State University, Detroit.
Findings from previous studies have linked uterine myomas to pregnancy complications including preterm labor, placental abruption, and postpartum hemorrhage.
To further study the effect of uterine myomas on pregnancy complications, Dr. Assad and colleagues reviewed data from 155 women who were diagnosed with myomas during pregnancy. Overall, 45% of the women had vaginal deliveries and 55% cesarean deliveries.
Malpresentation at delivery (the most common complication) occurred in 22% of the patients. Of these cases, 16.8% were breech, 3.9% were transverse, and 1.3% were oblique. Other complications included growth restriction (17.4%), preterm labor (17.4%), and premature rupture of membranes (16.1%). In addition, 7.7% of the women had first-trimester miscarriages and 5.8% had second-trimester miscarriages.
Overall, the risk of postpartum hemorrhage was 27.3% among women who had cesarean deliveries, compared with only 2.6% among women who had vaginal deliveries. Notably, a low-lying anterior fibroid was associated with an eightfold risk of postpartum hemorrhage among women who had cesarean deliveries, Dr. Assad noted.
“But there was no correlation between the number of fibroids and the risk of postpartum hemorrhage,” he said.
Early postpartum hemorrhage was defined as an estimated blood loss of more than 500 cc during a vaginal delivery and more than 1,000 cc during a cesarean delivery.
Myomectomies (which have been shown to reduce the risk of miscarriage in women with fibroids) were performed in 9% of the women who had cesarean deliveries, and the myomectomies were not associated with an increased risk of postpartum hemorrhage in these patients, Dr. Assad said.
LAS VEGAS — Uterine myomas that are present during pregnancy are significantly associated with pregnancy complications, including first- and second-trimester miscarriage, malpresentation of the baby at delivery, and preterm labor, Dr. Radwan Assad reported at the annual meeting of the American Association of Gynecologic Laparoscopists.
In addition, “a cesarean delivery in the presence of a low anterior myoma is associated with a high incidence of postpartum hemorrhage,” said Dr. Assad of Wayne State University, Detroit.
Findings from previous studies have linked uterine myomas to pregnancy complications including preterm labor, placental abruption, and postpartum hemorrhage.
To further study the effect of uterine myomas on pregnancy complications, Dr. Assad and colleagues reviewed data from 155 women who were diagnosed with myomas during pregnancy. Overall, 45% of the women had vaginal deliveries and 55% cesarean deliveries.
Malpresentation at delivery (the most common complication) occurred in 22% of the patients. Of these cases, 16.8% were breech, 3.9% were transverse, and 1.3% were oblique. Other complications included growth restriction (17.4%), preterm labor (17.4%), and premature rupture of membranes (16.1%). In addition, 7.7% of the women had first-trimester miscarriages and 5.8% had second-trimester miscarriages.
Overall, the risk of postpartum hemorrhage was 27.3% among women who had cesarean deliveries, compared with only 2.6% among women who had vaginal deliveries. Notably, a low-lying anterior fibroid was associated with an eightfold risk of postpartum hemorrhage among women who had cesarean deliveries, Dr. Assad noted.
“But there was no correlation between the number of fibroids and the risk of postpartum hemorrhage,” he said.
Early postpartum hemorrhage was defined as an estimated blood loss of more than 500 cc during a vaginal delivery and more than 1,000 cc during a cesarean delivery.
Myomectomies (which have been shown to reduce the risk of miscarriage in women with fibroids) were performed in 9% of the women who had cesarean deliveries, and the myomectomies were not associated with an increased risk of postpartum hemorrhage in these patients, Dr. Assad said.
LAS VEGAS — Uterine myomas that are present during pregnancy are significantly associated with pregnancy complications, including first- and second-trimester miscarriage, malpresentation of the baby at delivery, and preterm labor, Dr. Radwan Assad reported at the annual meeting of the American Association of Gynecologic Laparoscopists.
In addition, “a cesarean delivery in the presence of a low anterior myoma is associated with a high incidence of postpartum hemorrhage,” said Dr. Assad of Wayne State University, Detroit.
Findings from previous studies have linked uterine myomas to pregnancy complications including preterm labor, placental abruption, and postpartum hemorrhage.
To further study the effect of uterine myomas on pregnancy complications, Dr. Assad and colleagues reviewed data from 155 women who were diagnosed with myomas during pregnancy. Overall, 45% of the women had vaginal deliveries and 55% cesarean deliveries.
Malpresentation at delivery (the most common complication) occurred in 22% of the patients. Of these cases, 16.8% were breech, 3.9% were transverse, and 1.3% were oblique. Other complications included growth restriction (17.4%), preterm labor (17.4%), and premature rupture of membranes (16.1%). In addition, 7.7% of the women had first-trimester miscarriages and 5.8% had second-trimester miscarriages.
Overall, the risk of postpartum hemorrhage was 27.3% among women who had cesarean deliveries, compared with only 2.6% among women who had vaginal deliveries. Notably, a low-lying anterior fibroid was associated with an eightfold risk of postpartum hemorrhage among women who had cesarean deliveries, Dr. Assad noted.
“But there was no correlation between the number of fibroids and the risk of postpartum hemorrhage,” he said.
Early postpartum hemorrhage was defined as an estimated blood loss of more than 500 cc during a vaginal delivery and more than 1,000 cc during a cesarean delivery.
Myomectomies (which have been shown to reduce the risk of miscarriage in women with fibroids) were performed in 9% of the women who had cesarean deliveries, and the myomectomies were not associated with an increased risk of postpartum hemorrhage in these patients, Dr. Assad said.
Fish Oil Supplements May Benefit Infants' Eye-Hand Coordination
High doses of fish oil supplements in pregnant women improved eye and hand coordination in their babies at age 21/2 years, according to a randomized controlled trial published Dec. 21.
Researchers said their trial (Arch. Dis. Child. Fetal Neonatal Ed. 2006 Dec. 21 [Epub doi 10.1136/adc.2006.099085)] is the first to show improvements in eye-hand coordination with fish oil supplements, and said the results suggest that research into the beneficial effects of fish oil supplementation during pregnancy may require higher dosages.
“These preliminary data indicate that supplementation with a relatively high-dose fish oil during the last 20 weeks of pregnancy is not only safe but also seems to have potential beneficial effects that need to be explored further,” wrote the researchers, led by Jan Dunstan, research fellow with the University of Western Australia's school of pediatrics and child health. “Given the scarcity of data to support the efficacy of fish oil supplementation during pregnancy, our data have a potentially important role in informing on the effects of fish oil supplementation on early postnatal infant development.”
The researchers randomized 52 pregnant women into a group supplementing their diets with 2.2 g of docosahexaenoic acid (DHA) and 1.1 g eicosapentaenoic acid (EPA) per day. A control group of 46 received olive oil supplements. Women were excluded from the study if their normal diet exceeded two meals of fish per week.
The researchers measured phospholipids in the red blood cells of the cord blood of the babies, and conducted tests measuring the babies' development at 21/2 years.
Of the 72 babies that made it to the follow-up at 21/2 years, all of the babies in the intervention group had significantly elevated DHA and EPA levels and significantly lower levels of arachidonic acid in their cord blood, compared with the control babies.
At 21/2 years (mean age of 34.7 months), researchers could not identify significantly higher scores for the 33 babies in the fish oil group in growth, development, receptive language, and behavior, except for the eye and hand subscale of the Griffiths Mental Development Scales. On the eye and hand subscale, the intervention group's mean score was 114, compared with 108 for the control group.
“Although the underlying mechanism is not understood, DHA is known to facilitate rapid phototransduction in the retinal membrane, and deficiencies are associated with reduced retinal function in infant primates,” the researchers write. “Furthermore, effects on visual evoked potential could indicate that DHA may also have an effect on the development of the visual cortex.”
The researchers said the small size of their sample is a weakness of the study. Although theirs could be a chance finding, they said they found no adverse effects of fish oil supplementation in any of the measures of development.
High doses of fish oil supplements in pregnant women improved eye and hand coordination in their babies at age 21/2 years, according to a randomized controlled trial published Dec. 21.
Researchers said their trial (Arch. Dis. Child. Fetal Neonatal Ed. 2006 Dec. 21 [Epub doi 10.1136/adc.2006.099085)] is the first to show improvements in eye-hand coordination with fish oil supplements, and said the results suggest that research into the beneficial effects of fish oil supplementation during pregnancy may require higher dosages.
“These preliminary data indicate that supplementation with a relatively high-dose fish oil during the last 20 weeks of pregnancy is not only safe but also seems to have potential beneficial effects that need to be explored further,” wrote the researchers, led by Jan Dunstan, research fellow with the University of Western Australia's school of pediatrics and child health. “Given the scarcity of data to support the efficacy of fish oil supplementation during pregnancy, our data have a potentially important role in informing on the effects of fish oil supplementation on early postnatal infant development.”
The researchers randomized 52 pregnant women into a group supplementing their diets with 2.2 g of docosahexaenoic acid (DHA) and 1.1 g eicosapentaenoic acid (EPA) per day. A control group of 46 received olive oil supplements. Women were excluded from the study if their normal diet exceeded two meals of fish per week.
The researchers measured phospholipids in the red blood cells of the cord blood of the babies, and conducted tests measuring the babies' development at 21/2 years.
Of the 72 babies that made it to the follow-up at 21/2 years, all of the babies in the intervention group had significantly elevated DHA and EPA levels and significantly lower levels of arachidonic acid in their cord blood, compared with the control babies.
At 21/2 years (mean age of 34.7 months), researchers could not identify significantly higher scores for the 33 babies in the fish oil group in growth, development, receptive language, and behavior, except for the eye and hand subscale of the Griffiths Mental Development Scales. On the eye and hand subscale, the intervention group's mean score was 114, compared with 108 for the control group.
“Although the underlying mechanism is not understood, DHA is known to facilitate rapid phototransduction in the retinal membrane, and deficiencies are associated with reduced retinal function in infant primates,” the researchers write. “Furthermore, effects on visual evoked potential could indicate that DHA may also have an effect on the development of the visual cortex.”
The researchers said the small size of their sample is a weakness of the study. Although theirs could be a chance finding, they said they found no adverse effects of fish oil supplementation in any of the measures of development.
High doses of fish oil supplements in pregnant women improved eye and hand coordination in their babies at age 21/2 years, according to a randomized controlled trial published Dec. 21.
Researchers said their trial (Arch. Dis. Child. Fetal Neonatal Ed. 2006 Dec. 21 [Epub doi 10.1136/adc.2006.099085)] is the first to show improvements in eye-hand coordination with fish oil supplements, and said the results suggest that research into the beneficial effects of fish oil supplementation during pregnancy may require higher dosages.
“These preliminary data indicate that supplementation with a relatively high-dose fish oil during the last 20 weeks of pregnancy is not only safe but also seems to have potential beneficial effects that need to be explored further,” wrote the researchers, led by Jan Dunstan, research fellow with the University of Western Australia's school of pediatrics and child health. “Given the scarcity of data to support the efficacy of fish oil supplementation during pregnancy, our data have a potentially important role in informing on the effects of fish oil supplementation on early postnatal infant development.”
The researchers randomized 52 pregnant women into a group supplementing their diets with 2.2 g of docosahexaenoic acid (DHA) and 1.1 g eicosapentaenoic acid (EPA) per day. A control group of 46 received olive oil supplements. Women were excluded from the study if their normal diet exceeded two meals of fish per week.
The researchers measured phospholipids in the red blood cells of the cord blood of the babies, and conducted tests measuring the babies' development at 21/2 years.
Of the 72 babies that made it to the follow-up at 21/2 years, all of the babies in the intervention group had significantly elevated DHA and EPA levels and significantly lower levels of arachidonic acid in their cord blood, compared with the control babies.
At 21/2 years (mean age of 34.7 months), researchers could not identify significantly higher scores for the 33 babies in the fish oil group in growth, development, receptive language, and behavior, except for the eye and hand subscale of the Griffiths Mental Development Scales. On the eye and hand subscale, the intervention group's mean score was 114, compared with 108 for the control group.
“Although the underlying mechanism is not understood, DHA is known to facilitate rapid phototransduction in the retinal membrane, and deficiencies are associated with reduced retinal function in infant primates,” the researchers write. “Furthermore, effects on visual evoked potential could indicate that DHA may also have an effect on the development of the visual cortex.”
The researchers said the small size of their sample is a weakness of the study. Although theirs could be a chance finding, they said they found no adverse effects of fish oil supplementation in any of the measures of development.
Induction at 41 Weeks May Avert Complications
RIVIERA MAYA, MEXICO — Routine induction of labor at 41 weeks is safe for women with low-risk singleton pregnancies and may decrease the risk of postterm pregnancy complications for both mother and baby, Dr. Errol Norwitz said at a meeting on obstetrics, gynecology, perinatal medicine, neonatology, and the law.
“This would affect 30% of low-risk deliveries and 10%–15% of all deliveries, so this is a big management shift,” said Dr. Norwitz, director of maternal-fetal medicine at Yale-New Haven Hospital, Conn. “It would definitely affect your practice.”
But such a change would be both cost effective and safer for mother and baby, he asserted. Recent data suggest that routine induction of labor in these women is safer than previously thought, with little or no impact on cesarean delivery rates, and that the risks of postterm birth are greater than previously thought.
Stillbirth is the greatest risk for the postterm fetus, with a fourfold increase at 43 weeks and a sevenfold increase by 44 weeks, compared with 40 weeks. Newer studies have identified other problems as well, including fetal macrosomia, meconium staining, “fetal distress,” and uteroplacental insufficiency. Neonatal encephalopathy is also a risk, with a 13-fold increase at 42 weeks, compared with 38 weeks.
But the mother is also at risk, Dr. Norwitz said. “This is an underappreciated problem. Shoulder dystocia is much more common, as is severe perineal injury, with third- and fourth-degree tears. There is also an increased risk of postpartum hemorrhage.”
In 1997, the American College of Obstetricians and Gynecologists recommended induction of labor after 43 weeks for low-risk pregnancies, but the current guidelines, issued in 2004, don't offer specific recommendations. This omission is possibly the result of concerns that labor induction is associated with an increase in the incidence of cesarean deliveries—an association that may never be conclusively proved or disproved, Dr. Norwitz said. “It would take a randomized controlled trial of 150,000 post-term pregnancies to really answer this question, and I don't think we're going to get that. We have to appreciate that the literature in this area is limited.”
The best source of data is a 2000 Cochrane Database review, which included 26 trials of various size and quality (Cochrane Database Syst. Rev. 2000;2:CD000170). Those of highest quality, Dr. Norwitz said, were two randomized controlled trials of 108 (1992) and 440 (1994) pregnancies, and a Canadian trial of almost 3,500 conducted in 1992. Both 1992 trials showed a significant decrease in cesarean rates among pregnancies induced at 41 weeks, while the 1984 study showed no significant difference in cesarean rates between the two groups. The review also concluded that routine induction of labor after 41 weeks appeared to reduce perinatal mortality.
“It appears that in multiparous women and nulliparas with a favorable cervical exam, routine induction at 41 weeks doesn't carry an increased risk of a C-section,” Dr. Norwitz said. “But in nullips with an unfavorable cervical exam, we might see the rate increase slightly. For these women, we must weigh the risk of preventing postterm complications to mom and baby with the risks of a cesarean delivery.”
Dr. Norwitz offered an algorithm for managing post-term, low-risk, singleton pregnancies:
About 50% of all pregnancies reach the 40th week. At this time, discuss the option of induction and check the cervix, but do not institute fetal surveillance. About half of the group will deliver spontaneously within the next week. For the remaining patients, offer either induction of labor or expectant management at 41 weeks.
For the women who elect continued expectant management, discuss the risks of continuing the pregnancy beyond 41 weeks and document the discussion. Institute some method of fetal surveillance to assess the baby's condition. “No single test has ever been shown to be better than another, with the exception of Doppler velocimetry alone—that has not been shown to be adequately sensitive” Dr. Norwitz said. “Most of us do twice weekly fetal testing, and one of those assessments should include an estimation of amniotic fluid volume.”
Most of these women will give birth by 42 weeks, leaving only 3%–4% of pregnancies to continue into the 43rd week. At this time, induction of labor should routinely be recommended because the increased risk of stillbirth is significant, he said.
Most women who choose induction at 41 weeks will deliver successfully, but some inductions will fail. Those women can be admitted for rupture of membranes and oxytocin, or sent home and brought back for a repeat induction in 2–3 days if the fetal testing is reassuring, Dr. Norwitz said.
RIVIERA MAYA, MEXICO — Routine induction of labor at 41 weeks is safe for women with low-risk singleton pregnancies and may decrease the risk of postterm pregnancy complications for both mother and baby, Dr. Errol Norwitz said at a meeting on obstetrics, gynecology, perinatal medicine, neonatology, and the law.
“This would affect 30% of low-risk deliveries and 10%–15% of all deliveries, so this is a big management shift,” said Dr. Norwitz, director of maternal-fetal medicine at Yale-New Haven Hospital, Conn. “It would definitely affect your practice.”
But such a change would be both cost effective and safer for mother and baby, he asserted. Recent data suggest that routine induction of labor in these women is safer than previously thought, with little or no impact on cesarean delivery rates, and that the risks of postterm birth are greater than previously thought.
Stillbirth is the greatest risk for the postterm fetus, with a fourfold increase at 43 weeks and a sevenfold increase by 44 weeks, compared with 40 weeks. Newer studies have identified other problems as well, including fetal macrosomia, meconium staining, “fetal distress,” and uteroplacental insufficiency. Neonatal encephalopathy is also a risk, with a 13-fold increase at 42 weeks, compared with 38 weeks.
But the mother is also at risk, Dr. Norwitz said. “This is an underappreciated problem. Shoulder dystocia is much more common, as is severe perineal injury, with third- and fourth-degree tears. There is also an increased risk of postpartum hemorrhage.”
In 1997, the American College of Obstetricians and Gynecologists recommended induction of labor after 43 weeks for low-risk pregnancies, but the current guidelines, issued in 2004, don't offer specific recommendations. This omission is possibly the result of concerns that labor induction is associated with an increase in the incidence of cesarean deliveries—an association that may never be conclusively proved or disproved, Dr. Norwitz said. “It would take a randomized controlled trial of 150,000 post-term pregnancies to really answer this question, and I don't think we're going to get that. We have to appreciate that the literature in this area is limited.”
The best source of data is a 2000 Cochrane Database review, which included 26 trials of various size and quality (Cochrane Database Syst. Rev. 2000;2:CD000170). Those of highest quality, Dr. Norwitz said, were two randomized controlled trials of 108 (1992) and 440 (1994) pregnancies, and a Canadian trial of almost 3,500 conducted in 1992. Both 1992 trials showed a significant decrease in cesarean rates among pregnancies induced at 41 weeks, while the 1984 study showed no significant difference in cesarean rates between the two groups. The review also concluded that routine induction of labor after 41 weeks appeared to reduce perinatal mortality.
“It appears that in multiparous women and nulliparas with a favorable cervical exam, routine induction at 41 weeks doesn't carry an increased risk of a C-section,” Dr. Norwitz said. “But in nullips with an unfavorable cervical exam, we might see the rate increase slightly. For these women, we must weigh the risk of preventing postterm complications to mom and baby with the risks of a cesarean delivery.”
Dr. Norwitz offered an algorithm for managing post-term, low-risk, singleton pregnancies:
About 50% of all pregnancies reach the 40th week. At this time, discuss the option of induction and check the cervix, but do not institute fetal surveillance. About half of the group will deliver spontaneously within the next week. For the remaining patients, offer either induction of labor or expectant management at 41 weeks.
For the women who elect continued expectant management, discuss the risks of continuing the pregnancy beyond 41 weeks and document the discussion. Institute some method of fetal surveillance to assess the baby's condition. “No single test has ever been shown to be better than another, with the exception of Doppler velocimetry alone—that has not been shown to be adequately sensitive” Dr. Norwitz said. “Most of us do twice weekly fetal testing, and one of those assessments should include an estimation of amniotic fluid volume.”
Most of these women will give birth by 42 weeks, leaving only 3%–4% of pregnancies to continue into the 43rd week. At this time, induction of labor should routinely be recommended because the increased risk of stillbirth is significant, he said.
Most women who choose induction at 41 weeks will deliver successfully, but some inductions will fail. Those women can be admitted for rupture of membranes and oxytocin, or sent home and brought back for a repeat induction in 2–3 days if the fetal testing is reassuring, Dr. Norwitz said.
RIVIERA MAYA, MEXICO — Routine induction of labor at 41 weeks is safe for women with low-risk singleton pregnancies and may decrease the risk of postterm pregnancy complications for both mother and baby, Dr. Errol Norwitz said at a meeting on obstetrics, gynecology, perinatal medicine, neonatology, and the law.
“This would affect 30% of low-risk deliveries and 10%–15% of all deliveries, so this is a big management shift,” said Dr. Norwitz, director of maternal-fetal medicine at Yale-New Haven Hospital, Conn. “It would definitely affect your practice.”
But such a change would be both cost effective and safer for mother and baby, he asserted. Recent data suggest that routine induction of labor in these women is safer than previously thought, with little or no impact on cesarean delivery rates, and that the risks of postterm birth are greater than previously thought.
Stillbirth is the greatest risk for the postterm fetus, with a fourfold increase at 43 weeks and a sevenfold increase by 44 weeks, compared with 40 weeks. Newer studies have identified other problems as well, including fetal macrosomia, meconium staining, “fetal distress,” and uteroplacental insufficiency. Neonatal encephalopathy is also a risk, with a 13-fold increase at 42 weeks, compared with 38 weeks.
But the mother is also at risk, Dr. Norwitz said. “This is an underappreciated problem. Shoulder dystocia is much more common, as is severe perineal injury, with third- and fourth-degree tears. There is also an increased risk of postpartum hemorrhage.”
In 1997, the American College of Obstetricians and Gynecologists recommended induction of labor after 43 weeks for low-risk pregnancies, but the current guidelines, issued in 2004, don't offer specific recommendations. This omission is possibly the result of concerns that labor induction is associated with an increase in the incidence of cesarean deliveries—an association that may never be conclusively proved or disproved, Dr. Norwitz said. “It would take a randomized controlled trial of 150,000 post-term pregnancies to really answer this question, and I don't think we're going to get that. We have to appreciate that the literature in this area is limited.”
The best source of data is a 2000 Cochrane Database review, which included 26 trials of various size and quality (Cochrane Database Syst. Rev. 2000;2:CD000170). Those of highest quality, Dr. Norwitz said, were two randomized controlled trials of 108 (1992) and 440 (1994) pregnancies, and a Canadian trial of almost 3,500 conducted in 1992. Both 1992 trials showed a significant decrease in cesarean rates among pregnancies induced at 41 weeks, while the 1984 study showed no significant difference in cesarean rates between the two groups. The review also concluded that routine induction of labor after 41 weeks appeared to reduce perinatal mortality.
“It appears that in multiparous women and nulliparas with a favorable cervical exam, routine induction at 41 weeks doesn't carry an increased risk of a C-section,” Dr. Norwitz said. “But in nullips with an unfavorable cervical exam, we might see the rate increase slightly. For these women, we must weigh the risk of preventing postterm complications to mom and baby with the risks of a cesarean delivery.”
Dr. Norwitz offered an algorithm for managing post-term, low-risk, singleton pregnancies:
About 50% of all pregnancies reach the 40th week. At this time, discuss the option of induction and check the cervix, but do not institute fetal surveillance. About half of the group will deliver spontaneously within the next week. For the remaining patients, offer either induction of labor or expectant management at 41 weeks.
For the women who elect continued expectant management, discuss the risks of continuing the pregnancy beyond 41 weeks and document the discussion. Institute some method of fetal surveillance to assess the baby's condition. “No single test has ever been shown to be better than another, with the exception of Doppler velocimetry alone—that has not been shown to be adequately sensitive” Dr. Norwitz said. “Most of us do twice weekly fetal testing, and one of those assessments should include an estimation of amniotic fluid volume.”
Most of these women will give birth by 42 weeks, leaving only 3%–4% of pregnancies to continue into the 43rd week. At this time, induction of labor should routinely be recommended because the increased risk of stillbirth is significant, he said.
Most women who choose induction at 41 weeks will deliver successfully, but some inductions will fail. Those women can be admitted for rupture of membranes and oxytocin, or sent home and brought back for a repeat induction in 2–3 days if the fetal testing is reassuring, Dr. Norwitz said.
Screen for Postpartum Depression Before Delivery, Expert Advises
SAN FRANCISCO — Screen pregnant women to identify those who are at increased risk for postpartum depression, and plan home visits by a nurse with the at-risk group 10–14 days after delivery, Dr. Andrea J. Singer said at the Perspectives in Women's Health conference sponsored by OB.GYN. NEWS.
“Don't wait for the 6-week postpartum visit” in this at-risk group, advised Dr. Singer, director of women's primary care at Georgetown University Medical Center, Washington.
Approximately one in every eight pregnant women will develop postpartum depression, which generally appears within 3–4 months after delivery and affects roughly 560,000 U.S. women per year. Check a patient's history for clues to postpartum depression risk, she said.
Half of pregnant women with a history of postpartum depression will develop it again, she noted. Consider prophylactic therapy in this group, starting at the end of the third trimester or immediately following delivery.
One-third of women with major depression during pregnancy develop postpartum depression, as do one-fourth of women with a history of major depression before pregnancy.
Stressful events during pregnancy or the postpartum period, a history of mood disorder in a first-degree relative, or conflicts with the baby's father or the woman's primary partner increase risk for postpartum depression. Women with shorter time intervals between pregnancies (who have other young children at home) or who deliver low-birth-weight infants or infants with frequent health problems also are at higher risk.
At the least, ask each mother to complete the Edinburgh Postnatal Depression Scale at the first postpartum visit, she urged. Any woman whose total score is greater than 10 or who indicates that “the thought of harming myself has occurred to me” on the questionnaire is likely to be depressed and needs an assessment.
Dr. Singer is on the speakers' bureau of Pfizer, which makes the antidepressant drug sertraline.
SAN FRANCISCO — Screen pregnant women to identify those who are at increased risk for postpartum depression, and plan home visits by a nurse with the at-risk group 10–14 days after delivery, Dr. Andrea J. Singer said at the Perspectives in Women's Health conference sponsored by OB.GYN. NEWS.
“Don't wait for the 6-week postpartum visit” in this at-risk group, advised Dr. Singer, director of women's primary care at Georgetown University Medical Center, Washington.
Approximately one in every eight pregnant women will develop postpartum depression, which generally appears within 3–4 months after delivery and affects roughly 560,000 U.S. women per year. Check a patient's history for clues to postpartum depression risk, she said.
Half of pregnant women with a history of postpartum depression will develop it again, she noted. Consider prophylactic therapy in this group, starting at the end of the third trimester or immediately following delivery.
One-third of women with major depression during pregnancy develop postpartum depression, as do one-fourth of women with a history of major depression before pregnancy.
Stressful events during pregnancy or the postpartum period, a history of mood disorder in a first-degree relative, or conflicts with the baby's father or the woman's primary partner increase risk for postpartum depression. Women with shorter time intervals between pregnancies (who have other young children at home) or who deliver low-birth-weight infants or infants with frequent health problems also are at higher risk.
At the least, ask each mother to complete the Edinburgh Postnatal Depression Scale at the first postpartum visit, she urged. Any woman whose total score is greater than 10 or who indicates that “the thought of harming myself has occurred to me” on the questionnaire is likely to be depressed and needs an assessment.
Dr. Singer is on the speakers' bureau of Pfizer, which makes the antidepressant drug sertraline.
SAN FRANCISCO — Screen pregnant women to identify those who are at increased risk for postpartum depression, and plan home visits by a nurse with the at-risk group 10–14 days after delivery, Dr. Andrea J. Singer said at the Perspectives in Women's Health conference sponsored by OB.GYN. NEWS.
“Don't wait for the 6-week postpartum visit” in this at-risk group, advised Dr. Singer, director of women's primary care at Georgetown University Medical Center, Washington.
Approximately one in every eight pregnant women will develop postpartum depression, which generally appears within 3–4 months after delivery and affects roughly 560,000 U.S. women per year. Check a patient's history for clues to postpartum depression risk, she said.
Half of pregnant women with a history of postpartum depression will develop it again, she noted. Consider prophylactic therapy in this group, starting at the end of the third trimester or immediately following delivery.
One-third of women with major depression during pregnancy develop postpartum depression, as do one-fourth of women with a history of major depression before pregnancy.
Stressful events during pregnancy or the postpartum period, a history of mood disorder in a first-degree relative, or conflicts with the baby's father or the woman's primary partner increase risk for postpartum depression. Women with shorter time intervals between pregnancies (who have other young children at home) or who deliver low-birth-weight infants or infants with frequent health problems also are at higher risk.
At the least, ask each mother to complete the Edinburgh Postnatal Depression Scale at the first postpartum visit, she urged. Any woman whose total score is greater than 10 or who indicates that “the thought of harming myself has occurred to me” on the questionnaire is likely to be depressed and needs an assessment.
Dr. Singer is on the speakers' bureau of Pfizer, which makes the antidepressant drug sertraline.
Risk-Benefit Favorable for Breast-Feeding on SSRIs
SAN FRANCISCO — All psychotropic medications are excreted into breast milk, but the benefits of breast-feeding generally outweigh the relatively small risks to the baby from antidepressants, Dr. Andrea J. Singer said.
The nutritional advantages and the bonding that occurs between mother and child during breast-feeding outweigh concerns about antidepressant effects on the infant, she said at the Perspectives in Women's Health conference sponsored by OB.GYN. NEWS.
The dose of antidepressant that the infant receives from the mother during breast-feeding is much lower than the dose received in utero because the drug crosses the placenta. If a mother and fetus have done well on an antidepressant during pregnancy, stick with that therapy after delivery. “The decision is easy—just continue,” said Dr. Singer, director of women's primary care at Georgetown University Medical Center, Washington.
SSRIs are first-line therapy for lactating women with depression because they have the most data supporting safe use during breast-feeding and efficacy in treating postpartum depression.
The aminoketone drug bupropion is a “not unreasonable alternative,” but the amount of data on it is far more limited, she said.
Combining an SSRI with other supportive services is recommended for severe postpartum depression. There is no consensus for treatment of mild postpartum depression, Dr. Singer added. Consider psychotherapy either alone or with an SSRI for mild depression in lactating women.
Dr. Singer is on the speakers' bureau of Pfizer, which makes the SSRI sertraline.
Generally, sertraline is the treatment of choice for depressed lactating women because of the amount of data available on its use. The SSRIs paroxetine or fluvoxamine are first-line alternatives. Second-line treatment choices include citalopram and fluoxetine. Start with monotherapy when possible, she advised.
The long-term impact of trace levels of antidepressants in infants is unknown. Most SSRIs and bupropion are rated Pregnancy Category C by the Food and Drug Administration. Tricyclic antidepressants fall in Category C or D.
“Most of my psychiatric colleagues don't look at labels so much as the amount of clinical trial data. There is far more experience with the SSRIs, particularly sertraline,” she said.
SAN FRANCISCO — All psychotropic medications are excreted into breast milk, but the benefits of breast-feeding generally outweigh the relatively small risks to the baby from antidepressants, Dr. Andrea J. Singer said.
The nutritional advantages and the bonding that occurs between mother and child during breast-feeding outweigh concerns about antidepressant effects on the infant, she said at the Perspectives in Women's Health conference sponsored by OB.GYN. NEWS.
The dose of antidepressant that the infant receives from the mother during breast-feeding is much lower than the dose received in utero because the drug crosses the placenta. If a mother and fetus have done well on an antidepressant during pregnancy, stick with that therapy after delivery. “The decision is easy—just continue,” said Dr. Singer, director of women's primary care at Georgetown University Medical Center, Washington.
SSRIs are first-line therapy for lactating women with depression because they have the most data supporting safe use during breast-feeding and efficacy in treating postpartum depression.
The aminoketone drug bupropion is a “not unreasonable alternative,” but the amount of data on it is far more limited, she said.
Combining an SSRI with other supportive services is recommended for severe postpartum depression. There is no consensus for treatment of mild postpartum depression, Dr. Singer added. Consider psychotherapy either alone or with an SSRI for mild depression in lactating women.
Dr. Singer is on the speakers' bureau of Pfizer, which makes the SSRI sertraline.
Generally, sertraline is the treatment of choice for depressed lactating women because of the amount of data available on its use. The SSRIs paroxetine or fluvoxamine are first-line alternatives. Second-line treatment choices include citalopram and fluoxetine. Start with monotherapy when possible, she advised.
The long-term impact of trace levels of antidepressants in infants is unknown. Most SSRIs and bupropion are rated Pregnancy Category C by the Food and Drug Administration. Tricyclic antidepressants fall in Category C or D.
“Most of my psychiatric colleagues don't look at labels so much as the amount of clinical trial data. There is far more experience with the SSRIs, particularly sertraline,” she said.
SAN FRANCISCO — All psychotropic medications are excreted into breast milk, but the benefits of breast-feeding generally outweigh the relatively small risks to the baby from antidepressants, Dr. Andrea J. Singer said.
The nutritional advantages and the bonding that occurs between mother and child during breast-feeding outweigh concerns about antidepressant effects on the infant, she said at the Perspectives in Women's Health conference sponsored by OB.GYN. NEWS.
The dose of antidepressant that the infant receives from the mother during breast-feeding is much lower than the dose received in utero because the drug crosses the placenta. If a mother and fetus have done well on an antidepressant during pregnancy, stick with that therapy after delivery. “The decision is easy—just continue,” said Dr. Singer, director of women's primary care at Georgetown University Medical Center, Washington.
SSRIs are first-line therapy for lactating women with depression because they have the most data supporting safe use during breast-feeding and efficacy in treating postpartum depression.
The aminoketone drug bupropion is a “not unreasonable alternative,” but the amount of data on it is far more limited, she said.
Combining an SSRI with other supportive services is recommended for severe postpartum depression. There is no consensus for treatment of mild postpartum depression, Dr. Singer added. Consider psychotherapy either alone or with an SSRI for mild depression in lactating women.
Dr. Singer is on the speakers' bureau of Pfizer, which makes the SSRI sertraline.
Generally, sertraline is the treatment of choice for depressed lactating women because of the amount of data available on its use. The SSRIs paroxetine or fluvoxamine are first-line alternatives. Second-line treatment choices include citalopram and fluoxetine. Start with monotherapy when possible, she advised.
The long-term impact of trace levels of antidepressants in infants is unknown. Most SSRIs and bupropion are rated Pregnancy Category C by the Food and Drug Administration. Tricyclic antidepressants fall in Category C or D.
“Most of my psychiatric colleagues don't look at labels so much as the amount of clinical trial data. There is far more experience with the SSRIs, particularly sertraline,” she said.
NIH Sets Newborn Genetics Program
The National Institutes of Health has launched “Health Information Rx Program” to encourage physicians to refer parents of newborns diagnosed with genetic conditions to Genetics Home Reference, a free, patient-friendly Web site with information on more than 500 genetic topics. The Web site also provides information on newborn genetic screening for expectant mothers. To find out more about the program or to request a free copy of an “Information Rx” pad, which directs patients to the Web site, visit http://ghr.nlm.nih.gov
The National Institutes of Health has launched “Health Information Rx Program” to encourage physicians to refer parents of newborns diagnosed with genetic conditions to Genetics Home Reference, a free, patient-friendly Web site with information on more than 500 genetic topics. The Web site also provides information on newborn genetic screening for expectant mothers. To find out more about the program or to request a free copy of an “Information Rx” pad, which directs patients to the Web site, visit http://ghr.nlm.nih.gov
The National Institutes of Health has launched “Health Information Rx Program” to encourage physicians to refer parents of newborns diagnosed with genetic conditions to Genetics Home Reference, a free, patient-friendly Web site with information on more than 500 genetic topics. The Web site also provides information on newborn genetic screening for expectant mothers. To find out more about the program or to request a free copy of an “Information Rx” pad, which directs patients to the Web site, visit http://ghr.nlm.nih.gov
Treatment Aids Periodontitis, Not Birth Outcomes
Treating maternal periodontitis before 21 weeks' gestation did improve the disease but failed to lower the risk of preterm delivery, increase fetal birth weight, improve Apgar scores, reduce the number of small-for-gestational-age neonates, or decrease the rate of neonatal intensive care unit admissions, reported Bryan S. Michalowicz, D.D.S., and his associates.
Several previous studies have reported a strong link between periodontal disease and preterm birth, but others have found no association. Similarly, two previous clinical trials have concluded that periodontal treatment during pregnancy cuts the risk of preterm birth, but another found no benefit, the researchers said (N. Engl. J. Med. 2006;355:1885–94).
Their Obstetrics and Periodontal Therapy (OPT) study was a randomized, blinded trial in which 823 pregnant women with early to moderate generalized periodontitis were assigned to receive nonsurgical treatment either before 21 weeks (treatment group) or after delivery (control group). The women were seen at four U.S. medical centers between 2003 and 2005.
Treatment comprised periodontal scaling and root planing—removal of dental plaque and calculus from the tooth enamel and root—with ultrasonic and hand instruments, using local anesthesia as needed. All clinical measures of disease improved in all treated patients.
However, treatment did not improve the rate of preterm delivery or other related outcomes, said Dr. Michalowicz of the department of developmental and surgical sciences at the University of Minnesota, Minneapolis.
There was a nonsignificant reduction in spontaneous abortion and stillbirths in the treated group. However, “we view this finding with particular caution because only 19 patients in our study had either a spontaneous abortion or stillbirth and because we began evaluating rates of earlier pregnancy losses only after seven such events had occurred,” Dr. Michalowicz and his associates wrote.
In an editorial comment accompanying this report, Dr. Robert L. Goldenberg and Jennifer F. Culhane, Ph.D., of Drexel University, Philadelphia, said that these results on miscarriages and stillbirths might be more significant than the authors believed.
Periodontal treatment may well have affected early adverse outcomes “since observational studies suggest that periodontal disease is much more strongly associated with late miscarriage, stillbirth, and early spontaneous preterm birth than with preterm birth in general.
“One could hypothesize that periodontal treatment might preferentially reduce these other outcomes but not late preterm birth,” they said (N. Engl. J. Med. 2006;355:1925–7).
Dr. Goldenberg and Dr. Culhane also noted that treatment during pregnancy might be too late, and that prepregnancy intervention is needed. “We have hypothesized that once the inflammatory cascade is activated during pregnancy, interventions targeting this pathway may be ineffective in reducing the rate of preterm birth,” they noted.
Three larger ongoing trials of the issue are underway, and their results “will help clarify whether periodontal treatment has any role in reducing the rate of preterm birth. In the meantime, the findings of Michalowicz et al. do not support the provision of periodontal treatment in pregnancy for the purpose of reducing preterm birth,” Dr. Goldenberg and Dr. Culhane said.
Treating maternal periodontitis before 21 weeks' gestation did improve the disease but failed to lower the risk of preterm delivery, increase fetal birth weight, improve Apgar scores, reduce the number of small-for-gestational-age neonates, or decrease the rate of neonatal intensive care unit admissions, reported Bryan S. Michalowicz, D.D.S., and his associates.
Several previous studies have reported a strong link between periodontal disease and preterm birth, but others have found no association. Similarly, two previous clinical trials have concluded that periodontal treatment during pregnancy cuts the risk of preterm birth, but another found no benefit, the researchers said (N. Engl. J. Med. 2006;355:1885–94).
Their Obstetrics and Periodontal Therapy (OPT) study was a randomized, blinded trial in which 823 pregnant women with early to moderate generalized periodontitis were assigned to receive nonsurgical treatment either before 21 weeks (treatment group) or after delivery (control group). The women were seen at four U.S. medical centers between 2003 and 2005.
Treatment comprised periodontal scaling and root planing—removal of dental plaque and calculus from the tooth enamel and root—with ultrasonic and hand instruments, using local anesthesia as needed. All clinical measures of disease improved in all treated patients.
However, treatment did not improve the rate of preterm delivery or other related outcomes, said Dr. Michalowicz of the department of developmental and surgical sciences at the University of Minnesota, Minneapolis.
There was a nonsignificant reduction in spontaneous abortion and stillbirths in the treated group. However, “we view this finding with particular caution because only 19 patients in our study had either a spontaneous abortion or stillbirth and because we began evaluating rates of earlier pregnancy losses only after seven such events had occurred,” Dr. Michalowicz and his associates wrote.
In an editorial comment accompanying this report, Dr. Robert L. Goldenberg and Jennifer F. Culhane, Ph.D., of Drexel University, Philadelphia, said that these results on miscarriages and stillbirths might be more significant than the authors believed.
Periodontal treatment may well have affected early adverse outcomes “since observational studies suggest that periodontal disease is much more strongly associated with late miscarriage, stillbirth, and early spontaneous preterm birth than with preterm birth in general.
“One could hypothesize that periodontal treatment might preferentially reduce these other outcomes but not late preterm birth,” they said (N. Engl. J. Med. 2006;355:1925–7).
Dr. Goldenberg and Dr. Culhane also noted that treatment during pregnancy might be too late, and that prepregnancy intervention is needed. “We have hypothesized that once the inflammatory cascade is activated during pregnancy, interventions targeting this pathway may be ineffective in reducing the rate of preterm birth,” they noted.
Three larger ongoing trials of the issue are underway, and their results “will help clarify whether periodontal treatment has any role in reducing the rate of preterm birth. In the meantime, the findings of Michalowicz et al. do not support the provision of periodontal treatment in pregnancy for the purpose of reducing preterm birth,” Dr. Goldenberg and Dr. Culhane said.
Treating maternal periodontitis before 21 weeks' gestation did improve the disease but failed to lower the risk of preterm delivery, increase fetal birth weight, improve Apgar scores, reduce the number of small-for-gestational-age neonates, or decrease the rate of neonatal intensive care unit admissions, reported Bryan S. Michalowicz, D.D.S., and his associates.
Several previous studies have reported a strong link between periodontal disease and preterm birth, but others have found no association. Similarly, two previous clinical trials have concluded that periodontal treatment during pregnancy cuts the risk of preterm birth, but another found no benefit, the researchers said (N. Engl. J. Med. 2006;355:1885–94).
Their Obstetrics and Periodontal Therapy (OPT) study was a randomized, blinded trial in which 823 pregnant women with early to moderate generalized periodontitis were assigned to receive nonsurgical treatment either before 21 weeks (treatment group) or after delivery (control group). The women were seen at four U.S. medical centers between 2003 and 2005.
Treatment comprised periodontal scaling and root planing—removal of dental plaque and calculus from the tooth enamel and root—with ultrasonic and hand instruments, using local anesthesia as needed. All clinical measures of disease improved in all treated patients.
However, treatment did not improve the rate of preterm delivery or other related outcomes, said Dr. Michalowicz of the department of developmental and surgical sciences at the University of Minnesota, Minneapolis.
There was a nonsignificant reduction in spontaneous abortion and stillbirths in the treated group. However, “we view this finding with particular caution because only 19 patients in our study had either a spontaneous abortion or stillbirth and because we began evaluating rates of earlier pregnancy losses only after seven such events had occurred,” Dr. Michalowicz and his associates wrote.
In an editorial comment accompanying this report, Dr. Robert L. Goldenberg and Jennifer F. Culhane, Ph.D., of Drexel University, Philadelphia, said that these results on miscarriages and stillbirths might be more significant than the authors believed.
Periodontal treatment may well have affected early adverse outcomes “since observational studies suggest that periodontal disease is much more strongly associated with late miscarriage, stillbirth, and early spontaneous preterm birth than with preterm birth in general.
“One could hypothesize that periodontal treatment might preferentially reduce these other outcomes but not late preterm birth,” they said (N. Engl. J. Med. 2006;355:1925–7).
Dr. Goldenberg and Dr. Culhane also noted that treatment during pregnancy might be too late, and that prepregnancy intervention is needed. “We have hypothesized that once the inflammatory cascade is activated during pregnancy, interventions targeting this pathway may be ineffective in reducing the rate of preterm birth,” they noted.
Three larger ongoing trials of the issue are underway, and their results “will help clarify whether periodontal treatment has any role in reducing the rate of preterm birth. In the meantime, the findings of Michalowicz et al. do not support the provision of periodontal treatment in pregnancy for the purpose of reducing preterm birth,” Dr. Goldenberg and Dr. Culhane said.
Mother's Vitamin D Supplement May Benefit Infant
CHARLESTON, S.C. — Give breast-feeding women enough vitamin D and you may supplement their babies, too, according to the results of a small but promising pilot study presented at a pediatric meeting sponsored by the Medical University of South Carolina.
“Our question was: 'Would direct vitamin D supplementation meet the needs of both the mother and her nursing infant?'” said Dr. Carol L. Wagner of the department of neonatology at the university, in Charleston.
Insufficient vitamin D causes many problems, primarily a lack of calcium absorption that can lead to bone loss. In addition, recent research suggests a link between insufficient vitamin D and immune system disorders such as diabetes, Dr. Wagner said.
People in the developed world are at risk for vitamin D deficiency because of a primarily indoor lifestyle that has limited adequate vitamin D intake from sunlight, she added.
Data from several recent studies suggest that doses of vitamin D that are significantly higher than the current recommended daily allowance will not cause toxicity and are in fact needed for adequate circulating 25-hydroxyvitamin D concentrations (25[OH]D).
To determine whether giving mothers high doses of vitamin D provides adequate 25(OH)D for both mothers and infants without toxicity to either, Dr. Wagner and colleagues randomized 18 breast-feeding women to receive 400 IU or 6,400 IU of vitamin D3 as a daily pill for 6 months starting at 1 month post partum.
The mothers who were randomized to 6,400 IU of vitamin D3 showed a substantial increase in circulating calcium levels with no adverse effects.
In addition, compliance rates were more than 90% because the mothers said that they were more likely to remember to take a pill themselves than to give supplements to their babies.
The infants whose mothers took 400 IU received their own supplement of 300 IU daily, while the infants whose mothers took 6,400 IU received a placebo supplement.
“What we found was a wonderful increase,” in infant 25(OH)D levels from breast milk alone, Dr. Wagner said.
After 6 months, the average 25(OH)D level was 47 ng/mL in the mothers who received 6,400 IU and 46 ng/mL in their babies. By comparison, the average 25(OH)D level was 38 ng/mL in the mothers who received 400 IU and 43 ng/mL in their babies. There were no adverse events in either mother or infant related to vitamin D toxicity.
“Supplementing the mom with high-dose vitamin D is still considered unproven,” Dr. Wagner said. “We think it is safe, but we have to study it in large numbers.” A study of 389 lactating women at sites in Charleston, S.C., and Rochester, N.Y., is planned, and the researchers will assess factors including bone mineral density and immune function.
For now, Dr. Wagner encourages physicians to recommend vitamin D supplementation for breast-feeding infants, but if the circulating vitamin D levels in the mothers are 50 ng/mL or higher, the infants are probably getting enough, too. Strive for circulating 25(OH)D levels of at least 30 ng/mL in all patients, she emphasized.
The American Academy of Pediatrics currently recommends vitamin D supplementation for all breast-fed infants because mother's milk is generally deficient in vitamin D. But 25% of the vitamin D in lactating women goes into breast milk, and it seems that increasing vitamin D in mothers results in adequate vitamin D for the breast-fed infant, Dr. Wagner explained.
Because a mother is the only source of vitamin D for her developing fetus and the primary source for a breast-feeding infant, more research is needed on whether increasing maternal vitamin D will help infants, too.
CHARLESTON, S.C. — Give breast-feeding women enough vitamin D and you may supplement their babies, too, according to the results of a small but promising pilot study presented at a pediatric meeting sponsored by the Medical University of South Carolina.
“Our question was: 'Would direct vitamin D supplementation meet the needs of both the mother and her nursing infant?'” said Dr. Carol L. Wagner of the department of neonatology at the university, in Charleston.
Insufficient vitamin D causes many problems, primarily a lack of calcium absorption that can lead to bone loss. In addition, recent research suggests a link between insufficient vitamin D and immune system disorders such as diabetes, Dr. Wagner said.
People in the developed world are at risk for vitamin D deficiency because of a primarily indoor lifestyle that has limited adequate vitamin D intake from sunlight, she added.
Data from several recent studies suggest that doses of vitamin D that are significantly higher than the current recommended daily allowance will not cause toxicity and are in fact needed for adequate circulating 25-hydroxyvitamin D concentrations (25[OH]D).
To determine whether giving mothers high doses of vitamin D provides adequate 25(OH)D for both mothers and infants without toxicity to either, Dr. Wagner and colleagues randomized 18 breast-feeding women to receive 400 IU or 6,400 IU of vitamin D3 as a daily pill for 6 months starting at 1 month post partum.
The mothers who were randomized to 6,400 IU of vitamin D3 showed a substantial increase in circulating calcium levels with no adverse effects.
In addition, compliance rates were more than 90% because the mothers said that they were more likely to remember to take a pill themselves than to give supplements to their babies.
The infants whose mothers took 400 IU received their own supplement of 300 IU daily, while the infants whose mothers took 6,400 IU received a placebo supplement.
“What we found was a wonderful increase,” in infant 25(OH)D levels from breast milk alone, Dr. Wagner said.
After 6 months, the average 25(OH)D level was 47 ng/mL in the mothers who received 6,400 IU and 46 ng/mL in their babies. By comparison, the average 25(OH)D level was 38 ng/mL in the mothers who received 400 IU and 43 ng/mL in their babies. There were no adverse events in either mother or infant related to vitamin D toxicity.
“Supplementing the mom with high-dose vitamin D is still considered unproven,” Dr. Wagner said. “We think it is safe, but we have to study it in large numbers.” A study of 389 lactating women at sites in Charleston, S.C., and Rochester, N.Y., is planned, and the researchers will assess factors including bone mineral density and immune function.
For now, Dr. Wagner encourages physicians to recommend vitamin D supplementation for breast-feeding infants, but if the circulating vitamin D levels in the mothers are 50 ng/mL or higher, the infants are probably getting enough, too. Strive for circulating 25(OH)D levels of at least 30 ng/mL in all patients, she emphasized.
The American Academy of Pediatrics currently recommends vitamin D supplementation for all breast-fed infants because mother's milk is generally deficient in vitamin D. But 25% of the vitamin D in lactating women goes into breast milk, and it seems that increasing vitamin D in mothers results in adequate vitamin D for the breast-fed infant, Dr. Wagner explained.
Because a mother is the only source of vitamin D for her developing fetus and the primary source for a breast-feeding infant, more research is needed on whether increasing maternal vitamin D will help infants, too.
CHARLESTON, S.C. — Give breast-feeding women enough vitamin D and you may supplement their babies, too, according to the results of a small but promising pilot study presented at a pediatric meeting sponsored by the Medical University of South Carolina.
“Our question was: 'Would direct vitamin D supplementation meet the needs of both the mother and her nursing infant?'” said Dr. Carol L. Wagner of the department of neonatology at the university, in Charleston.
Insufficient vitamin D causes many problems, primarily a lack of calcium absorption that can lead to bone loss. In addition, recent research suggests a link between insufficient vitamin D and immune system disorders such as diabetes, Dr. Wagner said.
People in the developed world are at risk for vitamin D deficiency because of a primarily indoor lifestyle that has limited adequate vitamin D intake from sunlight, she added.
Data from several recent studies suggest that doses of vitamin D that are significantly higher than the current recommended daily allowance will not cause toxicity and are in fact needed for adequate circulating 25-hydroxyvitamin D concentrations (25[OH]D).
To determine whether giving mothers high doses of vitamin D provides adequate 25(OH)D for both mothers and infants without toxicity to either, Dr. Wagner and colleagues randomized 18 breast-feeding women to receive 400 IU or 6,400 IU of vitamin D3 as a daily pill for 6 months starting at 1 month post partum.
The mothers who were randomized to 6,400 IU of vitamin D3 showed a substantial increase in circulating calcium levels with no adverse effects.
In addition, compliance rates were more than 90% because the mothers said that they were more likely to remember to take a pill themselves than to give supplements to their babies.
The infants whose mothers took 400 IU received their own supplement of 300 IU daily, while the infants whose mothers took 6,400 IU received a placebo supplement.
“What we found was a wonderful increase,” in infant 25(OH)D levels from breast milk alone, Dr. Wagner said.
After 6 months, the average 25(OH)D level was 47 ng/mL in the mothers who received 6,400 IU and 46 ng/mL in their babies. By comparison, the average 25(OH)D level was 38 ng/mL in the mothers who received 400 IU and 43 ng/mL in their babies. There were no adverse events in either mother or infant related to vitamin D toxicity.
“Supplementing the mom with high-dose vitamin D is still considered unproven,” Dr. Wagner said. “We think it is safe, but we have to study it in large numbers.” A study of 389 lactating women at sites in Charleston, S.C., and Rochester, N.Y., is planned, and the researchers will assess factors including bone mineral density and immune function.
For now, Dr. Wagner encourages physicians to recommend vitamin D supplementation for breast-feeding infants, but if the circulating vitamin D levels in the mothers are 50 ng/mL or higher, the infants are probably getting enough, too. Strive for circulating 25(OH)D levels of at least 30 ng/mL in all patients, she emphasized.
The American Academy of Pediatrics currently recommends vitamin D supplementation for all breast-fed infants because mother's milk is generally deficient in vitamin D. But 25% of the vitamin D in lactating women goes into breast milk, and it seems that increasing vitamin D in mothers results in adequate vitamin D for the breast-fed infant, Dr. Wagner explained.
Because a mother is the only source of vitamin D for her developing fetus and the primary source for a breast-feeding infant, more research is needed on whether increasing maternal vitamin D will help infants, too.
Early Data Suggest Adalimumab Safe in Pregnancy
BERLIN — Treatment of pregnant women with the biologic immunomodulator adalimumab did not appear to adversely affect the fetuses or pregnancies in preliminary data from a prospective study that currently includes 23 exposed pregnancies.
“The findings do not suggest an increased risk for adverse pregnancy outcomes with exposure to adalimumab early in pregnancy,” although additional data from more pregnancies exposed to the drug are needed, Diana L. Johnson said at the 14th United European Gastroenterology Week.
Adalimumab (Humira) is a fully human antibody to tumor necrosis factor (TNF)-α, which gives it a mechanism of action that's similar to other biologic TNF-α inhibitors including etanercept (Enbrel), infliximab (Remicade), and certolizumab (Cimzia). To date, there is no evidence that the use of these drugs during pregnancy leads to malformations, spontaneous abortions, or prematurity, said Ms. Johnson, a toxicologist and study manager at the University of California, San Diego.
However, only limited data are available so far for all of these exposures.
The analysis of data from women who were treated with adalimumab during pregnancy comes from a larger study of autoimmune diseases in pregnancy that has been developed by the Organization of Teratology Information Specialists (OTIS).
The OTIS group is a network of university-based pregnancy-risk counseling services in North America.
The centerpiece of the autoimmune disease study is a prospective cohort study of women with rheumatoid arthritis who are being treated with an anti-TNF drug.
In addition, pregnant women who have similar drug exposures for other autoimmune diseases, such as psoriatic arthritis, ankylosing spondylitis, psoriasis, or Crohn's disease, are enrolled in a registry.
The OTIS study so far has data on the birth outcomes of 23 women who were treated with adalimumab early in pregnancy. Twelve of the women are in the prospective cohort, and 11 are in the registry.
These women have had a total of 21 live births and two spontaneous abortions, reported Ms. Johnson at the meeting, which was sponsored by the United European Gastroenterology Federation.
Twenty of the deliveries were term, and the single premature birth involved an infant with congenital hip dysplasia.
Women who are diagnosed with severe Crohn's disease and are on a successful anti-TNF regimen are usually advised to continue their medication if they become pregnant, although the pros and cons of ongoing treatment are discussed with them, commented Dr. Pia Munkholm, a gastroenterologist at Herlev Hospital in Copenhagen.
“There is an incentive to keep these patients in remission,” she said.
OTIS receives funding from eight pharmaceutical companies, as well as from other organizations.
BERLIN — Treatment of pregnant women with the biologic immunomodulator adalimumab did not appear to adversely affect the fetuses or pregnancies in preliminary data from a prospective study that currently includes 23 exposed pregnancies.
“The findings do not suggest an increased risk for adverse pregnancy outcomes with exposure to adalimumab early in pregnancy,” although additional data from more pregnancies exposed to the drug are needed, Diana L. Johnson said at the 14th United European Gastroenterology Week.
Adalimumab (Humira) is a fully human antibody to tumor necrosis factor (TNF)-α, which gives it a mechanism of action that's similar to other biologic TNF-α inhibitors including etanercept (Enbrel), infliximab (Remicade), and certolizumab (Cimzia). To date, there is no evidence that the use of these drugs during pregnancy leads to malformations, spontaneous abortions, or prematurity, said Ms. Johnson, a toxicologist and study manager at the University of California, San Diego.
However, only limited data are available so far for all of these exposures.
The analysis of data from women who were treated with adalimumab during pregnancy comes from a larger study of autoimmune diseases in pregnancy that has been developed by the Organization of Teratology Information Specialists (OTIS).
The OTIS group is a network of university-based pregnancy-risk counseling services in North America.
The centerpiece of the autoimmune disease study is a prospective cohort study of women with rheumatoid arthritis who are being treated with an anti-TNF drug.
In addition, pregnant women who have similar drug exposures for other autoimmune diseases, such as psoriatic arthritis, ankylosing spondylitis, psoriasis, or Crohn's disease, are enrolled in a registry.
The OTIS study so far has data on the birth outcomes of 23 women who were treated with adalimumab early in pregnancy. Twelve of the women are in the prospective cohort, and 11 are in the registry.
These women have had a total of 21 live births and two spontaneous abortions, reported Ms. Johnson at the meeting, which was sponsored by the United European Gastroenterology Federation.
Twenty of the deliveries were term, and the single premature birth involved an infant with congenital hip dysplasia.
Women who are diagnosed with severe Crohn's disease and are on a successful anti-TNF regimen are usually advised to continue their medication if they become pregnant, although the pros and cons of ongoing treatment are discussed with them, commented Dr. Pia Munkholm, a gastroenterologist at Herlev Hospital in Copenhagen.
“There is an incentive to keep these patients in remission,” she said.
OTIS receives funding from eight pharmaceutical companies, as well as from other organizations.
BERLIN — Treatment of pregnant women with the biologic immunomodulator adalimumab did not appear to adversely affect the fetuses or pregnancies in preliminary data from a prospective study that currently includes 23 exposed pregnancies.
“The findings do not suggest an increased risk for adverse pregnancy outcomes with exposure to adalimumab early in pregnancy,” although additional data from more pregnancies exposed to the drug are needed, Diana L. Johnson said at the 14th United European Gastroenterology Week.
Adalimumab (Humira) is a fully human antibody to tumor necrosis factor (TNF)-α, which gives it a mechanism of action that's similar to other biologic TNF-α inhibitors including etanercept (Enbrel), infliximab (Remicade), and certolizumab (Cimzia). To date, there is no evidence that the use of these drugs during pregnancy leads to malformations, spontaneous abortions, or prematurity, said Ms. Johnson, a toxicologist and study manager at the University of California, San Diego.
However, only limited data are available so far for all of these exposures.
The analysis of data from women who were treated with adalimumab during pregnancy comes from a larger study of autoimmune diseases in pregnancy that has been developed by the Organization of Teratology Information Specialists (OTIS).
The OTIS group is a network of university-based pregnancy-risk counseling services in North America.
The centerpiece of the autoimmune disease study is a prospective cohort study of women with rheumatoid arthritis who are being treated with an anti-TNF drug.
In addition, pregnant women who have similar drug exposures for other autoimmune diseases, such as psoriatic arthritis, ankylosing spondylitis, psoriasis, or Crohn's disease, are enrolled in a registry.
The OTIS study so far has data on the birth outcomes of 23 women who were treated with adalimumab early in pregnancy. Twelve of the women are in the prospective cohort, and 11 are in the registry.
These women have had a total of 21 live births and two spontaneous abortions, reported Ms. Johnson at the meeting, which was sponsored by the United European Gastroenterology Federation.
Twenty of the deliveries were term, and the single premature birth involved an infant with congenital hip dysplasia.
Women who are diagnosed with severe Crohn's disease and are on a successful anti-TNF regimen are usually advised to continue their medication if they become pregnant, although the pros and cons of ongoing treatment are discussed with them, commented Dr. Pia Munkholm, a gastroenterologist at Herlev Hospital in Copenhagen.
“There is an incentive to keep these patients in remission,” she said.
OTIS receives funding from eight pharmaceutical companies, as well as from other organizations.