Industry Is Slow to Post Info Onto Online Trial Registries

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NEW YORK — When questions were raised about possible concealment of clinical trial data, two pharmaceutical companies agreed last year to set up Web sites where such data would be posted.

It appeared at that time that others in the industry would follow suit, “but as it turns out, very little has happened,” Norman Sussman, M.D., said at a meeting on psychopharmacology sponsored by New York University.

An Internet search performed at the beginning of March, followed by inquiries to the companies themselves, found that information was for the most part incomplete, difficult to use, or entirely absent.

“This says something about the goodwill of the companies,” said Dr. Sussman, professor of psychiatry at the university.

In June 2004, New York State Attorney General Eliot Spitzer filed suit against GlaxoSmithKline Inc., charging that the company's selective release of trial data on the use of paroxetine (Paxil) in children constituted consumer fraud. As part of a settlement of the lawsuit at the end of August, the company agreed to post clinical trial results for all GSK drugs on its Web site.

An inquiry by the attorney general's office into data relating to off-label use of drugs manufactured by Forest Laboratories Inc. led to a similar agreement with that company.

Dr. Sussman's Internet investigation found that one pharmaceutical company has done what was promised, and it was neither of those originally involved: Eli Lilly. Its Web site (www.lillytrials.com

For completed trials, the site supplies PDF files of basic information—“not everything you want to know, but a sense of how the study was designed, the method, and outcomes,” he said. For the most part, it is raw data: “If you were expecting something simple, it's not here. You have to have an understanding of research methodology to evaluate these,” he said.

The “initiated trials” section lists phase II, III, and IV studies that were begun since July 2004, most of which are still recruiting patients. “The idea is that once you do this, you can no longer hide the results of the study,” Dr. Sussman said.

The speed with which Lilly put such complete data on its Web site “tells you that any company that wanted to could do it tomorrow. They all have internal documents that summarize studies,” he said.

The GlaxoSmithKline registry (http://ctr.gsk.co.uk/welcome.asp

The GSK presentation includes less narrative discussion of study findings than the Lilly site. “It's mostly numbers. … You have to look into the statistics and form your own conclusion. It's not intended for the average practitioner,” he said.

The other company that agreed to post data, Forest Laboratories, has set up a registry (www.forestclinicaltrials.com

An industry association, the Pharmaceutical Research and Manufacturers of America, maintains a Web site of its own (www.clinicalstudyresults.org

A government site (www.clinicaltrials.gov

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NEW YORK — When questions were raised about possible concealment of clinical trial data, two pharmaceutical companies agreed last year to set up Web sites where such data would be posted.

It appeared at that time that others in the industry would follow suit, “but as it turns out, very little has happened,” Norman Sussman, M.D., said at a meeting on psychopharmacology sponsored by New York University.

An Internet search performed at the beginning of March, followed by inquiries to the companies themselves, found that information was for the most part incomplete, difficult to use, or entirely absent.

“This says something about the goodwill of the companies,” said Dr. Sussman, professor of psychiatry at the university.

In June 2004, New York State Attorney General Eliot Spitzer filed suit against GlaxoSmithKline Inc., charging that the company's selective release of trial data on the use of paroxetine (Paxil) in children constituted consumer fraud. As part of a settlement of the lawsuit at the end of August, the company agreed to post clinical trial results for all GSK drugs on its Web site.

An inquiry by the attorney general's office into data relating to off-label use of drugs manufactured by Forest Laboratories Inc. led to a similar agreement with that company.

Dr. Sussman's Internet investigation found that one pharmaceutical company has done what was promised, and it was neither of those originally involved: Eli Lilly. Its Web site (www.lillytrials.com

For completed trials, the site supplies PDF files of basic information—“not everything you want to know, but a sense of how the study was designed, the method, and outcomes,” he said. For the most part, it is raw data: “If you were expecting something simple, it's not here. You have to have an understanding of research methodology to evaluate these,” he said.

The “initiated trials” section lists phase II, III, and IV studies that were begun since July 2004, most of which are still recruiting patients. “The idea is that once you do this, you can no longer hide the results of the study,” Dr. Sussman said.

The speed with which Lilly put such complete data on its Web site “tells you that any company that wanted to could do it tomorrow. They all have internal documents that summarize studies,” he said.

The GlaxoSmithKline registry (http://ctr.gsk.co.uk/welcome.asp

The GSK presentation includes less narrative discussion of study findings than the Lilly site. “It's mostly numbers. … You have to look into the statistics and form your own conclusion. It's not intended for the average practitioner,” he said.

The other company that agreed to post data, Forest Laboratories, has set up a registry (www.forestclinicaltrials.com

An industry association, the Pharmaceutical Research and Manufacturers of America, maintains a Web site of its own (www.clinicalstudyresults.org

A government site (www.clinicaltrials.gov

NEW YORK — When questions were raised about possible concealment of clinical trial data, two pharmaceutical companies agreed last year to set up Web sites where such data would be posted.

It appeared at that time that others in the industry would follow suit, “but as it turns out, very little has happened,” Norman Sussman, M.D., said at a meeting on psychopharmacology sponsored by New York University.

An Internet search performed at the beginning of March, followed by inquiries to the companies themselves, found that information was for the most part incomplete, difficult to use, or entirely absent.

“This says something about the goodwill of the companies,” said Dr. Sussman, professor of psychiatry at the university.

In June 2004, New York State Attorney General Eliot Spitzer filed suit against GlaxoSmithKline Inc., charging that the company's selective release of trial data on the use of paroxetine (Paxil) in children constituted consumer fraud. As part of a settlement of the lawsuit at the end of August, the company agreed to post clinical trial results for all GSK drugs on its Web site.

An inquiry by the attorney general's office into data relating to off-label use of drugs manufactured by Forest Laboratories Inc. led to a similar agreement with that company.

Dr. Sussman's Internet investigation found that one pharmaceutical company has done what was promised, and it was neither of those originally involved: Eli Lilly. Its Web site (www.lillytrials.com

For completed trials, the site supplies PDF files of basic information—“not everything you want to know, but a sense of how the study was designed, the method, and outcomes,” he said. For the most part, it is raw data: “If you were expecting something simple, it's not here. You have to have an understanding of research methodology to evaluate these,” he said.

The “initiated trials” section lists phase II, III, and IV studies that were begun since July 2004, most of which are still recruiting patients. “The idea is that once you do this, you can no longer hide the results of the study,” Dr. Sussman said.

The speed with which Lilly put such complete data on its Web site “tells you that any company that wanted to could do it tomorrow. They all have internal documents that summarize studies,” he said.

The GlaxoSmithKline registry (http://ctr.gsk.co.uk/welcome.asp

The GSK presentation includes less narrative discussion of study findings than the Lilly site. “It's mostly numbers. … You have to look into the statistics and form your own conclusion. It's not intended for the average practitioner,” he said.

The other company that agreed to post data, Forest Laboratories, has set up a registry (www.forestclinicaltrials.com

An industry association, the Pharmaceutical Research and Manufacturers of America, maintains a Web site of its own (www.clinicalstudyresults.org

A government site (www.clinicaltrials.gov

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3-D Ultrasound Visualizes Even Minor Fetal Defects

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3-D Ultrasound Visualizes Even Minor Fetal Defects

NEW YORK — Three-dimensional ultrasound represents an emerging advance in imaging with important applications in obstetrics, Alfred Z. Abuhamad, M.D., said at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

The ability to rotate images, change planes, and manipulate displays according to signal strength makes it possible to visualize skeletal and vascular structures and fluid spaces, in addition to providing detailed views of fetal appearance, said Dr. Abuhamad, professor and chair of obstetrics and gynecology and director of the division of maternal-fetal medicine at Eastern Virginia Medical School, Norfolk.

The term “3-D” is something of a misnomer in that the image is displayed on a 2-D monitor. “[Instead of '3-D'] the term should be volume sonography that gives the appearance of depth,” he said. The volume image is created by the summation of 2-D slices from multiple planes, as the probe is steered from side to side.

With a multiplanar display, an image constructed from sagittal, coronal, and transverse planes can be rotated along the x-, y-, and z-axis to visualize the same structure from different angles.

The surface display shows the external aspects of the fetus, allowing the same views as in 2-D ultrasound, to review in “tremendous detail” such fetal abnormalities as clefting of the lip and palate, he said.

With “maximum mode,” which manipulates the signal to enhance light (i.e. echoic) objects and dim dark (anechoic) ones, skeletal structures can be visualized, affording a look at the cranium and its fontanelles and sutures. It also facilitates assessment of bone quality and detection of fractures and permits close examination of the vertebral column.

“It's like an x-ray of the fetus,” Dr. Abuhamad said.

“Minimum mode” reveals vasculature; while “inversion mode,” which dims light structures and highlights dim ones, brings out fluid cavities and makes it possible to visualize such structures as the chambers of the heart and determine the number of gestational sacs, he said.

Other image manipulations permit the clinician to see the back of structures and to remove from the image, as with an “electronic scalpel,” structures that may obscure features of interest.

The 3-D procedure does not use more power, increase fetal exposure, or magnify the thermal effect, compared with 2-D ultrasound, he said.

Limitations of the technique include a steep learning curve. The technique is highly operator dependent, and the lack of standardization magnifies the possibility of human error, Dr. Abuhamad said. Also, artifacts such as motion of the woman or fetus, surface rendering, and shadowing can interfere with interpretation.

An estimated 10% of ultrasound units currently have this technology, he said.

Absence of a T12 rib on one side in a fetus with balanced translocation was missed by 2-D ultrasound, shown by 3-D.

3-D ultrasound clearly shows swelling of the dorsal aspect of both feet in a fetus with Turner syndrome. Photos courtesy Dr. Alfred Z. Abuhamad

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NEW YORK — Three-dimensional ultrasound represents an emerging advance in imaging with important applications in obstetrics, Alfred Z. Abuhamad, M.D., said at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

The ability to rotate images, change planes, and manipulate displays according to signal strength makes it possible to visualize skeletal and vascular structures and fluid spaces, in addition to providing detailed views of fetal appearance, said Dr. Abuhamad, professor and chair of obstetrics and gynecology and director of the division of maternal-fetal medicine at Eastern Virginia Medical School, Norfolk.

The term “3-D” is something of a misnomer in that the image is displayed on a 2-D monitor. “[Instead of '3-D'] the term should be volume sonography that gives the appearance of depth,” he said. The volume image is created by the summation of 2-D slices from multiple planes, as the probe is steered from side to side.

With a multiplanar display, an image constructed from sagittal, coronal, and transverse planes can be rotated along the x-, y-, and z-axis to visualize the same structure from different angles.

The surface display shows the external aspects of the fetus, allowing the same views as in 2-D ultrasound, to review in “tremendous detail” such fetal abnormalities as clefting of the lip and palate, he said.

With “maximum mode,” which manipulates the signal to enhance light (i.e. echoic) objects and dim dark (anechoic) ones, skeletal structures can be visualized, affording a look at the cranium and its fontanelles and sutures. It also facilitates assessment of bone quality and detection of fractures and permits close examination of the vertebral column.

“It's like an x-ray of the fetus,” Dr. Abuhamad said.

“Minimum mode” reveals vasculature; while “inversion mode,” which dims light structures and highlights dim ones, brings out fluid cavities and makes it possible to visualize such structures as the chambers of the heart and determine the number of gestational sacs, he said.

Other image manipulations permit the clinician to see the back of structures and to remove from the image, as with an “electronic scalpel,” structures that may obscure features of interest.

The 3-D procedure does not use more power, increase fetal exposure, or magnify the thermal effect, compared with 2-D ultrasound, he said.

Limitations of the technique include a steep learning curve. The technique is highly operator dependent, and the lack of standardization magnifies the possibility of human error, Dr. Abuhamad said. Also, artifacts such as motion of the woman or fetus, surface rendering, and shadowing can interfere with interpretation.

An estimated 10% of ultrasound units currently have this technology, he said.

Absence of a T12 rib on one side in a fetus with balanced translocation was missed by 2-D ultrasound, shown by 3-D.

3-D ultrasound clearly shows swelling of the dorsal aspect of both feet in a fetus with Turner syndrome. Photos courtesy Dr. Alfred Z. Abuhamad

NEW YORK — Three-dimensional ultrasound represents an emerging advance in imaging with important applications in obstetrics, Alfred Z. Abuhamad, M.D., said at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

The ability to rotate images, change planes, and manipulate displays according to signal strength makes it possible to visualize skeletal and vascular structures and fluid spaces, in addition to providing detailed views of fetal appearance, said Dr. Abuhamad, professor and chair of obstetrics and gynecology and director of the division of maternal-fetal medicine at Eastern Virginia Medical School, Norfolk.

The term “3-D” is something of a misnomer in that the image is displayed on a 2-D monitor. “[Instead of '3-D'] the term should be volume sonography that gives the appearance of depth,” he said. The volume image is created by the summation of 2-D slices from multiple planes, as the probe is steered from side to side.

With a multiplanar display, an image constructed from sagittal, coronal, and transverse planes can be rotated along the x-, y-, and z-axis to visualize the same structure from different angles.

The surface display shows the external aspects of the fetus, allowing the same views as in 2-D ultrasound, to review in “tremendous detail” such fetal abnormalities as clefting of the lip and palate, he said.

With “maximum mode,” which manipulates the signal to enhance light (i.e. echoic) objects and dim dark (anechoic) ones, skeletal structures can be visualized, affording a look at the cranium and its fontanelles and sutures. It also facilitates assessment of bone quality and detection of fractures and permits close examination of the vertebral column.

“It's like an x-ray of the fetus,” Dr. Abuhamad said.

“Minimum mode” reveals vasculature; while “inversion mode,” which dims light structures and highlights dim ones, brings out fluid cavities and makes it possible to visualize such structures as the chambers of the heart and determine the number of gestational sacs, he said.

Other image manipulations permit the clinician to see the back of structures and to remove from the image, as with an “electronic scalpel,” structures that may obscure features of interest.

The 3-D procedure does not use more power, increase fetal exposure, or magnify the thermal effect, compared with 2-D ultrasound, he said.

Limitations of the technique include a steep learning curve. The technique is highly operator dependent, and the lack of standardization magnifies the possibility of human error, Dr. Abuhamad said. Also, artifacts such as motion of the woman or fetus, surface rendering, and shadowing can interfere with interpretation.

An estimated 10% of ultrasound units currently have this technology, he said.

Absence of a T12 rib on one side in a fetus with balanced translocation was missed by 2-D ultrasound, shown by 3-D.

3-D ultrasound clearly shows swelling of the dorsal aspect of both feet in a fetus with Turner syndrome. Photos courtesy Dr. Alfred Z. Abuhamad

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Mild Postpartum Depression: Try Nondrug Options

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NEW YORK — Nonpharmacologic treatments are particularly worth considering when mood problems develop during pregnancy and in the postpartum period, Linda S. Mullen, M.D., said at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

Medication should not be dismissed as an option, however, and is generally preferable when symptoms are severe.

Pregnancy itself appears to be neither a time of particular mental well-being nor vulnerability; surveys find that about 20% of women suffer from mood or anxiety disorders at this time, essentially the same proportion as women in general, said Dr. Mullen, director of women's mental health at the university and the hospital.

But such difficulties clearly are more common in the postpartum period and run along a spectrum of severity from “baby blues” to psychosis.

“Postpartum blues” are extremely common, affecting 50%–85% of women. Rather than depression, typical symptoms are mood lability, anxiety, irritability, and difficulty in eating, sleeping, and caring for oneself and the baby. These symptoms may be troubling, but do not interfere markedly with functioning; they usually peak 4–5 days post partum and resolve by day 10.

“Reassurance rather than treatment is generally enough,” Dr. Mullen said. But if difficulties persist for at least 2 weeks, an evaluation for serious mood disorder is in order.

About one-fourth of women with postpartum blues later develop clinically significant depression, she said.

Postpartum depression actually can emerge any time within 2–3 months of childbirth. It is clinically indistinguishable from depression generally and may include comorbid anxiety syndromes such as panic, obsessive-compulsive disorder, or generalized anxiety.

“Many women don't come to see the physician until late; they think what they experience is a normal part of the postpartum, or feel ashamed at their difficulties in caring for their baby,” Dr. Mullen said.

Unlike depression in other groups, age, marital status, education level, and socioeconomic status are not associated with increased prevalence, but marital problems, inadequate social support, and recent stressful life events are major risk factors. Women with a history of depression also are at increased risk, she said.

Treatment depends in part on severity. For mild to moderate symptoms, certain types of psychotherapy seem as effective as medication and are preferred by many women, particularly those who are breastfeeding.

Cognitive-behavioral therapy, in particular, has been shown to be as effective as fluoxetine. Interpersonal therapy, which focuses on relationship issues, has also been found efficacious in mild to moderate depression in the postpartum. “It may be especially useful for women with marital difficulties,” Dr. Mullen said.

Couples therapy and group therapy are also helpful, and there is some evidence that psychoeducational groups for pregnant women at risk may prevent postpartum depression. Psychosocial management should include interventions to increase social support and help with child care, she said.

Light therapy appears to be effective for depression during pregnancy, and may be helpful in the postpartum as well.

When medication is necessary or preferred, conventional antidepressants at standard doses are as efficacious for postpartum depression as for depression generally.

Selective serotonin reuptake inhibitors are the agents of choice, and benzodiazepines may be added for concurrent anxiety, particularly in the first weeks of treatment.

The addition of psychotherapy makes medication more effective, Dr. Mullen said.

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NEW YORK — Nonpharmacologic treatments are particularly worth considering when mood problems develop during pregnancy and in the postpartum period, Linda S. Mullen, M.D., said at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

Medication should not be dismissed as an option, however, and is generally preferable when symptoms are severe.

Pregnancy itself appears to be neither a time of particular mental well-being nor vulnerability; surveys find that about 20% of women suffer from mood or anxiety disorders at this time, essentially the same proportion as women in general, said Dr. Mullen, director of women's mental health at the university and the hospital.

But such difficulties clearly are more common in the postpartum period and run along a spectrum of severity from “baby blues” to psychosis.

“Postpartum blues” are extremely common, affecting 50%–85% of women. Rather than depression, typical symptoms are mood lability, anxiety, irritability, and difficulty in eating, sleeping, and caring for oneself and the baby. These symptoms may be troubling, but do not interfere markedly with functioning; they usually peak 4–5 days post partum and resolve by day 10.

“Reassurance rather than treatment is generally enough,” Dr. Mullen said. But if difficulties persist for at least 2 weeks, an evaluation for serious mood disorder is in order.

About one-fourth of women with postpartum blues later develop clinically significant depression, she said.

Postpartum depression actually can emerge any time within 2–3 months of childbirth. It is clinically indistinguishable from depression generally and may include comorbid anxiety syndromes such as panic, obsessive-compulsive disorder, or generalized anxiety.

“Many women don't come to see the physician until late; they think what they experience is a normal part of the postpartum, or feel ashamed at their difficulties in caring for their baby,” Dr. Mullen said.

Unlike depression in other groups, age, marital status, education level, and socioeconomic status are not associated with increased prevalence, but marital problems, inadequate social support, and recent stressful life events are major risk factors. Women with a history of depression also are at increased risk, she said.

Treatment depends in part on severity. For mild to moderate symptoms, certain types of psychotherapy seem as effective as medication and are preferred by many women, particularly those who are breastfeeding.

Cognitive-behavioral therapy, in particular, has been shown to be as effective as fluoxetine. Interpersonal therapy, which focuses on relationship issues, has also been found efficacious in mild to moderate depression in the postpartum. “It may be especially useful for women with marital difficulties,” Dr. Mullen said.

Couples therapy and group therapy are also helpful, and there is some evidence that psychoeducational groups for pregnant women at risk may prevent postpartum depression. Psychosocial management should include interventions to increase social support and help with child care, she said.

Light therapy appears to be effective for depression during pregnancy, and may be helpful in the postpartum as well.

When medication is necessary or preferred, conventional antidepressants at standard doses are as efficacious for postpartum depression as for depression generally.

Selective serotonin reuptake inhibitors are the agents of choice, and benzodiazepines may be added for concurrent anxiety, particularly in the first weeks of treatment.

The addition of psychotherapy makes medication more effective, Dr. Mullen said.

NEW YORK — Nonpharmacologic treatments are particularly worth considering when mood problems develop during pregnancy and in the postpartum period, Linda S. Mullen, M.D., said at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

Medication should not be dismissed as an option, however, and is generally preferable when symptoms are severe.

Pregnancy itself appears to be neither a time of particular mental well-being nor vulnerability; surveys find that about 20% of women suffer from mood or anxiety disorders at this time, essentially the same proportion as women in general, said Dr. Mullen, director of women's mental health at the university and the hospital.

But such difficulties clearly are more common in the postpartum period and run along a spectrum of severity from “baby blues” to psychosis.

“Postpartum blues” are extremely common, affecting 50%–85% of women. Rather than depression, typical symptoms are mood lability, anxiety, irritability, and difficulty in eating, sleeping, and caring for oneself and the baby. These symptoms may be troubling, but do not interfere markedly with functioning; they usually peak 4–5 days post partum and resolve by day 10.

“Reassurance rather than treatment is generally enough,” Dr. Mullen said. But if difficulties persist for at least 2 weeks, an evaluation for serious mood disorder is in order.

About one-fourth of women with postpartum blues later develop clinically significant depression, she said.

Postpartum depression actually can emerge any time within 2–3 months of childbirth. It is clinically indistinguishable from depression generally and may include comorbid anxiety syndromes such as panic, obsessive-compulsive disorder, or generalized anxiety.

“Many women don't come to see the physician until late; they think what they experience is a normal part of the postpartum, or feel ashamed at their difficulties in caring for their baby,” Dr. Mullen said.

Unlike depression in other groups, age, marital status, education level, and socioeconomic status are not associated with increased prevalence, but marital problems, inadequate social support, and recent stressful life events are major risk factors. Women with a history of depression also are at increased risk, she said.

Treatment depends in part on severity. For mild to moderate symptoms, certain types of psychotherapy seem as effective as medication and are preferred by many women, particularly those who are breastfeeding.

Cognitive-behavioral therapy, in particular, has been shown to be as effective as fluoxetine. Interpersonal therapy, which focuses on relationship issues, has also been found efficacious in mild to moderate depression in the postpartum. “It may be especially useful for women with marital difficulties,” Dr. Mullen said.

Couples therapy and group therapy are also helpful, and there is some evidence that psychoeducational groups for pregnant women at risk may prevent postpartum depression. Psychosocial management should include interventions to increase social support and help with child care, she said.

Light therapy appears to be effective for depression during pregnancy, and may be helpful in the postpartum as well.

When medication is necessary or preferred, conventional antidepressants at standard doses are as efficacious for postpartum depression as for depression generally.

Selective serotonin reuptake inhibitors are the agents of choice, and benzodiazepines may be added for concurrent anxiety, particularly in the first weeks of treatment.

The addition of psychotherapy makes medication more effective, Dr. Mullen said.

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Buprenorphine Combo Aids Detoxification

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NEW YORK – Buprenorphine, particularly in combination with naloxone, offers a safe and effective approach to the office-based management of opiate addiction, Walter Ling, M.D., said at the annual conference of the Association for Research in Nervous and Mental Disease.

Buprenorphine represents “a treatment strategy and treatment philosophy” as well as a medication, and has the potential to “return the treatment of opiate addiction to the hands of physicians … for the first time in nearly a century,” said Dr. Ling, professor of psychiatry and director of the substance abuse program at the University of California, Los Angeles.

The clinical advantages of buprenorphine over opiate-replacement drugs like methadone reflect its pharmacologic properties. As a partial agonist of the μ-opiate receptor, the drug has both agonist- and antagonistlike actions, depending on concentration. The potential for dependence is low, and a ceiling effect creates a high safety profile. Tight receptor binding means a long duration of action, which slows the onset of abstinence and attenuates withdrawal symptoms.

Buprenorphine can be made even safer with the addition of the opiate antagonist naloxone in a sublingual preparation (commercially available as Suboxone). Buprenorphine is absorbed far more readily than naloxone in this form (70% vs. 10%), but the difference is lost if the combination is taken via another route.

“If injected, it will precipitate withdrawal,” Dr. Ling said at the meeting, cosponsored by the New York Academy of Medicine.

The sublingual formulation has little street value, discourages intravenous use, and allows for flexible dosing, he said.

Studies upon which the approval of buprenorphine was based showed that it is safe and effective relative to methadone and placebo. In those trials, drug-free urine samples increased in a dose-related manner, Dr. Ling said.

A trial of the buprenorphine-naloxone combination showed the feasibility of providing it for maintenance to detoxified, stabilized patients through the intended route of delivery via the private physician's office and community pharmacy. The retention rate was high. “Physicians and patients liked it,” he said.

Other research suggests the utility of buprenorphine-naloxone for detoxification in the inpatient or outpatient setting. In both cases, the drug was compared with clonidine, which is conventionally used in this application.

In the inpatient setting, 75% of patients who underwent detoxification assisted by buprenorphine-naloxone remained in the study and were drug free (as confirmed by urine samples) after 13 weeks, compared with 30% using clonidine.

In the outpatient application, 30% of buprenorphine-naloxone patients remained and had clean urine tests, compared with 5% with clonidine, he said.

The inpatient study indicated that it would be necessary to treat 3.4 times as many patients with clonidine than with buprenorphine-naloxone to achieve one successful detoxification. With outpatients, the ratio was 5.4:1, Dr. Ling said.

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NEW YORK – Buprenorphine, particularly in combination with naloxone, offers a safe and effective approach to the office-based management of opiate addiction, Walter Ling, M.D., said at the annual conference of the Association for Research in Nervous and Mental Disease.

Buprenorphine represents “a treatment strategy and treatment philosophy” as well as a medication, and has the potential to “return the treatment of opiate addiction to the hands of physicians … for the first time in nearly a century,” said Dr. Ling, professor of psychiatry and director of the substance abuse program at the University of California, Los Angeles.

The clinical advantages of buprenorphine over opiate-replacement drugs like methadone reflect its pharmacologic properties. As a partial agonist of the μ-opiate receptor, the drug has both agonist- and antagonistlike actions, depending on concentration. The potential for dependence is low, and a ceiling effect creates a high safety profile. Tight receptor binding means a long duration of action, which slows the onset of abstinence and attenuates withdrawal symptoms.

Buprenorphine can be made even safer with the addition of the opiate antagonist naloxone in a sublingual preparation (commercially available as Suboxone). Buprenorphine is absorbed far more readily than naloxone in this form (70% vs. 10%), but the difference is lost if the combination is taken via another route.

“If injected, it will precipitate withdrawal,” Dr. Ling said at the meeting, cosponsored by the New York Academy of Medicine.

The sublingual formulation has little street value, discourages intravenous use, and allows for flexible dosing, he said.

Studies upon which the approval of buprenorphine was based showed that it is safe and effective relative to methadone and placebo. In those trials, drug-free urine samples increased in a dose-related manner, Dr. Ling said.

A trial of the buprenorphine-naloxone combination showed the feasibility of providing it for maintenance to detoxified, stabilized patients through the intended route of delivery via the private physician's office and community pharmacy. The retention rate was high. “Physicians and patients liked it,” he said.

Other research suggests the utility of buprenorphine-naloxone for detoxification in the inpatient or outpatient setting. In both cases, the drug was compared with clonidine, which is conventionally used in this application.

In the inpatient setting, 75% of patients who underwent detoxification assisted by buprenorphine-naloxone remained in the study and were drug free (as confirmed by urine samples) after 13 weeks, compared with 30% using clonidine.

In the outpatient application, 30% of buprenorphine-naloxone patients remained and had clean urine tests, compared with 5% with clonidine, he said.

The inpatient study indicated that it would be necessary to treat 3.4 times as many patients with clonidine than with buprenorphine-naloxone to achieve one successful detoxification. With outpatients, the ratio was 5.4:1, Dr. Ling said.

NEW YORK – Buprenorphine, particularly in combination with naloxone, offers a safe and effective approach to the office-based management of opiate addiction, Walter Ling, M.D., said at the annual conference of the Association for Research in Nervous and Mental Disease.

Buprenorphine represents “a treatment strategy and treatment philosophy” as well as a medication, and has the potential to “return the treatment of opiate addiction to the hands of physicians … for the first time in nearly a century,” said Dr. Ling, professor of psychiatry and director of the substance abuse program at the University of California, Los Angeles.

The clinical advantages of buprenorphine over opiate-replacement drugs like methadone reflect its pharmacologic properties. As a partial agonist of the μ-opiate receptor, the drug has both agonist- and antagonistlike actions, depending on concentration. The potential for dependence is low, and a ceiling effect creates a high safety profile. Tight receptor binding means a long duration of action, which slows the onset of abstinence and attenuates withdrawal symptoms.

Buprenorphine can be made even safer with the addition of the opiate antagonist naloxone in a sublingual preparation (commercially available as Suboxone). Buprenorphine is absorbed far more readily than naloxone in this form (70% vs. 10%), but the difference is lost if the combination is taken via another route.

“If injected, it will precipitate withdrawal,” Dr. Ling said at the meeting, cosponsored by the New York Academy of Medicine.

The sublingual formulation has little street value, discourages intravenous use, and allows for flexible dosing, he said.

Studies upon which the approval of buprenorphine was based showed that it is safe and effective relative to methadone and placebo. In those trials, drug-free urine samples increased in a dose-related manner, Dr. Ling said.

A trial of the buprenorphine-naloxone combination showed the feasibility of providing it for maintenance to detoxified, stabilized patients through the intended route of delivery via the private physician's office and community pharmacy. The retention rate was high. “Physicians and patients liked it,” he said.

Other research suggests the utility of buprenorphine-naloxone for detoxification in the inpatient or outpatient setting. In both cases, the drug was compared with clonidine, which is conventionally used in this application.

In the inpatient setting, 75% of patients who underwent detoxification assisted by buprenorphine-naloxone remained in the study and were drug free (as confirmed by urine samples) after 13 weeks, compared with 30% using clonidine.

In the outpatient application, 30% of buprenorphine-naloxone patients remained and had clean urine tests, compared with 5% with clonidine, he said.

The inpatient study indicated that it would be necessary to treat 3.4 times as many patients with clonidine than with buprenorphine-naloxone to achieve one successful detoxification. With outpatients, the ratio was 5.4:1, Dr. Ling said.

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Vaginal Misoprostol for Early Failed Pregnancy

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NEW YORK — Vaginal misoprostol is an effective alternative to surgical intervention for management of early pregnancy failure, with a high degree of patient acceptability, according to a study reported at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

The more tissue present, the higher the success rate; surgical intervention is less often needed for embryonic or fetal demise and incomplete abortion than for anembryonic gestations.

Failed pregnancy in the first trimester is followed by spontaneous uterine expulsion of the products of conception in up to 80% of cases, but this may take 2 months, and many women don't want to wait. “About 60% prefer treatment to expectant management,” Carolyn Westhoff, M.D., professor of obstetrics and gynecology, epidemiology and population and family health at the university, said at the meeting.

The standard of care has become dilatation and curettage (D&C), increasingly done as an office procedure using vacuum aspiration.

Use of the synthetic prostaglandin analog misoprostol for early pregnancy failure has been reported since 1983, usually involving hospital admission and repeated administration by various routes. Definitions of success have varied (depending on time allowed for effect), and few have involved comparison groups.

It appears that vaginal administration is most effective; in four trials involving a total of 123 women, the drug in this form resulted in expulsion of 60%-90% of embryos of up to 13-week size, Dr. Westhoff said.

In a 2004 NIH pilot trial of vaginal misoprostol for anembryonic gestation and fetal/embryonic demise, a single application (repeated if necessary, after 48 hours) was successful (expulsion by 1 week, without the need for D&C) in 94% of 51 cases of embryonic/fetal demise, and in 69% of 29 anembryonic gestations.

Dr. Westhoff reported findings of a randomized multicenter trial conducted under the auspices of the National Institutes of Child and Maternal Health, which enrolled 652 women with early pregnancy failure (at less than 12 weeks' gestation or size).

Two-thirds of the women were given a single 800-mcg dose of vaginal misoprostol—the other women had D&C—with a second administration if a sac or lining of more than 30 mm was still present on transvaginal ultrasound examination at day 2. Vacuum aspiration was provided on request for medical indications such as heavy bleeding, or when expulsion had not occurred within 1 week.

Expulsion was most likely to be complete by day 3 among the 30 women who had had incomplete or inevitable abortion, a pattern that held on day 8, when 93% in this group had successfully expelled the products of conception, compared with 87% of the 281 women with embryonic or fetal demise and 81% of the 177 women with anembryonic gestation.

“Women with incomplete/inevitable abortion and intrauterine fetal demise did very well with misoprostol alone; most required only one dose. The results were less impressive for anembryonic gestation,” Dr. Westhoff said.

More than 80% of participants in every category said they would recommend the procedure to a friend, if the need arose, and more than 75% said they would opt for it themselves. “Acceptance was highest in the incomplete-abortion group,” she said.

One lesson from the trial was the clinical importance of a follow-up visit 2 days after misoprostol insertion. “A number of patients had tissue in the internal os, with attendant bleeding. It needed just ring forceps for removal, but if this had not been done, some [cases] would have turned into an emergency,” Dr. Westhoff said.

Only 28% of women telephoned their medical providers during the trial, perhaps reflecting the value of counseling on what symptoms to expect, she said.

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NEW YORK — Vaginal misoprostol is an effective alternative to surgical intervention for management of early pregnancy failure, with a high degree of patient acceptability, according to a study reported at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

The more tissue present, the higher the success rate; surgical intervention is less often needed for embryonic or fetal demise and incomplete abortion than for anembryonic gestations.

Failed pregnancy in the first trimester is followed by spontaneous uterine expulsion of the products of conception in up to 80% of cases, but this may take 2 months, and many women don't want to wait. “About 60% prefer treatment to expectant management,” Carolyn Westhoff, M.D., professor of obstetrics and gynecology, epidemiology and population and family health at the university, said at the meeting.

The standard of care has become dilatation and curettage (D&C), increasingly done as an office procedure using vacuum aspiration.

Use of the synthetic prostaglandin analog misoprostol for early pregnancy failure has been reported since 1983, usually involving hospital admission and repeated administration by various routes. Definitions of success have varied (depending on time allowed for effect), and few have involved comparison groups.

It appears that vaginal administration is most effective; in four trials involving a total of 123 women, the drug in this form resulted in expulsion of 60%-90% of embryos of up to 13-week size, Dr. Westhoff said.

In a 2004 NIH pilot trial of vaginal misoprostol for anembryonic gestation and fetal/embryonic demise, a single application (repeated if necessary, after 48 hours) was successful (expulsion by 1 week, without the need for D&C) in 94% of 51 cases of embryonic/fetal demise, and in 69% of 29 anembryonic gestations.

Dr. Westhoff reported findings of a randomized multicenter trial conducted under the auspices of the National Institutes of Child and Maternal Health, which enrolled 652 women with early pregnancy failure (at less than 12 weeks' gestation or size).

Two-thirds of the women were given a single 800-mcg dose of vaginal misoprostol—the other women had D&C—with a second administration if a sac or lining of more than 30 mm was still present on transvaginal ultrasound examination at day 2. Vacuum aspiration was provided on request for medical indications such as heavy bleeding, or when expulsion had not occurred within 1 week.

Expulsion was most likely to be complete by day 3 among the 30 women who had had incomplete or inevitable abortion, a pattern that held on day 8, when 93% in this group had successfully expelled the products of conception, compared with 87% of the 281 women with embryonic or fetal demise and 81% of the 177 women with anembryonic gestation.

“Women with incomplete/inevitable abortion and intrauterine fetal demise did very well with misoprostol alone; most required only one dose. The results were less impressive for anembryonic gestation,” Dr. Westhoff said.

More than 80% of participants in every category said they would recommend the procedure to a friend, if the need arose, and more than 75% said they would opt for it themselves. “Acceptance was highest in the incomplete-abortion group,” she said.

One lesson from the trial was the clinical importance of a follow-up visit 2 days after misoprostol insertion. “A number of patients had tissue in the internal os, with attendant bleeding. It needed just ring forceps for removal, but if this had not been done, some [cases] would have turned into an emergency,” Dr. Westhoff said.

Only 28% of women telephoned their medical providers during the trial, perhaps reflecting the value of counseling on what symptoms to expect, she said.

NEW YORK — Vaginal misoprostol is an effective alternative to surgical intervention for management of early pregnancy failure, with a high degree of patient acceptability, according to a study reported at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

The more tissue present, the higher the success rate; surgical intervention is less often needed for embryonic or fetal demise and incomplete abortion than for anembryonic gestations.

Failed pregnancy in the first trimester is followed by spontaneous uterine expulsion of the products of conception in up to 80% of cases, but this may take 2 months, and many women don't want to wait. “About 60% prefer treatment to expectant management,” Carolyn Westhoff, M.D., professor of obstetrics and gynecology, epidemiology and population and family health at the university, said at the meeting.

The standard of care has become dilatation and curettage (D&C), increasingly done as an office procedure using vacuum aspiration.

Use of the synthetic prostaglandin analog misoprostol for early pregnancy failure has been reported since 1983, usually involving hospital admission and repeated administration by various routes. Definitions of success have varied (depending on time allowed for effect), and few have involved comparison groups.

It appears that vaginal administration is most effective; in four trials involving a total of 123 women, the drug in this form resulted in expulsion of 60%-90% of embryos of up to 13-week size, Dr. Westhoff said.

In a 2004 NIH pilot trial of vaginal misoprostol for anembryonic gestation and fetal/embryonic demise, a single application (repeated if necessary, after 48 hours) was successful (expulsion by 1 week, without the need for D&C) in 94% of 51 cases of embryonic/fetal demise, and in 69% of 29 anembryonic gestations.

Dr. Westhoff reported findings of a randomized multicenter trial conducted under the auspices of the National Institutes of Child and Maternal Health, which enrolled 652 women with early pregnancy failure (at less than 12 weeks' gestation or size).

Two-thirds of the women were given a single 800-mcg dose of vaginal misoprostol—the other women had D&C—with a second administration if a sac or lining of more than 30 mm was still present on transvaginal ultrasound examination at day 2. Vacuum aspiration was provided on request for medical indications such as heavy bleeding, or when expulsion had not occurred within 1 week.

Expulsion was most likely to be complete by day 3 among the 30 women who had had incomplete or inevitable abortion, a pattern that held on day 8, when 93% in this group had successfully expelled the products of conception, compared with 87% of the 281 women with embryonic or fetal demise and 81% of the 177 women with anembryonic gestation.

“Women with incomplete/inevitable abortion and intrauterine fetal demise did very well with misoprostol alone; most required only one dose. The results were less impressive for anembryonic gestation,” Dr. Westhoff said.

More than 80% of participants in every category said they would recommend the procedure to a friend, if the need arose, and more than 75% said they would opt for it themselves. “Acceptance was highest in the incomplete-abortion group,” she said.

One lesson from the trial was the clinical importance of a follow-up visit 2 days after misoprostol insertion. “A number of patients had tissue in the internal os, with attendant bleeding. It needed just ring forceps for removal, but if this had not been done, some [cases] would have turned into an emergency,” Dr. Westhoff said.

Only 28% of women telephoned their medical providers during the trial, perhaps reflecting the value of counseling on what symptoms to expect, she said.

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Nondrug Options May Help Ease Depression : Some types of psychotherapy are as effective as medication in treating pregnancy-related depression.

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NEW YORK — Nonpharmacologic treatments are particularly worth considering when mood problems develop during pregnancy and in the postpartum period, Linda S. Mullen, M.D., said at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

Medication should not be dismissed as an option, however, and is generally preferable when symptoms are severe.

Pregnancy itself appears to be neither a time of particular mental well-being nor vulnerability; surveys find that about 20% of women suffer from mood or anxiety disorders at this time, essentially the same proportion as women in general, said Dr. Mullen, director of women's mental health at the university and the hospital.

But such difficulties clearly are more common in the postpartum period and run along a spectrum of severity from “baby blues” to psychosis.

“Postpartum blues” are extremely common, affecting 50%ndash;85% of women. Rather than depression, typical symptoms are mood lability, anxiety, irritability, and difficulty in eating, sleeping, and caring for oneself and the baby. These symptoms may be troubling, but do not interfere markedly with functioning; they usually peak 4ndash;5 days post partum and resolve by day 10.

“Reassurance rather than treatment is generally enough,” Dr. Mullen said. But if difficulties persist for at least 2 weeks, an evaluation for serious mood disorder is in order.

About one-fourth of women with postpartum blues later develop clinically significant depression, she said.

Postpartum depression actually can emerge any time within 2ndash;3 months of childbirth. It is clinically indistinguishable from depression generally and may include comorbid anxiety syndromes such as panic, obsessive-compulsive disorder, or generalized anxiety.

“Many women don't come to see the physician until late; they think what they experience is a normal part of the postpartum, or feel ashamed at their difficulties in caring for their baby,” Dr. Mullen said.

Unlike depression in other groups, age, marital status, education level, and socioeconomic status are not associated with increased prevalence, but marital problems, inadequate social support, and recent stressful life events are major risk factors. Women with a history of depression also are at increased risk, she said.

Treatment depends in part on severity. For mild to moderate symptoms, certain types of psychotherapy seem as effective as medication and are preferred by many women, particularly those who are breastfeeding.

Cognitive-behavioral therapy, in particular, has been shown to be as effective as fluoxetine. Interpersonal therapy, which focuses on relationship issues, has also been found efficacious in mild to moderate depression in the postpartum. “It may be especially useful for women with marital difficulties,” Dr. Mullen said.

Couples therapy and group therapy are also helpful, and there is some evidence that psychoeducational groups for pregnant women at risk may prevent postpartum depression. Psychosocial management should include interventions to increase social support and help with childcare, she said.

Light therapy appears to be effective for depression during pregnancy, and may be helpful in the postpartum as well.

When medication is necessary or preferred, conventional antidepressants at standard doses are as efficacious for postpartum depression as for depression generally. Selective serotonin reuptake inhibitors are the agents of choice, and benzodiazepines may be added for concurrent anxiety, particularly in the first weeks of treatment.

The addition of psychotherapy actually makes medication more effective, Dr. Mullen said.

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NEW YORK — Nonpharmacologic treatments are particularly worth considering when mood problems develop during pregnancy and in the postpartum period, Linda S. Mullen, M.D., said at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

Medication should not be dismissed as an option, however, and is generally preferable when symptoms are severe.

Pregnancy itself appears to be neither a time of particular mental well-being nor vulnerability; surveys find that about 20% of women suffer from mood or anxiety disorders at this time, essentially the same proportion as women in general, said Dr. Mullen, director of women's mental health at the university and the hospital.

But such difficulties clearly are more common in the postpartum period and run along a spectrum of severity from “baby blues” to psychosis.

“Postpartum blues” are extremely common, affecting 50%ndash;85% of women. Rather than depression, typical symptoms are mood lability, anxiety, irritability, and difficulty in eating, sleeping, and caring for oneself and the baby. These symptoms may be troubling, but do not interfere markedly with functioning; they usually peak 4ndash;5 days post partum and resolve by day 10.

“Reassurance rather than treatment is generally enough,” Dr. Mullen said. But if difficulties persist for at least 2 weeks, an evaluation for serious mood disorder is in order.

About one-fourth of women with postpartum blues later develop clinically significant depression, she said.

Postpartum depression actually can emerge any time within 2ndash;3 months of childbirth. It is clinically indistinguishable from depression generally and may include comorbid anxiety syndromes such as panic, obsessive-compulsive disorder, or generalized anxiety.

“Many women don't come to see the physician until late; they think what they experience is a normal part of the postpartum, or feel ashamed at their difficulties in caring for their baby,” Dr. Mullen said.

Unlike depression in other groups, age, marital status, education level, and socioeconomic status are not associated with increased prevalence, but marital problems, inadequate social support, and recent stressful life events are major risk factors. Women with a history of depression also are at increased risk, she said.

Treatment depends in part on severity. For mild to moderate symptoms, certain types of psychotherapy seem as effective as medication and are preferred by many women, particularly those who are breastfeeding.

Cognitive-behavioral therapy, in particular, has been shown to be as effective as fluoxetine. Interpersonal therapy, which focuses on relationship issues, has also been found efficacious in mild to moderate depression in the postpartum. “It may be especially useful for women with marital difficulties,” Dr. Mullen said.

Couples therapy and group therapy are also helpful, and there is some evidence that psychoeducational groups for pregnant women at risk may prevent postpartum depression. Psychosocial management should include interventions to increase social support and help with childcare, she said.

Light therapy appears to be effective for depression during pregnancy, and may be helpful in the postpartum as well.

When medication is necessary or preferred, conventional antidepressants at standard doses are as efficacious for postpartum depression as for depression generally. Selective serotonin reuptake inhibitors are the agents of choice, and benzodiazepines may be added for concurrent anxiety, particularly in the first weeks of treatment.

The addition of psychotherapy actually makes medication more effective, Dr. Mullen said.

NEW YORK — Nonpharmacologic treatments are particularly worth considering when mood problems develop during pregnancy and in the postpartum period, Linda S. Mullen, M.D., said at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

Medication should not be dismissed as an option, however, and is generally preferable when symptoms are severe.

Pregnancy itself appears to be neither a time of particular mental well-being nor vulnerability; surveys find that about 20% of women suffer from mood or anxiety disorders at this time, essentially the same proportion as women in general, said Dr. Mullen, director of women's mental health at the university and the hospital.

But such difficulties clearly are more common in the postpartum period and run along a spectrum of severity from “baby blues” to psychosis.

“Postpartum blues” are extremely common, affecting 50%ndash;85% of women. Rather than depression, typical symptoms are mood lability, anxiety, irritability, and difficulty in eating, sleeping, and caring for oneself and the baby. These symptoms may be troubling, but do not interfere markedly with functioning; they usually peak 4ndash;5 days post partum and resolve by day 10.

“Reassurance rather than treatment is generally enough,” Dr. Mullen said. But if difficulties persist for at least 2 weeks, an evaluation for serious mood disorder is in order.

About one-fourth of women with postpartum blues later develop clinically significant depression, she said.

Postpartum depression actually can emerge any time within 2ndash;3 months of childbirth. It is clinically indistinguishable from depression generally and may include comorbid anxiety syndromes such as panic, obsessive-compulsive disorder, or generalized anxiety.

“Many women don't come to see the physician until late; they think what they experience is a normal part of the postpartum, or feel ashamed at their difficulties in caring for their baby,” Dr. Mullen said.

Unlike depression in other groups, age, marital status, education level, and socioeconomic status are not associated with increased prevalence, but marital problems, inadequate social support, and recent stressful life events are major risk factors. Women with a history of depression also are at increased risk, she said.

Treatment depends in part on severity. For mild to moderate symptoms, certain types of psychotherapy seem as effective as medication and are preferred by many women, particularly those who are breastfeeding.

Cognitive-behavioral therapy, in particular, has been shown to be as effective as fluoxetine. Interpersonal therapy, which focuses on relationship issues, has also been found efficacious in mild to moderate depression in the postpartum. “It may be especially useful for women with marital difficulties,” Dr. Mullen said.

Couples therapy and group therapy are also helpful, and there is some evidence that psychoeducational groups for pregnant women at risk may prevent postpartum depression. Psychosocial management should include interventions to increase social support and help with childcare, she said.

Light therapy appears to be effective for depression during pregnancy, and may be helpful in the postpartum as well.

When medication is necessary or preferred, conventional antidepressants at standard doses are as efficacious for postpartum depression as for depression generally. Selective serotonin reuptake inhibitors are the agents of choice, and benzodiazepines may be added for concurrent anxiety, particularly in the first weeks of treatment.

The addition of psychotherapy actually makes medication more effective, Dr. Mullen said.

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3-D Ultrasound Reveals 'Tremendous Detail'

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NEW YORK — Three-dimensional ultrasound represents an emerging advance in imaging with important applications in obstetrics, Alfred Z. Abuhamad, M.D., said at an obstetrics symposium that was sponsored by Columbia University and New York Presbyterian Hospital.

The ability to rotate images, change planes, and manipulate displays according to signal strength makes it possible to visualize skeletal and vascular structures and fluid spaces, in addition to providing detailed views of fetal appearance, according to Dr. Abuhamad, who is professor and chair of obstetrics and gynecology and the director of the division of maternal-fetal medicine at Eastern Virginia Medical School, Norfolk.

The term “3-D” is something of a misnomer in that the image is displayed on a 2-D monitor.

“[Instead of '3-D'] the term should be volume sonography that gives the appearance of depth,” Dr. Abuhamad said.

The volume image is created by the summation of 2-D slices from multiple planes, as the probe is steered from side to side.

The size of the acquired image is determined by the angle across which the probe is moved. Since fetal movement makes the speed of volume acquisition highly important, “we use the smallest angle [needed for evaluation of the structure of interest] in the smallest box,” Dr. Abuhamad said.

With a multiplanar display, an image constructed from sagittal, coronal, and transverse planes can be rotated along the x-, y-, and z-axis to visualize the same structure from different angles. To maintain orientation, it is helpful to determine a reference point, and it may be necessary to use 2-D ultrasound to locate key structures.

The surface display shows the external aspects of the fetus, allowing the same views as in 2-D ultrasound, to review in “tremendous detail” such fetal abnormalities as clefting of the lip and palate, he said during the meeting.

With “maximum mode,” which manipulates the signal to enhance light (i.e. echoic) objects and dim dark (anechoic) ones, skeletal structures can be visualized, affording a look at the cranium and its fontanelles and sutures.

It also facilitates assessment of bone quality and detection of fractures and permits close examination of the vertebral column.

“It's like an x-ray of the fetus,” Dr. Abuhamad commented.

“Minimum mode” reveals vasculature; while “inversion mode,” which dims light structures and highlights dim ones, brings out fluid cavities and makes it possible to visualize such structures as the chambers of the heart and determine the number of gestational sacs, he said.

Other image manipulations permit the clinician to see the back of structures and to remove from the image, as with an “electronic scalpel,” structures that may obscure features of interest.

The 3-D procedure does not use more power, increase fetal exposure, or magnify the thermal effect, compared with 2-D ultrasound, he said.

Limitations of the technique include a steep learning curve and the need to dedicate sufficient time for training.

The quality of the volume image is limited by 2-D resolution. Artifacts such as motion of the woman or fetus, surface rendering, and shadowing can interfere with interpretation.

The technique is highly operator dependent, and the lack of standardization magnifies the possibility of human error, Dr. Abuhamad said.

An estimated 10% of ultrasound units currently have this technology, he said.

This 3-D image shows an absent T12 rib on one side in a fetus with balanced translocation.

Swelling involving the dorsal aspect of both feet in a fetus with Turner syndrome is shown here on 3D ultrasound. Photos courtesy Dr. Alfred Z. Abuhamad

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NEW YORK — Three-dimensional ultrasound represents an emerging advance in imaging with important applications in obstetrics, Alfred Z. Abuhamad, M.D., said at an obstetrics symposium that was sponsored by Columbia University and New York Presbyterian Hospital.

The ability to rotate images, change planes, and manipulate displays according to signal strength makes it possible to visualize skeletal and vascular structures and fluid spaces, in addition to providing detailed views of fetal appearance, according to Dr. Abuhamad, who is professor and chair of obstetrics and gynecology and the director of the division of maternal-fetal medicine at Eastern Virginia Medical School, Norfolk.

The term “3-D” is something of a misnomer in that the image is displayed on a 2-D monitor.

“[Instead of '3-D'] the term should be volume sonography that gives the appearance of depth,” Dr. Abuhamad said.

The volume image is created by the summation of 2-D slices from multiple planes, as the probe is steered from side to side.

The size of the acquired image is determined by the angle across which the probe is moved. Since fetal movement makes the speed of volume acquisition highly important, “we use the smallest angle [needed for evaluation of the structure of interest] in the smallest box,” Dr. Abuhamad said.

With a multiplanar display, an image constructed from sagittal, coronal, and transverse planes can be rotated along the x-, y-, and z-axis to visualize the same structure from different angles. To maintain orientation, it is helpful to determine a reference point, and it may be necessary to use 2-D ultrasound to locate key structures.

The surface display shows the external aspects of the fetus, allowing the same views as in 2-D ultrasound, to review in “tremendous detail” such fetal abnormalities as clefting of the lip and palate, he said during the meeting.

With “maximum mode,” which manipulates the signal to enhance light (i.e. echoic) objects and dim dark (anechoic) ones, skeletal structures can be visualized, affording a look at the cranium and its fontanelles and sutures.

It also facilitates assessment of bone quality and detection of fractures and permits close examination of the vertebral column.

“It's like an x-ray of the fetus,” Dr. Abuhamad commented.

“Minimum mode” reveals vasculature; while “inversion mode,” which dims light structures and highlights dim ones, brings out fluid cavities and makes it possible to visualize such structures as the chambers of the heart and determine the number of gestational sacs, he said.

Other image manipulations permit the clinician to see the back of structures and to remove from the image, as with an “electronic scalpel,” structures that may obscure features of interest.

The 3-D procedure does not use more power, increase fetal exposure, or magnify the thermal effect, compared with 2-D ultrasound, he said.

Limitations of the technique include a steep learning curve and the need to dedicate sufficient time for training.

The quality of the volume image is limited by 2-D resolution. Artifacts such as motion of the woman or fetus, surface rendering, and shadowing can interfere with interpretation.

The technique is highly operator dependent, and the lack of standardization magnifies the possibility of human error, Dr. Abuhamad said.

An estimated 10% of ultrasound units currently have this technology, he said.

This 3-D image shows an absent T12 rib on one side in a fetus with balanced translocation.

Swelling involving the dorsal aspect of both feet in a fetus with Turner syndrome is shown here on 3D ultrasound. Photos courtesy Dr. Alfred Z. Abuhamad

NEW YORK — Three-dimensional ultrasound represents an emerging advance in imaging with important applications in obstetrics, Alfred Z. Abuhamad, M.D., said at an obstetrics symposium that was sponsored by Columbia University and New York Presbyterian Hospital.

The ability to rotate images, change planes, and manipulate displays according to signal strength makes it possible to visualize skeletal and vascular structures and fluid spaces, in addition to providing detailed views of fetal appearance, according to Dr. Abuhamad, who is professor and chair of obstetrics and gynecology and the director of the division of maternal-fetal medicine at Eastern Virginia Medical School, Norfolk.

The term “3-D” is something of a misnomer in that the image is displayed on a 2-D monitor.

“[Instead of '3-D'] the term should be volume sonography that gives the appearance of depth,” Dr. Abuhamad said.

The volume image is created by the summation of 2-D slices from multiple planes, as the probe is steered from side to side.

The size of the acquired image is determined by the angle across which the probe is moved. Since fetal movement makes the speed of volume acquisition highly important, “we use the smallest angle [needed for evaluation of the structure of interest] in the smallest box,” Dr. Abuhamad said.

With a multiplanar display, an image constructed from sagittal, coronal, and transverse planes can be rotated along the x-, y-, and z-axis to visualize the same structure from different angles. To maintain orientation, it is helpful to determine a reference point, and it may be necessary to use 2-D ultrasound to locate key structures.

The surface display shows the external aspects of the fetus, allowing the same views as in 2-D ultrasound, to review in “tremendous detail” such fetal abnormalities as clefting of the lip and palate, he said during the meeting.

With “maximum mode,” which manipulates the signal to enhance light (i.e. echoic) objects and dim dark (anechoic) ones, skeletal structures can be visualized, affording a look at the cranium and its fontanelles and sutures.

It also facilitates assessment of bone quality and detection of fractures and permits close examination of the vertebral column.

“It's like an x-ray of the fetus,” Dr. Abuhamad commented.

“Minimum mode” reveals vasculature; while “inversion mode,” which dims light structures and highlights dim ones, brings out fluid cavities and makes it possible to visualize such structures as the chambers of the heart and determine the number of gestational sacs, he said.

Other image manipulations permit the clinician to see the back of structures and to remove from the image, as with an “electronic scalpel,” structures that may obscure features of interest.

The 3-D procedure does not use more power, increase fetal exposure, or magnify the thermal effect, compared with 2-D ultrasound, he said.

Limitations of the technique include a steep learning curve and the need to dedicate sufficient time for training.

The quality of the volume image is limited by 2-D resolution. Artifacts such as motion of the woman or fetus, surface rendering, and shadowing can interfere with interpretation.

The technique is highly operator dependent, and the lack of standardization magnifies the possibility of human error, Dr. Abuhamad said.

An estimated 10% of ultrasound units currently have this technology, he said.

This 3-D image shows an absent T12 rib on one side in a fetus with balanced translocation.

Swelling involving the dorsal aspect of both feet in a fetus with Turner syndrome is shown here on 3D ultrasound. Photos courtesy Dr. Alfred Z. Abuhamad

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Warn Patients About Heart Risks After Preeclampsia : Preeclampsia is a manifestation of underlying silent disease that will develop later into a clinical condition.

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Warn Patients About Heart Risks After Preeclampsia : Preeclampsia is a manifestation of underlying silent disease that will develop later into a clinical condition.

NEW YORK — Women who develop preeclampsia should be counseled about the risk in subsequent gestations and strategies to contain these risks, according to Baha M. Sibai, M.D.

In addition, more general implications about health in later life should be discussed with the patient, said Dr. Sibai, who is professor and chairman of obstetrics and gynecology at the University of Cincinnati.

He made his report at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

About 20%-30% of women who have had an episode of preeclampsia will develop the disorder in a subsequent pregnancy, which makes this history at least as significant a risk factor for future preeclampsia as chronic hypertension, renal disease, and pregestational diabetes.

The earlier in the first gestation preeclampsia developed, the higher the risk of recurrence in the next: the condition returned in more than half of women who had their first episode before week 27, compared with a 40% recurrence when the index episode was between week 27 and 30, and 20% at week 37 or after.

A severe episode of preeclampsia or eclampsia also is associated with a worse outcome in subsequent pregnancies, with an increased risk of intrauterine growth retardation, perinatal loss, and abruptio placentae. Here, too, the earlier the episode occurred in the first gestation, the greater the risk to the second, Dr. Sibai said.

Preventive measures can contain the risk of preeclampsia and poor outcome in subsequent pregnancies. These include attention to weight, blood pressure, and blood sugar.

“Aggressive control of hypertension before and early in pregnancy can reduce the risk of preeclampsia from 50% to [a range of] 10%-15%,” Dr. Sibai commented.

In women with diabetes, good control of blood sugar from early in the pregnancy will markedly reduce the rate of preeclampsia, he said.

In vitro fertilization should involve the transfer of no more than two embryos, as a risk-containment measure.

A number of other strategies have been suggested to reduce the incidence of preeclampsia. Prophylactic aspirin has had particular attention, but a large multicenter trial found no difference in outcome among women at highest risk. A metaanalysis of studies using calcium supplementation likewise found no benefit.

Women who have had preeclampsia should also be counseled about its implications for health problems later in life, such as chronic hypertension, diabetes, and ischemic heart disease.

“Preeclampsia is a manifestation of underlying silent disease that will develop into a clinical condition that develops later; it doesn't cause [later health problems],” he said.

The incidence of chronic hypertension in women who have had a severe episode of preeclampsia, at an average follow-up of 7 years, ranges from 7% when the preeclampsia developed after 37 weeks, to 25% when it had developed before 27 weeks.

The risk of later renal and cardiovascular disease is particularly heightened after an episode of preeclampsia that developed before 30 weeks' gestation, that was severe, or that recurred, according to Dr. Sibai. In fact, he said, preeclampsia during one singleton gestation doubles the risk of ischemic heart disease and raises it nearly threefold when preeclampsia is severe.

Gestational hypertension without proteinuria is associated with a 1.6 relative risk of ischemic heart disease.

“The risk factors for preeclampsia and coronary artery disease overlap considerably,” Dr. Sibai observed during the meeting.

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NEW YORK — Women who develop preeclampsia should be counseled about the risk in subsequent gestations and strategies to contain these risks, according to Baha M. Sibai, M.D.

In addition, more general implications about health in later life should be discussed with the patient, said Dr. Sibai, who is professor and chairman of obstetrics and gynecology at the University of Cincinnati.

He made his report at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

About 20%-30% of women who have had an episode of preeclampsia will develop the disorder in a subsequent pregnancy, which makes this history at least as significant a risk factor for future preeclampsia as chronic hypertension, renal disease, and pregestational diabetes.

The earlier in the first gestation preeclampsia developed, the higher the risk of recurrence in the next: the condition returned in more than half of women who had their first episode before week 27, compared with a 40% recurrence when the index episode was between week 27 and 30, and 20% at week 37 or after.

A severe episode of preeclampsia or eclampsia also is associated with a worse outcome in subsequent pregnancies, with an increased risk of intrauterine growth retardation, perinatal loss, and abruptio placentae. Here, too, the earlier the episode occurred in the first gestation, the greater the risk to the second, Dr. Sibai said.

Preventive measures can contain the risk of preeclampsia and poor outcome in subsequent pregnancies. These include attention to weight, blood pressure, and blood sugar.

“Aggressive control of hypertension before and early in pregnancy can reduce the risk of preeclampsia from 50% to [a range of] 10%-15%,” Dr. Sibai commented.

In women with diabetes, good control of blood sugar from early in the pregnancy will markedly reduce the rate of preeclampsia, he said.

In vitro fertilization should involve the transfer of no more than two embryos, as a risk-containment measure.

A number of other strategies have been suggested to reduce the incidence of preeclampsia. Prophylactic aspirin has had particular attention, but a large multicenter trial found no difference in outcome among women at highest risk. A metaanalysis of studies using calcium supplementation likewise found no benefit.

Women who have had preeclampsia should also be counseled about its implications for health problems later in life, such as chronic hypertension, diabetes, and ischemic heart disease.

“Preeclampsia is a manifestation of underlying silent disease that will develop into a clinical condition that develops later; it doesn't cause [later health problems],” he said.

The incidence of chronic hypertension in women who have had a severe episode of preeclampsia, at an average follow-up of 7 years, ranges from 7% when the preeclampsia developed after 37 weeks, to 25% when it had developed before 27 weeks.

The risk of later renal and cardiovascular disease is particularly heightened after an episode of preeclampsia that developed before 30 weeks' gestation, that was severe, or that recurred, according to Dr. Sibai. In fact, he said, preeclampsia during one singleton gestation doubles the risk of ischemic heart disease and raises it nearly threefold when preeclampsia is severe.

Gestational hypertension without proteinuria is associated with a 1.6 relative risk of ischemic heart disease.

“The risk factors for preeclampsia and coronary artery disease overlap considerably,” Dr. Sibai observed during the meeting.

NEW YORK — Women who develop preeclampsia should be counseled about the risk in subsequent gestations and strategies to contain these risks, according to Baha M. Sibai, M.D.

In addition, more general implications about health in later life should be discussed with the patient, said Dr. Sibai, who is professor and chairman of obstetrics and gynecology at the University of Cincinnati.

He made his report at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

About 20%-30% of women who have had an episode of preeclampsia will develop the disorder in a subsequent pregnancy, which makes this history at least as significant a risk factor for future preeclampsia as chronic hypertension, renal disease, and pregestational diabetes.

The earlier in the first gestation preeclampsia developed, the higher the risk of recurrence in the next: the condition returned in more than half of women who had their first episode before week 27, compared with a 40% recurrence when the index episode was between week 27 and 30, and 20% at week 37 or after.

A severe episode of preeclampsia or eclampsia also is associated with a worse outcome in subsequent pregnancies, with an increased risk of intrauterine growth retardation, perinatal loss, and abruptio placentae. Here, too, the earlier the episode occurred in the first gestation, the greater the risk to the second, Dr. Sibai said.

Preventive measures can contain the risk of preeclampsia and poor outcome in subsequent pregnancies. These include attention to weight, blood pressure, and blood sugar.

“Aggressive control of hypertension before and early in pregnancy can reduce the risk of preeclampsia from 50% to [a range of] 10%-15%,” Dr. Sibai commented.

In women with diabetes, good control of blood sugar from early in the pregnancy will markedly reduce the rate of preeclampsia, he said.

In vitro fertilization should involve the transfer of no more than two embryos, as a risk-containment measure.

A number of other strategies have been suggested to reduce the incidence of preeclampsia. Prophylactic aspirin has had particular attention, but a large multicenter trial found no difference in outcome among women at highest risk. A metaanalysis of studies using calcium supplementation likewise found no benefit.

Women who have had preeclampsia should also be counseled about its implications for health problems later in life, such as chronic hypertension, diabetes, and ischemic heart disease.

“Preeclampsia is a manifestation of underlying silent disease that will develop into a clinical condition that develops later; it doesn't cause [later health problems],” he said.

The incidence of chronic hypertension in women who have had a severe episode of preeclampsia, at an average follow-up of 7 years, ranges from 7% when the preeclampsia developed after 37 weeks, to 25% when it had developed before 27 weeks.

The risk of later renal and cardiovascular disease is particularly heightened after an episode of preeclampsia that developed before 30 weeks' gestation, that was severe, or that recurred, according to Dr. Sibai. In fact, he said, preeclampsia during one singleton gestation doubles the risk of ischemic heart disease and raises it nearly threefold when preeclampsia is severe.

Gestational hypertension without proteinuria is associated with a 1.6 relative risk of ischemic heart disease.

“The risk factors for preeclampsia and coronary artery disease overlap considerably,” Dr. Sibai observed during the meeting.

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Keep Priorities Straight When Treating Eclampsia

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NEW YORK — Eclampsia has become increasingly rare in Western countries, but it still occurs in 1 in 2,000-3,500 pregnancies—and obstetric clinics must be prepared to treat it, Baha M. Sibai, M.D., said at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

Although most episodes occur late in pregnancy, an increasing number occur more than 2 days after delivery, and patients should be counseled accordingly, said Dr. Sibai, professor and chairman of the obstetrics and gynecology department at the University of Cincinnati.

Eclampsia does not always come with a warning. It has been reported that in 15%-20% of cases neither hypertension nor proteinuria has occurred.

“Most women with eclampsia have had good prenatal care,” Dr. Sibai said. In a 1992 U.K. study of 383 women, 85% had been seen by a medical care provider within a week before the episode.

Eclampsia is largely a late event: in a sample of 399 U.S. women, the episode occurred after the 32nd week of gestation in 72%, and before week 28 in roughly 10%.

In a substantial number of cases—28%, in the U.S. study—the condition developed after delivery; in two-thirds of these cases, it happened more than 48 hours later.

“More and more, the onset of convulsions is in the postpartum period. We've done an excellent job educating women to report signs and symptoms during pregnancy, but a poor one in educating them that they can have eclampsia after leaving the hospital,” Dr. Sibai said.

The lapse can have medicolegal implications, he said.

Emergency management of eclampsia should focus on protecting the mother from injury (e.g., cushioning extremities and preventing a fall off the bed), ensuring adequate oxygenation, and preventing aspiration. Once these are addressed, steps should be taken to avoid recurrent convulsions.

“Never give anything to stop the convulsion: no one dies from a seizure, and you could do damage if you give the wrong dose,” Dr. Sibai said. Most seizures are self-limiting, and medications to contain them may depress respiration.

Hypertension should be the next concern, and then delivery. “[It] should be the last thing on your mind,” he said.

If hypoxemia develops, 8-10 L/min of supplementary oxygen should be supplied by face mask, and pulse oximetry monitored. Sodium bicarbonate may be required for acidemia.

To prevent further convulsions, IV magnesium sulfate should be begun with a loading dose of 6 g over a 20-minute period, followed by maintenance at 2 g/hour. The anticonvulsants diazepam and phenytoin, which can depress respiration and compromise alveolar reflexes, carry a higher mortality rate and should be avoided.

“Don't listen to what the neurologist or internist tells you to do,” Dr. Sibai said.

The risk of magnesium toxicity should be kept in mind: look for such signs of rising serum levels as double vision, a feeling of warmth or flushing, and lethargy; monitor patellar reflexes hourly.

“Always talk to the patient. Slurred speech shows paralysis of the muscles of the jaw,” he said.

Magnesium sulfate should be discontinued immediately while a blood level is taken, and restarted with appropriate adjustments. If serum magnesium is above 15 mg/dL—a level that threatens respiratory and cardiac arrest—1 g of calcium gluconate should be given intravenously and intubation and assisted ventilation provided if necessary.

For control of severe hypertension, labetalol and nifedipine are drugs of choice; hydralazine should be avoided, he said.

When possible, delivery should be done within 24 hours. Cesarean delivery is not always necessary, and vaginal delivery can be done with epidural or spinal anesthesia.

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NEW YORK — Eclampsia has become increasingly rare in Western countries, but it still occurs in 1 in 2,000-3,500 pregnancies—and obstetric clinics must be prepared to treat it, Baha M. Sibai, M.D., said at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

Although most episodes occur late in pregnancy, an increasing number occur more than 2 days after delivery, and patients should be counseled accordingly, said Dr. Sibai, professor and chairman of the obstetrics and gynecology department at the University of Cincinnati.

Eclampsia does not always come with a warning. It has been reported that in 15%-20% of cases neither hypertension nor proteinuria has occurred.

“Most women with eclampsia have had good prenatal care,” Dr. Sibai said. In a 1992 U.K. study of 383 women, 85% had been seen by a medical care provider within a week before the episode.

Eclampsia is largely a late event: in a sample of 399 U.S. women, the episode occurred after the 32nd week of gestation in 72%, and before week 28 in roughly 10%.

In a substantial number of cases—28%, in the U.S. study—the condition developed after delivery; in two-thirds of these cases, it happened more than 48 hours later.

“More and more, the onset of convulsions is in the postpartum period. We've done an excellent job educating women to report signs and symptoms during pregnancy, but a poor one in educating them that they can have eclampsia after leaving the hospital,” Dr. Sibai said.

The lapse can have medicolegal implications, he said.

Emergency management of eclampsia should focus on protecting the mother from injury (e.g., cushioning extremities and preventing a fall off the bed), ensuring adequate oxygenation, and preventing aspiration. Once these are addressed, steps should be taken to avoid recurrent convulsions.

“Never give anything to stop the convulsion: no one dies from a seizure, and you could do damage if you give the wrong dose,” Dr. Sibai said. Most seizures are self-limiting, and medications to contain them may depress respiration.

Hypertension should be the next concern, and then delivery. “[It] should be the last thing on your mind,” he said.

If hypoxemia develops, 8-10 L/min of supplementary oxygen should be supplied by face mask, and pulse oximetry monitored. Sodium bicarbonate may be required for acidemia.

To prevent further convulsions, IV magnesium sulfate should be begun with a loading dose of 6 g over a 20-minute period, followed by maintenance at 2 g/hour. The anticonvulsants diazepam and phenytoin, which can depress respiration and compromise alveolar reflexes, carry a higher mortality rate and should be avoided.

“Don't listen to what the neurologist or internist tells you to do,” Dr. Sibai said.

The risk of magnesium toxicity should be kept in mind: look for such signs of rising serum levels as double vision, a feeling of warmth or flushing, and lethargy; monitor patellar reflexes hourly.

“Always talk to the patient. Slurred speech shows paralysis of the muscles of the jaw,” he said.

Magnesium sulfate should be discontinued immediately while a blood level is taken, and restarted with appropriate adjustments. If serum magnesium is above 15 mg/dL—a level that threatens respiratory and cardiac arrest—1 g of calcium gluconate should be given intravenously and intubation and assisted ventilation provided if necessary.

For control of severe hypertension, labetalol and nifedipine are drugs of choice; hydralazine should be avoided, he said.

When possible, delivery should be done within 24 hours. Cesarean delivery is not always necessary, and vaginal delivery can be done with epidural or spinal anesthesia.

NEW YORK — Eclampsia has become increasingly rare in Western countries, but it still occurs in 1 in 2,000-3,500 pregnancies—and obstetric clinics must be prepared to treat it, Baha M. Sibai, M.D., said at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

Although most episodes occur late in pregnancy, an increasing number occur more than 2 days after delivery, and patients should be counseled accordingly, said Dr. Sibai, professor and chairman of the obstetrics and gynecology department at the University of Cincinnati.

Eclampsia does not always come with a warning. It has been reported that in 15%-20% of cases neither hypertension nor proteinuria has occurred.

“Most women with eclampsia have had good prenatal care,” Dr. Sibai said. In a 1992 U.K. study of 383 women, 85% had been seen by a medical care provider within a week before the episode.

Eclampsia is largely a late event: in a sample of 399 U.S. women, the episode occurred after the 32nd week of gestation in 72%, and before week 28 in roughly 10%.

In a substantial number of cases—28%, in the U.S. study—the condition developed after delivery; in two-thirds of these cases, it happened more than 48 hours later.

“More and more, the onset of convulsions is in the postpartum period. We've done an excellent job educating women to report signs and symptoms during pregnancy, but a poor one in educating them that they can have eclampsia after leaving the hospital,” Dr. Sibai said.

The lapse can have medicolegal implications, he said.

Emergency management of eclampsia should focus on protecting the mother from injury (e.g., cushioning extremities and preventing a fall off the bed), ensuring adequate oxygenation, and preventing aspiration. Once these are addressed, steps should be taken to avoid recurrent convulsions.

“Never give anything to stop the convulsion: no one dies from a seizure, and you could do damage if you give the wrong dose,” Dr. Sibai said. Most seizures are self-limiting, and medications to contain them may depress respiration.

Hypertension should be the next concern, and then delivery. “[It] should be the last thing on your mind,” he said.

If hypoxemia develops, 8-10 L/min of supplementary oxygen should be supplied by face mask, and pulse oximetry monitored. Sodium bicarbonate may be required for acidemia.

To prevent further convulsions, IV magnesium sulfate should be begun with a loading dose of 6 g over a 20-minute period, followed by maintenance at 2 g/hour. The anticonvulsants diazepam and phenytoin, which can depress respiration and compromise alveolar reflexes, carry a higher mortality rate and should be avoided.

“Don't listen to what the neurologist or internist tells you to do,” Dr. Sibai said.

The risk of magnesium toxicity should be kept in mind: look for such signs of rising serum levels as double vision, a feeling of warmth or flushing, and lethargy; monitor patellar reflexes hourly.

“Always talk to the patient. Slurred speech shows paralysis of the muscles of the jaw,” he said.

Magnesium sulfate should be discontinued immediately while a blood level is taken, and restarted with appropriate adjustments. If serum magnesium is above 15 mg/dL—a level that threatens respiratory and cardiac arrest—1 g of calcium gluconate should be given intravenously and intubation and assisted ventilation provided if necessary.

For control of severe hypertension, labetalol and nifedipine are drugs of choice; hydralazine should be avoided, he said.

When possible, delivery should be done within 24 hours. Cesarean delivery is not always necessary, and vaginal delivery can be done with epidural or spinal anesthesia.

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Preeclampsia Counseling:Don't Limit Advice to Childbearing Years

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NEW YORK — Women who develop preeclampsia should be counseled about the risk in subsequent gestations and strategies to contain these risks, according to Baha M. Sibai, M.D.

In addition, more general implications about health in later life should be discussed with the patient, said Dr. Sibai, professor and chairman of obstetrics and gynecology at the University of Cincinnati. He made his report at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

About 20%-30% of women who have had an episode of preeclampsia will develop it in a subsequent pregnancy, which makes this history at least as significant a risk factor for future preeclampsia as chronic hypertension, renal disease, and pregestational diabetes.

The earlier in the first gestation preeclampsia developed, the higher the risk of recurrence in the next: The condition returned in more than half of women who had their first episode before week 27, compared with a 40% recurrence when the index episode was between week 27 and 30, and 20% at week 37 or after.

A severe episode of preeclampsia or eclampsia also is associated with a worse outcome in subsequent pregnancies, with an increased risk of intrauterine growth retardation, perinatal loss, and abruptio placentae. Here, too, the earlier the episode occurred in the first gestation, the greater the risk to the second, Dr. Sibai said. Preventive measures can contain the risk of preeclampsia and poor outcome in subsequent pregnancies. These include attention to weight, blood pressure, and blood sugar. “Aggressive control of hypertension before and early in pregnancy can reduce the risk of preeclampsia from 50% to [a range of] 10%-15%,” Dr. Sibai said.

In women with diabetes, good control of blood sugar from early in the pregnancy will markedly reduce the rate of preeclampsia, he said.

In vitro fertilization should involve the transfer of no more than two embryos, as a risk-containment measure.

A number of other strategies have been suggested to reduce the incidence of preeclampsia. Prophylactic aspirin has had particular attention, but a large multicenter trial found no difference in outcome among women at highest risk.

A metaanalysis of studies using calcium supplementation likewise found no benefit, he said.

Women who have had preeclampsia should also be counseled about its implications for health problems later in life, such as chronic hypertension, diabetes, and ischemic heart disease. “Preeclampsia is a manifestation of underlying silent disease that will develop into a clinical condition that develops later; it doesn't cause [later health problems],” Dr. Sibai said.

The incidence of chronic hypertension in women who have had a severe episode of preeclampsia, at an average follow-up of 7 years, ranges from 7% when the preeclampsia developed after 37 weeks, to 25% when it had developed before 27 weeks.

The risk of later renal and cardiovascular disease is particularly heightened after an episode of preeclampsia that developed before 30 weeks, that was severe, or that recurred, Dr. Sibai said.

In fact, preeclampsia during one singleton gestation doubles the risk of ischemic heart disease and raises it nearly threefold when preeclampsia is severe. Gestational hypertension without proteinuria is associated with a 1.6 relative risk of ischemic heart disease.

“The risk factors for preeclampsia and coronary artery disease overlap considerably,” Dr. Sibai observed.

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NEW YORK — Women who develop preeclampsia should be counseled about the risk in subsequent gestations and strategies to contain these risks, according to Baha M. Sibai, M.D.

In addition, more general implications about health in later life should be discussed with the patient, said Dr. Sibai, professor and chairman of obstetrics and gynecology at the University of Cincinnati. He made his report at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

About 20%-30% of women who have had an episode of preeclampsia will develop it in a subsequent pregnancy, which makes this history at least as significant a risk factor for future preeclampsia as chronic hypertension, renal disease, and pregestational diabetes.

The earlier in the first gestation preeclampsia developed, the higher the risk of recurrence in the next: The condition returned in more than half of women who had their first episode before week 27, compared with a 40% recurrence when the index episode was between week 27 and 30, and 20% at week 37 or after.

A severe episode of preeclampsia or eclampsia also is associated with a worse outcome in subsequent pregnancies, with an increased risk of intrauterine growth retardation, perinatal loss, and abruptio placentae. Here, too, the earlier the episode occurred in the first gestation, the greater the risk to the second, Dr. Sibai said. Preventive measures can contain the risk of preeclampsia and poor outcome in subsequent pregnancies. These include attention to weight, blood pressure, and blood sugar. “Aggressive control of hypertension before and early in pregnancy can reduce the risk of preeclampsia from 50% to [a range of] 10%-15%,” Dr. Sibai said.

In women with diabetes, good control of blood sugar from early in the pregnancy will markedly reduce the rate of preeclampsia, he said.

In vitro fertilization should involve the transfer of no more than two embryos, as a risk-containment measure.

A number of other strategies have been suggested to reduce the incidence of preeclampsia. Prophylactic aspirin has had particular attention, but a large multicenter trial found no difference in outcome among women at highest risk.

A metaanalysis of studies using calcium supplementation likewise found no benefit, he said.

Women who have had preeclampsia should also be counseled about its implications for health problems later in life, such as chronic hypertension, diabetes, and ischemic heart disease. “Preeclampsia is a manifestation of underlying silent disease that will develop into a clinical condition that develops later; it doesn't cause [later health problems],” Dr. Sibai said.

The incidence of chronic hypertension in women who have had a severe episode of preeclampsia, at an average follow-up of 7 years, ranges from 7% when the preeclampsia developed after 37 weeks, to 25% when it had developed before 27 weeks.

The risk of later renal and cardiovascular disease is particularly heightened after an episode of preeclampsia that developed before 30 weeks, that was severe, or that recurred, Dr. Sibai said.

In fact, preeclampsia during one singleton gestation doubles the risk of ischemic heart disease and raises it nearly threefold when preeclampsia is severe. Gestational hypertension without proteinuria is associated with a 1.6 relative risk of ischemic heart disease.

“The risk factors for preeclampsia and coronary artery disease overlap considerably,” Dr. Sibai observed.

NEW YORK — Women who develop preeclampsia should be counseled about the risk in subsequent gestations and strategies to contain these risks, according to Baha M. Sibai, M.D.

In addition, more general implications about health in later life should be discussed with the patient, said Dr. Sibai, professor and chairman of obstetrics and gynecology at the University of Cincinnati. He made his report at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

About 20%-30% of women who have had an episode of preeclampsia will develop it in a subsequent pregnancy, which makes this history at least as significant a risk factor for future preeclampsia as chronic hypertension, renal disease, and pregestational diabetes.

The earlier in the first gestation preeclampsia developed, the higher the risk of recurrence in the next: The condition returned in more than half of women who had their first episode before week 27, compared with a 40% recurrence when the index episode was between week 27 and 30, and 20% at week 37 or after.

A severe episode of preeclampsia or eclampsia also is associated with a worse outcome in subsequent pregnancies, with an increased risk of intrauterine growth retardation, perinatal loss, and abruptio placentae. Here, too, the earlier the episode occurred in the first gestation, the greater the risk to the second, Dr. Sibai said. Preventive measures can contain the risk of preeclampsia and poor outcome in subsequent pregnancies. These include attention to weight, blood pressure, and blood sugar. “Aggressive control of hypertension before and early in pregnancy can reduce the risk of preeclampsia from 50% to [a range of] 10%-15%,” Dr. Sibai said.

In women with diabetes, good control of blood sugar from early in the pregnancy will markedly reduce the rate of preeclampsia, he said.

In vitro fertilization should involve the transfer of no more than two embryos, as a risk-containment measure.

A number of other strategies have been suggested to reduce the incidence of preeclampsia. Prophylactic aspirin has had particular attention, but a large multicenter trial found no difference in outcome among women at highest risk.

A metaanalysis of studies using calcium supplementation likewise found no benefit, he said.

Women who have had preeclampsia should also be counseled about its implications for health problems later in life, such as chronic hypertension, diabetes, and ischemic heart disease. “Preeclampsia is a manifestation of underlying silent disease that will develop into a clinical condition that develops later; it doesn't cause [later health problems],” Dr. Sibai said.

The incidence of chronic hypertension in women who have had a severe episode of preeclampsia, at an average follow-up of 7 years, ranges from 7% when the preeclampsia developed after 37 weeks, to 25% when it had developed before 27 weeks.

The risk of later renal and cardiovascular disease is particularly heightened after an episode of preeclampsia that developed before 30 weeks, that was severe, or that recurred, Dr. Sibai said.

In fact, preeclampsia during one singleton gestation doubles the risk of ischemic heart disease and raises it nearly threefold when preeclampsia is severe. Gestational hypertension without proteinuria is associated with a 1.6 relative risk of ischemic heart disease.

“The risk factors for preeclampsia and coronary artery disease overlap considerably,” Dr. Sibai observed.

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