MDedge ObGyn

The U.S. Preventive Services Task Force has published a final recommendation statement on aspirin use to prevent cardiovascular disease.

The statement advises against starting aspirin for the primary prevention of cardiovascular disease in individuals aged 60 years or older.

For people aged 40-59 years, the USPSTF suggests that aspirin could be considered in those at increased risk of cardiovascular disease (10-year risk of 10% or greater) but that the decision should be individualized.

It notes that in the 40-59 age group, evidence indicates that the net benefit of aspirin use is small, and that persons who are not at increased risk for bleeding are more likely to benefit.

It adds that these recommendations apply only to people who do not have a history of cardiovascular disease and are not already taking daily aspirin.

The USPSTF statement was published online in the Journal of the American Medical Association. It is accompanied by an evidence review, a modeling study, a patient page, and an editorial.

A draft version of the recommendation statement, evidence review, and modeling report were previously available for public comment. The final recommendation statement is consistent with the draft version.

The task force concludes that there is adequate evidence that low-dose aspirin has a small benefit to reduce risk for cardiovascular events (nonfatal myocardial infarction and stroke) in adults 40 years or older who have no history of cardiovascular disease but are at increased cardiovascular risk.

Evidence shows that the absolute magnitude of benefit increases with increasing 10-year cardiovascular risk and that the magnitude of the lifetime benefits is greater when aspirin is initiated at a younger age.

But it adds that there is also adequate evidence that aspirin use in adults increases the risk for gastrointestinal bleeding, intracranial bleeding, and hemorrhagic stroke. The USPSTF determined that the magnitude of the harms is small overall but increases in older age groups, particularly in adults older than 60 years.

For patients who are eligible and choose to start taking aspirin, the benefits become smaller with advancing age, and data suggest that clinicians and patients should consider stopping aspirin use around age 75 years, the statement advises.

It also says that evidence is unclear whether aspirin use reduces the risk of colorectal cancer incidence or mortality.

USPSTF vice chair Michael Barry, MD, director of the Informed Medical Decisions Program in the Health Decision Sciences Center at Massachusetts General Hospital, Boston, told this news organization that these recommendations apply only to patients not taking aspirin already and who have no evidence of existing cardiovascular disease.

“In adults aged 60 or over we do not recommend starting aspirin for primary prevention. That is because in this age group the risk of bleeding outweighs the cardiovascular benefit,” he said.

“For adults aged 40-59 years with a greater than 10% predicted risk of cardiovascular disease, there appears to be a net benefit from taking aspirin, but this net benefit is relatively small and will vary with other factors such as magnitude of cardiovascular and bleeding risk. People should talk to their physician about these factors and whether to take aspirin or not,” he added.      

Dr. Barry noted that these recommendations do not apply to people who are already taking aspirin for primary prevention. “These people need to talk to their physicians about whether they should continue. They need to review the reasons why they started aspirin in the first place, and they need to have their bleeding risk evaluated. Someone who has taken aspirin long term without any bleeding complications has a lower risk of future bleeding complications,” he said.

The task force recommends an aspirin dose of 81 mg daily for those people deciding to take aspirin for primary prevention.    

“There is an abundance of evidence that less than 100 mg a day is enough. The lower the dose the lower the bleeding risk. So, the most convenient dose is the widely available 81-mg baby aspirin tablet,” Dr. Barry noted. “While enteric coated products are meant to reduce gastric irritation, the data do not show any difference in bleeding risk between various aspirin formulations,” he added.

Dr. Barry pointed out that aspirin is just one tool for reducing cardiovascular risk.

“People can reduce their risk significantly in many other ways including taking regular exercise, eating a healthy diet, controlling blood pressure and diabetes, and taking statins if they are at increased cardiovascular risk.”

He noted that recent trials have suggested that aspirin has only a marginal value over and above all these other factors. And the risk reduction with aspirin is smaller than with some other interventions.

“For example, aspirin is associated with a 12% reduction in MI whereas statins are associated with a 25%-30% reduction. Statins are a more powerful tool in reducing cardiovascular risk than aspirin, so perhaps people should consider taking statins first. The benefit of aspirin may be smaller in individuals already taking a statin, and clinicians need to think about the big picture,” Dr. Barry said.

He explained that physicians need to evaluate the cardiovascular and bleeding risk in each individual patient. “While there are widely available tools to estimate cardiovascular risk, there are no easy tools yet available to evaluate bleeding risk, so physicians need to consider clinical factors such as history of peptic ulcers.”

He suggests for the many people who have an average bleeding risk, then personal preference may come into play. “In the 40-59 age group, the benefits and harms of aspirin are pretty well-balanced. For the average person we think there may be a small net benefit, but this is small enough for personal preference to be considered as well.”
 

Pendulum swinging away from aspirin use

In an editorial accompanying publication of the task force statement in JAMA, Allan S. Brett, MD, clinical professor of internal medicine at the University of Colorado at Denver, Aurora, explains that the USPSTF recommendations on aspirin use for primary prevention of cardiovascular disease have changed numerous times over the past 30 years, with the last update in 2016 narrowing the eligible population.

In the new recommendation statement, “the pendulum has swung further away from aspirin prophylaxis for primary prevention: The guideline does not recommend routine preventive aspirin for anyone,” Dr. Brett notes.

He points out that an important development between the 2016 and current version was the publication in 2018 of three large placebo-controlled randomized clinical trials of primary prevention with aspirin – ARRIVE, ASPREE and ASCEND – which taken together “cast doubt about net benefit for aspirin prophylaxis in current practice.”

Asked how physicians should go about “individualizing” the decision on the use of aspirin in the 40-59 age group at increased cardiovascular risk, Dr. Brett suggests that some patents will have a general philosophy of medical care of “don’t prescribe medication for me unless there is strong evidence to support it,” while others may favor preventive interventions even in borderline cases.

But he notes that many patients have no strong general preferences and often ask a trusted clinician to decide for them. “For such patients, the best approach is for clinicians to be knowledgeable about the data on primary prevention with aspirin. Close reading of the new USPSTF guideline and its companion evidence review, and becoming familiar with the three more recent aspirin trials, is a good way to prepare for these clinical encounters,” he concludes.
 

A cardiologist’s view

Commenting on the task force statement for this news organization, Andrew Freeman, MD, a cardiologist at National Jewish Health, Denver, noted that cardiology societies are already making similar recommendations on aspirin use in primary prevention. “The American College of Cardiology prevention guidelines have been giving similar advice for a couple of years now. It takes a few years for professional societies to catch up with each other,” he said.

“Over the last few years, it has become obvious that the benefit of aspirin is not really very positive until a patient has had a cardiovascular event. In primary prevention, it doesn’t become beneficial unless they are at quite a high risk of having an event,” Dr. Freeman noted.

“In general, most cardiologists are now telling people that, despite what they may have been told in the past, they don’t need to be on aspirin unless they have had a cardiovascular event,” he added. “Our understanding has changed over the years and the weight of evidence has now become clear that the risk of bleeding is not insignificant.”

Dr. Freeman agreed with the shared decision-making advocated for patients in the 40-59 age group. “If a patient is particularly worried about a family history of heart disease, taking aspirin may make some sense, but for most people who have not had a cardiovascular event, the net benefit is very low and gets lower with age as the bleeding risk increases,” he said.  

The USPSTF is an independent, voluntary body. The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.

A version of this article first appeared on Medscape.com.

The U.S. Preventive Services Task Force has published a final recommendation statement on aspirin use to prevent cardiovascular disease.

The statement advises against starting aspirin for the primary prevention of cardiovascular disease in individuals aged 60 years or older.

For people aged 40-59 years, the USPSTF suggests that aspirin could be considered in those at increased risk of cardiovascular disease (10-year risk of 10% or greater) but that the decision should be individualized.

It notes that in the 40-59 age group, evidence indicates that the net benefit of aspirin use is small, and that persons who are not at increased risk for bleeding are more likely to benefit.

It adds that these recommendations apply only to people who do not have a history of cardiovascular disease and are not already taking daily aspirin.

The USPSTF statement was published online in the Journal of the American Medical Association. It is accompanied by an evidence review, a modeling study, a patient page, and an editorial.

A draft version of the recommendation statement, evidence review, and modeling report were previously available for public comment. The final recommendation statement is consistent with the draft version.

The task force concludes that there is adequate evidence that low-dose aspirin has a small benefit to reduce risk for cardiovascular events (nonfatal myocardial infarction and stroke) in adults 40 years or older who have no history of cardiovascular disease but are at increased cardiovascular risk.

Evidence shows that the absolute magnitude of benefit increases with increasing 10-year cardiovascular risk and that the magnitude of the lifetime benefits is greater when aspirin is initiated at a younger age.

But it adds that there is also adequate evidence that aspirin use in adults increases the risk for gastrointestinal bleeding, intracranial bleeding, and hemorrhagic stroke. The USPSTF determined that the magnitude of the harms is small overall but increases in older age groups, particularly in adults older than 60 years.

For patients who are eligible and choose to start taking aspirin, the benefits become smaller with advancing age, and data suggest that clinicians and patients should consider stopping aspirin use around age 75 years, the statement advises.

It also says that evidence is unclear whether aspirin use reduces the risk of colorectal cancer incidence or mortality.

USPSTF vice chair Michael Barry, MD, director of the Informed Medical Decisions Program in the Health Decision Sciences Center at Massachusetts General Hospital, Boston, told this news organization that these recommendations apply only to patients not taking aspirin already and who have no evidence of existing cardiovascular disease.

“In adults aged 60 or over we do not recommend starting aspirin for primary prevention. That is because in this age group the risk of bleeding outweighs the cardiovascular benefit,” he said.

“For adults aged 40-59 years with a greater than 10% predicted risk of cardiovascular disease, there appears to be a net benefit from taking aspirin, but this net benefit is relatively small and will vary with other factors such as magnitude of cardiovascular and bleeding risk. People should talk to their physician about these factors and whether to take aspirin or not,” he added.      

Dr. Barry noted that these recommendations do not apply to people who are already taking aspirin for primary prevention. “These people need to talk to their physicians about whether they should continue. They need to review the reasons why they started aspirin in the first place, and they need to have their bleeding risk evaluated. Someone who has taken aspirin long term without any bleeding complications has a lower risk of future bleeding complications,” he said.

The task force recommends an aspirin dose of 81 mg daily for those people deciding to take aspirin for primary prevention.    

“There is an abundance of evidence that less than 100 mg a day is enough. The lower the dose the lower the bleeding risk. So, the most convenient dose is the widely available 81-mg baby aspirin tablet,” Dr. Barry noted. “While enteric coated products are meant to reduce gastric irritation, the data do not show any difference in bleeding risk between various aspirin formulations,” he added.

Dr. Barry pointed out that aspirin is just one tool for reducing cardiovascular risk.

“People can reduce their risk significantly in many other ways including taking regular exercise, eating a healthy diet, controlling blood pressure and diabetes, and taking statins if they are at increased cardiovascular risk.”

He noted that recent trials have suggested that aspirin has only a marginal value over and above all these other factors. And the risk reduction with aspirin is smaller than with some other interventions.

“For example, aspirin is associated with a 12% reduction in MI whereas statins are associated with a 25%-30% reduction. Statins are a more powerful tool in reducing cardiovascular risk than aspirin, so perhaps people should consider taking statins first. The benefit of aspirin may be smaller in individuals already taking a statin, and clinicians need to think about the big picture,” Dr. Barry said.

He explained that physicians need to evaluate the cardiovascular and bleeding risk in each individual patient. “While there are widely available tools to estimate cardiovascular risk, there are no easy tools yet available to evaluate bleeding risk, so physicians need to consider clinical factors such as history of peptic ulcers.”

He suggests for the many people who have an average bleeding risk, then personal preference may come into play. “In the 40-59 age group, the benefits and harms of aspirin are pretty well-balanced. For the average person we think there may be a small net benefit, but this is small enough for personal preference to be considered as well.”
 

Pendulum swinging away from aspirin use

In an editorial accompanying publication of the task force statement in JAMA, Allan S. Brett, MD, clinical professor of internal medicine at the University of Colorado at Denver, Aurora, explains that the USPSTF recommendations on aspirin use for primary prevention of cardiovascular disease have changed numerous times over the past 30 years, with the last update in 2016 narrowing the eligible population.

In the new recommendation statement, “the pendulum has swung further away from aspirin prophylaxis for primary prevention: The guideline does not recommend routine preventive aspirin for anyone,” Dr. Brett notes.

He points out that an important development between the 2016 and current version was the publication in 2018 of three large placebo-controlled randomized clinical trials of primary prevention with aspirin – ARRIVE, ASPREE and ASCEND – which taken together “cast doubt about net benefit for aspirin prophylaxis in current practice.”

Asked how physicians should go about “individualizing” the decision on the use of aspirin in the 40-59 age group at increased cardiovascular risk, Dr. Brett suggests that some patents will have a general philosophy of medical care of “don’t prescribe medication for me unless there is strong evidence to support it,” while others may favor preventive interventions even in borderline cases.

But he notes that many patients have no strong general preferences and often ask a trusted clinician to decide for them. “For such patients, the best approach is for clinicians to be knowledgeable about the data on primary prevention with aspirin. Close reading of the new USPSTF guideline and its companion evidence review, and becoming familiar with the three more recent aspirin trials, is a good way to prepare for these clinical encounters,” he concludes.
 

A cardiologist’s view

Commenting on the task force statement for this news organization, Andrew Freeman, MD, a cardiologist at National Jewish Health, Denver, noted that cardiology societies are already making similar recommendations on aspirin use in primary prevention. “The American College of Cardiology prevention guidelines have been giving similar advice for a couple of years now. It takes a few years for professional societies to catch up with each other,” he said.

“Over the last few years, it has become obvious that the benefit of aspirin is not really very positive until a patient has had a cardiovascular event. In primary prevention, it doesn’t become beneficial unless they are at quite a high risk of having an event,” Dr. Freeman noted.

“In general, most cardiologists are now telling people that, despite what they may have been told in the past, they don’t need to be on aspirin unless they have had a cardiovascular event,” he added. “Our understanding has changed over the years and the weight of evidence has now become clear that the risk of bleeding is not insignificant.”

Dr. Freeman agreed with the shared decision-making advocated for patients in the 40-59 age group. “If a patient is particularly worried about a family history of heart disease, taking aspirin may make some sense, but for most people who have not had a cardiovascular event, the net benefit is very low and gets lower with age as the bleeding risk increases,” he said.  

The USPSTF is an independent, voluntary body. The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.

A version of this article first appeared on Medscape.com.

The U.S. Preventive Services Task Force has published a final recommendation statement on aspirin use to prevent cardiovascular disease.

The statement advises against starting aspirin for the primary prevention of cardiovascular disease in individuals aged 60 years or older.

For people aged 40-59 years, the USPSTF suggests that aspirin could be considered in those at increased risk of cardiovascular disease (10-year risk of 10% or greater) but that the decision should be individualized.

It notes that in the 40-59 age group, evidence indicates that the net benefit of aspirin use is small, and that persons who are not at increased risk for bleeding are more likely to benefit.

It adds that these recommendations apply only to people who do not have a history of cardiovascular disease and are not already taking daily aspirin.

The USPSTF statement was published online in the Journal of the American Medical Association. It is accompanied by an evidence review, a modeling study, a patient page, and an editorial.

A draft version of the recommendation statement, evidence review, and modeling report were previously available for public comment. The final recommendation statement is consistent with the draft version.

The task force concludes that there is adequate evidence that low-dose aspirin has a small benefit to reduce risk for cardiovascular events (nonfatal myocardial infarction and stroke) in adults 40 years or older who have no history of cardiovascular disease but are at increased cardiovascular risk.

Evidence shows that the absolute magnitude of benefit increases with increasing 10-year cardiovascular risk and that the magnitude of the lifetime benefits is greater when aspirin is initiated at a younger age.

But it adds that there is also adequate evidence that aspirin use in adults increases the risk for gastrointestinal bleeding, intracranial bleeding, and hemorrhagic stroke. The USPSTF determined that the magnitude of the harms is small overall but increases in older age groups, particularly in adults older than 60 years.

For patients who are eligible and choose to start taking aspirin, the benefits become smaller with advancing age, and data suggest that clinicians and patients should consider stopping aspirin use around age 75 years, the statement advises.

It also says that evidence is unclear whether aspirin use reduces the risk of colorectal cancer incidence or mortality.

USPSTF vice chair Michael Barry, MD, director of the Informed Medical Decisions Program in the Health Decision Sciences Center at Massachusetts General Hospital, Boston, told this news organization that these recommendations apply only to patients not taking aspirin already and who have no evidence of existing cardiovascular disease.

“In adults aged 60 or over we do not recommend starting aspirin for primary prevention. That is because in this age group the risk of bleeding outweighs the cardiovascular benefit,” he said.

“For adults aged 40-59 years with a greater than 10% predicted risk of cardiovascular disease, there appears to be a net benefit from taking aspirin, but this net benefit is relatively small and will vary with other factors such as magnitude of cardiovascular and bleeding risk. People should talk to their physician about these factors and whether to take aspirin or not,” he added.      

Dr. Barry noted that these recommendations do not apply to people who are already taking aspirin for primary prevention. “These people need to talk to their physicians about whether they should continue. They need to review the reasons why they started aspirin in the first place, and they need to have their bleeding risk evaluated. Someone who has taken aspirin long term without any bleeding complications has a lower risk of future bleeding complications,” he said.

The task force recommends an aspirin dose of 81 mg daily for those people deciding to take aspirin for primary prevention.    

“There is an abundance of evidence that less than 100 mg a day is enough. The lower the dose the lower the bleeding risk. So, the most convenient dose is the widely available 81-mg baby aspirin tablet,” Dr. Barry noted. “While enteric coated products are meant to reduce gastric irritation, the data do not show any difference in bleeding risk between various aspirin formulations,” he added.

Dr. Barry pointed out that aspirin is just one tool for reducing cardiovascular risk.

“People can reduce their risk significantly in many other ways including taking regular exercise, eating a healthy diet, controlling blood pressure and diabetes, and taking statins if they are at increased cardiovascular risk.”

He noted that recent trials have suggested that aspirin has only a marginal value over and above all these other factors. And the risk reduction with aspirin is smaller than with some other interventions.

“For example, aspirin is associated with a 12% reduction in MI whereas statins are associated with a 25%-30% reduction. Statins are a more powerful tool in reducing cardiovascular risk than aspirin, so perhaps people should consider taking statins first. The benefit of aspirin may be smaller in individuals already taking a statin, and clinicians need to think about the big picture,” Dr. Barry said.

He explained that physicians need to evaluate the cardiovascular and bleeding risk in each individual patient. “While there are widely available tools to estimate cardiovascular risk, there are no easy tools yet available to evaluate bleeding risk, so physicians need to consider clinical factors such as history of peptic ulcers.”

He suggests for the many people who have an average bleeding risk, then personal preference may come into play. “In the 40-59 age group, the benefits and harms of aspirin are pretty well-balanced. For the average person we think there may be a small net benefit, but this is small enough for personal preference to be considered as well.”
 

Pendulum swinging away from aspirin use

In an editorial accompanying publication of the task force statement in JAMA, Allan S. Brett, MD, clinical professor of internal medicine at the University of Colorado at Denver, Aurora, explains that the USPSTF recommendations on aspirin use for primary prevention of cardiovascular disease have changed numerous times over the past 30 years, with the last update in 2016 narrowing the eligible population.

In the new recommendation statement, “the pendulum has swung further away from aspirin prophylaxis for primary prevention: The guideline does not recommend routine preventive aspirin for anyone,” Dr. Brett notes.

He points out that an important development between the 2016 and current version was the publication in 2018 of three large placebo-controlled randomized clinical trials of primary prevention with aspirin – ARRIVE, ASPREE and ASCEND – which taken together “cast doubt about net benefit for aspirin prophylaxis in current practice.”

Asked how physicians should go about “individualizing” the decision on the use of aspirin in the 40-59 age group at increased cardiovascular risk, Dr. Brett suggests that some patents will have a general philosophy of medical care of “don’t prescribe medication for me unless there is strong evidence to support it,” while others may favor preventive interventions even in borderline cases.

But he notes that many patients have no strong general preferences and often ask a trusted clinician to decide for them. “For such patients, the best approach is for clinicians to be knowledgeable about the data on primary prevention with aspirin. Close reading of the new USPSTF guideline and its companion evidence review, and becoming familiar with the three more recent aspirin trials, is a good way to prepare for these clinical encounters,” he concludes.
 

A cardiologist’s view

Commenting on the task force statement for this news organization, Andrew Freeman, MD, a cardiologist at National Jewish Health, Denver, noted that cardiology societies are already making similar recommendations on aspirin use in primary prevention. “The American College of Cardiology prevention guidelines have been giving similar advice for a couple of years now. It takes a few years for professional societies to catch up with each other,” he said.

“Over the last few years, it has become obvious that the benefit of aspirin is not really very positive until a patient has had a cardiovascular event. In primary prevention, it doesn’t become beneficial unless they are at quite a high risk of having an event,” Dr. Freeman noted.

“In general, most cardiologists are now telling people that, despite what they may have been told in the past, they don’t need to be on aspirin unless they have had a cardiovascular event,” he added. “Our understanding has changed over the years and the weight of evidence has now become clear that the risk of bleeding is not insignificant.”

Dr. Freeman agreed with the shared decision-making advocated for patients in the 40-59 age group. “If a patient is particularly worried about a family history of heart disease, taking aspirin may make some sense, but for most people who have not had a cardiovascular event, the net benefit is very low and gets lower with age as the bleeding risk increases,” he said.  

The USPSTF is an independent, voluntary body. The U.S. Congress mandates that the Agency for Healthcare Research and Quality support the operations of the USPSTF.

A version of this article first appeared on Medscape.com.

In 2021, the Food and Drug Administration approved 50 new drugs, but 24 will not be described here because they would probably not be used in pregnancy. The 24 are Aduhelm (aducanumab) to treat Alzheimer’s disease; Azstarys (serdexmethylphenidate and dexmethylphenidate), a combination CNS stimulant indicated for the treatment of ADHD; Cabenuva (cabotegravir and rilpivirine) to treat HIV; Voxzogo (vosoritide) for children with achondroplasia and open epiphyses; Qelbree (viloxazine) used in children aged 6-17 years to treat ADHD; and Pylarify (piflufolastat) for prostate cancer. Other anticancer drugs that will not be covered are Cosela (trilaciclib), Cytalux (pafolacianine), Exkivity (mobocertinib); Fotivda (tivozanib), Jemperli (dostarlimab-gxly), Lumakras (sotorasib), Pepaxto (melphalan flufenamide), Rybrevant (amivantamab-vmjw), Rylaze (asparaginase erwinia chrysanthemi), Scemblix (asciminib), Tepmetko (tepotinib), Tivdak (tisotumab vedotin-tftv), Truseltiq (infigratinib), Ukoniq (umbralisib), and Zynlonta (loncastuximab tesirine-lpyl).

Skytrofa (lonapegsomatropin-tcgd) will not be described below because it is indicated to treat short stature and is unlikely to be used in pregnancy. Nextstellis (drospirenone and estetrol) is used to prevent pregnancy.

Typically, for new drugs there will be no published reports describing their use in pregnant women. That information will come much later. In the sections below, the indications, effects on pregnant animals, and the potential for harm of a fetus/embryo are described. However, the relevance of animal data to human pregnancies is not great.

Adbry (tralokinumab) (molecular weight [MW], 147 kilodaltons), is indicated for the treatment of moderate to severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The drug did not harm fetal monkeys at doses that were 10 times the maximum recommended human dose.

Besremi (ropeginterferon alfa-2b-njft) (MW, 60 kDa) is an interferon alfa-2b indicated for the treatment of adults with polycythemia vera. It is given by subcutaneous injection every 2 weeks. Animal studies assessing reproductive toxicity have not been conducted. The manufacturer states that the drug may cause fetal harm and should be assumed to have abortifacient potential.

Brexafemme (ibrexafungerp) (MW, 922) is indicated for the treatment of vulvovaginal candidiasis. The drug was teratogenic in pregnant rabbits but not in pregnant rats. The manufacturer recommends females with reproductive potential should use effective contraception during treatment and for 4 days after the final dose.

Bylvay (odevixibat) (MW unknown) is indicated for the treatment of pruritus in patients aged 3 months and older. There are no human data regarding its use in pregnant women. The drug was teratogenic in pregnant rabbits. Although there are no data, the drug has low absorption following oral administration and breastfeeding is not expected to result in exposure of the infant.

Empaveli (pegcetacoplan) (MW, 44 kDa) is used to treat paroxysmal nocturnal hemoglobinuria. When the drug was given to pregnant cynomolgus monkeys there was an increase in abortions and stillbirths.

Evkeeza (evinacumab-dgnb) (MW, 146k) is used to treat homozygous familial hypercholesterolemia. The drug was teratogenic in rabbits but not rats.

Fexinidazole (MW not specified) is indicated to treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense. Additional information not available.

Kerendia (finerenone) (MW, 378), is indicated to reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes. The drug was teratogenic in rats.

Korsuva (difelikefalin) (MW, 679) is a kappa opioid–receptor agonist indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. No adverse effects were observed in pregnant rats and rabbits. The limited human data on use of Korsuva in pregnant women are not sufficient to evaluate a drug associated risk for major birth defects or miscarriage.

Leqvio (inclisiran) (MW, 17,285) is indicated to treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy. The drug was not teratogenic in rats and rabbits.

Livmarli (maralixibat) (MW, 710) is indicated for the treatment of cholestatic pruritus associated with Alagille syndrome. Because systemic absorption is low, the recommended clinical dose is not expected to result in measurable fetal exposure. No effects on fetal rats were observed.

Livtencity (maribavir) (MW, 376) is used to treat posttransplant cytomegalovirus infection that has not responded to other treatment. Embryo/fetal survival was reduced in rats but not in rabbits at doses less then the human dose.

Lupkynis (voclosporin) (MW, 1,215) is used to treat nephritis. Avoid use of Lupkynis in pregnant women because of the alcohol content of the drug formulation. The drug was embryocidal and feticidal in rats and rabbits but with no treatment-related fetal malformations or variations.

Lybalvi (olanzapine and samidorphan) (MW, 312 and 505) is a combination drug used to treat schizophrenia and bipolar disorder. It was fetal toxic in pregnant rats and rabbits but with no evidence of malformations. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including this drug, during pregnancy. Health care providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit the Reproductive Psychiatry Resource and Information Center of the MGH Center for Women’s Mental Health.

Nexviazyme (avalglucosidase alfa-ngpt) (MW, 124k) is a hydrolytic lysosomal glycogen-specific enzyme indicated for the treatment of patients aged 1 year and older with late-onset Pompe disease. The drug was not teratogenic in mice and rabbits.

Nulibry (fosdenopterin) (MW, 480) is used to reduce the risk of mortality in molybdenum cofactor deficiency type A. Studies have not been conducted in pregnant animals.

Ponvory (ponesimod) (MW, 461) is used to treat relapsing forms of multiple sclerosis. The drug caused severe adverse effects in pregnant rats and rabbits.

Qulipta (atogepant) (MW, 604) is indicated to prevent episodic migraines. It is embryo/fetal toxic in rats and rabbits.

Saphnelo (anifrolumab-fnia) (MW, 148k) is used to treat moderate to severe systemic lupus erythematosus along with standard therapy. In pregnant cynomolgus monkeys, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 28 times the exposure at the maximum recommended human dose.

Tavneos (avacopan) (MW, 582) is indicated to treat severe active antineutrophil cytoplasmic autoantibody–associated vasculitis in combination with standard therapy including glucocorticoids. There appears to be an increased risk for hepatotoxicity. The drug caused no defects in hamsters and rabbits, but in rabbits there was an increase in abortions.

Tezspire (tezepelumab-ekko) (MW, 147k) is indicated to treat severe asthma as an add-on maintenance therapy. No adverse fetal effects were observed in pregnant cynomolgus monkeys.

Verquvo (vericiguat) (MW, 426) is used to mitigate the risk of cardiovascular death and hospitalization for chronic heart failure. The drug was teratogenic in pregnant rabbits but not rats.

Vyvgart (efgartigimod alfa-fcab) (MW, 54k) is indicated to treat generalized myasthenia gravis. The drug did not cause birth defects in rats and rabbits.

Welireg (belzutifan) (MW, 383) is used to treat von Hippel–Lindau disease. In pregnant rats, the drug caused embryo-fetal lethality, reduced fetal body weight, and caused fetal skeletal malformations at maternal exposures of at least 0.2 times the human exposures.

Zegalogue (dasiglucagon) (MW, 3,382) is used to treat severe hypoglycemia. The drug did not cause birth defects in pregnant rats and rabbits.
 

Breastfeeding

It is not known if the above drugs will be in breast milk, but the safest course for an infant is to not breast feed if the mother is taking any of the above drugs.

Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].

In 2021, the Food and Drug Administration approved 50 new drugs, but 24 will not be described here because they would probably not be used in pregnancy. The 24 are Aduhelm (aducanumab) to treat Alzheimer’s disease; Azstarys (serdexmethylphenidate and dexmethylphenidate), a combination CNS stimulant indicated for the treatment of ADHD; Cabenuva (cabotegravir and rilpivirine) to treat HIV; Voxzogo (vosoritide) for children with achondroplasia and open epiphyses; Qelbree (viloxazine) used in children aged 6-17 years to treat ADHD; and Pylarify (piflufolastat) for prostate cancer. Other anticancer drugs that will not be covered are Cosela (trilaciclib), Cytalux (pafolacianine), Exkivity (mobocertinib); Fotivda (tivozanib), Jemperli (dostarlimab-gxly), Lumakras (sotorasib), Pepaxto (melphalan flufenamide), Rybrevant (amivantamab-vmjw), Rylaze (asparaginase erwinia chrysanthemi), Scemblix (asciminib), Tepmetko (tepotinib), Tivdak (tisotumab vedotin-tftv), Truseltiq (infigratinib), Ukoniq (umbralisib), and Zynlonta (loncastuximab tesirine-lpyl).

Skytrofa (lonapegsomatropin-tcgd) will not be described below because it is indicated to treat short stature and is unlikely to be used in pregnancy. Nextstellis (drospirenone and estetrol) is used to prevent pregnancy.

Typically, for new drugs there will be no published reports describing their use in pregnant women. That information will come much later. In the sections below, the indications, effects on pregnant animals, and the potential for harm of a fetus/embryo are described. However, the relevance of animal data to human pregnancies is not great.

Adbry (tralokinumab) (molecular weight [MW], 147 kilodaltons), is indicated for the treatment of moderate to severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The drug did not harm fetal monkeys at doses that were 10 times the maximum recommended human dose.

Besremi (ropeginterferon alfa-2b-njft) (MW, 60 kDa) is an interferon alfa-2b indicated for the treatment of adults with polycythemia vera. It is given by subcutaneous injection every 2 weeks. Animal studies assessing reproductive toxicity have not been conducted. The manufacturer states that the drug may cause fetal harm and should be assumed to have abortifacient potential.

Brexafemme (ibrexafungerp) (MW, 922) is indicated for the treatment of vulvovaginal candidiasis. The drug was teratogenic in pregnant rabbits but not in pregnant rats. The manufacturer recommends females with reproductive potential should use effective contraception during treatment and for 4 days after the final dose.

Bylvay (odevixibat) (MW unknown) is indicated for the treatment of pruritus in patients aged 3 months and older. There are no human data regarding its use in pregnant women. The drug was teratogenic in pregnant rabbits. Although there are no data, the drug has low absorption following oral administration and breastfeeding is not expected to result in exposure of the infant.

Empaveli (pegcetacoplan) (MW, 44 kDa) is used to treat paroxysmal nocturnal hemoglobinuria. When the drug was given to pregnant cynomolgus monkeys there was an increase in abortions and stillbirths.

Evkeeza (evinacumab-dgnb) (MW, 146k) is used to treat homozygous familial hypercholesterolemia. The drug was teratogenic in rabbits but not rats.

Fexinidazole (MW not specified) is indicated to treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense. Additional information not available.

Kerendia (finerenone) (MW, 378), is indicated to reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes. The drug was teratogenic in rats.

Korsuva (difelikefalin) (MW, 679) is a kappa opioid–receptor agonist indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. No adverse effects were observed in pregnant rats and rabbits. The limited human data on use of Korsuva in pregnant women are not sufficient to evaluate a drug associated risk for major birth defects or miscarriage.

Leqvio (inclisiran) (MW, 17,285) is indicated to treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy. The drug was not teratogenic in rats and rabbits.

Livmarli (maralixibat) (MW, 710) is indicated for the treatment of cholestatic pruritus associated with Alagille syndrome. Because systemic absorption is low, the recommended clinical dose is not expected to result in measurable fetal exposure. No effects on fetal rats were observed.

Livtencity (maribavir) (MW, 376) is used to treat posttransplant cytomegalovirus infection that has not responded to other treatment. Embryo/fetal survival was reduced in rats but not in rabbits at doses less then the human dose.

Lupkynis (voclosporin) (MW, 1,215) is used to treat nephritis. Avoid use of Lupkynis in pregnant women because of the alcohol content of the drug formulation. The drug was embryocidal and feticidal in rats and rabbits but with no treatment-related fetal malformations or variations.

Lybalvi (olanzapine and samidorphan) (MW, 312 and 505) is a combination drug used to treat schizophrenia and bipolar disorder. It was fetal toxic in pregnant rats and rabbits but with no evidence of malformations. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including this drug, during pregnancy. Health care providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit the Reproductive Psychiatry Resource and Information Center of the MGH Center for Women’s Mental Health.

Nexviazyme (avalglucosidase alfa-ngpt) (MW, 124k) is a hydrolytic lysosomal glycogen-specific enzyme indicated for the treatment of patients aged 1 year and older with late-onset Pompe disease. The drug was not teratogenic in mice and rabbits.

Nulibry (fosdenopterin) (MW, 480) is used to reduce the risk of mortality in molybdenum cofactor deficiency type A. Studies have not been conducted in pregnant animals.

Ponvory (ponesimod) (MW, 461) is used to treat relapsing forms of multiple sclerosis. The drug caused severe adverse effects in pregnant rats and rabbits.

Qulipta (atogepant) (MW, 604) is indicated to prevent episodic migraines. It is embryo/fetal toxic in rats and rabbits.

Saphnelo (anifrolumab-fnia) (MW, 148k) is used to treat moderate to severe systemic lupus erythematosus along with standard therapy. In pregnant cynomolgus monkeys, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 28 times the exposure at the maximum recommended human dose.

Tavneos (avacopan) (MW, 582) is indicated to treat severe active antineutrophil cytoplasmic autoantibody–associated vasculitis in combination with standard therapy including glucocorticoids. There appears to be an increased risk for hepatotoxicity. The drug caused no defects in hamsters and rabbits, but in rabbits there was an increase in abortions.

Tezspire (tezepelumab-ekko) (MW, 147k) is indicated to treat severe asthma as an add-on maintenance therapy. No adverse fetal effects were observed in pregnant cynomolgus monkeys.

Verquvo (vericiguat) (MW, 426) is used to mitigate the risk of cardiovascular death and hospitalization for chronic heart failure. The drug was teratogenic in pregnant rabbits but not rats.

Vyvgart (efgartigimod alfa-fcab) (MW, 54k) is indicated to treat generalized myasthenia gravis. The drug did not cause birth defects in rats and rabbits.

Welireg (belzutifan) (MW, 383) is used to treat von Hippel–Lindau disease. In pregnant rats, the drug caused embryo-fetal lethality, reduced fetal body weight, and caused fetal skeletal malformations at maternal exposures of at least 0.2 times the human exposures.

Zegalogue (dasiglucagon) (MW, 3,382) is used to treat severe hypoglycemia. The drug did not cause birth defects in pregnant rats and rabbits.
 

Breastfeeding

It is not known if the above drugs will be in breast milk, but the safest course for an infant is to not breast feed if the mother is taking any of the above drugs.

Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].

In 2021, the Food and Drug Administration approved 50 new drugs, but 24 will not be described here because they would probably not be used in pregnancy. The 24 are Aduhelm (aducanumab) to treat Alzheimer’s disease; Azstarys (serdexmethylphenidate and dexmethylphenidate), a combination CNS stimulant indicated for the treatment of ADHD; Cabenuva (cabotegravir and rilpivirine) to treat HIV; Voxzogo (vosoritide) for children with achondroplasia and open epiphyses; Qelbree (viloxazine) used in children aged 6-17 years to treat ADHD; and Pylarify (piflufolastat) for prostate cancer. Other anticancer drugs that will not be covered are Cosela (trilaciclib), Cytalux (pafolacianine), Exkivity (mobocertinib); Fotivda (tivozanib), Jemperli (dostarlimab-gxly), Lumakras (sotorasib), Pepaxto (melphalan flufenamide), Rybrevant (amivantamab-vmjw), Rylaze (asparaginase erwinia chrysanthemi), Scemblix (asciminib), Tepmetko (tepotinib), Tivdak (tisotumab vedotin-tftv), Truseltiq (infigratinib), Ukoniq (umbralisib), and Zynlonta (loncastuximab tesirine-lpyl).

Skytrofa (lonapegsomatropin-tcgd) will not be described below because it is indicated to treat short stature and is unlikely to be used in pregnancy. Nextstellis (drospirenone and estetrol) is used to prevent pregnancy.

Typically, for new drugs there will be no published reports describing their use in pregnant women. That information will come much later. In the sections below, the indications, effects on pregnant animals, and the potential for harm of a fetus/embryo are described. However, the relevance of animal data to human pregnancies is not great.

Adbry (tralokinumab) (molecular weight [MW], 147 kilodaltons), is indicated for the treatment of moderate to severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The drug did not harm fetal monkeys at doses that were 10 times the maximum recommended human dose.

Besremi (ropeginterferon alfa-2b-njft) (MW, 60 kDa) is an interferon alfa-2b indicated for the treatment of adults with polycythemia vera. It is given by subcutaneous injection every 2 weeks. Animal studies assessing reproductive toxicity have not been conducted. The manufacturer states that the drug may cause fetal harm and should be assumed to have abortifacient potential.

Brexafemme (ibrexafungerp) (MW, 922) is indicated for the treatment of vulvovaginal candidiasis. The drug was teratogenic in pregnant rabbits but not in pregnant rats. The manufacturer recommends females with reproductive potential should use effective contraception during treatment and for 4 days after the final dose.

Bylvay (odevixibat) (MW unknown) is indicated for the treatment of pruritus in patients aged 3 months and older. There are no human data regarding its use in pregnant women. The drug was teratogenic in pregnant rabbits. Although there are no data, the drug has low absorption following oral administration and breastfeeding is not expected to result in exposure of the infant.

Empaveli (pegcetacoplan) (MW, 44 kDa) is used to treat paroxysmal nocturnal hemoglobinuria. When the drug was given to pregnant cynomolgus monkeys there was an increase in abortions and stillbirths.

Evkeeza (evinacumab-dgnb) (MW, 146k) is used to treat homozygous familial hypercholesterolemia. The drug was teratogenic in rabbits but not rats.

Fexinidazole (MW not specified) is indicated to treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense. Additional information not available.

Kerendia (finerenone) (MW, 378), is indicated to reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes. The drug was teratogenic in rats.

Korsuva (difelikefalin) (MW, 679) is a kappa opioid–receptor agonist indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. No adverse effects were observed in pregnant rats and rabbits. The limited human data on use of Korsuva in pregnant women are not sufficient to evaluate a drug associated risk for major birth defects or miscarriage.

Leqvio (inclisiran) (MW, 17,285) is indicated to treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy. The drug was not teratogenic in rats and rabbits.

Livmarli (maralixibat) (MW, 710) is indicated for the treatment of cholestatic pruritus associated with Alagille syndrome. Because systemic absorption is low, the recommended clinical dose is not expected to result in measurable fetal exposure. No effects on fetal rats were observed.

Livtencity (maribavir) (MW, 376) is used to treat posttransplant cytomegalovirus infection that has not responded to other treatment. Embryo/fetal survival was reduced in rats but not in rabbits at doses less then the human dose.

Lupkynis (voclosporin) (MW, 1,215) is used to treat nephritis. Avoid use of Lupkynis in pregnant women because of the alcohol content of the drug formulation. The drug was embryocidal and feticidal in rats and rabbits but with no treatment-related fetal malformations or variations.

Lybalvi (olanzapine and samidorphan) (MW, 312 and 505) is a combination drug used to treat schizophrenia and bipolar disorder. It was fetal toxic in pregnant rats and rabbits but with no evidence of malformations. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including this drug, during pregnancy. Health care providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit the Reproductive Psychiatry Resource and Information Center of the MGH Center for Women’s Mental Health.

Nexviazyme (avalglucosidase alfa-ngpt) (MW, 124k) is a hydrolytic lysosomal glycogen-specific enzyme indicated for the treatment of patients aged 1 year and older with late-onset Pompe disease. The drug was not teratogenic in mice and rabbits.

Nulibry (fosdenopterin) (MW, 480) is used to reduce the risk of mortality in molybdenum cofactor deficiency type A. Studies have not been conducted in pregnant animals.

Ponvory (ponesimod) (MW, 461) is used to treat relapsing forms of multiple sclerosis. The drug caused severe adverse effects in pregnant rats and rabbits.

Qulipta (atogepant) (MW, 604) is indicated to prevent episodic migraines. It is embryo/fetal toxic in rats and rabbits.

Saphnelo (anifrolumab-fnia) (MW, 148k) is used to treat moderate to severe systemic lupus erythematosus along with standard therapy. In pregnant cynomolgus monkeys, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 28 times the exposure at the maximum recommended human dose.

Tavneos (avacopan) (MW, 582) is indicated to treat severe active antineutrophil cytoplasmic autoantibody–associated vasculitis in combination with standard therapy including glucocorticoids. There appears to be an increased risk for hepatotoxicity. The drug caused no defects in hamsters and rabbits, but in rabbits there was an increase in abortions.

Tezspire (tezepelumab-ekko) (MW, 147k) is indicated to treat severe asthma as an add-on maintenance therapy. No adverse fetal effects were observed in pregnant cynomolgus monkeys.

Verquvo (vericiguat) (MW, 426) is used to mitigate the risk of cardiovascular death and hospitalization for chronic heart failure. The drug was teratogenic in pregnant rabbits but not rats.

Vyvgart (efgartigimod alfa-fcab) (MW, 54k) is indicated to treat generalized myasthenia gravis. The drug did not cause birth defects in rats and rabbits.

Welireg (belzutifan) (MW, 383) is used to treat von Hippel–Lindau disease. In pregnant rats, the drug caused embryo-fetal lethality, reduced fetal body weight, and caused fetal skeletal malformations at maternal exposures of at least 0.2 times the human exposures.

Zegalogue (dasiglucagon) (MW, 3,382) is used to treat severe hypoglycemia. The drug did not cause birth defects in pregnant rats and rabbits.
 

Breastfeeding

It is not known if the above drugs will be in breast milk, but the safest course for an infant is to not breast feed if the mother is taking any of the above drugs.

Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].

One year after hospitalization for COVID-19 only a minority of people feel fully recovered, with being female, obesity, and having had mechanical ventilation in hospital risk factors for not feeling fully recovered.

In the new U.K. study of more than 2,000 patients, presented at this year’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022), and published in The Lancet Respiratory Medicine, research showed that one in four patients feel fully well again 1 year after hospitalization for COVID-19.

For their study, researchers from the University of Leicester used data from the post-hospitalization COVID-19 (PHOSP-COVID) prospective, longitudinal cohort study, which assessed adults aged 18 years and over who had been hospitalized with COVID-19 across the United Kingdom and subsequently discharged. The researchers assessed the recovery of 2,320 participants discharged from 39 U.K. hospitals between March 7, 2020, and April 18, 2021, who were assessed via patient-reported outcome measures, physical performance, and organ function at 5 months and at 1 year after hospital discharge. Blood samples were taken at the 5-month visit to be analyzed for the presence of various inflammatory proteins.

All participants were assessed at 5 months after discharge and 807 participants (33%) completed both the 5-month and 1-year visits at the time of the analysis. The study is ongoing. The 807 patients were mean age of 59 years, 36% were women, and 28% received invasive mechanical ventilation. The proportion of patients reporting full recovery was similar between 5 months (26%) and 1 year (29%).
 

Female sex and obesity major risk factors for not recovering

Being female, obese, and having had mechanical ventilation in hospital makes someone 32%, 50%, and 58%, respectively, less likely to feel fully recovered 1 year after COVID-19 hospitalization, the authors said.

“We found female sex and obesity were major risk factors for not recovering at one year,” said the researchers, led by Rachael Evans, PhD, Louise V. Wain, and Christopher E. Brightling, PhD, National Institute for Health Research, Leicester Biomedical Research Centre, University of Leicester.

The authors said fatigue, muscle pain, physically slowing down, poor sleep, and breathlessness were most common ongoing long COVID symptoms. They noted how the total number and range of ongoing symptoms at 1 year was “striking,” positively associated with the severity of long COVID, and emphasizes the “multisystem nature of long COVID.”
 

Several inflammatory mediators increased

An earlier publication from this study identified four groups or “clusters” of symptom severity at 5 months, which were confirmed by this new study at 1 year, the authors said. They reported that 20% had very severe physical and mental health impairment, 30% had severe physical and mental health impairment, 11% had moderate physical health impairment with cognitive impairment, and 39% had mild mental and physical health impairment.

They added that having obesity, reduced exercise capacity, a greater number of symptoms, and increased levels of C-reactive protein were associated with the “more severe clusters.” In both the very severe and the moderate with cognitive impairment clusters, levels of interleukin-6 (IL-6) were higher when compared with the mild cluster.

“The limited recovery from 5 months to 1 year after hospitalisation in our study across symptoms, mental health, exercise capacity, organ impairment, and quality-of-life is striking,” the researchers noted.

“In our clusters, female sex and obesity were also associated with more severe ongoing health impairments including reduced exercise performance and health-related quality of life at one year,” and suggested that this potentially highlighted a group that “might need higher intensity interventions such as supervised rehabilitation,” they added.

There are no specific therapeutics for long COVID, the researchers said, noting that “effective interventions are urgently required.” The persistent systemic inflammation identified, particularly in those in the very severe and moderate with cognitive impairment clusters, suggested that these groups “might respond to anti-inflammatory strategies,” the authors wrote.

“We found that a minority of participants felt fully recovered 1 year after hospital discharge, with minimal improvement after a 5-month assessment,” they noted.

They added that the findings suggest the need for complex interventions that target both physical and mental health impairments to alleviate symptoms, and that specific therapeutic approaches to manage posttraumatic stress disorder might also be needed. The authors pointed out how “pharmacological and non-pharmacological interventions are urgently needed,” with a “precision-medicine approach with potential treatable traits of systemic inflammation and obesity.”

They said their study highlighted the “urgent need for health-care services to support the large and rapidly increasing patient population in whom a substantial burden of symptoms exist, including reduced exercise capacity and substantially decreased health-related quality of life one year after hospital discharge.”

They warned that without effective treatments, long COVID could become a “highly prevalent new long-term condition.”

A version of this article first appeared on Medscape UK.

One year after hospitalization for COVID-19 only a minority of people feel fully recovered, with being female, obesity, and having had mechanical ventilation in hospital risk factors for not feeling fully recovered.

In the new U.K. study of more than 2,000 patients, presented at this year’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022), and published in The Lancet Respiratory Medicine, research showed that one in four patients feel fully well again 1 year after hospitalization for COVID-19.

For their study, researchers from the University of Leicester used data from the post-hospitalization COVID-19 (PHOSP-COVID) prospective, longitudinal cohort study, which assessed adults aged 18 years and over who had been hospitalized with COVID-19 across the United Kingdom and subsequently discharged. The researchers assessed the recovery of 2,320 participants discharged from 39 U.K. hospitals between March 7, 2020, and April 18, 2021, who were assessed via patient-reported outcome measures, physical performance, and organ function at 5 months and at 1 year after hospital discharge. Blood samples were taken at the 5-month visit to be analyzed for the presence of various inflammatory proteins.

All participants were assessed at 5 months after discharge and 807 participants (33%) completed both the 5-month and 1-year visits at the time of the analysis. The study is ongoing. The 807 patients were mean age of 59 years, 36% were women, and 28% received invasive mechanical ventilation. The proportion of patients reporting full recovery was similar between 5 months (26%) and 1 year (29%).
 

Female sex and obesity major risk factors for not recovering

Being female, obese, and having had mechanical ventilation in hospital makes someone 32%, 50%, and 58%, respectively, less likely to feel fully recovered 1 year after COVID-19 hospitalization, the authors said.

“We found female sex and obesity were major risk factors for not recovering at one year,” said the researchers, led by Rachael Evans, PhD, Louise V. Wain, and Christopher E. Brightling, PhD, National Institute for Health Research, Leicester Biomedical Research Centre, University of Leicester.

The authors said fatigue, muscle pain, physically slowing down, poor sleep, and breathlessness were most common ongoing long COVID symptoms. They noted how the total number and range of ongoing symptoms at 1 year was “striking,” positively associated with the severity of long COVID, and emphasizes the “multisystem nature of long COVID.”
 

Several inflammatory mediators increased

An earlier publication from this study identified four groups or “clusters” of symptom severity at 5 months, which were confirmed by this new study at 1 year, the authors said. They reported that 20% had very severe physical and mental health impairment, 30% had severe physical and mental health impairment, 11% had moderate physical health impairment with cognitive impairment, and 39% had mild mental and physical health impairment.

They added that having obesity, reduced exercise capacity, a greater number of symptoms, and increased levels of C-reactive protein were associated with the “more severe clusters.” In both the very severe and the moderate with cognitive impairment clusters, levels of interleukin-6 (IL-6) were higher when compared with the mild cluster.

“The limited recovery from 5 months to 1 year after hospitalisation in our study across symptoms, mental health, exercise capacity, organ impairment, and quality-of-life is striking,” the researchers noted.

“In our clusters, female sex and obesity were also associated with more severe ongoing health impairments including reduced exercise performance and health-related quality of life at one year,” and suggested that this potentially highlighted a group that “might need higher intensity interventions such as supervised rehabilitation,” they added.

There are no specific therapeutics for long COVID, the researchers said, noting that “effective interventions are urgently required.” The persistent systemic inflammation identified, particularly in those in the very severe and moderate with cognitive impairment clusters, suggested that these groups “might respond to anti-inflammatory strategies,” the authors wrote.

“We found that a minority of participants felt fully recovered 1 year after hospital discharge, with minimal improvement after a 5-month assessment,” they noted.

They added that the findings suggest the need for complex interventions that target both physical and mental health impairments to alleviate symptoms, and that specific therapeutic approaches to manage posttraumatic stress disorder might also be needed. The authors pointed out how “pharmacological and non-pharmacological interventions are urgently needed,” with a “precision-medicine approach with potential treatable traits of systemic inflammation and obesity.”

They said their study highlighted the “urgent need for health-care services to support the large and rapidly increasing patient population in whom a substantial burden of symptoms exist, including reduced exercise capacity and substantially decreased health-related quality of life one year after hospital discharge.”

They warned that without effective treatments, long COVID could become a “highly prevalent new long-term condition.”

A version of this article first appeared on Medscape UK.

One year after hospitalization for COVID-19 only a minority of people feel fully recovered, with being female, obesity, and having had mechanical ventilation in hospital risk factors for not feeling fully recovered.

In the new U.K. study of more than 2,000 patients, presented at this year’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022), and published in The Lancet Respiratory Medicine, research showed that one in four patients feel fully well again 1 year after hospitalization for COVID-19.

For their study, researchers from the University of Leicester used data from the post-hospitalization COVID-19 (PHOSP-COVID) prospective, longitudinal cohort study, which assessed adults aged 18 years and over who had been hospitalized with COVID-19 across the United Kingdom and subsequently discharged. The researchers assessed the recovery of 2,320 participants discharged from 39 U.K. hospitals between March 7, 2020, and April 18, 2021, who were assessed via patient-reported outcome measures, physical performance, and organ function at 5 months and at 1 year after hospital discharge. Blood samples were taken at the 5-month visit to be analyzed for the presence of various inflammatory proteins.

All participants were assessed at 5 months after discharge and 807 participants (33%) completed both the 5-month and 1-year visits at the time of the analysis. The study is ongoing. The 807 patients were mean age of 59 years, 36% were women, and 28% received invasive mechanical ventilation. The proportion of patients reporting full recovery was similar between 5 months (26%) and 1 year (29%).
 

Female sex and obesity major risk factors for not recovering

Being female, obese, and having had mechanical ventilation in hospital makes someone 32%, 50%, and 58%, respectively, less likely to feel fully recovered 1 year after COVID-19 hospitalization, the authors said.

“We found female sex and obesity were major risk factors for not recovering at one year,” said the researchers, led by Rachael Evans, PhD, Louise V. Wain, and Christopher E. Brightling, PhD, National Institute for Health Research, Leicester Biomedical Research Centre, University of Leicester.

The authors said fatigue, muscle pain, physically slowing down, poor sleep, and breathlessness were most common ongoing long COVID symptoms. They noted how the total number and range of ongoing symptoms at 1 year was “striking,” positively associated with the severity of long COVID, and emphasizes the “multisystem nature of long COVID.”
 

Several inflammatory mediators increased

An earlier publication from this study identified four groups or “clusters” of symptom severity at 5 months, which were confirmed by this new study at 1 year, the authors said. They reported that 20% had very severe physical and mental health impairment, 30% had severe physical and mental health impairment, 11% had moderate physical health impairment with cognitive impairment, and 39% had mild mental and physical health impairment.

They added that having obesity, reduced exercise capacity, a greater number of symptoms, and increased levels of C-reactive protein were associated with the “more severe clusters.” In both the very severe and the moderate with cognitive impairment clusters, levels of interleukin-6 (IL-6) were higher when compared with the mild cluster.

“The limited recovery from 5 months to 1 year after hospitalisation in our study across symptoms, mental health, exercise capacity, organ impairment, and quality-of-life is striking,” the researchers noted.

“In our clusters, female sex and obesity were also associated with more severe ongoing health impairments including reduced exercise performance and health-related quality of life at one year,” and suggested that this potentially highlighted a group that “might need higher intensity interventions such as supervised rehabilitation,” they added.

There are no specific therapeutics for long COVID, the researchers said, noting that “effective interventions are urgently required.” The persistent systemic inflammation identified, particularly in those in the very severe and moderate with cognitive impairment clusters, suggested that these groups “might respond to anti-inflammatory strategies,” the authors wrote.

“We found that a minority of participants felt fully recovered 1 year after hospital discharge, with minimal improvement after a 5-month assessment,” they noted.

They added that the findings suggest the need for complex interventions that target both physical and mental health impairments to alleviate symptoms, and that specific therapeutic approaches to manage posttraumatic stress disorder might also be needed. The authors pointed out how “pharmacological and non-pharmacological interventions are urgently needed,” with a “precision-medicine approach with potential treatable traits of systemic inflammation and obesity.”

They said their study highlighted the “urgent need for health-care services to support the large and rapidly increasing patient population in whom a substantial burden of symptoms exist, including reduced exercise capacity and substantially decreased health-related quality of life one year after hospital discharge.”

They warned that without effective treatments, long COVID could become a “highly prevalent new long-term condition.”

A version of this article first appeared on Medscape UK.

Political elections can be hard on the heart, suggests a study that showed a substantial uptick in hospital admissions for acute cardiovascular conditions immediately after the 2020 American presidential election.

The analysis of nearly 6.4 million adults showed that the rate of hospitalization for acute cardiovascular disease (CVD) was 17% higher in the 5 days after the election than in a 5-day period 2 weeks earlier.

The rate of acute myocardial infarction (AMI) was 42% higher, with no significant difference for heart failure or stroke hospital admissions.

“These findings suggest that awareness of the heightened risk of CVD and strategies to mitigate risk during notable political events are needed,” write Matthew T. Mefford, PhD, of Kaiser Permanente Southern California, Pasadena, and colleagues.

The study was published in the April issue of JAMA Network Open.
 

Stress and the heart

In the American Psychological Association Stress in America 2020 survey conducted roughly 3 months before the 2020 presidential election, 77% of adults cited the future of the country as a substantial source of stress, enhanced by the ongoing COVID-19 pandemic, the authors note. More than two-thirds said the election was a substantial source of stress.

Dr. Mefford and colleagues compared CVD hospitalizations at Kaiser Permanente Southern and Northern California hospitals in the 5-day risk window of Nov. 4-8, 2020, with the control window of Oct. 21-25, 2020.

There were 666 CVD hospitalizations (760.47 per 100,000 person-years [PY]) in the risk window, compared with 569 (647.97 per 100,000 PY) in the control window (rate ratio, 1.17; 95% confidence interval, 1.05-1.31).

There were also significantly more hospitalizations for AMI immediately after the election than before (179 vs. 126 AMI hospitalizations; 204.4 vs. 143.5 per 100,000 PY; RR, 1.42; 95% CI, 1.13-1.79).

There was no significant difference between the risk and control periods for hospitalizations because of stroke or heart failure.

The study also suggests higher rates of acute CVD after the election in older adults, men, and White individuals. Political affiliation was not examined in the study.

“Importantly, results were consistent before and after excluding patients with confirmed COVID-19 infection,” the study team notes.

Yet, the potential influence of COVID-19 stressors on increasing CVD risk cannot be ruled out, they say.

However, COVID-19 stressors occurred over a much longer period and are less likely to explain the transient risks observed in the defined risk and control windows that are in close proximity to the 2020 election, the investigators point out.

There is growing evidence that psychological health contributes to CVD.

Previous studies shown a higher risk for acute CVD around population-wide psychosocial or environmental stressors, but less was known about acute CVD risk in relation to political events.

The researchers note future studies evaluating stress-relieving interventions may be important for understanding the intersection of political events, associated stress, and acute CVD risk.

Partial funding for the study was provided by a grant from the W.K. Kellogg Foundation. The authors have no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

Political elections can be hard on the heart, suggests a study that showed a substantial uptick in hospital admissions for acute cardiovascular conditions immediately after the 2020 American presidential election.

The analysis of nearly 6.4 million adults showed that the rate of hospitalization for acute cardiovascular disease (CVD) was 17% higher in the 5 days after the election than in a 5-day period 2 weeks earlier.

The rate of acute myocardial infarction (AMI) was 42% higher, with no significant difference for heart failure or stroke hospital admissions.

“These findings suggest that awareness of the heightened risk of CVD and strategies to mitigate risk during notable political events are needed,” write Matthew T. Mefford, PhD, of Kaiser Permanente Southern California, Pasadena, and colleagues.

The study was published in the April issue of JAMA Network Open.
 

Stress and the heart

In the American Psychological Association Stress in America 2020 survey conducted roughly 3 months before the 2020 presidential election, 77% of adults cited the future of the country as a substantial source of stress, enhanced by the ongoing COVID-19 pandemic, the authors note. More than two-thirds said the election was a substantial source of stress.

Dr. Mefford and colleagues compared CVD hospitalizations at Kaiser Permanente Southern and Northern California hospitals in the 5-day risk window of Nov. 4-8, 2020, with the control window of Oct. 21-25, 2020.

There were 666 CVD hospitalizations (760.47 per 100,000 person-years [PY]) in the risk window, compared with 569 (647.97 per 100,000 PY) in the control window (rate ratio, 1.17; 95% confidence interval, 1.05-1.31).

There were also significantly more hospitalizations for AMI immediately after the election than before (179 vs. 126 AMI hospitalizations; 204.4 vs. 143.5 per 100,000 PY; RR, 1.42; 95% CI, 1.13-1.79).

There was no significant difference between the risk and control periods for hospitalizations because of stroke or heart failure.

The study also suggests higher rates of acute CVD after the election in older adults, men, and White individuals. Political affiliation was not examined in the study.

“Importantly, results were consistent before and after excluding patients with confirmed COVID-19 infection,” the study team notes.

Yet, the potential influence of COVID-19 stressors on increasing CVD risk cannot be ruled out, they say.

However, COVID-19 stressors occurred over a much longer period and are less likely to explain the transient risks observed in the defined risk and control windows that are in close proximity to the 2020 election, the investigators point out.

There is growing evidence that psychological health contributes to CVD.

Previous studies shown a higher risk for acute CVD around population-wide psychosocial or environmental stressors, but less was known about acute CVD risk in relation to political events.

The researchers note future studies evaluating stress-relieving interventions may be important for understanding the intersection of political events, associated stress, and acute CVD risk.

Partial funding for the study was provided by a grant from the W.K. Kellogg Foundation. The authors have no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

Political elections can be hard on the heart, suggests a study that showed a substantial uptick in hospital admissions for acute cardiovascular conditions immediately after the 2020 American presidential election.

The analysis of nearly 6.4 million adults showed that the rate of hospitalization for acute cardiovascular disease (CVD) was 17% higher in the 5 days after the election than in a 5-day period 2 weeks earlier.

The rate of acute myocardial infarction (AMI) was 42% higher, with no significant difference for heart failure or stroke hospital admissions.

“These findings suggest that awareness of the heightened risk of CVD and strategies to mitigate risk during notable political events are needed,” write Matthew T. Mefford, PhD, of Kaiser Permanente Southern California, Pasadena, and colleagues.

The study was published in the April issue of JAMA Network Open.
 

Stress and the heart

In the American Psychological Association Stress in America 2020 survey conducted roughly 3 months before the 2020 presidential election, 77% of adults cited the future of the country as a substantial source of stress, enhanced by the ongoing COVID-19 pandemic, the authors note. More than two-thirds said the election was a substantial source of stress.

Dr. Mefford and colleagues compared CVD hospitalizations at Kaiser Permanente Southern and Northern California hospitals in the 5-day risk window of Nov. 4-8, 2020, with the control window of Oct. 21-25, 2020.

There were 666 CVD hospitalizations (760.47 per 100,000 person-years [PY]) in the risk window, compared with 569 (647.97 per 100,000 PY) in the control window (rate ratio, 1.17; 95% confidence interval, 1.05-1.31).

There were also significantly more hospitalizations for AMI immediately after the election than before (179 vs. 126 AMI hospitalizations; 204.4 vs. 143.5 per 100,000 PY; RR, 1.42; 95% CI, 1.13-1.79).

There was no significant difference between the risk and control periods for hospitalizations because of stroke or heart failure.

The study also suggests higher rates of acute CVD after the election in older adults, men, and White individuals. Political affiliation was not examined in the study.

“Importantly, results were consistent before and after excluding patients with confirmed COVID-19 infection,” the study team notes.

Yet, the potential influence of COVID-19 stressors on increasing CVD risk cannot be ruled out, they say.

However, COVID-19 stressors occurred over a much longer period and are less likely to explain the transient risks observed in the defined risk and control windows that are in close proximity to the 2020 election, the investigators point out.

There is growing evidence that psychological health contributes to CVD.

Previous studies shown a higher risk for acute CVD around population-wide psychosocial or environmental stressors, but less was known about acute CVD risk in relation to political events.

The researchers note future studies evaluating stress-relieving interventions may be important for understanding the intersection of political events, associated stress, and acute CVD risk.

Partial funding for the study was provided by a grant from the W.K. Kellogg Foundation. The authors have no relevant conflicts of interest.

A version of this article first appeared on Medscape.com.

Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.

These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.

The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.

The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.

The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.

“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”

The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”

Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.

The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.

“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”

A version of this article first appeared on WebMD.com.

Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.

These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.

The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.

The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.

The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.

“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”

The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”

Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.

The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.

“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”

A version of this article first appeared on WebMD.com.

Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.

These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.

The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.

The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.

The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.

“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”

The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”

Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.

The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.

“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”

A version of this article first appeared on WebMD.com.

Pregnant women who underwent immediate surgery to treat a ruptured or abscessed appendix had lower risk of infectious complications, compared with those whose complicated appendicitis was managed without surgery, according to new research.

Most cases that began with nonoperative management eventually required surgery, and the operative delay was associated with an increased risk of preterm labor, preterm delivery, and abortion.

“Our study findings may help to define the preferred management strategy in complicated appendicitis during pregnancy to be immediate operation,” Kazuhide Matsushima, MD, an assistant professor of clinical surgery at the University of Southern California, Los Angeles, and colleagues wrote.

The retrospective study was published in JAMA Network Open.

While acute appendicitis is relatively rare during pregnancy, it is the most common nonobstetric emergency in pregnant women, Dr. Matsushima said. This condition occurs in an estimated 1 in 700 to 1 in 1,500 pregnancies, and some data suggest that pregnant women are at higher risk for perforation and other forms of complicated appendicitis.

National guidelines support appendectomy as the first-line treatment for pregnant women with acute uncomplicated appendicitis, but there is no clear guidance on the best treatment approach for managing complicated appendicitis in this population, the authors note.

To better understand how surgical and nonoperational interventions affected outcomes, investigators analyzed data from the National Inpatient Sample from January 2003 to September 2015 to identify pregnant women with complicated appendicitis. The condition was defined as “acute appendicitis with generalized peritonitis” and “acute appendicitis with peritoneal abscess.” Patients were excluded if they had complications such as ectopic pregnancy and hydatidiform mole.

Investigators split the patients into three groups: those who underwent immediate operation for complicated appendicitis, those whose appendicitis was successfully managed without surgery, and those in whom nonoperative management of their condition failed, resulting in delayed surgery. Failed nonoperative management was defined as at least 1 day of nonoperative management followed by a laparoscopic or open appendectomy.

Of the 8,087 pregnant women identified during the study with complicated appendicitis, 55.5% underwent immediate appendectomy, 11.8% were successfully treated without surgical intervention, and 32.7% had delayed operations after initial failed nonoperative management. There was no significant difference in preterm delivery, preterm labor, or abortion between the immediate operative and successful nonoperative groups; however, the successful nonoperative group was more than twice as likely to experience premature rupture of membranes (odds ratio, 2.77; P = .03). Patients successfully treated without surgery also were at higher risk for infections such as amniotic infection (OR, 4.35; P < .001), pneumonia (OR, 2.52; P < .001), and sepsis (OR, 1.52; P = .01), compared with patients who underwent immediate operation.

Patients who had delayed surgery were 45% more likely to experience preterm delivery, preterm labor, or abortion (OR, 1.45; P < .001), compared with the immediate surgery group. The delayed surgery group was also at higher risk for antepartum hemorrhage (OR, 1.56; P = .03) and premature rupture of membranes (OR, 3.44; P = .002). They were more than four times as likely to have amniotic infection (OR, 4.74; P < .001), twice as likely to contract pneumonia (OR, 2.01; P < .001), and 58% more likely to develop sepsis (OR, 1.58; P < .001), compared with the immediate surgery group. The researchers calculated that every day surgery was delayed, the risk of preterm delivery, preterm labor, and abortion rose by 23% (OR, 1.23; P < .001).

Delayed surgery and successful nonoperative management were also associated with higher hospital charges and longer hospital stays.

Because this was a retrospective study, there are some limitations to the findings, Dr. Matsushima said, and therefore it should not be used to justify changing standards of care; however, it does give more information on the risks associated with different interventions. “It’s very important to have a discussion with the patient and make a shared decision,” he told this news organization, “because each option has significant risks and benefits.”

Because the data were from a database, he added, the research team was not able to see if outcomes from immediate surgery, nonoperative management, and delayed surgery differed in each trimester.

Kenneth W. Sharp, MD, a professor of surgery at Vanderbilt University Medical Center in Nashville, Tenn., agreed that the study does have limitations, such as lack of information on how complicated appendicitis was identified and diagnosed; however, the study does provide guidance to surgeons in a surgical area with “very sparse literature,” he told this news organization. Dr. Sharp is also a regent from the American College of Surgeons, which arranged the interview.

“Especially with these very complicated patients, it was never clear what to do,” he said. “With the recent studies showing that treatment of appendicitis with antibiotics works for a large number of people, people start extrapolating [those findings] to complicated appendicitis and they start extrapolating it to pregnant women, none of which the studies were meant to show anything about,” he said.

This analysis gives additional information to inform treatment decisions in pregnant women who may be hesitant to undergo this abdominal surgery because of possible complications, like pregnancy loss, he added. “Now, I can say to them that the data would suggest that with your particular complicated appendicitis, we should operate sooner, not later.”

Dr. Matsushima and Dr. Sharp have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Pregnant women who underwent immediate surgery to treat a ruptured or abscessed appendix had lower risk of infectious complications, compared with those whose complicated appendicitis was managed without surgery, according to new research.

Most cases that began with nonoperative management eventually required surgery, and the operative delay was associated with an increased risk of preterm labor, preterm delivery, and abortion.

“Our study findings may help to define the preferred management strategy in complicated appendicitis during pregnancy to be immediate operation,” Kazuhide Matsushima, MD, an assistant professor of clinical surgery at the University of Southern California, Los Angeles, and colleagues wrote.

The retrospective study was published in JAMA Network Open.

While acute appendicitis is relatively rare during pregnancy, it is the most common nonobstetric emergency in pregnant women, Dr. Matsushima said. This condition occurs in an estimated 1 in 700 to 1 in 1,500 pregnancies, and some data suggest that pregnant women are at higher risk for perforation and other forms of complicated appendicitis.

National guidelines support appendectomy as the first-line treatment for pregnant women with acute uncomplicated appendicitis, but there is no clear guidance on the best treatment approach for managing complicated appendicitis in this population, the authors note.

To better understand how surgical and nonoperational interventions affected outcomes, investigators analyzed data from the National Inpatient Sample from January 2003 to September 2015 to identify pregnant women with complicated appendicitis. The condition was defined as “acute appendicitis with generalized peritonitis” and “acute appendicitis with peritoneal abscess.” Patients were excluded if they had complications such as ectopic pregnancy and hydatidiform mole.

Investigators split the patients into three groups: those who underwent immediate operation for complicated appendicitis, those whose appendicitis was successfully managed without surgery, and those in whom nonoperative management of their condition failed, resulting in delayed surgery. Failed nonoperative management was defined as at least 1 day of nonoperative management followed by a laparoscopic or open appendectomy.

Of the 8,087 pregnant women identified during the study with complicated appendicitis, 55.5% underwent immediate appendectomy, 11.8% were successfully treated without surgical intervention, and 32.7% had delayed operations after initial failed nonoperative management. There was no significant difference in preterm delivery, preterm labor, or abortion between the immediate operative and successful nonoperative groups; however, the successful nonoperative group was more than twice as likely to experience premature rupture of membranes (odds ratio, 2.77; P = .03). Patients successfully treated without surgery also were at higher risk for infections such as amniotic infection (OR, 4.35; P < .001), pneumonia (OR, 2.52; P < .001), and sepsis (OR, 1.52; P = .01), compared with patients who underwent immediate operation.

Patients who had delayed surgery were 45% more likely to experience preterm delivery, preterm labor, or abortion (OR, 1.45; P < .001), compared with the immediate surgery group. The delayed surgery group was also at higher risk for antepartum hemorrhage (OR, 1.56; P = .03) and premature rupture of membranes (OR, 3.44; P = .002). They were more than four times as likely to have amniotic infection (OR, 4.74; P < .001), twice as likely to contract pneumonia (OR, 2.01; P < .001), and 58% more likely to develop sepsis (OR, 1.58; P < .001), compared with the immediate surgery group. The researchers calculated that every day surgery was delayed, the risk of preterm delivery, preterm labor, and abortion rose by 23% (OR, 1.23; P < .001).

Delayed surgery and successful nonoperative management were also associated with higher hospital charges and longer hospital stays.

Because this was a retrospective study, there are some limitations to the findings, Dr. Matsushima said, and therefore it should not be used to justify changing standards of care; however, it does give more information on the risks associated with different interventions. “It’s very important to have a discussion with the patient and make a shared decision,” he told this news organization, “because each option has significant risks and benefits.”

Because the data were from a database, he added, the research team was not able to see if outcomes from immediate surgery, nonoperative management, and delayed surgery differed in each trimester.

Kenneth W. Sharp, MD, a professor of surgery at Vanderbilt University Medical Center in Nashville, Tenn., agreed that the study does have limitations, such as lack of information on how complicated appendicitis was identified and diagnosed; however, the study does provide guidance to surgeons in a surgical area with “very sparse literature,” he told this news organization. Dr. Sharp is also a regent from the American College of Surgeons, which arranged the interview.

“Especially with these very complicated patients, it was never clear what to do,” he said. “With the recent studies showing that treatment of appendicitis with antibiotics works for a large number of people, people start extrapolating [those findings] to complicated appendicitis and they start extrapolating it to pregnant women, none of which the studies were meant to show anything about,” he said.

This analysis gives additional information to inform treatment decisions in pregnant women who may be hesitant to undergo this abdominal surgery because of possible complications, like pregnancy loss, he added. “Now, I can say to them that the data would suggest that with your particular complicated appendicitis, we should operate sooner, not later.”

Dr. Matsushima and Dr. Sharp have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Pregnant women who underwent immediate surgery to treat a ruptured or abscessed appendix had lower risk of infectious complications, compared with those whose complicated appendicitis was managed without surgery, according to new research.

Most cases that began with nonoperative management eventually required surgery, and the operative delay was associated with an increased risk of preterm labor, preterm delivery, and abortion.

“Our study findings may help to define the preferred management strategy in complicated appendicitis during pregnancy to be immediate operation,” Kazuhide Matsushima, MD, an assistant professor of clinical surgery at the University of Southern California, Los Angeles, and colleagues wrote.

The retrospective study was published in JAMA Network Open.

While acute appendicitis is relatively rare during pregnancy, it is the most common nonobstetric emergency in pregnant women, Dr. Matsushima said. This condition occurs in an estimated 1 in 700 to 1 in 1,500 pregnancies, and some data suggest that pregnant women are at higher risk for perforation and other forms of complicated appendicitis.

National guidelines support appendectomy as the first-line treatment for pregnant women with acute uncomplicated appendicitis, but there is no clear guidance on the best treatment approach for managing complicated appendicitis in this population, the authors note.

To better understand how surgical and nonoperational interventions affected outcomes, investigators analyzed data from the National Inpatient Sample from January 2003 to September 2015 to identify pregnant women with complicated appendicitis. The condition was defined as “acute appendicitis with generalized peritonitis” and “acute appendicitis with peritoneal abscess.” Patients were excluded if they had complications such as ectopic pregnancy and hydatidiform mole.

Investigators split the patients into three groups: those who underwent immediate operation for complicated appendicitis, those whose appendicitis was successfully managed without surgery, and those in whom nonoperative management of their condition failed, resulting in delayed surgery. Failed nonoperative management was defined as at least 1 day of nonoperative management followed by a laparoscopic or open appendectomy.

Of the 8,087 pregnant women identified during the study with complicated appendicitis, 55.5% underwent immediate appendectomy, 11.8% were successfully treated without surgical intervention, and 32.7% had delayed operations after initial failed nonoperative management. There was no significant difference in preterm delivery, preterm labor, or abortion between the immediate operative and successful nonoperative groups; however, the successful nonoperative group was more than twice as likely to experience premature rupture of membranes (odds ratio, 2.77; P = .03). Patients successfully treated without surgery also were at higher risk for infections such as amniotic infection (OR, 4.35; P < .001), pneumonia (OR, 2.52; P < .001), and sepsis (OR, 1.52; P = .01), compared with patients who underwent immediate operation.

Patients who had delayed surgery were 45% more likely to experience preterm delivery, preterm labor, or abortion (OR, 1.45; P < .001), compared with the immediate surgery group. The delayed surgery group was also at higher risk for antepartum hemorrhage (OR, 1.56; P = .03) and premature rupture of membranes (OR, 3.44; P = .002). They were more than four times as likely to have amniotic infection (OR, 4.74; P < .001), twice as likely to contract pneumonia (OR, 2.01; P < .001), and 58% more likely to develop sepsis (OR, 1.58; P < .001), compared with the immediate surgery group. The researchers calculated that every day surgery was delayed, the risk of preterm delivery, preterm labor, and abortion rose by 23% (OR, 1.23; P < .001).

Delayed surgery and successful nonoperative management were also associated with higher hospital charges and longer hospital stays.

Because this was a retrospective study, there are some limitations to the findings, Dr. Matsushima said, and therefore it should not be used to justify changing standards of care; however, it does give more information on the risks associated with different interventions. “It’s very important to have a discussion with the patient and make a shared decision,” he told this news organization, “because each option has significant risks and benefits.”

Because the data were from a database, he added, the research team was not able to see if outcomes from immediate surgery, nonoperative management, and delayed surgery differed in each trimester.

Kenneth W. Sharp, MD, a professor of surgery at Vanderbilt University Medical Center in Nashville, Tenn., agreed that the study does have limitations, such as lack of information on how complicated appendicitis was identified and diagnosed; however, the study does provide guidance to surgeons in a surgical area with “very sparse literature,” he told this news organization. Dr. Sharp is also a regent from the American College of Surgeons, which arranged the interview.

“Especially with these very complicated patients, it was never clear what to do,” he said. “With the recent studies showing that treatment of appendicitis with antibiotics works for a large number of people, people start extrapolating [those findings] to complicated appendicitis and they start extrapolating it to pregnant women, none of which the studies were meant to show anything about,” he said.

This analysis gives additional information to inform treatment decisions in pregnant women who may be hesitant to undergo this abdominal surgery because of possible complications, like pregnancy loss, he added. “Now, I can say to them that the data would suggest that with your particular complicated appendicitis, we should operate sooner, not later.”

Dr. Matsushima and Dr. Sharp have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Key clinical point: Prenatal standard estimated fetal weight (EFW) z-scores can predict small-for-gestational-age (SGA) fetuses with greater accuracy than abdominal circumference (AC) z-scores and postnatal reference standards.

Major finding: The INTERGROWTH-21st project-derived EFW z-scores showed higher accuracy in identifying fetuses with a birthweight of <10th and <3rd percentiles than AC z-scores (both P < .05) and postnatal standards (both P < .05). The Hadlock group-derived EFW z-scores performed better in identifying fetuses <10th percentiles (P < .05) and similarly in identifying fetuses <3rd percentile (P = .344) than AC z-scores, whereas they were more accurate than postnatal standards with both birth-weight percentiles (both P < .05).

Study details: This retrospective study included 406 singleton pregnant women at an increased risk for fetal growth restriction who underwent ultrasound examinations between 24 and 36 weeks of gestation.

Disclosures: The study received no financial support. No conflicts of interest were reported.

Source: Visentin S et al. A prenatal standard for fetal weight improves the prenatal diagnosis of small for gestational age fetuses in pregnancies at increased risk. BMC Pregnancy Childbirth. 2022;22:254 (Mar 26). Doi: 10.1186/s12884-022-04545-x

Key clinical point: Prenatal standard estimated fetal weight (EFW) z-scores can predict small-for-gestational-age (SGA) fetuses with greater accuracy than abdominal circumference (AC) z-scores and postnatal reference standards.

Major finding: The INTERGROWTH-21st project-derived EFW z-scores showed higher accuracy in identifying fetuses with a birthweight of <10th and <3rd percentiles than AC z-scores (both P < .05) and postnatal standards (both P < .05). The Hadlock group-derived EFW z-scores performed better in identifying fetuses <10th percentiles (P < .05) and similarly in identifying fetuses <3rd percentile (P = .344) than AC z-scores, whereas they were more accurate than postnatal standards with both birth-weight percentiles (both P < .05).

Study details: This retrospective study included 406 singleton pregnant women at an increased risk for fetal growth restriction who underwent ultrasound examinations between 24 and 36 weeks of gestation.

Disclosures: The study received no financial support. No conflicts of interest were reported.

Source: Visentin S et al. A prenatal standard for fetal weight improves the prenatal diagnosis of small for gestational age fetuses in pregnancies at increased risk. BMC Pregnancy Childbirth. 2022;22:254 (Mar 26). Doi: 10.1186/s12884-022-04545-x

Key clinical point: Prenatal standard estimated fetal weight (EFW) z-scores can predict small-for-gestational-age (SGA) fetuses with greater accuracy than abdominal circumference (AC) z-scores and postnatal reference standards.

Major finding: The INTERGROWTH-21st project-derived EFW z-scores showed higher accuracy in identifying fetuses with a birthweight of <10th and <3rd percentiles than AC z-scores (both P < .05) and postnatal standards (both P < .05). The Hadlock group-derived EFW z-scores performed better in identifying fetuses <10th percentiles (P < .05) and similarly in identifying fetuses <3rd percentile (P = .344) than AC z-scores, whereas they were more accurate than postnatal standards with both birth-weight percentiles (both P < .05).

Study details: This retrospective study included 406 singleton pregnant women at an increased risk for fetal growth restriction who underwent ultrasound examinations between 24 and 36 weeks of gestation.

Disclosures: The study received no financial support. No conflicts of interest were reported.

Source: Visentin S et al. A prenatal standard for fetal weight improves the prenatal diagnosis of small for gestational age fetuses in pregnancies at increased risk. BMC Pregnancy Childbirth. 2022;22:254 (Mar 26). Doi: 10.1186/s12884-022-04545-x

Key clinical point: Accuracy of ultrasonography for the prenatal diagnosis of placenta accreta spectrum (PAS) disorder is comparable with that of magnetic resonance imaging (MRI).

Major finding: Ultrasonography and MRI showed similar sensitivity (0.90; 95% CI 0.86-0.93 vs. 0.89; 95% CI 0.85-0.92), specificity (0.83; 95% CI 0.79-0.86 vs. 0.87; 95% CI 0.83-0.89), and diagnostic odds ratio (39.5; 95% CI 19.6-79.7 vs. 37.4; 95% CI 17.0-82.3) for PAS diagnosis, with no significant difference between their pooled diagnostic sensitivity (P = .808) and specificity (P = .413).

Study details: This is a meta-analysis of 18 studies including 861 pregnancies at a potential risk for PAS, of which 339 were diagnosed with PAS.

Disclosures: The study was sponsored by the Natural Science Foundation of Science and Technology Commission of Shanghai Municipality. The authors declared no conflicts of interest.

Source: Hong S et al. Performance comparison of ultrasonography and magnetic resonance imaging in their diagnostic accuracy of placenta accreta spectrum disorders: A systematic review and meta-analysis. Insights Imaging. 2022;13:50 (Mar 22). Doi: 10.1186/s13244-022-01192-w

Key clinical point: Accuracy of ultrasonography for the prenatal diagnosis of placenta accreta spectrum (PAS) disorder is comparable with that of magnetic resonance imaging (MRI).

Major finding: Ultrasonography and MRI showed similar sensitivity (0.90; 95% CI 0.86-0.93 vs. 0.89; 95% CI 0.85-0.92), specificity (0.83; 95% CI 0.79-0.86 vs. 0.87; 95% CI 0.83-0.89), and diagnostic odds ratio (39.5; 95% CI 19.6-79.7 vs. 37.4; 95% CI 17.0-82.3) for PAS diagnosis, with no significant difference between their pooled diagnostic sensitivity (P = .808) and specificity (P = .413).

Study details: This is a meta-analysis of 18 studies including 861 pregnancies at a potential risk for PAS, of which 339 were diagnosed with PAS.

Disclosures: The study was sponsored by the Natural Science Foundation of Science and Technology Commission of Shanghai Municipality. The authors declared no conflicts of interest.

Source: Hong S et al. Performance comparison of ultrasonography and magnetic resonance imaging in their diagnostic accuracy of placenta accreta spectrum disorders: A systematic review and meta-analysis. Insights Imaging. 2022;13:50 (Mar 22). Doi: 10.1186/s13244-022-01192-w

Key clinical point: Accuracy of ultrasonography for the prenatal diagnosis of placenta accreta spectrum (PAS) disorder is comparable with that of magnetic resonance imaging (MRI).

Major finding: Ultrasonography and MRI showed similar sensitivity (0.90; 95% CI 0.86-0.93 vs. 0.89; 95% CI 0.85-0.92), specificity (0.83; 95% CI 0.79-0.86 vs. 0.87; 95% CI 0.83-0.89), and diagnostic odds ratio (39.5; 95% CI 19.6-79.7 vs. 37.4; 95% CI 17.0-82.3) for PAS diagnosis, with no significant difference between their pooled diagnostic sensitivity (P = .808) and specificity (P = .413).

Study details: This is a meta-analysis of 18 studies including 861 pregnancies at a potential risk for PAS, of which 339 were diagnosed with PAS.

Disclosures: The study was sponsored by the Natural Science Foundation of Science and Technology Commission of Shanghai Municipality. The authors declared no conflicts of interest.

Source: Hong S et al. Performance comparison of ultrasonography and magnetic resonance imaging in their diagnostic accuracy of placenta accreta spectrum disorders: A systematic review and meta-analysis. Insights Imaging. 2022;13:50 (Mar 22). Doi: 10.1186/s13244-022-01192-w

Key clinical point: Noninvasive prenatal fetal rhesus D (RHD) screening after 11 weeks of gestation offers high accuracy and reliability in routine clinical practice.

Major finding: Fetal RHD testing had a 100% sensitivity (95% CI 95.3%-100.0%) and a 100% specificity (95% CI 91.6%-100.0%), with the negative and positive predictive values being 100.0%. No false-negative or false-positive screening results were reported.

Study details: This was a single-center study wherein fetal RHD testing (real-time polymerase chain reaction targeting RHD exons 5 and 7) was performed using blood samples from 205 RHD-negative pregnant women at ≥11 weeks of gestation and test performance was evaluated using cord blood samples obtained from 62% (n = 127) of women.

Disclosures: The study was sponsored by the Scientific Fund of Hematology. The authors reported no conflicts of interest.

Source: Blomme S et al. Routine noninvasive prenatal screening for fetal Rh D in maternal plasma—A 2-year experience from a single center in Belgium. Transfusion. 2022 (Mar 30). Doi: 10.1111/trf.16868

Key clinical point: Noninvasive prenatal fetal rhesus D (RHD) screening after 11 weeks of gestation offers high accuracy and reliability in routine clinical practice.

Major finding: Fetal RHD testing had a 100% sensitivity (95% CI 95.3%-100.0%) and a 100% specificity (95% CI 91.6%-100.0%), with the negative and positive predictive values being 100.0%. No false-negative or false-positive screening results were reported.

Study details: This was a single-center study wherein fetal RHD testing (real-time polymerase chain reaction targeting RHD exons 5 and 7) was performed using blood samples from 205 RHD-negative pregnant women at ≥11 weeks of gestation and test performance was evaluated using cord blood samples obtained from 62% (n = 127) of women.

Disclosures: The study was sponsored by the Scientific Fund of Hematology. The authors reported no conflicts of interest.

Source: Blomme S et al. Routine noninvasive prenatal screening for fetal Rh D in maternal plasma—A 2-year experience from a single center in Belgium. Transfusion. 2022 (Mar 30). Doi: 10.1111/trf.16868

Key clinical point: Noninvasive prenatal fetal rhesus D (RHD) screening after 11 weeks of gestation offers high accuracy and reliability in routine clinical practice.

Major finding: Fetal RHD testing had a 100% sensitivity (95% CI 95.3%-100.0%) and a 100% specificity (95% CI 91.6%-100.0%), with the negative and positive predictive values being 100.0%. No false-negative or false-positive screening results were reported.

Study details: This was a single-center study wherein fetal RHD testing (real-time polymerase chain reaction targeting RHD exons 5 and 7) was performed using blood samples from 205 RHD-negative pregnant women at ≥11 weeks of gestation and test performance was evaluated using cord blood samples obtained from 62% (n = 127) of women.

Disclosures: The study was sponsored by the Scientific Fund of Hematology. The authors reported no conflicts of interest.

Source: Blomme S et al. Routine noninvasive prenatal screening for fetal Rh D in maternal plasma—A 2-year experience from a single center in Belgium. Transfusion. 2022 (Mar 30). Doi: 10.1111/trf.16868

Key clinical point: Maternal placental growth factor (PlGF) levels measured before labor may aid the prediction of cesarean delivery owing to fetal dysfunction and fetal heart rate (FHR) function at delivery.

Major finding: Women having vaginal delivery had significantly higher pre-labor PlGF levels than those having a cesarean delivery owing to fetal dysfunction (157 ± 106 vs. 74 ± 62 pg/mL; P = .03). PlGF levels showed a significant negative correlation (r = −0.42; P = .01) with FHR findings at delivery according to the five-tier classification system.

Study details: The study analyzed PlGF levels in 33 primiparous singleton pregnant women at 35-42 weeks of gestation who were hospitalized before the onset of labor, of which 26 women had vaginal delivery and 7 had a cesarean delivery due to fetal indications.

Disclosures: The study received no financial support. The authors declared no conflicts of interest.

Source: Tanaka H et al. Placental growth factor level is correlated with intrapartum fetal heart rate findings. BMC Pregnancy Childbirth. 2022;22:215 (Mar 17). Doi: 10.1186/s12884-022-04562-w

Key clinical point: Maternal placental growth factor (PlGF) levels measured before labor may aid the prediction of cesarean delivery owing to fetal dysfunction and fetal heart rate (FHR) function at delivery.

Major finding: Women having vaginal delivery had significantly higher pre-labor PlGF levels than those having a cesarean delivery owing to fetal dysfunction (157 ± 106 vs. 74 ± 62 pg/mL; P = .03). PlGF levels showed a significant negative correlation (r = −0.42; P = .01) with FHR findings at delivery according to the five-tier classification system.

Study details: The study analyzed PlGF levels in 33 primiparous singleton pregnant women at 35-42 weeks of gestation who were hospitalized before the onset of labor, of which 26 women had vaginal delivery and 7 had a cesarean delivery due to fetal indications.

Disclosures: The study received no financial support. The authors declared no conflicts of interest.

Source: Tanaka H et al. Placental growth factor level is correlated with intrapartum fetal heart rate findings. BMC Pregnancy Childbirth. 2022;22:215 (Mar 17). Doi: 10.1186/s12884-022-04562-w

Key clinical point: Maternal placental growth factor (PlGF) levels measured before labor may aid the prediction of cesarean delivery owing to fetal dysfunction and fetal heart rate (FHR) function at delivery.

Major finding: Women having vaginal delivery had significantly higher pre-labor PlGF levels than those having a cesarean delivery owing to fetal dysfunction (157 ± 106 vs. 74 ± 62 pg/mL; P = .03). PlGF levels showed a significant negative correlation (r = −0.42; P = .01) with FHR findings at delivery according to the five-tier classification system.

Study details: The study analyzed PlGF levels in 33 primiparous singleton pregnant women at 35-42 weeks of gestation who were hospitalized before the onset of labor, of which 26 women had vaginal delivery and 7 had a cesarean delivery due to fetal indications.

Disclosures: The study received no financial support. The authors declared no conflicts of interest.

Source: Tanaka H et al. Placental growth factor level is correlated with intrapartum fetal heart rate findings. BMC Pregnancy Childbirth. 2022;22:215 (Mar 17). Doi: 10.1186/s12884-022-04562-w