Intimate partner violence and PTSD increase menopausal symptom risk

Be alert to intimate partner violence
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Intimate partner violence or sexual assault may have a significant effect on menopausal symptoms in women, according to a cohort study published in JAMA Internal Medicine.

Karen Winton/iStockphoto

Researchers analyzed data from 2,016 women aged 40 years or older who were enrolled in the observational Reproductive Risks of Incontinence Study; 40% were non-Latina white, 21% were black, 20% were Latina or Hispanic, and 19% were Asian. Of this cohort, 21% had experienced emotional intimate partner violence (IPV) – 64 (3.2%) in the past 12 months – 16% had experienced physical IPV, 14% had experienced both, and 19% reported sexual assault. More than one in five women (23%) met the criteria for clinically significant PTSD.

Women who had experienced emotional domestic abuse were 36% more likely to report difficulty sleeping, 50% more like to experience night sweats, and 60% more likely to experience pain with intercourse, compared with women who had not experienced any abuse.

Physical abuse was associated with 33% higher odds of night sweats, and sexual assault was associated with 41% higher odds of vaginal dryness, 42% higher odds of vaginal irritation, and 44% higher odds of pain with intercourse.

Women with clinically significant PTSD symptoms were significantly more likely to experience all the symptoms of menopause, including twofold higher odds of pain with intercourse and threefold higher odds of difficulty sleeping. When authors accounted for the effect of PTSD symptoms in the cohort, they found that only the association between emotional abuse and night sweats or pain with intercourse, and between sexual assault and vaginal dryness, remained independently significant.



Carolyn J. Gibson, PhD, MPH, of the San Francisco Veterans Affairs Health Care System, and coauthors said that the biological and hormonal changes that underpin menopausal symptoms, as well as health risk behaviors, cardiometabolic risk factors, and other chronic health conditions associated with menopause, all are impacted by trauma and its psychological effects.

“Chronic hyperarousal and hypervigilance, common in individuals who have experienced trauma and characteristic symptoms of PTSD, may affect sleep and symptom sensitivity,” they wrote.

The reverse is also true; that the symptoms of menopause can impact the symptoms of PTSD by affecting a woman’s sense of self-efficacy, interpersonal engagements, and heighten the stress associated with this period of transition.

“The clinical management of menopause symptoms may also be enhanced by trauma-informed care, including recognition of challenges that may impair efforts to address menopause-related concerns among women affected by trauma,” the authors wrote.

Clinicians also could help by providing education about the link between trauma and health, providing their patients with a safe and supportive treatment environment, and facilitating referrals for psychological or trauma-specific services when needed, they said.

The research was supported by the San Francisco Veterans Affairs Medical Center and Kaiser Permanente Northern California, and funded by the University of California San Francisco–Kaiser Permanente Grants Program for Delivery Science, the Office of Research on Women’s Health Specialized Center of Research, and grants from the National Institute of Diabetes and Digestive and Kidney Diseases.

SOURCE: Gibson C et al. JAMA Intern Med. 2018 Nov 19. doi: 10.1001/jamainternmed.2018.5233.

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An estimated 33% of women in the United States have been sexually assaulted, and an estimated 25% have experienced IPV, so be aware of how common this “wicked problem” is, the way it impacts health, and what role you can play in educating and helping patients by connecting them to available resources.

But that is not enough. Consider measures such as training yourself and staff in how to assess for IPV and sexual assault and use of EHR to integrate IPV assessment into routine clinical care, as well as developing protocols to be followed when a patient discloses IPV or sexual assault. A multidisciplinary approach also can help, including victim service advocates and behavioral health clinicians to provide care and support.

State requirements for reporting partner and sexual violence differ, so be aware of your state laws.

A strength of this study is that it included emotional as well as physical IPV, which often is left out although it has serious impacts.

Rebecca C. Thurston, PhD, is from the department of psychiatry at the University of Pittsburgh, and Elizabeth Miller, MD, PhD, is from the division of adolescent and young adult medicine at the UPMC Children’s Hospital of Pittsburgh. These comments were taken from an accompanying editorial (JAMA Intern Med. 2018 Nov 19. doi: 10.1001/jamainternmed.2018.5242). Dr. Thurston declared research support from the National Institutes of Health and consultancies for Pfizer, Procter & Gamble, and MAS Innovations.

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An estimated 33% of women in the United States have been sexually assaulted, and an estimated 25% have experienced IPV, so be aware of how common this “wicked problem” is, the way it impacts health, and what role you can play in educating and helping patients by connecting them to available resources.

But that is not enough. Consider measures such as training yourself and staff in how to assess for IPV and sexual assault and use of EHR to integrate IPV assessment into routine clinical care, as well as developing protocols to be followed when a patient discloses IPV or sexual assault. A multidisciplinary approach also can help, including victim service advocates and behavioral health clinicians to provide care and support.

State requirements for reporting partner and sexual violence differ, so be aware of your state laws.

A strength of this study is that it included emotional as well as physical IPV, which often is left out although it has serious impacts.

Rebecca C. Thurston, PhD, is from the department of psychiatry at the University of Pittsburgh, and Elizabeth Miller, MD, PhD, is from the division of adolescent and young adult medicine at the UPMC Children’s Hospital of Pittsburgh. These comments were taken from an accompanying editorial (JAMA Intern Med. 2018 Nov 19. doi: 10.1001/jamainternmed.2018.5242). Dr. Thurston declared research support from the National Institutes of Health and consultancies for Pfizer, Procter & Gamble, and MAS Innovations.

Body

 

An estimated 33% of women in the United States have been sexually assaulted, and an estimated 25% have experienced IPV, so be aware of how common this “wicked problem” is, the way it impacts health, and what role you can play in educating and helping patients by connecting them to available resources.

But that is not enough. Consider measures such as training yourself and staff in how to assess for IPV and sexual assault and use of EHR to integrate IPV assessment into routine clinical care, as well as developing protocols to be followed when a patient discloses IPV or sexual assault. A multidisciplinary approach also can help, including victim service advocates and behavioral health clinicians to provide care and support.

State requirements for reporting partner and sexual violence differ, so be aware of your state laws.

A strength of this study is that it included emotional as well as physical IPV, which often is left out although it has serious impacts.

Rebecca C. Thurston, PhD, is from the department of psychiatry at the University of Pittsburgh, and Elizabeth Miller, MD, PhD, is from the division of adolescent and young adult medicine at the UPMC Children’s Hospital of Pittsburgh. These comments were taken from an accompanying editorial (JAMA Intern Med. 2018 Nov 19. doi: 10.1001/jamainternmed.2018.5242). Dr. Thurston declared research support from the National Institutes of Health and consultancies for Pfizer, Procter & Gamble, and MAS Innovations.

Title
Be alert to intimate partner violence
Be alert to intimate partner violence

 

Intimate partner violence or sexual assault may have a significant effect on menopausal symptoms in women, according to a cohort study published in JAMA Internal Medicine.

Karen Winton/iStockphoto

Researchers analyzed data from 2,016 women aged 40 years or older who were enrolled in the observational Reproductive Risks of Incontinence Study; 40% were non-Latina white, 21% were black, 20% were Latina or Hispanic, and 19% were Asian. Of this cohort, 21% had experienced emotional intimate partner violence (IPV) – 64 (3.2%) in the past 12 months – 16% had experienced physical IPV, 14% had experienced both, and 19% reported sexual assault. More than one in five women (23%) met the criteria for clinically significant PTSD.

Women who had experienced emotional domestic abuse were 36% more likely to report difficulty sleeping, 50% more like to experience night sweats, and 60% more likely to experience pain with intercourse, compared with women who had not experienced any abuse.

Physical abuse was associated with 33% higher odds of night sweats, and sexual assault was associated with 41% higher odds of vaginal dryness, 42% higher odds of vaginal irritation, and 44% higher odds of pain with intercourse.

Women with clinically significant PTSD symptoms were significantly more likely to experience all the symptoms of menopause, including twofold higher odds of pain with intercourse and threefold higher odds of difficulty sleeping. When authors accounted for the effect of PTSD symptoms in the cohort, they found that only the association between emotional abuse and night sweats or pain with intercourse, and between sexual assault and vaginal dryness, remained independently significant.



Carolyn J. Gibson, PhD, MPH, of the San Francisco Veterans Affairs Health Care System, and coauthors said that the biological and hormonal changes that underpin menopausal symptoms, as well as health risk behaviors, cardiometabolic risk factors, and other chronic health conditions associated with menopause, all are impacted by trauma and its psychological effects.

“Chronic hyperarousal and hypervigilance, common in individuals who have experienced trauma and characteristic symptoms of PTSD, may affect sleep and symptom sensitivity,” they wrote.

The reverse is also true; that the symptoms of menopause can impact the symptoms of PTSD by affecting a woman’s sense of self-efficacy, interpersonal engagements, and heighten the stress associated with this period of transition.

“The clinical management of menopause symptoms may also be enhanced by trauma-informed care, including recognition of challenges that may impair efforts to address menopause-related concerns among women affected by trauma,” the authors wrote.

Clinicians also could help by providing education about the link between trauma and health, providing their patients with a safe and supportive treatment environment, and facilitating referrals for psychological or trauma-specific services when needed, they said.

The research was supported by the San Francisco Veterans Affairs Medical Center and Kaiser Permanente Northern California, and funded by the University of California San Francisco–Kaiser Permanente Grants Program for Delivery Science, the Office of Research on Women’s Health Specialized Center of Research, and grants from the National Institute of Diabetes and Digestive and Kidney Diseases.

SOURCE: Gibson C et al. JAMA Intern Med. 2018 Nov 19. doi: 10.1001/jamainternmed.2018.5233.

 

Intimate partner violence or sexual assault may have a significant effect on menopausal symptoms in women, according to a cohort study published in JAMA Internal Medicine.

Karen Winton/iStockphoto

Researchers analyzed data from 2,016 women aged 40 years or older who were enrolled in the observational Reproductive Risks of Incontinence Study; 40% were non-Latina white, 21% were black, 20% were Latina or Hispanic, and 19% were Asian. Of this cohort, 21% had experienced emotional intimate partner violence (IPV) – 64 (3.2%) in the past 12 months – 16% had experienced physical IPV, 14% had experienced both, and 19% reported sexual assault. More than one in five women (23%) met the criteria for clinically significant PTSD.

Women who had experienced emotional domestic abuse were 36% more likely to report difficulty sleeping, 50% more like to experience night sweats, and 60% more likely to experience pain with intercourse, compared with women who had not experienced any abuse.

Physical abuse was associated with 33% higher odds of night sweats, and sexual assault was associated with 41% higher odds of vaginal dryness, 42% higher odds of vaginal irritation, and 44% higher odds of pain with intercourse.

Women with clinically significant PTSD symptoms were significantly more likely to experience all the symptoms of menopause, including twofold higher odds of pain with intercourse and threefold higher odds of difficulty sleeping. When authors accounted for the effect of PTSD symptoms in the cohort, they found that only the association between emotional abuse and night sweats or pain with intercourse, and between sexual assault and vaginal dryness, remained independently significant.



Carolyn J. Gibson, PhD, MPH, of the San Francisco Veterans Affairs Health Care System, and coauthors said that the biological and hormonal changes that underpin menopausal symptoms, as well as health risk behaviors, cardiometabolic risk factors, and other chronic health conditions associated with menopause, all are impacted by trauma and its psychological effects.

“Chronic hyperarousal and hypervigilance, common in individuals who have experienced trauma and characteristic symptoms of PTSD, may affect sleep and symptom sensitivity,” they wrote.

The reverse is also true; that the symptoms of menopause can impact the symptoms of PTSD by affecting a woman’s sense of self-efficacy, interpersonal engagements, and heighten the stress associated with this period of transition.

“The clinical management of menopause symptoms may also be enhanced by trauma-informed care, including recognition of challenges that may impair efforts to address menopause-related concerns among women affected by trauma,” the authors wrote.

Clinicians also could help by providing education about the link between trauma and health, providing their patients with a safe and supportive treatment environment, and facilitating referrals for psychological or trauma-specific services when needed, they said.

The research was supported by the San Francisco Veterans Affairs Medical Center and Kaiser Permanente Northern California, and funded by the University of California San Francisco–Kaiser Permanente Grants Program for Delivery Science, the Office of Research on Women’s Health Specialized Center of Research, and grants from the National Institute of Diabetes and Digestive and Kidney Diseases.

SOURCE: Gibson C et al. JAMA Intern Med. 2018 Nov 19. doi: 10.1001/jamainternmed.2018.5233.

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Key clinical point: Intimate partner violence increases the risk of menopausal symptoms.

Major finding: Women with PTSD are significantly more likely than those without to experience all menopausal symptoms.

Study details: A cohort study in 2,016 women aged 40 years and older.

Disclosures: The research was supported by the San Francisco Veterans Affairs Medical Center and Kaiser Permanente Northern California, and funded by the University of California San Francisco–Kaiser Permanente Grants Program for Delivery Science, the Office of Research on Women’s Health Specialized Center of Research, and grants from the National Institute of Diabetes and Digestive and Kidney Diseases.

Source: Gibson C et al. JAMA Intern Med. 2018 Nov 19. doi:10.1001/jamainternmed.2018.5233.

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Smaller assistant ports mean less prolapse repair pain

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– Patients experience less right-sided pain after laparoscopic sacrocolpopexy when surgeons use an 8-mm assistant port instead of a 12-mm port, results from a small trial show.

M. Alexander Otto/MDedge News
Dr. Yufan Brandon Chen

In the trial, conducted at Loyola University Medical Center in Maywood, Ill.,17 women were randomized to undergo the procedure with an 8-mm assistant port, and 18 with a 12-mm port, both on the right side of the abdomen.

Overall, pain severity was low at 2 weeks postop in both groups at just over 1 point on a 10-point visual analogue scale and not statistically different. However, patients who had a 12-mm assistant port were more likely to report right-sided pain, compared with those who had an 8-mm assistant port (60% vs.18%, P = 0.027).

“I saw a lot of these patients in the clinic at 2 weeks, and even though the overall pain score was low, they kept complaining about a dull, achy pain on the right side. They were using ibuprofen, and some of them had even restricted [their activities] because they were afraid they were going to pop a stitch,” said study lead Yufan B. Chen, MD, a urogynecology fellow at Loyola.

He said the research team thinks the difference in port-site pain “is clinically significant. Even if we had more patients in our study, I think it’s still likely our results would have been the same. Since our study ended, we have stopped using the 12-mm port in most of our cases; we use the 8-mm port for the assistant,” he said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

The tradeoff was that there were more needle struggles with the 8-mm port, 3.1/case vs. 0.6/case (P = .004). Surgeons found inserting and withdrawing the Gore-Tex needle through the smaller port more difficult. But there were no needle losses in either group and no differences in operative time – an average of about 95 minutes.

“The larger port size essentially benefits the surgeon more than the patient. This is kind of a common theme in minimally invasive surgery where less is actually more,” he said. Since the study, “we have identified why we have challenges with the needle transport; it’s usually because the needle gets bent, so we just unbend it a little bit with our needle drivers before we remove it,” Dr. Chen said.

Even so, “there may be a role in using the 12-mm port when you have assistants who are not [that] experienced,” he said.

Laparoscopic sacrocolpopexy is done through four ports at Loyola: a 12-mm umbilical port for the scope; two 5-mm ports on the left for the primary surgeon; and the right side port for the assistant, through which the Gore-Tex needle is passed.

In the study, there were no demographic or preop differences between the two groups of women. About 60% were white, with a mean age of 61 years. About 10% of the women had had prior abdominal surgery.

The study received no industry funding, and the investigators had no disclosures.

SOURCE: Chen YB et al. 2018 AAGL Global Congress, Abstract 197.

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– Patients experience less right-sided pain after laparoscopic sacrocolpopexy when surgeons use an 8-mm assistant port instead of a 12-mm port, results from a small trial show.

M. Alexander Otto/MDedge News
Dr. Yufan Brandon Chen

In the trial, conducted at Loyola University Medical Center in Maywood, Ill.,17 women were randomized to undergo the procedure with an 8-mm assistant port, and 18 with a 12-mm port, both on the right side of the abdomen.

Overall, pain severity was low at 2 weeks postop in both groups at just over 1 point on a 10-point visual analogue scale and not statistically different. However, patients who had a 12-mm assistant port were more likely to report right-sided pain, compared with those who had an 8-mm assistant port (60% vs.18%, P = 0.027).

“I saw a lot of these patients in the clinic at 2 weeks, and even though the overall pain score was low, they kept complaining about a dull, achy pain on the right side. They were using ibuprofen, and some of them had even restricted [their activities] because they were afraid they were going to pop a stitch,” said study lead Yufan B. Chen, MD, a urogynecology fellow at Loyola.

He said the research team thinks the difference in port-site pain “is clinically significant. Even if we had more patients in our study, I think it’s still likely our results would have been the same. Since our study ended, we have stopped using the 12-mm port in most of our cases; we use the 8-mm port for the assistant,” he said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

The tradeoff was that there were more needle struggles with the 8-mm port, 3.1/case vs. 0.6/case (P = .004). Surgeons found inserting and withdrawing the Gore-Tex needle through the smaller port more difficult. But there were no needle losses in either group and no differences in operative time – an average of about 95 minutes.

“The larger port size essentially benefits the surgeon more than the patient. This is kind of a common theme in minimally invasive surgery where less is actually more,” he said. Since the study, “we have identified why we have challenges with the needle transport; it’s usually because the needle gets bent, so we just unbend it a little bit with our needle drivers before we remove it,” Dr. Chen said.

Even so, “there may be a role in using the 12-mm port when you have assistants who are not [that] experienced,” he said.

Laparoscopic sacrocolpopexy is done through four ports at Loyola: a 12-mm umbilical port for the scope; two 5-mm ports on the left for the primary surgeon; and the right side port for the assistant, through which the Gore-Tex needle is passed.

In the study, there were no demographic or preop differences between the two groups of women. About 60% were white, with a mean age of 61 years. About 10% of the women had had prior abdominal surgery.

The study received no industry funding, and the investigators had no disclosures.

SOURCE: Chen YB et al. 2018 AAGL Global Congress, Abstract 197.

– Patients experience less right-sided pain after laparoscopic sacrocolpopexy when surgeons use an 8-mm assistant port instead of a 12-mm port, results from a small trial show.

M. Alexander Otto/MDedge News
Dr. Yufan Brandon Chen

In the trial, conducted at Loyola University Medical Center in Maywood, Ill.,17 women were randomized to undergo the procedure with an 8-mm assistant port, and 18 with a 12-mm port, both on the right side of the abdomen.

Overall, pain severity was low at 2 weeks postop in both groups at just over 1 point on a 10-point visual analogue scale and not statistically different. However, patients who had a 12-mm assistant port were more likely to report right-sided pain, compared with those who had an 8-mm assistant port (60% vs.18%, P = 0.027).

“I saw a lot of these patients in the clinic at 2 weeks, and even though the overall pain score was low, they kept complaining about a dull, achy pain on the right side. They were using ibuprofen, and some of them had even restricted [their activities] because they were afraid they were going to pop a stitch,” said study lead Yufan B. Chen, MD, a urogynecology fellow at Loyola.

He said the research team thinks the difference in port-site pain “is clinically significant. Even if we had more patients in our study, I think it’s still likely our results would have been the same. Since our study ended, we have stopped using the 12-mm port in most of our cases; we use the 8-mm port for the assistant,” he said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

The tradeoff was that there were more needle struggles with the 8-mm port, 3.1/case vs. 0.6/case (P = .004). Surgeons found inserting and withdrawing the Gore-Tex needle through the smaller port more difficult. But there were no needle losses in either group and no differences in operative time – an average of about 95 minutes.

“The larger port size essentially benefits the surgeon more than the patient. This is kind of a common theme in minimally invasive surgery where less is actually more,” he said. Since the study, “we have identified why we have challenges with the needle transport; it’s usually because the needle gets bent, so we just unbend it a little bit with our needle drivers before we remove it,” Dr. Chen said.

Even so, “there may be a role in using the 12-mm port when you have assistants who are not [that] experienced,” he said.

Laparoscopic sacrocolpopexy is done through four ports at Loyola: a 12-mm umbilical port for the scope; two 5-mm ports on the left for the primary surgeon; and the right side port for the assistant, through which the Gore-Tex needle is passed.

In the study, there were no demographic or preop differences between the two groups of women. About 60% were white, with a mean age of 61 years. About 10% of the women had had prior abdominal surgery.

The study received no industry funding, and the investigators had no disclosures.

SOURCE: Chen YB et al. 2018 AAGL Global Congress, Abstract 197.

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Key clinical point: Patients experienced less pain at 2 weeks with a smaller port; there are also more needle struggles, but that can be easily fixed.

Major finding: Patients who had a 12-mm assistant port were more likely to report right-sided pain, compared with those who received an 8- mm assistant port (60% vs. 18%, P = 0.027).

Study details: Randomized trial with 35 women.

Disclosures: The study received no industry funding, and the investigators had no disclosures.

Source: Chen YB et al. 2018 AAGL Global Congress, Abstract 197.

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Try to normalize albumin before laparoscopic hysterectomy

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– Serum albumin is an everyday health marker commonly used for risk assessment in open abdominal procedures, but it’s often not checked before laparoscopic hysterectomies.

M. Alexander Otto/MDedge News
Dr. Suzanne Lababidi

Low levels mean something is off, be it malnutrition, inflammation, chronic disease, or other problems. If it can be normalized before surgery, it should be; women probably will do better, according to investigators from the University of Kentucky, Lexington.

“In minimally invasive gynecologic procedures, we haven’t come to adopt this marker just quite yet. It could be included in the routine battery of tests” at minimal cost. “I think it’s something we should consider,” said ob.gyn. resident Suzanne Lababidi, MD.

The team was curious why serum albumin generally is not a part of routine testing for laparoscopic hysterectomy. The first step was to see if it made a difference, so they reviewed 43,289 cases in the National Surgical Quality Improvement Program database. The women were “par for the course;” 51 years old, on average; and had a mean body mass index of 31.9 kg/m2. More than one-third were hypertensive. Mean albumin was in the normal range at 4.1 g/dL, Dr. Lababidi said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

Her team did not come up with a cut-point to delay surgery – that’s the goal of further research – but they noticed on linear regression that women with lower preop albumin had higher rates of surgical site infections and intraoperative transfusions, plus higher rates of postop pneumonia; renal failure; urinary tract infection; sepsis; and deep vein thrombosis, among other issues – and even after controlling for hypertension, diabetes, and other comorbidities. The findings met statistical significance.

It’s true that patients with low albumin might have gone into the operating room sicker, but no matter; Dr. Lababidi’s point was that preop serum albumin is something to pay attention to and correct whenever possible before laparoscopic hysterectomies.

“It’s important to realize that albumin is something that can be improved over time.” Preop levels are something to consider for “counseling and optimizing patients to improve surgical outcomes,” she said.

The next step toward an albumin cut-point is to weed out confounders by further stratifying patients based on albumin levels, she said.

The work received no industry funding. Dr. Lababidi had no disclosures.

SOURCE: Lababidi S et al. 2018 AAGL Global Congress, Abstract 199.

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– Serum albumin is an everyday health marker commonly used for risk assessment in open abdominal procedures, but it’s often not checked before laparoscopic hysterectomies.

M. Alexander Otto/MDedge News
Dr. Suzanne Lababidi

Low levels mean something is off, be it malnutrition, inflammation, chronic disease, or other problems. If it can be normalized before surgery, it should be; women probably will do better, according to investigators from the University of Kentucky, Lexington.

“In minimally invasive gynecologic procedures, we haven’t come to adopt this marker just quite yet. It could be included in the routine battery of tests” at minimal cost. “I think it’s something we should consider,” said ob.gyn. resident Suzanne Lababidi, MD.

The team was curious why serum albumin generally is not a part of routine testing for laparoscopic hysterectomy. The first step was to see if it made a difference, so they reviewed 43,289 cases in the National Surgical Quality Improvement Program database. The women were “par for the course;” 51 years old, on average; and had a mean body mass index of 31.9 kg/m2. More than one-third were hypertensive. Mean albumin was in the normal range at 4.1 g/dL, Dr. Lababidi said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

Her team did not come up with a cut-point to delay surgery – that’s the goal of further research – but they noticed on linear regression that women with lower preop albumin had higher rates of surgical site infections and intraoperative transfusions, plus higher rates of postop pneumonia; renal failure; urinary tract infection; sepsis; and deep vein thrombosis, among other issues – and even after controlling for hypertension, diabetes, and other comorbidities. The findings met statistical significance.

It’s true that patients with low albumin might have gone into the operating room sicker, but no matter; Dr. Lababidi’s point was that preop serum albumin is something to pay attention to and correct whenever possible before laparoscopic hysterectomies.

“It’s important to realize that albumin is something that can be improved over time.” Preop levels are something to consider for “counseling and optimizing patients to improve surgical outcomes,” she said.

The next step toward an albumin cut-point is to weed out confounders by further stratifying patients based on albumin levels, she said.

The work received no industry funding. Dr. Lababidi had no disclosures.

SOURCE: Lababidi S et al. 2018 AAGL Global Congress, Abstract 199.

– Serum albumin is an everyday health marker commonly used for risk assessment in open abdominal procedures, but it’s often not checked before laparoscopic hysterectomies.

M. Alexander Otto/MDedge News
Dr. Suzanne Lababidi

Low levels mean something is off, be it malnutrition, inflammation, chronic disease, or other problems. If it can be normalized before surgery, it should be; women probably will do better, according to investigators from the University of Kentucky, Lexington.

“In minimally invasive gynecologic procedures, we haven’t come to adopt this marker just quite yet. It could be included in the routine battery of tests” at minimal cost. “I think it’s something we should consider,” said ob.gyn. resident Suzanne Lababidi, MD.

The team was curious why serum albumin generally is not a part of routine testing for laparoscopic hysterectomy. The first step was to see if it made a difference, so they reviewed 43,289 cases in the National Surgical Quality Improvement Program database. The women were “par for the course;” 51 years old, on average; and had a mean body mass index of 31.9 kg/m2. More than one-third were hypertensive. Mean albumin was in the normal range at 4.1 g/dL, Dr. Lababidi said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

Her team did not come up with a cut-point to delay surgery – that’s the goal of further research – but they noticed on linear regression that women with lower preop albumin had higher rates of surgical site infections and intraoperative transfusions, plus higher rates of postop pneumonia; renal failure; urinary tract infection; sepsis; and deep vein thrombosis, among other issues – and even after controlling for hypertension, diabetes, and other comorbidities. The findings met statistical significance.

It’s true that patients with low albumin might have gone into the operating room sicker, but no matter; Dr. Lababidi’s point was that preop serum albumin is something to pay attention to and correct whenever possible before laparoscopic hysterectomies.

“It’s important to realize that albumin is something that can be improved over time.” Preop levels are something to consider for “counseling and optimizing patients to improve surgical outcomes,” she said.

The next step toward an albumin cut-point is to weed out confounders by further stratifying patients based on albumin levels, she said.

The work received no industry funding. Dr. Lababidi had no disclosures.

SOURCE: Lababidi S et al. 2018 AAGL Global Congress, Abstract 199.

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Antibiotics backed as standard of care for myomectomies

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– The surgical site infection rate was 2.9% among women who received perioperative antibiotics for fibroid surgery, but 7.8% among those who did not, in a review of 1,433 cases at Massachusetts General Hospital and Brigham and Women’s Hospital, Boston.

M. Alexander Otto/MDedge News
Dr. Nisse Clark

That is despite the fact that antibiotic cases were longer – 155 minutes vs. 89 minutes – and had more blood loss, 200 ml vs. 117 ml. Antibiotic cases also had larger specimen weights – 346 g vs. 176 g – and were more likely to have the uterine cavity entered, 30.2% vs. 14.4%.

“Surgical site infections were more common in the no-antibiotics group despite these being less complex cases.” There was “nearly a fivefold increased odds of surgical site infection or any infectious complication when no antibiotics were given,” after controlling for infection risk factors, including smoking and diabetes, said investigator Nisse V. Clark, MD, a minimally invasive gynecologic surgeon affiliated with Massachusetts General Hospital.

There are no perioperative antibiotic guidelines for myomectomies; maybe there should be. Almost 94% of the women in the review did receive antibiotics at the Harvard-affiliated hospitals, but the nationwide average has been pegged at about two-thirds, she said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

The antibiotic cases usually received a cephalosporin before surgery, and were about evenly about evenly split between abdominal, robotic, and laparoscopic approaches.

About one-third of the 90 women (6.3%) who did not get antibiotics had hysteroscopic procedures in which antibiotics usually are not given because the peritoneal cavity is not breeched. Most of the rest, however, were laparoscopic cases. It’s unknown why they weren’t given antibiotics. In her own practice, Dr. Clark said preop antibiotics are the rule for laparoscopic myomectomies.

The surgical site infection difference was driven largely by higher incidences of pelvic abscesses and other organ space infections in the no-antibiotic group.

The only significant demographic difference between the two groups was that women who received antibiotics were slightly younger (mean 38 versus 39.7 years). Antibiotic cases were in the hospital a mean of 1 day, compared with 0.2 days in the no-antibiotic group.

In addition to diabetes and smoking, the team adjusted for age, surgery route, body mass index, uterine entry, intraoperative complications, and myoma weight in their multivariate analysis. Still, women in the no-antibiotic group were 4.59 times more likely to have a surgical site infection, 4.76 more likely to have any infectious complication, and almost 8 times more likely to have a major infectious complication. All of the findings were statistically significant.

The study had no industry funding, and Dr. Clark had no disclosures.

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– The surgical site infection rate was 2.9% among women who received perioperative antibiotics for fibroid surgery, but 7.8% among those who did not, in a review of 1,433 cases at Massachusetts General Hospital and Brigham and Women’s Hospital, Boston.

M. Alexander Otto/MDedge News
Dr. Nisse Clark

That is despite the fact that antibiotic cases were longer – 155 minutes vs. 89 minutes – and had more blood loss, 200 ml vs. 117 ml. Antibiotic cases also had larger specimen weights – 346 g vs. 176 g – and were more likely to have the uterine cavity entered, 30.2% vs. 14.4%.

“Surgical site infections were more common in the no-antibiotics group despite these being less complex cases.” There was “nearly a fivefold increased odds of surgical site infection or any infectious complication when no antibiotics were given,” after controlling for infection risk factors, including smoking and diabetes, said investigator Nisse V. Clark, MD, a minimally invasive gynecologic surgeon affiliated with Massachusetts General Hospital.

There are no perioperative antibiotic guidelines for myomectomies; maybe there should be. Almost 94% of the women in the review did receive antibiotics at the Harvard-affiliated hospitals, but the nationwide average has been pegged at about two-thirds, she said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

The antibiotic cases usually received a cephalosporin before surgery, and were about evenly about evenly split between abdominal, robotic, and laparoscopic approaches.

About one-third of the 90 women (6.3%) who did not get antibiotics had hysteroscopic procedures in which antibiotics usually are not given because the peritoneal cavity is not breeched. Most of the rest, however, were laparoscopic cases. It’s unknown why they weren’t given antibiotics. In her own practice, Dr. Clark said preop antibiotics are the rule for laparoscopic myomectomies.

The surgical site infection difference was driven largely by higher incidences of pelvic abscesses and other organ space infections in the no-antibiotic group.

The only significant demographic difference between the two groups was that women who received antibiotics were slightly younger (mean 38 versus 39.7 years). Antibiotic cases were in the hospital a mean of 1 day, compared with 0.2 days in the no-antibiotic group.

In addition to diabetes and smoking, the team adjusted for age, surgery route, body mass index, uterine entry, intraoperative complications, and myoma weight in their multivariate analysis. Still, women in the no-antibiotic group were 4.59 times more likely to have a surgical site infection, 4.76 more likely to have any infectious complication, and almost 8 times more likely to have a major infectious complication. All of the findings were statistically significant.

The study had no industry funding, and Dr. Clark had no disclosures.

– The surgical site infection rate was 2.9% among women who received perioperative antibiotics for fibroid surgery, but 7.8% among those who did not, in a review of 1,433 cases at Massachusetts General Hospital and Brigham and Women’s Hospital, Boston.

M. Alexander Otto/MDedge News
Dr. Nisse Clark

That is despite the fact that antibiotic cases were longer – 155 minutes vs. 89 minutes – and had more blood loss, 200 ml vs. 117 ml. Antibiotic cases also had larger specimen weights – 346 g vs. 176 g – and were more likely to have the uterine cavity entered, 30.2% vs. 14.4%.

“Surgical site infections were more common in the no-antibiotics group despite these being less complex cases.” There was “nearly a fivefold increased odds of surgical site infection or any infectious complication when no antibiotics were given,” after controlling for infection risk factors, including smoking and diabetes, said investigator Nisse V. Clark, MD, a minimally invasive gynecologic surgeon affiliated with Massachusetts General Hospital.

There are no perioperative antibiotic guidelines for myomectomies; maybe there should be. Almost 94% of the women in the review did receive antibiotics at the Harvard-affiliated hospitals, but the nationwide average has been pegged at about two-thirds, she said at the meeting, sponsored by the American Association of Gynecologic Laparoscopists.

The antibiotic cases usually received a cephalosporin before surgery, and were about evenly about evenly split between abdominal, robotic, and laparoscopic approaches.

About one-third of the 90 women (6.3%) who did not get antibiotics had hysteroscopic procedures in which antibiotics usually are not given because the peritoneal cavity is not breeched. Most of the rest, however, were laparoscopic cases. It’s unknown why they weren’t given antibiotics. In her own practice, Dr. Clark said preop antibiotics are the rule for laparoscopic myomectomies.

The surgical site infection difference was driven largely by higher incidences of pelvic abscesses and other organ space infections in the no-antibiotic group.

The only significant demographic difference between the two groups was that women who received antibiotics were slightly younger (mean 38 versus 39.7 years). Antibiotic cases were in the hospital a mean of 1 day, compared with 0.2 days in the no-antibiotic group.

In addition to diabetes and smoking, the team adjusted for age, surgery route, body mass index, uterine entry, intraoperative complications, and myoma weight in their multivariate analysis. Still, women in the no-antibiotic group were 4.59 times more likely to have a surgical site infection, 4.76 more likely to have any infectious complication, and almost 8 times more likely to have a major infectious complication. All of the findings were statistically significant.

The study had no industry funding, and Dr. Clark had no disclosures.

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Key clinical point: A Boston study suggests that even low-risk cases benefit from antibiotics.

Major finding: The surgical site infection rate was 2.9% among women who received perioperative antibiotics for fibroid surgery, but 7.8% among those who did not.

Study details: Review of 1,433 myomectomies at two academic medical centers.

Disclosures: The study had no industry funding, and Dr. Clark had no disclosures.

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Two-stage preeclampsia screening cuts cost, preserves effectiveness

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Using maternal characteristics to identify high-risk pregnant women for second-stage preeclampsia screening achieved similar detection rates as screening all pregnant women, based on data from a prospective study of 61,174 singleton pregnancies.

About 90% of preeclampsia cases can be predicted using the “triple test” of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI) and serum placental growth factor (PlGF) plus a combination of maternal factors at 11 to 13 weeks’ gestation, wrote Alan Wright, PhD, of the University of Exeter, United Kingdom, and colleagues. The need for detection of preeclampsia is important, as high-risk pregnant women who take aspirin before 16 weeks’ gestation can reduce early preeclampsia by 90% and preterm preeclampsia by 60%, they said.

However, “measurements of serum PlGF and UtA-PI are not part of routine care and would be associated with an additional cost,” Dr. Wright and his colleagues noted in the American Journal of Obstetrics & Gynecology.

In the study, the researchers used a competing risks model to combine MAP, UtA-PI, and PlGF and maternal factors to compare detection rates if the triple test were used for a subset of high-risk women. Most of the women in the study were white.

Overall, Dr. Wright and his colleagues found, if first-stage screening method is maternal factors, then measurements of MAP, UtA-PI, and PlGF can be reserved for 70% of the pregnant population.

When the researchers compared various components of the triple test, they found that, if the first stage of screening included maternal factors along with MAP and UtA-PI, measurement of PlGF could be saved for 30%-40% of pregnant women. Similarly, if first-stage screening included maternal factors, MAP, and PlGF, measurement of UtA-PI can be saved for 20%-30% of the population, they said.

The study findings were limited by several factors, including the homogeneity of the population studied, the researchers noted. “The risk for development of [preeclampsia] is higher in women of black or South Asian racial origin than in white women,” Dr. Wright and his colleagues wrote. “Consequently, in screening in a population of mixed racial origins, for a given risk cut-off, the [detection rate] and [screen positive rate] would be higher in black and South Asian than white women and the overall performance would be dependent on the proportion of the various racial groups within that population.”

However, the results support the effectiveness of using only certain tests paired with maternal factors to identify high-risk patients for further screening.

“Inevitably, biomarker screening for only part of the population will have financial benefits over conducting the test for the entire population,” the researchers said.

Dr. Wright and his colleagues reported no conflicts of interest. The study was supported in part by the Fetal Medicine Foundation, and the reagents and equipment used for the measurement of serum placental growth factor were provided by PerkinElmer Life and Analytical Sciences.

SOURCE: Wright A et al. Am J Obstet Gynecol. 2018. doi: 10.1016/j.ajog.2018.10.092.

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Using maternal characteristics to identify high-risk pregnant women for second-stage preeclampsia screening achieved similar detection rates as screening all pregnant women, based on data from a prospective study of 61,174 singleton pregnancies.

About 90% of preeclampsia cases can be predicted using the “triple test” of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI) and serum placental growth factor (PlGF) plus a combination of maternal factors at 11 to 13 weeks’ gestation, wrote Alan Wright, PhD, of the University of Exeter, United Kingdom, and colleagues. The need for detection of preeclampsia is important, as high-risk pregnant women who take aspirin before 16 weeks’ gestation can reduce early preeclampsia by 90% and preterm preeclampsia by 60%, they said.

However, “measurements of serum PlGF and UtA-PI are not part of routine care and would be associated with an additional cost,” Dr. Wright and his colleagues noted in the American Journal of Obstetrics & Gynecology.

In the study, the researchers used a competing risks model to combine MAP, UtA-PI, and PlGF and maternal factors to compare detection rates if the triple test were used for a subset of high-risk women. Most of the women in the study were white.

Overall, Dr. Wright and his colleagues found, if first-stage screening method is maternal factors, then measurements of MAP, UtA-PI, and PlGF can be reserved for 70% of the pregnant population.

When the researchers compared various components of the triple test, they found that, if the first stage of screening included maternal factors along with MAP and UtA-PI, measurement of PlGF could be saved for 30%-40% of pregnant women. Similarly, if first-stage screening included maternal factors, MAP, and PlGF, measurement of UtA-PI can be saved for 20%-30% of the population, they said.

The study findings were limited by several factors, including the homogeneity of the population studied, the researchers noted. “The risk for development of [preeclampsia] is higher in women of black or South Asian racial origin than in white women,” Dr. Wright and his colleagues wrote. “Consequently, in screening in a population of mixed racial origins, for a given risk cut-off, the [detection rate] and [screen positive rate] would be higher in black and South Asian than white women and the overall performance would be dependent on the proportion of the various racial groups within that population.”

However, the results support the effectiveness of using only certain tests paired with maternal factors to identify high-risk patients for further screening.

“Inevitably, biomarker screening for only part of the population will have financial benefits over conducting the test for the entire population,” the researchers said.

Dr. Wright and his colleagues reported no conflicts of interest. The study was supported in part by the Fetal Medicine Foundation, and the reagents and equipment used for the measurement of serum placental growth factor were provided by PerkinElmer Life and Analytical Sciences.

SOURCE: Wright A et al. Am J Obstet Gynecol. 2018. doi: 10.1016/j.ajog.2018.10.092.

Using maternal characteristics to identify high-risk pregnant women for second-stage preeclampsia screening achieved similar detection rates as screening all pregnant women, based on data from a prospective study of 61,174 singleton pregnancies.

About 90% of preeclampsia cases can be predicted using the “triple test” of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI) and serum placental growth factor (PlGF) plus a combination of maternal factors at 11 to 13 weeks’ gestation, wrote Alan Wright, PhD, of the University of Exeter, United Kingdom, and colleagues. The need for detection of preeclampsia is important, as high-risk pregnant women who take aspirin before 16 weeks’ gestation can reduce early preeclampsia by 90% and preterm preeclampsia by 60%, they said.

However, “measurements of serum PlGF and UtA-PI are not part of routine care and would be associated with an additional cost,” Dr. Wright and his colleagues noted in the American Journal of Obstetrics & Gynecology.

In the study, the researchers used a competing risks model to combine MAP, UtA-PI, and PlGF and maternal factors to compare detection rates if the triple test were used for a subset of high-risk women. Most of the women in the study were white.

Overall, Dr. Wright and his colleagues found, if first-stage screening method is maternal factors, then measurements of MAP, UtA-PI, and PlGF can be reserved for 70% of the pregnant population.

When the researchers compared various components of the triple test, they found that, if the first stage of screening included maternal factors along with MAP and UtA-PI, measurement of PlGF could be saved for 30%-40% of pregnant women. Similarly, if first-stage screening included maternal factors, MAP, and PlGF, measurement of UtA-PI can be saved for 20%-30% of the population, they said.

The study findings were limited by several factors, including the homogeneity of the population studied, the researchers noted. “The risk for development of [preeclampsia] is higher in women of black or South Asian racial origin than in white women,” Dr. Wright and his colleagues wrote. “Consequently, in screening in a population of mixed racial origins, for a given risk cut-off, the [detection rate] and [screen positive rate] would be higher in black and South Asian than white women and the overall performance would be dependent on the proportion of the various racial groups within that population.”

However, the results support the effectiveness of using only certain tests paired with maternal factors to identify high-risk patients for further screening.

“Inevitably, biomarker screening for only part of the population will have financial benefits over conducting the test for the entire population,” the researchers said.

Dr. Wright and his colleagues reported no conflicts of interest. The study was supported in part by the Fetal Medicine Foundation, and the reagents and equipment used for the measurement of serum placental growth factor were provided by PerkinElmer Life and Analytical Sciences.

SOURCE: Wright A et al. Am J Obstet Gynecol. 2018. doi: 10.1016/j.ajog.2018.10.092.

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FROM THE AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY

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Key clinical point: Reserving two-stage testing for preeclampsia to high-risk subgroups can cut costs without cutting effectiveness.

Major finding: The more costly measurements of MAP, UtA-PI, and PlGF can be reserved for 70% of pregnant women with similar preeclampsia detection rates as testing the entire population.

Study details: The data come from a prospective study of 61,174 singleton pregnancies.

Disclosures: The researchers reported no conflicts of interest. The study was supported in part by the Fetal Medicine Foundation; the reagents and equipment used for the measurement of serum placental growth factor were provided by PerkinElmer Life and Analytical Sciences.

Source: Wright A et al. Am J Obstet Gynecol. 2018. doi: 10.1016/j.ajog.2018.10.092.

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CKD, and even dialysis, may not be barriers to pregnancy

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– Nephrologists are often uncomfortable with the idea of advising women with chronic kidney disease (CKD) about pregnancy, a physician told colleagues. They must do better, she said, with sensitivity and insight into once-extreme possibilities like pregnancy during dialysis.

“For many women, having a child is a life goal, and our women with chronic kidney disease are not different,” said Michelle Hladunewich, MD, of Toronto’s Sunnybrook Health Sciences Center. “When we don’t know what we should do, we tend to over-aggressively counsel our women, and that can traumatize them. It’s our role as nephrologists to help them find the safest window to have their pregnancy,” she said at the meeting sponsored by the American Society of Nephrology.

According to Dr. Hladunewich, there are tens of thousands of women of child-bearing age in the United States who have CKD, end-stage renal disease (ESRD), and kidney transplants. However, she said, research presented at Kidney Week 2018 suggested that many nephrologists do not feel confident about counseling patients regarding issues such as pregnancy outcomes in CKD. “We are not that comfortable with it, but we have to become more comfortable,” she said. “We need to be prepared to talk about contraception if they don’t want to have a child or the plan about how to have a child if they do.”

It’s especially important to understand that while women can fear birth defects and the exacerbation of their disease, they may also feel “they’re not fulfilling a societal norm to have a child like everyone else,” she said.

The risks of pregnancy in CKD can affect the mother (via worse kidney function) and/or the fetus (preeclampsia, poor fetal growth, preterm delivery).

In a 2015 study, Italian researchers compared 504 pregnancies in women with CKD to 836 low-risk pregnancies in women without CKD. They found that the risks of adverse outcomes increased in women at higher stages of CKD, compared with those at lower stages: “Renal function matters, and a stepwise increase in the risk of adverse maternal-fetal outcomes is observed from stage 1 to stages 4-5.”

In addition, the researchers noted that their research suggests “the presence of a baseline risk linked to CKD per se” (J Am Soc Nephrol. 2015 Aug; 26[8]:2011-22).

Dr. Hladunewich recommended focusing on “the safest window of opportunity.” Some patients will progress to end-stage renal disease, and an earlier pregnancy during CKD is a better option, she said. As a result, encouraging an earlier pregnancy can be a wise idea.

In some cases, though, a patient may be far into the stages of CKD. Dr. Hladunewich spoke about the case of a 31-year-old patient with a 29-year history of type 1 diabetes mellitus. She’d had one miscarriage, one preterm birth, and one twin pregnancy that was terminated because of safety concerns including rapid loss of kidney function.

The patient saw Dr. Hladunewich when she had a glomerular filtration rate of 25 mL/min, 3.5 g per 24 hour of proteinuria, and hypertension. The patient had a question: “Dr. Michelle, when can I try again?”

Dr. Hladunewich joked that “I had a small stroke.” But then, she said, “I got to the business of pregnancy counseling.”

She told the woman that her progression to end-stage renal disease was likely inevitable, and “adverse pregnancy outcomes were almost guaranteed.”

The woman responded: “Not now? When?” That, Dr. Hladunewich said, “was when I had my second stroke.”

But there is a possible solution: Pregnancy during dialysis. “Historically, we’ve said absolutely no pregnancy on dialysis,” she said, “but times are changing. We believe aggressive dialysis improves fetal maternal and fetal outcomes.”

Indeed, Dr. Hladunewich led a 2014 study that linked extensive dialysis during pregnancy (compared with less dialysis) to a better likelihood of outcomes such as live birth rate and normal birth weight (JASN May 2014;25[5]:1103-9).

As she noted, “we do offer it as a reproductive option” to patients like the one she mentioned – those who are in ESRD, approaching it, or are nearing the end of their child-bearing years with no transplant in sight. In transplant cases, she said, adequate graft function is linked to good pregnancy outcomes.

Dr. Hladunewich added that it’s important to monitor and adjust treatment of patients during the postpartum period. She said it’s especially important to understand the risks of drugs during breastfeeding. Both dialysis and transplant patients can breastfeed, she said.

Dr. Hladunewich reports no disclosures.

SOURCE: Kidney Week 2018, Abstract FR-OR078.

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– Nephrologists are often uncomfortable with the idea of advising women with chronic kidney disease (CKD) about pregnancy, a physician told colleagues. They must do better, she said, with sensitivity and insight into once-extreme possibilities like pregnancy during dialysis.

“For many women, having a child is a life goal, and our women with chronic kidney disease are not different,” said Michelle Hladunewich, MD, of Toronto’s Sunnybrook Health Sciences Center. “When we don’t know what we should do, we tend to over-aggressively counsel our women, and that can traumatize them. It’s our role as nephrologists to help them find the safest window to have their pregnancy,” she said at the meeting sponsored by the American Society of Nephrology.

According to Dr. Hladunewich, there are tens of thousands of women of child-bearing age in the United States who have CKD, end-stage renal disease (ESRD), and kidney transplants. However, she said, research presented at Kidney Week 2018 suggested that many nephrologists do not feel confident about counseling patients regarding issues such as pregnancy outcomes in CKD. “We are not that comfortable with it, but we have to become more comfortable,” she said. “We need to be prepared to talk about contraception if they don’t want to have a child or the plan about how to have a child if they do.”

It’s especially important to understand that while women can fear birth defects and the exacerbation of their disease, they may also feel “they’re not fulfilling a societal norm to have a child like everyone else,” she said.

The risks of pregnancy in CKD can affect the mother (via worse kidney function) and/or the fetus (preeclampsia, poor fetal growth, preterm delivery).

In a 2015 study, Italian researchers compared 504 pregnancies in women with CKD to 836 low-risk pregnancies in women without CKD. They found that the risks of adverse outcomes increased in women at higher stages of CKD, compared with those at lower stages: “Renal function matters, and a stepwise increase in the risk of adverse maternal-fetal outcomes is observed from stage 1 to stages 4-5.”

In addition, the researchers noted that their research suggests “the presence of a baseline risk linked to CKD per se” (J Am Soc Nephrol. 2015 Aug; 26[8]:2011-22).

Dr. Hladunewich recommended focusing on “the safest window of opportunity.” Some patients will progress to end-stage renal disease, and an earlier pregnancy during CKD is a better option, she said. As a result, encouraging an earlier pregnancy can be a wise idea.

In some cases, though, a patient may be far into the stages of CKD. Dr. Hladunewich spoke about the case of a 31-year-old patient with a 29-year history of type 1 diabetes mellitus. She’d had one miscarriage, one preterm birth, and one twin pregnancy that was terminated because of safety concerns including rapid loss of kidney function.

The patient saw Dr. Hladunewich when she had a glomerular filtration rate of 25 mL/min, 3.5 g per 24 hour of proteinuria, and hypertension. The patient had a question: “Dr. Michelle, when can I try again?”

Dr. Hladunewich joked that “I had a small stroke.” But then, she said, “I got to the business of pregnancy counseling.”

She told the woman that her progression to end-stage renal disease was likely inevitable, and “adverse pregnancy outcomes were almost guaranteed.”

The woman responded: “Not now? When?” That, Dr. Hladunewich said, “was when I had my second stroke.”

But there is a possible solution: Pregnancy during dialysis. “Historically, we’ve said absolutely no pregnancy on dialysis,” she said, “but times are changing. We believe aggressive dialysis improves fetal maternal and fetal outcomes.”

Indeed, Dr. Hladunewich led a 2014 study that linked extensive dialysis during pregnancy (compared with less dialysis) to a better likelihood of outcomes such as live birth rate and normal birth weight (JASN May 2014;25[5]:1103-9).

As she noted, “we do offer it as a reproductive option” to patients like the one she mentioned – those who are in ESRD, approaching it, or are nearing the end of their child-bearing years with no transplant in sight. In transplant cases, she said, adequate graft function is linked to good pregnancy outcomes.

Dr. Hladunewich added that it’s important to monitor and adjust treatment of patients during the postpartum period. She said it’s especially important to understand the risks of drugs during breastfeeding. Both dialysis and transplant patients can breastfeed, she said.

Dr. Hladunewich reports no disclosures.

SOURCE: Kidney Week 2018, Abstract FR-OR078.

– Nephrologists are often uncomfortable with the idea of advising women with chronic kidney disease (CKD) about pregnancy, a physician told colleagues. They must do better, she said, with sensitivity and insight into once-extreme possibilities like pregnancy during dialysis.

“For many women, having a child is a life goal, and our women with chronic kidney disease are not different,” said Michelle Hladunewich, MD, of Toronto’s Sunnybrook Health Sciences Center. “When we don’t know what we should do, we tend to over-aggressively counsel our women, and that can traumatize them. It’s our role as nephrologists to help them find the safest window to have their pregnancy,” she said at the meeting sponsored by the American Society of Nephrology.

According to Dr. Hladunewich, there are tens of thousands of women of child-bearing age in the United States who have CKD, end-stage renal disease (ESRD), and kidney transplants. However, she said, research presented at Kidney Week 2018 suggested that many nephrologists do not feel confident about counseling patients regarding issues such as pregnancy outcomes in CKD. “We are not that comfortable with it, but we have to become more comfortable,” she said. “We need to be prepared to talk about contraception if they don’t want to have a child or the plan about how to have a child if they do.”

It’s especially important to understand that while women can fear birth defects and the exacerbation of their disease, they may also feel “they’re not fulfilling a societal norm to have a child like everyone else,” she said.

The risks of pregnancy in CKD can affect the mother (via worse kidney function) and/or the fetus (preeclampsia, poor fetal growth, preterm delivery).

In a 2015 study, Italian researchers compared 504 pregnancies in women with CKD to 836 low-risk pregnancies in women without CKD. They found that the risks of adverse outcomes increased in women at higher stages of CKD, compared with those at lower stages: “Renal function matters, and a stepwise increase in the risk of adverse maternal-fetal outcomes is observed from stage 1 to stages 4-5.”

In addition, the researchers noted that their research suggests “the presence of a baseline risk linked to CKD per se” (J Am Soc Nephrol. 2015 Aug; 26[8]:2011-22).

Dr. Hladunewich recommended focusing on “the safest window of opportunity.” Some patients will progress to end-stage renal disease, and an earlier pregnancy during CKD is a better option, she said. As a result, encouraging an earlier pregnancy can be a wise idea.

In some cases, though, a patient may be far into the stages of CKD. Dr. Hladunewich spoke about the case of a 31-year-old patient with a 29-year history of type 1 diabetes mellitus. She’d had one miscarriage, one preterm birth, and one twin pregnancy that was terminated because of safety concerns including rapid loss of kidney function.

The patient saw Dr. Hladunewich when she had a glomerular filtration rate of 25 mL/min, 3.5 g per 24 hour of proteinuria, and hypertension. The patient had a question: “Dr. Michelle, when can I try again?”

Dr. Hladunewich joked that “I had a small stroke.” But then, she said, “I got to the business of pregnancy counseling.”

She told the woman that her progression to end-stage renal disease was likely inevitable, and “adverse pregnancy outcomes were almost guaranteed.”

The woman responded: “Not now? When?” That, Dr. Hladunewich said, “was when I had my second stroke.”

But there is a possible solution: Pregnancy during dialysis. “Historically, we’ve said absolutely no pregnancy on dialysis,” she said, “but times are changing. We believe aggressive dialysis improves fetal maternal and fetal outcomes.”

Indeed, Dr. Hladunewich led a 2014 study that linked extensive dialysis during pregnancy (compared with less dialysis) to a better likelihood of outcomes such as live birth rate and normal birth weight (JASN May 2014;25[5]:1103-9).

As she noted, “we do offer it as a reproductive option” to patients like the one she mentioned – those who are in ESRD, approaching it, or are nearing the end of their child-bearing years with no transplant in sight. In transplant cases, she said, adequate graft function is linked to good pregnancy outcomes.

Dr. Hladunewich added that it’s important to monitor and adjust treatment of patients during the postpartum period. She said it’s especially important to understand the risks of drugs during breastfeeding. Both dialysis and transplant patients can breastfeed, she said.

Dr. Hladunewich reports no disclosures.

SOURCE: Kidney Week 2018, Abstract FR-OR078.

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Despite declines in prenatal use of alcohol and cigarettes, cannabis use is on the rise

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Despite general decreases in cigarette and alcohol use among pregnant women during 2002-2016, cannabis use in pregnancy persisted and has actually increased slightly over the past 14 years, reported Arpana Agrawal, PhD, and her associates, of the Washington University, St. Louis.

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Dr. Agrawal and her associates analyzed data from the National Survey of Drug Use and Health from 2002-2016 to quantify changes in alcohol, cigarette, and cannabis use among pregnant women aged 18-44 years. Survey-adjusted prevalence estimates of alcohol, cigarette, and cannabis use in 2002 were 10%, 18%, and 3%, respectively, versus corresponding rates in 2016 of 8%, 10%, and 5%, according to their research letter in JAMA Pediatrics.

A sampling of 12,058 women aged 18-25 years (n = 8,170) or 26-44 years (n = 3,888) was taken from a population of more than 436,056 women included in the National Survey database. Fully 3,554 of the women included in the final study group were in their first trimester of pregnancy.

The findings in Dr. Agrawal’s study were similar to another study conducted by Brown et al., although the exact prevalence for cannabis use differed slightly.

In addition to observing a reduction in the use of alcohol and cigarettes, the authors also noted a significant decline in the combined use of alcohol and cigarettes together. For alcohol use specifically, the greatest decrease was seen among women aged 18-25 years. For cigarette smoking in pregnancy, the most significant decreases were seen in white women, those aged 18-25 years, and those who had achieved completion of high school or more advanced studies.

Overall, the effects were modest when sample sizes were stratified by trimester: decreases in cigarette smoking were observed in the first trimester, and more significantly, later in pregnancy. For alcohol, nominal reductions were observed in the second and third trimesters. Cannabis use, on the other hand, increased in the first trimester, but showed no significant increases during the second and third trimesters.

“Greater public awareness regarding the consequences of prenatal cannabis exposure in offspring health is necessary,” Dr. Agrawal and her colleagues wrote.

The authors had no relevant disclosures to report. Funding was provided by grants from the National Institute on Drug Abuse, the National Institute of Child Health and Human Development, and the National Institute on Alcohol Abuse and Alcoholism.
 

SOURCE: Agrawal A et al. JAMA Pediatr. 2018 Nov 5. doi: 10.1001/jamapediatrics.2018.3096.

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Despite general decreases in cigarette and alcohol use among pregnant women during 2002-2016, cannabis use in pregnancy persisted and has actually increased slightly over the past 14 years, reported Arpana Agrawal, PhD, and her associates, of the Washington University, St. Louis.

Doug Menuez/thinkstock

Dr. Agrawal and her associates analyzed data from the National Survey of Drug Use and Health from 2002-2016 to quantify changes in alcohol, cigarette, and cannabis use among pregnant women aged 18-44 years. Survey-adjusted prevalence estimates of alcohol, cigarette, and cannabis use in 2002 were 10%, 18%, and 3%, respectively, versus corresponding rates in 2016 of 8%, 10%, and 5%, according to their research letter in JAMA Pediatrics.

A sampling of 12,058 women aged 18-25 years (n = 8,170) or 26-44 years (n = 3,888) was taken from a population of more than 436,056 women included in the National Survey database. Fully 3,554 of the women included in the final study group were in their first trimester of pregnancy.

The findings in Dr. Agrawal’s study were similar to another study conducted by Brown et al., although the exact prevalence for cannabis use differed slightly.

In addition to observing a reduction in the use of alcohol and cigarettes, the authors also noted a significant decline in the combined use of alcohol and cigarettes together. For alcohol use specifically, the greatest decrease was seen among women aged 18-25 years. For cigarette smoking in pregnancy, the most significant decreases were seen in white women, those aged 18-25 years, and those who had achieved completion of high school or more advanced studies.

Overall, the effects were modest when sample sizes were stratified by trimester: decreases in cigarette smoking were observed in the first trimester, and more significantly, later in pregnancy. For alcohol, nominal reductions were observed in the second and third trimesters. Cannabis use, on the other hand, increased in the first trimester, but showed no significant increases during the second and third trimesters.

“Greater public awareness regarding the consequences of prenatal cannabis exposure in offspring health is necessary,” Dr. Agrawal and her colleagues wrote.

The authors had no relevant disclosures to report. Funding was provided by grants from the National Institute on Drug Abuse, the National Institute of Child Health and Human Development, and the National Institute on Alcohol Abuse and Alcoholism.
 

SOURCE: Agrawal A et al. JAMA Pediatr. 2018 Nov 5. doi: 10.1001/jamapediatrics.2018.3096.

Despite general decreases in cigarette and alcohol use among pregnant women during 2002-2016, cannabis use in pregnancy persisted and has actually increased slightly over the past 14 years, reported Arpana Agrawal, PhD, and her associates, of the Washington University, St. Louis.

Doug Menuez/thinkstock

Dr. Agrawal and her associates analyzed data from the National Survey of Drug Use and Health from 2002-2016 to quantify changes in alcohol, cigarette, and cannabis use among pregnant women aged 18-44 years. Survey-adjusted prevalence estimates of alcohol, cigarette, and cannabis use in 2002 were 10%, 18%, and 3%, respectively, versus corresponding rates in 2016 of 8%, 10%, and 5%, according to their research letter in JAMA Pediatrics.

A sampling of 12,058 women aged 18-25 years (n = 8,170) or 26-44 years (n = 3,888) was taken from a population of more than 436,056 women included in the National Survey database. Fully 3,554 of the women included in the final study group were in their first trimester of pregnancy.

The findings in Dr. Agrawal’s study were similar to another study conducted by Brown et al., although the exact prevalence for cannabis use differed slightly.

In addition to observing a reduction in the use of alcohol and cigarettes, the authors also noted a significant decline in the combined use of alcohol and cigarettes together. For alcohol use specifically, the greatest decrease was seen among women aged 18-25 years. For cigarette smoking in pregnancy, the most significant decreases were seen in white women, those aged 18-25 years, and those who had achieved completion of high school or more advanced studies.

Overall, the effects were modest when sample sizes were stratified by trimester: decreases in cigarette smoking were observed in the first trimester, and more significantly, later in pregnancy. For alcohol, nominal reductions were observed in the second and third trimesters. Cannabis use, on the other hand, increased in the first trimester, but showed no significant increases during the second and third trimesters.

“Greater public awareness regarding the consequences of prenatal cannabis exposure in offspring health is necessary,” Dr. Agrawal and her colleagues wrote.

The authors had no relevant disclosures to report. Funding was provided by grants from the National Institute on Drug Abuse, the National Institute of Child Health and Human Development, and the National Institute on Alcohol Abuse and Alcoholism.
 

SOURCE: Agrawal A et al. JAMA Pediatr. 2018 Nov 5. doi: 10.1001/jamapediatrics.2018.3096.

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Key clinical point: Over the 14-year study period, cannabis use increased during the first trimester, which is a key phase of fetal neural development.

Major finding: Greatest increase in use of cannabis over the 14 years of the study was seen during the first trimester; the increase in use of cannabis in the second and third trimesters was not significant.

Study details: A study of 12,058 pregnant women from 2002-2016.

Disclosures: The authors had no relevant financial disclosures. Funding was provided by grants from the National Institute on Drug Abuse, the National Institute of Child Health and Human Development, and the National Institute on Alcohol Abuse and Alcoholism.

Source: Agrawal A et al. JAMA Pediatr. 2018 Nov 5. doi: 10.1001/jamapediatrics.2018.3096.

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RFM awareness program not effective at preventing stillbirths

Discourage RFM reporting to prevent excess intervention
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Because reduced fetal movement is associated with higher stillbirth risk, asking women to be alert to RFM and report it immediately has emerged as a potential intervention to prevent stillbirth. But a large, randomized trial of one reporting and management protocol showed no reduction in stillbirths, only a rise in C-sections and preterm inductions.

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Jane E. Norman, MD, of the University of Edinburgh, and her colleagues published results from a trial in the Lancet, in which 409,175 pregnant women (mean age, 30 years) across 33 hospitals in the United Kingdom and Ireland received either standard care or the experimental RFM care intervention before delivery. Women were seen during an experimental 3-month period, in which all were treated according to the protocol, or the 3-month control period that preceded it. A 2-month washout period occurred between allocations as institutions adapted to the study protocol.

The trial intervention consisted of training clinical staff on the implications and management of RFM, distributing written information on RFM to women at about 20 weeks’ gestation, and a management protocol aimed at quick action following a report of RFM at 24 or more weeks’ gestation. The protocol included cardiotocography within 2 hours of presentation followed by measurement of liquor volume and a growth scan, along with umbilical artery Doppler where available. Delivery was recommended for women at 37 or more weeks’ gestation with estimated fetal weight below the 10th centile, abdominal circumference below the 10th centile, a low liquor volume, an abnormal cardiotocograph, or recurrent RFM.

Incidence of stillbirth at or beyond 24 weeks was 4.40 per 1,000 births during the control period and 4.06 per 1,000 births in the intervention period (adjusted odds ratio, 0.90; 95% confidence interval, 0.75-1.07; P = .23), the researchers found. No differences were seen when stratifying for different gestational ages.

Meanwhile, induction of labor before 39 weeks was more frequent during intervention period at 40% of deliveries, compared with 34% during the control time (P less than .0001), and at term (41% vs. 36%; P = .0015). C-section was higher in the intervention group at 28% versus 26% (P = .0001). Neonatal ICU stays were not more common but were likely to be longer in the intervention period, with stays of 2 days or longer occurring in 6.7% of deliveries versus 6.2% (P =.0001).

The investigators concluded that their protocol, in its current design, was not effective and could not be recommended because of the significant increase in interventions.

Dr. Norman and her colleagues wrote that the findings would “reignite the controversy about the efficacy of RFM awareness to reduce stillbirth and the underlying mechanisms linking RFM and stillbirth.” However, the results do not mean that RFM is a sign of inevitable fetal death or that there is no role for RFM awareness as a stillbirth-prevention strategy. Other large trials testing RFM-based interventions are still underway, they noted.

“Further research to identify better predictive tests for stillbirth [to enable targeting of the only current treatment of earlier delivery] is urgently needed,” the investigators added.

In a related study also published in the Lancet, Lucy K. Smith, PhD, of the University of Leicester (England), and her colleagues reported that the real burden of stillbirth in Europe, while much lower than in the developing world, is still a third higher than reported using the current international cutoff established by the World Health Organization.

Dr. Smith and her colleagues examined national cohort data from 19 European countries between 2004 and 2015 for pregnancy outcomes from 22 completed weeks’ gestation. In 2015, they found more than 9,000 stillbirths occurred among more than 25 million births, and 3,022 of these (32%) occurred between 22 and 28 weeks’ gestation.

The WHO officially defines stillbirth as any baby born without life at 28 weeks or beyond, although it recommends that countries collect data on fetal death from 22 weeks. However, discrepancies between and even within countries in reporting laws and their implementation “inhibit reliable international comparisons” at those earlier gestational ages, Dr. Smith and her colleagues wrote.

The researchers, pooling data from the 19 countries, found that the stillbirth rate at 24-28 weeks’ gestation declined from 0.97 per 1,000 births (95% CI, 0.80-1.14) to 0.70 per 1,000 births (95% CI, 0.57-0.82) between 2004 and 2015, a reduction of 25% (risk ratio; 0.75; 95% CI, 0.65-0.85).

“The decrease of 25% in stillbirths at 24 weeks to less than 28 weeks is very similar to that seen globally for stillbirths of 28 weeks of gestation [25.5% worldwide and 24.5% in developed regions] and above for a similar time period of 2000-2015, suggesting consistent improvements over time in the reduction of stillbirths from 24 completed weeks of gestation,” the researchers wrote in their analysis.

Data from France, Spain, and Cyprus was not included in the analysis as these countries did not collect fetal death reports for the gestational periods in the study. Also, for a few countries in the study, late terminations of pregnancy could not be distinguished from spontaneous fetal death.

“The consistency in reporting of births over time at 24 weeks to less than 28 weeks of gestation and the similarity of reduction in the rate of stillbirth over time to births at 28 completed weeks of gestation and above suggest that stillbirths at 24 weeks to less than 28 weeks of gestation can be routinely included in rates of stillbirth for international comparisons from now on,” at least in high-income countries, the investigators wrote.

The study by Norman et al. was funded by the Scottish government, Tommy’s Health Center, and Sands, a U.K. stillbirth charity. The article presents research funded in part by the National Institute for Health Research. Several investigators, including the lead author, reported financial support from these entities. One author reported salary from National Health Service Lothian. All other authors reported no relevant financial disclosures. The study by Smith et al. was funded by the European Union and National Institute for Health Research. Dr. Smith received funding from a National Institute for Health Research Career Development Fellowship. All other authors reported no financial conflicts of interest.

SOURCES: Norman JE et al. Lancet. 2018;392:1629-38; Smith LK et al. Lancet. 2018;392:1639-46.

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The well-conducted, randomized trial by Norman et al. enrolled over 400,000 women at 33 trials to see if reduced fetal movement reporting would significantly reduce stillbirths. It did not, but it did increase C-sections, Kate F. Walker, PhD, and Jim G. Thornton wrote in an invited commentary.

“Repeated episodes of reduced fetal movement can be so stressful to the mother that some doctors are persuaded to induce, even if further tests are normal. There also are anecdotes of women feigning reduced fetal movements to attain an ultrasound scan or induction of labor. The prevalence of women falsifying RFM is important because, although induction of birth at full term is unlikely to seriously harm the mother or the baby, preterm induction has risks,” they wrote.

“Failure of health care providers to respond to reported changes to fetal movement is probably impossible. However, discouraging campaigns that promote awareness preterm, improving induction guidelines, and not inducing delivery in response to perception of altered movement alone would seem to be sensible first steps,” Dr. Walker and Mr. Thornton concluded.

Dr. Walker and Mr. Thornton are with the division of child health, obstetrics, and gynecology at the University of Nottingham (England). They reported no financial interests related to their commentary (Lancet. 2018 Nov 3. doi: 10.1016/S0140-6736[18]31720-3).

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The well-conducted, randomized trial by Norman et al. enrolled over 400,000 women at 33 trials to see if reduced fetal movement reporting would significantly reduce stillbirths. It did not, but it did increase C-sections, Kate F. Walker, PhD, and Jim G. Thornton wrote in an invited commentary.

“Repeated episodes of reduced fetal movement can be so stressful to the mother that some doctors are persuaded to induce, even if further tests are normal. There also are anecdotes of women feigning reduced fetal movements to attain an ultrasound scan or induction of labor. The prevalence of women falsifying RFM is important because, although induction of birth at full term is unlikely to seriously harm the mother or the baby, preterm induction has risks,” they wrote.

“Failure of health care providers to respond to reported changes to fetal movement is probably impossible. However, discouraging campaigns that promote awareness preterm, improving induction guidelines, and not inducing delivery in response to perception of altered movement alone would seem to be sensible first steps,” Dr. Walker and Mr. Thornton concluded.

Dr. Walker and Mr. Thornton are with the division of child health, obstetrics, and gynecology at the University of Nottingham (England). They reported no financial interests related to their commentary (Lancet. 2018 Nov 3. doi: 10.1016/S0140-6736[18]31720-3).

Body

 

The well-conducted, randomized trial by Norman et al. enrolled over 400,000 women at 33 trials to see if reduced fetal movement reporting would significantly reduce stillbirths. It did not, but it did increase C-sections, Kate F. Walker, PhD, and Jim G. Thornton wrote in an invited commentary.

“Repeated episodes of reduced fetal movement can be so stressful to the mother that some doctors are persuaded to induce, even if further tests are normal. There also are anecdotes of women feigning reduced fetal movements to attain an ultrasound scan or induction of labor. The prevalence of women falsifying RFM is important because, although induction of birth at full term is unlikely to seriously harm the mother or the baby, preterm induction has risks,” they wrote.

“Failure of health care providers to respond to reported changes to fetal movement is probably impossible. However, discouraging campaigns that promote awareness preterm, improving induction guidelines, and not inducing delivery in response to perception of altered movement alone would seem to be sensible first steps,” Dr. Walker and Mr. Thornton concluded.

Dr. Walker and Mr. Thornton are with the division of child health, obstetrics, and gynecology at the University of Nottingham (England). They reported no financial interests related to their commentary (Lancet. 2018 Nov 3. doi: 10.1016/S0140-6736[18]31720-3).

Title
Discourage RFM reporting to prevent excess intervention
Discourage RFM reporting to prevent excess intervention

 

Because reduced fetal movement is associated with higher stillbirth risk, asking women to be alert to RFM and report it immediately has emerged as a potential intervention to prevent stillbirth. But a large, randomized trial of one reporting and management protocol showed no reduction in stillbirths, only a rise in C-sections and preterm inductions.

Jupiterimages/thinkstock

Jane E. Norman, MD, of the University of Edinburgh, and her colleagues published results from a trial in the Lancet, in which 409,175 pregnant women (mean age, 30 years) across 33 hospitals in the United Kingdom and Ireland received either standard care or the experimental RFM care intervention before delivery. Women were seen during an experimental 3-month period, in which all were treated according to the protocol, or the 3-month control period that preceded it. A 2-month washout period occurred between allocations as institutions adapted to the study protocol.

The trial intervention consisted of training clinical staff on the implications and management of RFM, distributing written information on RFM to women at about 20 weeks’ gestation, and a management protocol aimed at quick action following a report of RFM at 24 or more weeks’ gestation. The protocol included cardiotocography within 2 hours of presentation followed by measurement of liquor volume and a growth scan, along with umbilical artery Doppler where available. Delivery was recommended for women at 37 or more weeks’ gestation with estimated fetal weight below the 10th centile, abdominal circumference below the 10th centile, a low liquor volume, an abnormal cardiotocograph, or recurrent RFM.

Incidence of stillbirth at or beyond 24 weeks was 4.40 per 1,000 births during the control period and 4.06 per 1,000 births in the intervention period (adjusted odds ratio, 0.90; 95% confidence interval, 0.75-1.07; P = .23), the researchers found. No differences were seen when stratifying for different gestational ages.

Meanwhile, induction of labor before 39 weeks was more frequent during intervention period at 40% of deliveries, compared with 34% during the control time (P less than .0001), and at term (41% vs. 36%; P = .0015). C-section was higher in the intervention group at 28% versus 26% (P = .0001). Neonatal ICU stays were not more common but were likely to be longer in the intervention period, with stays of 2 days or longer occurring in 6.7% of deliveries versus 6.2% (P =.0001).

The investigators concluded that their protocol, in its current design, was not effective and could not be recommended because of the significant increase in interventions.

Dr. Norman and her colleagues wrote that the findings would “reignite the controversy about the efficacy of RFM awareness to reduce stillbirth and the underlying mechanisms linking RFM and stillbirth.” However, the results do not mean that RFM is a sign of inevitable fetal death or that there is no role for RFM awareness as a stillbirth-prevention strategy. Other large trials testing RFM-based interventions are still underway, they noted.

“Further research to identify better predictive tests for stillbirth [to enable targeting of the only current treatment of earlier delivery] is urgently needed,” the investigators added.

In a related study also published in the Lancet, Lucy K. Smith, PhD, of the University of Leicester (England), and her colleagues reported that the real burden of stillbirth in Europe, while much lower than in the developing world, is still a third higher than reported using the current international cutoff established by the World Health Organization.

Dr. Smith and her colleagues examined national cohort data from 19 European countries between 2004 and 2015 for pregnancy outcomes from 22 completed weeks’ gestation. In 2015, they found more than 9,000 stillbirths occurred among more than 25 million births, and 3,022 of these (32%) occurred between 22 and 28 weeks’ gestation.

The WHO officially defines stillbirth as any baby born without life at 28 weeks or beyond, although it recommends that countries collect data on fetal death from 22 weeks. However, discrepancies between and even within countries in reporting laws and their implementation “inhibit reliable international comparisons” at those earlier gestational ages, Dr. Smith and her colleagues wrote.

The researchers, pooling data from the 19 countries, found that the stillbirth rate at 24-28 weeks’ gestation declined from 0.97 per 1,000 births (95% CI, 0.80-1.14) to 0.70 per 1,000 births (95% CI, 0.57-0.82) between 2004 and 2015, a reduction of 25% (risk ratio; 0.75; 95% CI, 0.65-0.85).

“The decrease of 25% in stillbirths at 24 weeks to less than 28 weeks is very similar to that seen globally for stillbirths of 28 weeks of gestation [25.5% worldwide and 24.5% in developed regions] and above for a similar time period of 2000-2015, suggesting consistent improvements over time in the reduction of stillbirths from 24 completed weeks of gestation,” the researchers wrote in their analysis.

Data from France, Spain, and Cyprus was not included in the analysis as these countries did not collect fetal death reports for the gestational periods in the study. Also, for a few countries in the study, late terminations of pregnancy could not be distinguished from spontaneous fetal death.

“The consistency in reporting of births over time at 24 weeks to less than 28 weeks of gestation and the similarity of reduction in the rate of stillbirth over time to births at 28 completed weeks of gestation and above suggest that stillbirths at 24 weeks to less than 28 weeks of gestation can be routinely included in rates of stillbirth for international comparisons from now on,” at least in high-income countries, the investigators wrote.

The study by Norman et al. was funded by the Scottish government, Tommy’s Health Center, and Sands, a U.K. stillbirth charity. The article presents research funded in part by the National Institute for Health Research. Several investigators, including the lead author, reported financial support from these entities. One author reported salary from National Health Service Lothian. All other authors reported no relevant financial disclosures. The study by Smith et al. was funded by the European Union and National Institute for Health Research. Dr. Smith received funding from a National Institute for Health Research Career Development Fellowship. All other authors reported no financial conflicts of interest.

SOURCES: Norman JE et al. Lancet. 2018;392:1629-38; Smith LK et al. Lancet. 2018;392:1639-46.

 

Because reduced fetal movement is associated with higher stillbirth risk, asking women to be alert to RFM and report it immediately has emerged as a potential intervention to prevent stillbirth. But a large, randomized trial of one reporting and management protocol showed no reduction in stillbirths, only a rise in C-sections and preterm inductions.

Jupiterimages/thinkstock

Jane E. Norman, MD, of the University of Edinburgh, and her colleagues published results from a trial in the Lancet, in which 409,175 pregnant women (mean age, 30 years) across 33 hospitals in the United Kingdom and Ireland received either standard care or the experimental RFM care intervention before delivery. Women were seen during an experimental 3-month period, in which all were treated according to the protocol, or the 3-month control period that preceded it. A 2-month washout period occurred between allocations as institutions adapted to the study protocol.

The trial intervention consisted of training clinical staff on the implications and management of RFM, distributing written information on RFM to women at about 20 weeks’ gestation, and a management protocol aimed at quick action following a report of RFM at 24 or more weeks’ gestation. The protocol included cardiotocography within 2 hours of presentation followed by measurement of liquor volume and a growth scan, along with umbilical artery Doppler where available. Delivery was recommended for women at 37 or more weeks’ gestation with estimated fetal weight below the 10th centile, abdominal circumference below the 10th centile, a low liquor volume, an abnormal cardiotocograph, or recurrent RFM.

Incidence of stillbirth at or beyond 24 weeks was 4.40 per 1,000 births during the control period and 4.06 per 1,000 births in the intervention period (adjusted odds ratio, 0.90; 95% confidence interval, 0.75-1.07; P = .23), the researchers found. No differences were seen when stratifying for different gestational ages.

Meanwhile, induction of labor before 39 weeks was more frequent during intervention period at 40% of deliveries, compared with 34% during the control time (P less than .0001), and at term (41% vs. 36%; P = .0015). C-section was higher in the intervention group at 28% versus 26% (P = .0001). Neonatal ICU stays were not more common but were likely to be longer in the intervention period, with stays of 2 days or longer occurring in 6.7% of deliveries versus 6.2% (P =.0001).

The investigators concluded that their protocol, in its current design, was not effective and could not be recommended because of the significant increase in interventions.

Dr. Norman and her colleagues wrote that the findings would “reignite the controversy about the efficacy of RFM awareness to reduce stillbirth and the underlying mechanisms linking RFM and stillbirth.” However, the results do not mean that RFM is a sign of inevitable fetal death or that there is no role for RFM awareness as a stillbirth-prevention strategy. Other large trials testing RFM-based interventions are still underway, they noted.

“Further research to identify better predictive tests for stillbirth [to enable targeting of the only current treatment of earlier delivery] is urgently needed,” the investigators added.

In a related study also published in the Lancet, Lucy K. Smith, PhD, of the University of Leicester (England), and her colleagues reported that the real burden of stillbirth in Europe, while much lower than in the developing world, is still a third higher than reported using the current international cutoff established by the World Health Organization.

Dr. Smith and her colleagues examined national cohort data from 19 European countries between 2004 and 2015 for pregnancy outcomes from 22 completed weeks’ gestation. In 2015, they found more than 9,000 stillbirths occurred among more than 25 million births, and 3,022 of these (32%) occurred between 22 and 28 weeks’ gestation.

The WHO officially defines stillbirth as any baby born without life at 28 weeks or beyond, although it recommends that countries collect data on fetal death from 22 weeks. However, discrepancies between and even within countries in reporting laws and their implementation “inhibit reliable international comparisons” at those earlier gestational ages, Dr. Smith and her colleagues wrote.

The researchers, pooling data from the 19 countries, found that the stillbirth rate at 24-28 weeks’ gestation declined from 0.97 per 1,000 births (95% CI, 0.80-1.14) to 0.70 per 1,000 births (95% CI, 0.57-0.82) between 2004 and 2015, a reduction of 25% (risk ratio; 0.75; 95% CI, 0.65-0.85).

“The decrease of 25% in stillbirths at 24 weeks to less than 28 weeks is very similar to that seen globally for stillbirths of 28 weeks of gestation [25.5% worldwide and 24.5% in developed regions] and above for a similar time period of 2000-2015, suggesting consistent improvements over time in the reduction of stillbirths from 24 completed weeks of gestation,” the researchers wrote in their analysis.

Data from France, Spain, and Cyprus was not included in the analysis as these countries did not collect fetal death reports for the gestational periods in the study. Also, for a few countries in the study, late terminations of pregnancy could not be distinguished from spontaneous fetal death.

“The consistency in reporting of births over time at 24 weeks to less than 28 weeks of gestation and the similarity of reduction in the rate of stillbirth over time to births at 28 completed weeks of gestation and above suggest that stillbirths at 24 weeks to less than 28 weeks of gestation can be routinely included in rates of stillbirth for international comparisons from now on,” at least in high-income countries, the investigators wrote.

The study by Norman et al. was funded by the Scottish government, Tommy’s Health Center, and Sands, a U.K. stillbirth charity. The article presents research funded in part by the National Institute for Health Research. Several investigators, including the lead author, reported financial support from these entities. One author reported salary from National Health Service Lothian. All other authors reported no relevant financial disclosures. The study by Smith et al. was funded by the European Union and National Institute for Health Research. Dr. Smith received funding from a National Institute for Health Research Career Development Fellowship. All other authors reported no financial conflicts of interest.

SOURCES: Norman JE et al. Lancet. 2018;392:1629-38; Smith LK et al. Lancet. 2018;392:1639-46.

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Key clinical point: An intervention designed to detect and act quickly on reduced fetal movements did not meaningfully reduce stillbirth.

Major finding: Incidence of stillbirth at 24 weeks’ gestation or later was 4.06 per 1,000 in the intervention group and 4.40 per 1,000 with standard care (adjusted odds ratio, 0.90; 95% confidence interval, 0.75-1.07; P = .23).

Study details: Data from more than 400,000 pregnancies across 33 hospitals in the United Kingdom and Ireland; women were seen during a 3-month period of standard care or a 3-month intervention period.

Disclosures: The study by Norman et al. was funded by the Scottish government, Tommy’s Health Center, and Sands, a U.K. stillbirth charity. The article presents research funded in part by the National Institute for Health Research. Several investigators, including the lead author, reported financial support from these entities. One author reported salary from National Health Service Lothian. All other authors reported no relevant financial disclosures. The study by Smith et al. was funded by the European Union and National Institute for Health Research. Dr. Smith received funding from a National Institute for Health Research Career Development Fellowship. All other authors reported no financial conflicts of interest.

Sources: Norman JE et al. Lancet. 2018;392:1629-38; Smith LK et al. Lancet. 2018;392:1639-46.

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Higher prenatal exposure to daylight tied to lower depression risk

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Prenatal programming of the circadian and limbic systems might play a role in the odds of developing lifetime depression, a longitudinal study of almost 161,000 women shows.

“Our results could add support to an emerging hypothesis that perinatal photoperiod may influence depression risk,” wrote Elizabeth E. Devore of Brigham and Women’s Hospital, Boston, and her associates. “If replicated, ... these results could translate into safe and inexpensive light-related interventions for mothers and babies.”

In the study, which was published in the Journal of Psychiatric Research, Ms. Devore and her associates examined the influence of daylight exposure during maternal pregnancy and lifetime depression risk in the resulting offspring. They found that increased exposure to daylight during maternal pregnancy correlated with reduced lifetime risk of depression. Of greatest significance was exposure during the second trimester, a critical period during which neuronal generation, migration, and organization take place, wrote Ms. Devore, who also is affiliated with Harvard Medical School, Boston, and her associates.

The effects of daylight exposure were considered modest within the study population, but the authors emphasized that the finding would have much “larger effects at the population level,” given the occurrence of depression in the general population. They added that their findings reinforce a growing consensus that perinatal exposure to daylight could have the ability to influence the risk of developing a mood disorder.

The investigators accessed the Nurses’ Health Study (NHS) and the NHS II, established in 1976 and 1989, respectively, to assess risk factors for chronic conditions in female nurses. Both studies biennially surveyed demographic data on health, lifestyle, and medication use through mailed questionnaires. The first group was composed of 121,701 women aged 30-55 years; the second included 116,430 women aged 25-42 years. Altogether, 160,737 women born full-term were included in the study; 20,912 were excluded from the original survey group for not reporting depression status, as well as an additional 43,325 for not reporting their state of birth.

From data collected regarding participants’ day and state of birth, the researchers were able to estimate total length of daylight exposure during pregnancy using mathematical equations published by the National Oceanic and Atmospheric Administration.

Longitudinal coordinates pinpointing the center of population density for a participant’s birth state were used to identify the location of each participant during gestation. Using those assumptions, the authors were able to establish the two key data points evaluated for the study: total daylight exposure during pregnancy gestation, which was calculated by adding the lengths of all 280 days of the pregnancy, and extreme differences in daylight exposure that might have occurred throughout the pregnancy, which was measured by subtracting the longest and shortest day lengths during gestation.

The investigators paid particular attention to reported levels of depression, evidence of suicide, and personal characteristics and lifestyle factors, such as race, hair color, and early-life socioeconomic factors, including parents’ homeownership at the time of offspring birth; birth weight; history of having been breastfed; and parental occupation throughout the participant’s childhood.

Participants did not begin reporting antidepressant use for the first time until 1996; history of clinician-reported diagnoses of depression began in 2000, Ms. Devore and her associates reported.

Total daylight exposure during pregnancy was found to have “a borderline significant association with odds of lifetime depression,” but the trend was not convincing qualitatively, “and individual estimates across quintiles of exposure” were not considered to be statistically significant. In fact, the authors found that a larger difference between minimum and maximum daylight exposure throughout pregnancy significantly lowered lifetime risk of depression. Women with the largest differences in minimum/maximum daylight exposure during gestation had a 12% lower risk of depression in the NHS population. That reduced risk increased to 15% with the NHS II group. When both cohorts were combined, the reduced risk of depression was 13%.

When evaluating the role that daylight exposure plays with regard to trimester of pregnancy, the authors did note an association for the first trimester, but the association was much stronger for the second trimester; no association was found for the third trimester.

In terms of the effects of daylight exposure on incidence of suicide, no significant associations were found.

Because birth latitude and birth season were of key interest in this study, their relative contribution to total daylight exposure and extreme differences in exposure were considered. Citing observations from the National Health and Nutrition Examination Survey (NHANES), the authors noted that those born at higher latitudes were found to have significantly lower risk of depression. In this study, the authors found that women born in northern latitudes were found to have a 7% risk for lifetime depression, compared with women born in middle latitudes. Conversely, women born in southern latitudes had a 15% risk of depression. No association was found between birth season and incidence of depression, regardless of how season was defined.

The investigators cited several limitations. One is that they did not collect behavioral factors such as the time women spent outdoors. “Our method of exposure calculation relied on the assumption that participants’ mothers were exposed to sunlight from sunrise to sunset,” Ms. Devore and her associates wrote. This way of assessing exposure might have biased their results.

Nevertheless, they said, more studies are needed to examine the role that birth latitude and birth season might play with regard to depression.

The research for this study was supported by the National Institute of Mental Health and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health. Additional infrastructure support for the Nurses’ Health Studies was provided by the National Cancer Institute.

The authors declared no conflicts of interest. Ms. Devore has reported receiving consulting fees from Epi Excellence and Bohn Epidemiology.
 

SOURCE: Devore EE et al. J. Psychiatric Res. 2018. 104(08):e20180225.

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Prenatal programming of the circadian and limbic systems might play a role in the odds of developing lifetime depression, a longitudinal study of almost 161,000 women shows.

“Our results could add support to an emerging hypothesis that perinatal photoperiod may influence depression risk,” wrote Elizabeth E. Devore of Brigham and Women’s Hospital, Boston, and her associates. “If replicated, ... these results could translate into safe and inexpensive light-related interventions for mothers and babies.”

In the study, which was published in the Journal of Psychiatric Research, Ms. Devore and her associates examined the influence of daylight exposure during maternal pregnancy and lifetime depression risk in the resulting offspring. They found that increased exposure to daylight during maternal pregnancy correlated with reduced lifetime risk of depression. Of greatest significance was exposure during the second trimester, a critical period during which neuronal generation, migration, and organization take place, wrote Ms. Devore, who also is affiliated with Harvard Medical School, Boston, and her associates.

The effects of daylight exposure were considered modest within the study population, but the authors emphasized that the finding would have much “larger effects at the population level,” given the occurrence of depression in the general population. They added that their findings reinforce a growing consensus that perinatal exposure to daylight could have the ability to influence the risk of developing a mood disorder.

The investigators accessed the Nurses’ Health Study (NHS) and the NHS II, established in 1976 and 1989, respectively, to assess risk factors for chronic conditions in female nurses. Both studies biennially surveyed demographic data on health, lifestyle, and medication use through mailed questionnaires. The first group was composed of 121,701 women aged 30-55 years; the second included 116,430 women aged 25-42 years. Altogether, 160,737 women born full-term were included in the study; 20,912 were excluded from the original survey group for not reporting depression status, as well as an additional 43,325 for not reporting their state of birth.

From data collected regarding participants’ day and state of birth, the researchers were able to estimate total length of daylight exposure during pregnancy using mathematical equations published by the National Oceanic and Atmospheric Administration.

Longitudinal coordinates pinpointing the center of population density for a participant’s birth state were used to identify the location of each participant during gestation. Using those assumptions, the authors were able to establish the two key data points evaluated for the study: total daylight exposure during pregnancy gestation, which was calculated by adding the lengths of all 280 days of the pregnancy, and extreme differences in daylight exposure that might have occurred throughout the pregnancy, which was measured by subtracting the longest and shortest day lengths during gestation.

The investigators paid particular attention to reported levels of depression, evidence of suicide, and personal characteristics and lifestyle factors, such as race, hair color, and early-life socioeconomic factors, including parents’ homeownership at the time of offspring birth; birth weight; history of having been breastfed; and parental occupation throughout the participant’s childhood.

Participants did not begin reporting antidepressant use for the first time until 1996; history of clinician-reported diagnoses of depression began in 2000, Ms. Devore and her associates reported.

Total daylight exposure during pregnancy was found to have “a borderline significant association with odds of lifetime depression,” but the trend was not convincing qualitatively, “and individual estimates across quintiles of exposure” were not considered to be statistically significant. In fact, the authors found that a larger difference between minimum and maximum daylight exposure throughout pregnancy significantly lowered lifetime risk of depression. Women with the largest differences in minimum/maximum daylight exposure during gestation had a 12% lower risk of depression in the NHS population. That reduced risk increased to 15% with the NHS II group. When both cohorts were combined, the reduced risk of depression was 13%.

When evaluating the role that daylight exposure plays with regard to trimester of pregnancy, the authors did note an association for the first trimester, but the association was much stronger for the second trimester; no association was found for the third trimester.

In terms of the effects of daylight exposure on incidence of suicide, no significant associations were found.

Because birth latitude and birth season were of key interest in this study, their relative contribution to total daylight exposure and extreme differences in exposure were considered. Citing observations from the National Health and Nutrition Examination Survey (NHANES), the authors noted that those born at higher latitudes were found to have significantly lower risk of depression. In this study, the authors found that women born in northern latitudes were found to have a 7% risk for lifetime depression, compared with women born in middle latitudes. Conversely, women born in southern latitudes had a 15% risk of depression. No association was found between birth season and incidence of depression, regardless of how season was defined.

The investigators cited several limitations. One is that they did not collect behavioral factors such as the time women spent outdoors. “Our method of exposure calculation relied on the assumption that participants’ mothers were exposed to sunlight from sunrise to sunset,” Ms. Devore and her associates wrote. This way of assessing exposure might have biased their results.

Nevertheless, they said, more studies are needed to examine the role that birth latitude and birth season might play with regard to depression.

The research for this study was supported by the National Institute of Mental Health and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health. Additional infrastructure support for the Nurses’ Health Studies was provided by the National Cancer Institute.

The authors declared no conflicts of interest. Ms. Devore has reported receiving consulting fees from Epi Excellence and Bohn Epidemiology.
 

SOURCE: Devore EE et al. J. Psychiatric Res. 2018. 104(08):e20180225.

 

Prenatal programming of the circadian and limbic systems might play a role in the odds of developing lifetime depression, a longitudinal study of almost 161,000 women shows.

“Our results could add support to an emerging hypothesis that perinatal photoperiod may influence depression risk,” wrote Elizabeth E. Devore of Brigham and Women’s Hospital, Boston, and her associates. “If replicated, ... these results could translate into safe and inexpensive light-related interventions for mothers and babies.”

In the study, which was published in the Journal of Psychiatric Research, Ms. Devore and her associates examined the influence of daylight exposure during maternal pregnancy and lifetime depression risk in the resulting offspring. They found that increased exposure to daylight during maternal pregnancy correlated with reduced lifetime risk of depression. Of greatest significance was exposure during the second trimester, a critical period during which neuronal generation, migration, and organization take place, wrote Ms. Devore, who also is affiliated with Harvard Medical School, Boston, and her associates.

The effects of daylight exposure were considered modest within the study population, but the authors emphasized that the finding would have much “larger effects at the population level,” given the occurrence of depression in the general population. They added that their findings reinforce a growing consensus that perinatal exposure to daylight could have the ability to influence the risk of developing a mood disorder.

The investigators accessed the Nurses’ Health Study (NHS) and the NHS II, established in 1976 and 1989, respectively, to assess risk factors for chronic conditions in female nurses. Both studies biennially surveyed demographic data on health, lifestyle, and medication use through mailed questionnaires. The first group was composed of 121,701 women aged 30-55 years; the second included 116,430 women aged 25-42 years. Altogether, 160,737 women born full-term were included in the study; 20,912 were excluded from the original survey group for not reporting depression status, as well as an additional 43,325 for not reporting their state of birth.

From data collected regarding participants’ day and state of birth, the researchers were able to estimate total length of daylight exposure during pregnancy using mathematical equations published by the National Oceanic and Atmospheric Administration.

Longitudinal coordinates pinpointing the center of population density for a participant’s birth state were used to identify the location of each participant during gestation. Using those assumptions, the authors were able to establish the two key data points evaluated for the study: total daylight exposure during pregnancy gestation, which was calculated by adding the lengths of all 280 days of the pregnancy, and extreme differences in daylight exposure that might have occurred throughout the pregnancy, which was measured by subtracting the longest and shortest day lengths during gestation.

The investigators paid particular attention to reported levels of depression, evidence of suicide, and personal characteristics and lifestyle factors, such as race, hair color, and early-life socioeconomic factors, including parents’ homeownership at the time of offspring birth; birth weight; history of having been breastfed; and parental occupation throughout the participant’s childhood.

Participants did not begin reporting antidepressant use for the first time until 1996; history of clinician-reported diagnoses of depression began in 2000, Ms. Devore and her associates reported.

Total daylight exposure during pregnancy was found to have “a borderline significant association with odds of lifetime depression,” but the trend was not convincing qualitatively, “and individual estimates across quintiles of exposure” were not considered to be statistically significant. In fact, the authors found that a larger difference between minimum and maximum daylight exposure throughout pregnancy significantly lowered lifetime risk of depression. Women with the largest differences in minimum/maximum daylight exposure during gestation had a 12% lower risk of depression in the NHS population. That reduced risk increased to 15% with the NHS II group. When both cohorts were combined, the reduced risk of depression was 13%.

When evaluating the role that daylight exposure plays with regard to trimester of pregnancy, the authors did note an association for the first trimester, but the association was much stronger for the second trimester; no association was found for the third trimester.

In terms of the effects of daylight exposure on incidence of suicide, no significant associations were found.

Because birth latitude and birth season were of key interest in this study, their relative contribution to total daylight exposure and extreme differences in exposure were considered. Citing observations from the National Health and Nutrition Examination Survey (NHANES), the authors noted that those born at higher latitudes were found to have significantly lower risk of depression. In this study, the authors found that women born in northern latitudes were found to have a 7% risk for lifetime depression, compared with women born in middle latitudes. Conversely, women born in southern latitudes had a 15% risk of depression. No association was found between birth season and incidence of depression, regardless of how season was defined.

The investigators cited several limitations. One is that they did not collect behavioral factors such as the time women spent outdoors. “Our method of exposure calculation relied on the assumption that participants’ mothers were exposed to sunlight from sunrise to sunset,” Ms. Devore and her associates wrote. This way of assessing exposure might have biased their results.

Nevertheless, they said, more studies are needed to examine the role that birth latitude and birth season might play with regard to depression.

The research for this study was supported by the National Institute of Mental Health and the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health. Additional infrastructure support for the Nurses’ Health Studies was provided by the National Cancer Institute.

The authors declared no conflicts of interest. Ms. Devore has reported receiving consulting fees from Epi Excellence and Bohn Epidemiology.
 

SOURCE: Devore EE et al. J. Psychiatric Res. 2018. 104(08):e20180225.

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Key clinical point: Future studies that are able to replicate findings have the potential to offer safe, inexpensive light-based treatments for both mothers and babies.

Major finding: Benefits of daytime light exposure are highest with second-trimester exposure.

Study details: Longitudinal cohort study of almost 161,000 women who were born full term.

Disclosures: The authors declared no conflicts of interest. Ms. Devore reported receiving consulting fees from Epi Excellence and Bohn Epidemiology.

Source: Devore EE et al. J Psychiatric Res. 2018.104(08):e20180225.
 

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Trump administration rule erodes ACA contraceptive mandate

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More employers can opt out of providing contraception coverage to their employees under final regulations from the Trump administration that narrow the Affordable Care Act’s contraceptive mandate.

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The two regulations, released Nov. 7, allow an expanded group of employers and insurers to get out of covering contraception methods by objecting on either religious or moral grounds.

The first rule broadens exemptions to the ACA’s contraceptive mandate to entities that object to services covered by the mandate on the basis of sincerely held religious beliefs. The second rule protects nonprofit organizations and small businesses that have nonreligious moral convictions that oppose services covered by the mandate. The religious and moral exemptions apply to institutions of education, issuers, and individuals, but not to governmental entities.

When first proposed in 2017, Trump administration officials said the new policies would “better balance the government’s interest in promoting coverage for contraceptive and sterilization services with the government’s interests in providing conscience protections for entities with sincerely held moral convictions.” The U.S. Department of Health & Human Services estimates that the rules, which take effect in January 2019, will affect no more than 200 employers.

The American College of Obstetricians and Gynecologists expressed concern that the final rules will restrict patient access to meaningful contraceptive methods and will erode decades of progress in increasing women’s reproductive autonomy and restrict patient access to contraception.

“Women, families and our nation all benefit from seamless, affordable access to contraception,” ACOG President Lisa M. Hollier, MD, said in a statement. “Contraception improves women’s health and well-being, reduces unintended pregnancy, enables pregnancy spacing for safer pregnancies and deliveries, and empowers women’s engagement in the workforce and economic self-sufficiency. A woman’s employer should not determine whether or not she has this access.”

Marjorie Dannenfelser, president of Susan B. Anthony List, an anti-abortion group, praised the final rules, calling them needed protections from the burdensome Obama-era ACA abortifacient drug mandate.

“President Trump and HHS Secretary Azar delivered a huge victory for conscience rights and religious liberty in America,” Ms. Dannenfelser said in a statement. “No longer will Catholic nuns who care for the elderly poor be forced by the government to provide abortion-inducing drugs in their health care plans. Not only that, moral objectors such as Susan B. Anthony List, will also no longer have to pay for life-ending drugs that are antithetical to their mission and for which we have argued there is certainly no compelling state interest.”

The ACA initially required all employers to cover birth control for employees with no copayments, except for group health plans of religious employers, which were deemed exempt. Those religious employers were primarily churches and other houses of worship. After a number of complaints and legal challenges, the Obama administration created a workaround for nonprofit religious employers to opt out of the mandate.

However, critics argued the process itself was a violation of their religious freedom. The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016. The issue was never resolved. In May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.

Under the approved regulations, employers or insurers can stop their coverage of contraceptive services if they have religious beliefs or moral convictions against covering birth control. Exempted entities and individuals also can choose to cover some, but not all, contraceptive services, depending on their specific religious or moral objection, according to an HHS fact sheet.

The agency emphasized that the regulations leave in place government programs that provide free or subsidized contraceptive coverage to low-income women, such as through community health centers, and that the rules do not ban any employer from covering contraceptives.

The regulations become effective 60 days after they are published in the Federal Register.

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More employers can opt out of providing contraception coverage to their employees under final regulations from the Trump administration that narrow the Affordable Care Act’s contraceptive mandate.

copyright Thinkstock

The two regulations, released Nov. 7, allow an expanded group of employers and insurers to get out of covering contraception methods by objecting on either religious or moral grounds.

The first rule broadens exemptions to the ACA’s contraceptive mandate to entities that object to services covered by the mandate on the basis of sincerely held religious beliefs. The second rule protects nonprofit organizations and small businesses that have nonreligious moral convictions that oppose services covered by the mandate. The religious and moral exemptions apply to institutions of education, issuers, and individuals, but not to governmental entities.

When first proposed in 2017, Trump administration officials said the new policies would “better balance the government’s interest in promoting coverage for contraceptive and sterilization services with the government’s interests in providing conscience protections for entities with sincerely held moral convictions.” The U.S. Department of Health & Human Services estimates that the rules, which take effect in January 2019, will affect no more than 200 employers.

The American College of Obstetricians and Gynecologists expressed concern that the final rules will restrict patient access to meaningful contraceptive methods and will erode decades of progress in increasing women’s reproductive autonomy and restrict patient access to contraception.

“Women, families and our nation all benefit from seamless, affordable access to contraception,” ACOG President Lisa M. Hollier, MD, said in a statement. “Contraception improves women’s health and well-being, reduces unintended pregnancy, enables pregnancy spacing for safer pregnancies and deliveries, and empowers women’s engagement in the workforce and economic self-sufficiency. A woman’s employer should not determine whether or not she has this access.”

Marjorie Dannenfelser, president of Susan B. Anthony List, an anti-abortion group, praised the final rules, calling them needed protections from the burdensome Obama-era ACA abortifacient drug mandate.

“President Trump and HHS Secretary Azar delivered a huge victory for conscience rights and religious liberty in America,” Ms. Dannenfelser said in a statement. “No longer will Catholic nuns who care for the elderly poor be forced by the government to provide abortion-inducing drugs in their health care plans. Not only that, moral objectors such as Susan B. Anthony List, will also no longer have to pay for life-ending drugs that are antithetical to their mission and for which we have argued there is certainly no compelling state interest.”

The ACA initially required all employers to cover birth control for employees with no copayments, except for group health plans of religious employers, which were deemed exempt. Those religious employers were primarily churches and other houses of worship. After a number of complaints and legal challenges, the Obama administration created a workaround for nonprofit religious employers to opt out of the mandate.

However, critics argued the process itself was a violation of their religious freedom. The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016. The issue was never resolved. In May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.

Under the approved regulations, employers or insurers can stop their coverage of contraceptive services if they have religious beliefs or moral convictions against covering birth control. Exempted entities and individuals also can choose to cover some, but not all, contraceptive services, depending on their specific religious or moral objection, according to an HHS fact sheet.

The agency emphasized that the regulations leave in place government programs that provide free or subsidized contraceptive coverage to low-income women, such as through community health centers, and that the rules do not ban any employer from covering contraceptives.

The regulations become effective 60 days after they are published in the Federal Register.

More employers can opt out of providing contraception coverage to their employees under final regulations from the Trump administration that narrow the Affordable Care Act’s contraceptive mandate.

copyright Thinkstock

The two regulations, released Nov. 7, allow an expanded group of employers and insurers to get out of covering contraception methods by objecting on either religious or moral grounds.

The first rule broadens exemptions to the ACA’s contraceptive mandate to entities that object to services covered by the mandate on the basis of sincerely held religious beliefs. The second rule protects nonprofit organizations and small businesses that have nonreligious moral convictions that oppose services covered by the mandate. The religious and moral exemptions apply to institutions of education, issuers, and individuals, but not to governmental entities.

When first proposed in 2017, Trump administration officials said the new policies would “better balance the government’s interest in promoting coverage for contraceptive and sterilization services with the government’s interests in providing conscience protections for entities with sincerely held moral convictions.” The U.S. Department of Health & Human Services estimates that the rules, which take effect in January 2019, will affect no more than 200 employers.

The American College of Obstetricians and Gynecologists expressed concern that the final rules will restrict patient access to meaningful contraceptive methods and will erode decades of progress in increasing women’s reproductive autonomy and restrict patient access to contraception.

“Women, families and our nation all benefit from seamless, affordable access to contraception,” ACOG President Lisa M. Hollier, MD, said in a statement. “Contraception improves women’s health and well-being, reduces unintended pregnancy, enables pregnancy spacing for safer pregnancies and deliveries, and empowers women’s engagement in the workforce and economic self-sufficiency. A woman’s employer should not determine whether or not she has this access.”

Marjorie Dannenfelser, president of Susan B. Anthony List, an anti-abortion group, praised the final rules, calling them needed protections from the burdensome Obama-era ACA abortifacient drug mandate.

“President Trump and HHS Secretary Azar delivered a huge victory for conscience rights and religious liberty in America,” Ms. Dannenfelser said in a statement. “No longer will Catholic nuns who care for the elderly poor be forced by the government to provide abortion-inducing drugs in their health care plans. Not only that, moral objectors such as Susan B. Anthony List, will also no longer have to pay for life-ending drugs that are antithetical to their mission and for which we have argued there is certainly no compelling state interest.”

The ACA initially required all employers to cover birth control for employees with no copayments, except for group health plans of religious employers, which were deemed exempt. Those religious employers were primarily churches and other houses of worship. After a number of complaints and legal challenges, the Obama administration created a workaround for nonprofit religious employers to opt out of the mandate.

However, critics argued the process itself was a violation of their religious freedom. The issue led to the case of Zubik v. Burwell, a legal challenge over the mandate exemption that went before the U.S. Supreme Court in March 2016. The issue was never resolved. In May 2016, the Supreme Court vacated the lower court rulings related to Zubik v. Burwell and remanded the case back to the four appeals courts that had originally ruled on the issue.

Under the approved regulations, employers or insurers can stop their coverage of contraceptive services if they have religious beliefs or moral convictions against covering birth control. Exempted entities and individuals also can choose to cover some, but not all, contraceptive services, depending on their specific religious or moral objection, according to an HHS fact sheet.

The agency emphasized that the regulations leave in place government programs that provide free or subsidized contraceptive coverage to low-income women, such as through community health centers, and that the rules do not ban any employer from covering contraceptives.

The regulations become effective 60 days after they are published in the Federal Register.

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