North American Society for Pediatric and Adolescent Gynecology (NASPAG): Annual Clinical Meeting

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2015
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NASPAG: Obesity raises unique contraceptive concerns in teens

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NASPAG: Obesity raises unique contraceptive concerns in teens

ORLANDO – The data with respect to the effects of obesity on the efficacy of contraceptives in adolescents are limited, but the general consensus is that if efficacy is reduced, it isn’t by enough to make a real difference, according to Dr. Alene Toulany.

The effect of obesity is likely to be very small, and studies that have looked at pharmacokinetics in obesity have estimated that body weight accounts for only about 10%-20% of the variability of hormone levels, Dr. Toulany said at the North American Society for Pediatric and Adolescent Gynecology annual meeting.

“We know that this is within the normal range for individuals who are not obese, she said.

Dr. Alene Toulany

The concerns regarding efficacy in obese patients are understandable, as obesity increases the metabolic rate, increases clearance of hepatically metabolized drugs, increases circulating blood volume, and affects the absorption of contraceptive steroids through the adipose tissue, she said, adding that “it makes sense that the serum drug levels may be insufficient to maintain contraceptive effects, but the data are very limited and inconsistent.”

That’s not to say obesity isn’t a concern, added Dr. Toulany, an adolescent medicine specialist at the Hospital for Sick Children, Toronto, and the University of Toronto.

“Without fail, all of us will be seeing patients with obesity,” she said. The rate of adolescent obesity has quadrupled in the last 3 decades, increasing from 5% among those aged 12-19 years in 1980 to more than 20% now. A third are currently overweight or obese.

Further, sexually active obese women, regardless of age, are significantly less likely to use contraception, and obese teens are more likely to engage in risky sexual behaviors than are nonobese teens.

For these reasons, it is important to find the most effective contraceptive method, taking into account other risk factors and the likelihood of compliance, she said, noting that obesity is an independent risk factor for venous thromboembolism (VTE) and that studies suggest the risk is additive in users of estrogen-containing contraceptives.

However, she said, the benefits outweigh the risks of pregnancy in obesity – especially of unintended pregnancy.

The absolute risk of VTE in healthy women of reproductive age is small, and in adolescents it’s even smaller, she explained.

“The presence of risk factors for VTE should be taken into account when we see these youth in our clinics, but we can and should offer estrogen-containing contraceptives as long as there are no other risk factors,” she said.

Contraceptive options in young obese patients include:

• Intrauterine devices. There is no evidence that either copper IUDs or progestin-releasing IUDs have reduced efficacy in obese adolescents.

• Implants. These are highly effective in obese women, and even though the concentrations may be 30%-60% lower in obese women, they do remain above the contraceptive threshold for at least the first 3 years, Dr. Toulany said.

• Depot medroxyprogesterone acetate. There is some concern about weight gain with this injectable progestin-only contraceptive, particularly in those who are already obese, but it remains an option, as the levels do remain above what is needed to prevent ovulation. Interestingly, the persistence of ovulation suppression following discontinuation is different in obese women, and may be prolonged, compared with nonobese women; it is important to counsel patients about this, she said.

“So although randomized, controlled trials report no significant weight gain, we do agree with these observational studies that show that overweight and obese teens gain more weight with Depo-Provera than with oral contraceptives or with no contraceptives,” she said.

• Oral contraceptive pills. Although these may be less effective in obese adolescents, they remain an option and may be the best option in a given patient. Combined oral contraceptives are believed to be generally effective for pregnancy prevention, but “may be less forgiving of imperfect use,” and thus may not be the best choice in those who may have problems with adherence, for example.

The contraceptive patch is probably not a good option, because efficacy may be diminished as a result of absorption through the adipose tissues in those weighing more than 90 kg, Dr .Toulany said. Evidence is insufficient regarding the use of contraceptive rings in obese patients.

Bariatric surgery is increasingly being performed in adolescents, and this raises unique concerns with respect to contraception, Dr. Toulany said.

“We recommend discontinuing estrogen-containing contraceptives 1 month before surgery to reduce the risk of VTE postoperatively,” she said.

After bariatric surgery, those who undergo a restrictive procedure such as gastric banding or a gastric sleeve procedure that reduces the volume of the stomach can use oral contraceptives, but postsurgery vomiting and diarrhea could increase the risk of complications. In those who undergo surgery using a technique that involves a significant malabsorption component, such as Roux-en-Y gastric bypass, nonoral contraceptives are the best option.

 

 

“Most patients going for bariatric surgery have an IUD inserted at the time of surgery, and that’s what we would recommend,” Dr. Toulany said.

She reported having no relevant financial disclosures.

[email protected]

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ORLANDO – The data with respect to the effects of obesity on the efficacy of contraceptives in adolescents are limited, but the general consensus is that if efficacy is reduced, it isn’t by enough to make a real difference, according to Dr. Alene Toulany.

The effect of obesity is likely to be very small, and studies that have looked at pharmacokinetics in obesity have estimated that body weight accounts for only about 10%-20% of the variability of hormone levels, Dr. Toulany said at the North American Society for Pediatric and Adolescent Gynecology annual meeting.

“We know that this is within the normal range for individuals who are not obese, she said.

Dr. Alene Toulany

The concerns regarding efficacy in obese patients are understandable, as obesity increases the metabolic rate, increases clearance of hepatically metabolized drugs, increases circulating blood volume, and affects the absorption of contraceptive steroids through the adipose tissue, she said, adding that “it makes sense that the serum drug levels may be insufficient to maintain contraceptive effects, but the data are very limited and inconsistent.”

That’s not to say obesity isn’t a concern, added Dr. Toulany, an adolescent medicine specialist at the Hospital for Sick Children, Toronto, and the University of Toronto.

“Without fail, all of us will be seeing patients with obesity,” she said. The rate of adolescent obesity has quadrupled in the last 3 decades, increasing from 5% among those aged 12-19 years in 1980 to more than 20% now. A third are currently overweight or obese.

Further, sexually active obese women, regardless of age, are significantly less likely to use contraception, and obese teens are more likely to engage in risky sexual behaviors than are nonobese teens.

For these reasons, it is important to find the most effective contraceptive method, taking into account other risk factors and the likelihood of compliance, she said, noting that obesity is an independent risk factor for venous thromboembolism (VTE) and that studies suggest the risk is additive in users of estrogen-containing contraceptives.

However, she said, the benefits outweigh the risks of pregnancy in obesity – especially of unintended pregnancy.

The absolute risk of VTE in healthy women of reproductive age is small, and in adolescents it’s even smaller, she explained.

“The presence of risk factors for VTE should be taken into account when we see these youth in our clinics, but we can and should offer estrogen-containing contraceptives as long as there are no other risk factors,” she said.

Contraceptive options in young obese patients include:

• Intrauterine devices. There is no evidence that either copper IUDs or progestin-releasing IUDs have reduced efficacy in obese adolescents.

• Implants. These are highly effective in obese women, and even though the concentrations may be 30%-60% lower in obese women, they do remain above the contraceptive threshold for at least the first 3 years, Dr. Toulany said.

• Depot medroxyprogesterone acetate. There is some concern about weight gain with this injectable progestin-only contraceptive, particularly in those who are already obese, but it remains an option, as the levels do remain above what is needed to prevent ovulation. Interestingly, the persistence of ovulation suppression following discontinuation is different in obese women, and may be prolonged, compared with nonobese women; it is important to counsel patients about this, she said.

“So although randomized, controlled trials report no significant weight gain, we do agree with these observational studies that show that overweight and obese teens gain more weight with Depo-Provera than with oral contraceptives or with no contraceptives,” she said.

• Oral contraceptive pills. Although these may be less effective in obese adolescents, they remain an option and may be the best option in a given patient. Combined oral contraceptives are believed to be generally effective for pregnancy prevention, but “may be less forgiving of imperfect use,” and thus may not be the best choice in those who may have problems with adherence, for example.

The contraceptive patch is probably not a good option, because efficacy may be diminished as a result of absorption through the adipose tissues in those weighing more than 90 kg, Dr .Toulany said. Evidence is insufficient regarding the use of contraceptive rings in obese patients.

Bariatric surgery is increasingly being performed in adolescents, and this raises unique concerns with respect to contraception, Dr. Toulany said.

“We recommend discontinuing estrogen-containing contraceptives 1 month before surgery to reduce the risk of VTE postoperatively,” she said.

After bariatric surgery, those who undergo a restrictive procedure such as gastric banding or a gastric sleeve procedure that reduces the volume of the stomach can use oral contraceptives, but postsurgery vomiting and diarrhea could increase the risk of complications. In those who undergo surgery using a technique that involves a significant malabsorption component, such as Roux-en-Y gastric bypass, nonoral contraceptives are the best option.

 

 

“Most patients going for bariatric surgery have an IUD inserted at the time of surgery, and that’s what we would recommend,” Dr. Toulany said.

She reported having no relevant financial disclosures.

[email protected]

ORLANDO – The data with respect to the effects of obesity on the efficacy of contraceptives in adolescents are limited, but the general consensus is that if efficacy is reduced, it isn’t by enough to make a real difference, according to Dr. Alene Toulany.

The effect of obesity is likely to be very small, and studies that have looked at pharmacokinetics in obesity have estimated that body weight accounts for only about 10%-20% of the variability of hormone levels, Dr. Toulany said at the North American Society for Pediatric and Adolescent Gynecology annual meeting.

“We know that this is within the normal range for individuals who are not obese, she said.

Dr. Alene Toulany

The concerns regarding efficacy in obese patients are understandable, as obesity increases the metabolic rate, increases clearance of hepatically metabolized drugs, increases circulating blood volume, and affects the absorption of contraceptive steroids through the adipose tissue, she said, adding that “it makes sense that the serum drug levels may be insufficient to maintain contraceptive effects, but the data are very limited and inconsistent.”

That’s not to say obesity isn’t a concern, added Dr. Toulany, an adolescent medicine specialist at the Hospital for Sick Children, Toronto, and the University of Toronto.

“Without fail, all of us will be seeing patients with obesity,” she said. The rate of adolescent obesity has quadrupled in the last 3 decades, increasing from 5% among those aged 12-19 years in 1980 to more than 20% now. A third are currently overweight or obese.

Further, sexually active obese women, regardless of age, are significantly less likely to use contraception, and obese teens are more likely to engage in risky sexual behaviors than are nonobese teens.

For these reasons, it is important to find the most effective contraceptive method, taking into account other risk factors and the likelihood of compliance, she said, noting that obesity is an independent risk factor for venous thromboembolism (VTE) and that studies suggest the risk is additive in users of estrogen-containing contraceptives.

However, she said, the benefits outweigh the risks of pregnancy in obesity – especially of unintended pregnancy.

The absolute risk of VTE in healthy women of reproductive age is small, and in adolescents it’s even smaller, she explained.

“The presence of risk factors for VTE should be taken into account when we see these youth in our clinics, but we can and should offer estrogen-containing contraceptives as long as there are no other risk factors,” she said.

Contraceptive options in young obese patients include:

• Intrauterine devices. There is no evidence that either copper IUDs or progestin-releasing IUDs have reduced efficacy in obese adolescents.

• Implants. These are highly effective in obese women, and even though the concentrations may be 30%-60% lower in obese women, they do remain above the contraceptive threshold for at least the first 3 years, Dr. Toulany said.

• Depot medroxyprogesterone acetate. There is some concern about weight gain with this injectable progestin-only contraceptive, particularly in those who are already obese, but it remains an option, as the levels do remain above what is needed to prevent ovulation. Interestingly, the persistence of ovulation suppression following discontinuation is different in obese women, and may be prolonged, compared with nonobese women; it is important to counsel patients about this, she said.

“So although randomized, controlled trials report no significant weight gain, we do agree with these observational studies that show that overweight and obese teens gain more weight with Depo-Provera than with oral contraceptives or with no contraceptives,” she said.

• Oral contraceptive pills. Although these may be less effective in obese adolescents, they remain an option and may be the best option in a given patient. Combined oral contraceptives are believed to be generally effective for pregnancy prevention, but “may be less forgiving of imperfect use,” and thus may not be the best choice in those who may have problems with adherence, for example.

The contraceptive patch is probably not a good option, because efficacy may be diminished as a result of absorption through the adipose tissues in those weighing more than 90 kg, Dr .Toulany said. Evidence is insufficient regarding the use of contraceptive rings in obese patients.

Bariatric surgery is increasingly being performed in adolescents, and this raises unique concerns with respect to contraception, Dr. Toulany said.

“We recommend discontinuing estrogen-containing contraceptives 1 month before surgery to reduce the risk of VTE postoperatively,” she said.

After bariatric surgery, those who undergo a restrictive procedure such as gastric banding or a gastric sleeve procedure that reduces the volume of the stomach can use oral contraceptives, but postsurgery vomiting and diarrhea could increase the risk of complications. In those who undergo surgery using a technique that involves a significant malabsorption component, such as Roux-en-Y gastric bypass, nonoral contraceptives are the best option.

 

 

“Most patients going for bariatric surgery have an IUD inserted at the time of surgery, and that’s what we would recommend,” Dr. Toulany said.

She reported having no relevant financial disclosures.

[email protected]

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Viral illness often precedes genital aphthous ulcers in adolescents

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Viral illness often precedes genital aphthous ulcers in adolescents

ORLANDO – Infectious processes, such as those associated with vulvar abscesses and aphthous ulcers, are among the more common culprits in young patients who present to the emergency department with pelvic pain, according to Dr. Heather Appelbaum.

Vulvar abscesses should be distinguished from Bartholin’s gland abscesses and cysts (which tend to occur more medially) and should be treated to cover for methicillin-resistant Staphylococcus aureus; Bactrim and clindamycin are good choices, Dr. Appelbaum, director of the division of pediatric and adolescent gynecology at Long Island Jewish Medical Center, New Hyde Park, N.Y., said during a workshop on pediatric gynecologic emergencies at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Similarly, aphthous ulcers of the vulva should not be confused with herpes. These ulcers are deep, with irregular borders. They usually occur in non–sexually active individuals and are exquisitely tender, she said.

They look different than herpes and have “a totally different history associated with them,” she said, adding that even in girls who don’t seem to be giving an honest history, keep in mind that aphthous ulcers don’t look anything like herpes.

Aphthous ulcers are usually associated with a viral syndrome. A good history will typically reveal a preceding viral-type illness or sore throat. Parvovirus, Epstein-Barr virus, and cytomegalovirus all can be associated with aphthous ulcers, but in most cases the virus is unknown.

“In any case, recognizing this is very important, and for a primary lesion like this, it is important to look for ulcers in other locations,” she said.

Ulcers in the mouth, for example, also can be associated with a viral syndrome, but could be a sign of Behçet’s disease, Crohn’s disease, or some other autoimmune disorder, especially if the ulcers are recurrent, she noted.

Treatment for aphthous ulcers of the vulva is generally supportive. The lesions can weep and become necrotic. They often are associated with a lot of discharge and are purulent.

“They scare mom, they scare the kid, and they scare the clinician, but they really just need to be treated with supportive therapy, because they generally go away in 7-10 days,” Dr Appelbaum said, adding that because the lesions are exquisitely tender, she recommends that patients sit in a warm bath multiple times daily.

Warm baths are really the most soothing thing for these patients, she added, noting that topical lidocaine can be used, but sometimes it burns and doesn’t help much.

“But Percocet does, Tylenol does, and sitting in that warm bath frequently really does. And a lot of hand holding of parents is obviously essential. But it does go away and it resolves without any structural defect or, typically, any long-term sequelae or recurrence,” she said.

The characteristics of genital ulcers were further explored in an unrelated study presented in a poster at the meeting. Dr. Amy Sass and her colleagues from the University of Colorado and Children’s Hospital Colorado, Aurora, reviewed a series of 110 cases of acute genital ulcers (AGUs) in adolescents presenting between March 2002 and August 2014.

None tested positive for bacterial infection, herpes simplex virus, or cytomegalovirus, and six were positive for Epstein-Barr virus (EBV). An additional 18 had a past EBV infection; 34 tested negative for EBV.

Symptoms included vulvar pain and painful urination in all patients, fever in 89%, pharyngitis in 67%, cough in 63%, and headache in 57%.

Nine patients experienced one recurrence, nine had two recurrences, two had three recurrences, and one had five recurrences; 73% of the 38 recurrences occurred in the setting of viral illness, and 27% occurred in the setting of physical exhaustion or emotional stress. The timing of recurrence ranged from 2 weeks to 7 years after the initial episode.

Case patients had a mean age of 13.6 years, and 48% were postmenarcheal, 29% were premenarcheal, and menarcheal status was unknown in 33%. The vast majority (99%) were not sexually active, 36% had a history of oral aphthous ulcers, and 10 had concurrent oral aphthous ulcers at the time of diagnosis.

The mean number of days before AGU onset following prodromal illness was 3 days, and the mean number of days to AGU resolution was 13 days.

Treatment was most often oral NSAIDS, topical lidocaine jelly or lidocaine-epinephrine-tetracaine gel, and sitz baths.

“Acute genital ulcers in sexually inexperienced adolescent are painful and distressing,”the investigators wrote, noting that the differential diagnosis for AGUs includes sexually transmitted infections, autoimmune disease, genital manifestations of systemic illness, and drug reactions.

“Unfortunately, a causative etiology is often not identified, they added.

 

 

The investigators designed the study to shed some light on AGUs, as the available literature is limited, and many providers may not be familiar with the evaluation and management of patients with AGUs, they said.

The findings demonstrate that AGUs occur most often in postmenarcheal adolescents vs. premenarcheal adolescents. Most cases in this series were preceded by 3 days of febrile viral illness and were associated with elevated inflammatory markers. Only six had an infectious etiology identified, and those patients had acute mononucleosis infection.

Of note, two patients developed complications of labial fusion during healing requiring surgical separation.

A third had a past history of oral aphthous ulcers, and 10 had concurrent oral aphthous ulcers, suggesting a diagnosis of complex aphthosis, they said.

Recurrences most often occurred in the setting of febrile viral illness, physical exhaustion, or emotional stress.

The authors reported having no relevant financial disclosures.

[email protected]

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ORLANDO – Infectious processes, such as those associated with vulvar abscesses and aphthous ulcers, are among the more common culprits in young patients who present to the emergency department with pelvic pain, according to Dr. Heather Appelbaum.

Vulvar abscesses should be distinguished from Bartholin’s gland abscesses and cysts (which tend to occur more medially) and should be treated to cover for methicillin-resistant Staphylococcus aureus; Bactrim and clindamycin are good choices, Dr. Appelbaum, director of the division of pediatric and adolescent gynecology at Long Island Jewish Medical Center, New Hyde Park, N.Y., said during a workshop on pediatric gynecologic emergencies at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Similarly, aphthous ulcers of the vulva should not be confused with herpes. These ulcers are deep, with irregular borders. They usually occur in non–sexually active individuals and are exquisitely tender, she said.

They look different than herpes and have “a totally different history associated with them,” she said, adding that even in girls who don’t seem to be giving an honest history, keep in mind that aphthous ulcers don’t look anything like herpes.

Aphthous ulcers are usually associated with a viral syndrome. A good history will typically reveal a preceding viral-type illness or sore throat. Parvovirus, Epstein-Barr virus, and cytomegalovirus all can be associated with aphthous ulcers, but in most cases the virus is unknown.

“In any case, recognizing this is very important, and for a primary lesion like this, it is important to look for ulcers in other locations,” she said.

Ulcers in the mouth, for example, also can be associated with a viral syndrome, but could be a sign of Behçet’s disease, Crohn’s disease, or some other autoimmune disorder, especially if the ulcers are recurrent, she noted.

Treatment for aphthous ulcers of the vulva is generally supportive. The lesions can weep and become necrotic. They often are associated with a lot of discharge and are purulent.

“They scare mom, they scare the kid, and they scare the clinician, but they really just need to be treated with supportive therapy, because they generally go away in 7-10 days,” Dr Appelbaum said, adding that because the lesions are exquisitely tender, she recommends that patients sit in a warm bath multiple times daily.

Warm baths are really the most soothing thing for these patients, she added, noting that topical lidocaine can be used, but sometimes it burns and doesn’t help much.

“But Percocet does, Tylenol does, and sitting in that warm bath frequently really does. And a lot of hand holding of parents is obviously essential. But it does go away and it resolves without any structural defect or, typically, any long-term sequelae or recurrence,” she said.

The characteristics of genital ulcers were further explored in an unrelated study presented in a poster at the meeting. Dr. Amy Sass and her colleagues from the University of Colorado and Children’s Hospital Colorado, Aurora, reviewed a series of 110 cases of acute genital ulcers (AGUs) in adolescents presenting between March 2002 and August 2014.

None tested positive for bacterial infection, herpes simplex virus, or cytomegalovirus, and six were positive for Epstein-Barr virus (EBV). An additional 18 had a past EBV infection; 34 tested negative for EBV.

Symptoms included vulvar pain and painful urination in all patients, fever in 89%, pharyngitis in 67%, cough in 63%, and headache in 57%.

Nine patients experienced one recurrence, nine had two recurrences, two had three recurrences, and one had five recurrences; 73% of the 38 recurrences occurred in the setting of viral illness, and 27% occurred in the setting of physical exhaustion or emotional stress. The timing of recurrence ranged from 2 weeks to 7 years after the initial episode.

Case patients had a mean age of 13.6 years, and 48% were postmenarcheal, 29% were premenarcheal, and menarcheal status was unknown in 33%. The vast majority (99%) were not sexually active, 36% had a history of oral aphthous ulcers, and 10 had concurrent oral aphthous ulcers at the time of diagnosis.

The mean number of days before AGU onset following prodromal illness was 3 days, and the mean number of days to AGU resolution was 13 days.

Treatment was most often oral NSAIDS, topical lidocaine jelly or lidocaine-epinephrine-tetracaine gel, and sitz baths.

“Acute genital ulcers in sexually inexperienced adolescent are painful and distressing,”the investigators wrote, noting that the differential diagnosis for AGUs includes sexually transmitted infections, autoimmune disease, genital manifestations of systemic illness, and drug reactions.

“Unfortunately, a causative etiology is often not identified, they added.

 

 

The investigators designed the study to shed some light on AGUs, as the available literature is limited, and many providers may not be familiar with the evaluation and management of patients with AGUs, they said.

The findings demonstrate that AGUs occur most often in postmenarcheal adolescents vs. premenarcheal adolescents. Most cases in this series were preceded by 3 days of febrile viral illness and were associated with elevated inflammatory markers. Only six had an infectious etiology identified, and those patients had acute mononucleosis infection.

Of note, two patients developed complications of labial fusion during healing requiring surgical separation.

A third had a past history of oral aphthous ulcers, and 10 had concurrent oral aphthous ulcers, suggesting a diagnosis of complex aphthosis, they said.

Recurrences most often occurred in the setting of febrile viral illness, physical exhaustion, or emotional stress.

The authors reported having no relevant financial disclosures.

[email protected]

ORLANDO – Infectious processes, such as those associated with vulvar abscesses and aphthous ulcers, are among the more common culprits in young patients who present to the emergency department with pelvic pain, according to Dr. Heather Appelbaum.

Vulvar abscesses should be distinguished from Bartholin’s gland abscesses and cysts (which tend to occur more medially) and should be treated to cover for methicillin-resistant Staphylococcus aureus; Bactrim and clindamycin are good choices, Dr. Appelbaum, director of the division of pediatric and adolescent gynecology at Long Island Jewish Medical Center, New Hyde Park, N.Y., said during a workshop on pediatric gynecologic emergencies at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Similarly, aphthous ulcers of the vulva should not be confused with herpes. These ulcers are deep, with irregular borders. They usually occur in non–sexually active individuals and are exquisitely tender, she said.

They look different than herpes and have “a totally different history associated with them,” she said, adding that even in girls who don’t seem to be giving an honest history, keep in mind that aphthous ulcers don’t look anything like herpes.

Aphthous ulcers are usually associated with a viral syndrome. A good history will typically reveal a preceding viral-type illness or sore throat. Parvovirus, Epstein-Barr virus, and cytomegalovirus all can be associated with aphthous ulcers, but in most cases the virus is unknown.

“In any case, recognizing this is very important, and for a primary lesion like this, it is important to look for ulcers in other locations,” she said.

Ulcers in the mouth, for example, also can be associated with a viral syndrome, but could be a sign of Behçet’s disease, Crohn’s disease, or some other autoimmune disorder, especially if the ulcers are recurrent, she noted.

Treatment for aphthous ulcers of the vulva is generally supportive. The lesions can weep and become necrotic. They often are associated with a lot of discharge and are purulent.

“They scare mom, they scare the kid, and they scare the clinician, but they really just need to be treated with supportive therapy, because they generally go away in 7-10 days,” Dr Appelbaum said, adding that because the lesions are exquisitely tender, she recommends that patients sit in a warm bath multiple times daily.

Warm baths are really the most soothing thing for these patients, she added, noting that topical lidocaine can be used, but sometimes it burns and doesn’t help much.

“But Percocet does, Tylenol does, and sitting in that warm bath frequently really does. And a lot of hand holding of parents is obviously essential. But it does go away and it resolves without any structural defect or, typically, any long-term sequelae or recurrence,” she said.

The characteristics of genital ulcers were further explored in an unrelated study presented in a poster at the meeting. Dr. Amy Sass and her colleagues from the University of Colorado and Children’s Hospital Colorado, Aurora, reviewed a series of 110 cases of acute genital ulcers (AGUs) in adolescents presenting between March 2002 and August 2014.

None tested positive for bacterial infection, herpes simplex virus, or cytomegalovirus, and six were positive for Epstein-Barr virus (EBV). An additional 18 had a past EBV infection; 34 tested negative for EBV.

Symptoms included vulvar pain and painful urination in all patients, fever in 89%, pharyngitis in 67%, cough in 63%, and headache in 57%.

Nine patients experienced one recurrence, nine had two recurrences, two had three recurrences, and one had five recurrences; 73% of the 38 recurrences occurred in the setting of viral illness, and 27% occurred in the setting of physical exhaustion or emotional stress. The timing of recurrence ranged from 2 weeks to 7 years after the initial episode.

Case patients had a mean age of 13.6 years, and 48% were postmenarcheal, 29% were premenarcheal, and menarcheal status was unknown in 33%. The vast majority (99%) were not sexually active, 36% had a history of oral aphthous ulcers, and 10 had concurrent oral aphthous ulcers at the time of diagnosis.

The mean number of days before AGU onset following prodromal illness was 3 days, and the mean number of days to AGU resolution was 13 days.

Treatment was most often oral NSAIDS, topical lidocaine jelly or lidocaine-epinephrine-tetracaine gel, and sitz baths.

“Acute genital ulcers in sexually inexperienced adolescent are painful and distressing,”the investigators wrote, noting that the differential diagnosis for AGUs includes sexually transmitted infections, autoimmune disease, genital manifestations of systemic illness, and drug reactions.

“Unfortunately, a causative etiology is often not identified, they added.

 

 

The investigators designed the study to shed some light on AGUs, as the available literature is limited, and many providers may not be familiar with the evaluation and management of patients with AGUs, they said.

The findings demonstrate that AGUs occur most often in postmenarcheal adolescents vs. premenarcheal adolescents. Most cases in this series were preceded by 3 days of febrile viral illness and were associated with elevated inflammatory markers. Only six had an infectious etiology identified, and those patients had acute mononucleosis infection.

Of note, two patients developed complications of labial fusion during healing requiring surgical separation.

A third had a past history of oral aphthous ulcers, and 10 had concurrent oral aphthous ulcers, suggesting a diagnosis of complex aphthosis, they said.

Recurrences most often occurred in the setting of febrile viral illness, physical exhaustion, or emotional stress.

The authors reported having no relevant financial disclosures.

[email protected]

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NASPAG: Migraines don’t always preclude combined OCs

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ORLANDO– Most adolescent girls who report having headaches – including some of those who report migraines with aura – can safely use combined oral contraceptive pills, according to Dr. Sari Kives.

The available literature suggests that there is some resistance to prescribing such contraception for adolescents with headaches, but most adolescents don’t have the types of headaches that are of concern, Dr. Kives of the University of Toronto said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

 

Fuse/ThinkStockPhotos.com

owever, it is important to get a good characterization of the headaches, keeping in mind that teens may have difficulty relating their symptoms, she said.

“It’s important to understand what the headache actually is. Is it a tension headache, which is by far the most common headache you will see in adolescents?” she said, noting that menstrual migraines and classical migraines are less common in adolescents.

Menstrual migraines account for about 7%-8% of migraines, occur 2-3 days before menses, can last throughout the period, don’t occur any other time of the month, and can be quite debilitating. They usually are secondary to estrogen withdrawal, Dr. Kives said, adding that a decade ago, add-back estrogen was commonly given during the week off of oral contraceptives in those with menstrual headaches.

 

Dr. Sari Kives

Now it is common practice to use continuous pills or extended-cycle pills, she said, explaining that eliminating the estrogen fluctuation improves the headaches.

Classical migraines also occur commonly in adolescent girls. Some may include focal neurological symptoms that may be triggered by hormonal changes, stress, certain foods and beverages, certain scents or fumes, fatigue, hunger, or trauma.

It is important to ask about such symptoms, Dr. Kives said.

“And that’s probably the most important question you can ask. For me, a focal neurological symptom is, ‘I go blind in my left eye. I lose sensation in my right arm,’ ” she said, providing examples.

Some symptoms are characteristic of “atypical aura,” and some are associated with “typical aura” – an important distinction when determining whether combined OCs are safe for a given patient.

Atypical aura usually has sudden unilateral onset and lasts more than 30-60 minutes. Headache may or may not be present, and visual symptoms may include loss of vision, amaurosis fugax (painless transient monocular visual loss), and visual field anomaly. Sensory and motor symptoms can include lower limb anesthesia or hypoesthesia (decrease in sensation).

Typical aura has more progressive onset, lasts less than an hour, and precedes migraine. Patients may experience bilateral scintillating scotoma, fortification spectra, and blurred vision. These are usually limited to visual symptoms, Dr. Kives said, but sensory and motor symptoms can occur. They tend to occur in relation to the visual symptoms, and may affect the upper limbs, mouth, and tongue – causing tingling or pinching sensations.

Individuals who have migraine with aura account for only about 20% of those with migraine headaches, and the vast majority are going to have visual aura.

“They can have sensory and motor symptoms, but the visual ones are the ones where you have to be very specific,” she said, noting that in her experience, 99% of cases are visual.

“If it’s a short visual aura, less than an hour, and it’s not repetitive, I will consider an oral contraceptive pill in this group of patients, but you have to balance it against what their history sounds like,” she said.

Typically, combined OCs are contraindicated in patients with migraine with aura because of an increased risk of cerebrovascular accident, but in Canada, guidelines provide allowances for this “unique group of individuals with migraines with aura that are limited to visual symptoms and that last less than 1 hour,” she said.

Remember that photophobia, phonophobia, nausea and vomiting, visual blurring, and generalized visual spots/flashing lights do not constitute aura, she said.

This is important, because using too stringent a definition of “migraine with aura” will leave a substantial number of individuals with limited contraceptive options, particularly options that are effective and promote cycle control and compliance, she said.

Although there is a definite risk associated with combined OCs in those with migraine with aura – with an added risk in those who smoke, the risks are low in adolescents, compared with older patients.

“The adult women who walks in with hypertension, or who is a smoker who gets oral contraception – that is a very different patient than the 14-year-old who says, ‘I may get flashing lights before my headache, but not on a regular basis.’ Those are completely different entity patients, in my opinion,” Dr. Kives said.

 

 

If she does prescribe combined OCs for an adolescent with migraines, she advises the patient to stop the pills if the headaches get worse, she said. In many cases, however, headaches improve, because they were menstrual migraines and not classical migraines, she said, adding that “improvement in headaches is a reassuring sign.” The bottom line, Dr. Kives said, is that migraine without aura doesn’t preclude prescribing of any contraceptive options in adolescents, and that migraine with aura is a relative contraindication; low-dose combined oral contraceptive pills are safe for those with migraine with aura that primarily includes visual symptoms lasting less than an hour.

However, the risk of cerebrovascular accidents is increased in those with migraines, so other risk factors, such as family history, obesity, hypertension, and smoking, should be considered.

“If they have no other risk factors, their risk probably is quite low,” Dr. Kives said.

She reported having no relevant financial disclosures.

[email protected]

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ORLANDO– Most adolescent girls who report having headaches – including some of those who report migraines with aura – can safely use combined oral contraceptive pills, according to Dr. Sari Kives.

The available literature suggests that there is some resistance to prescribing such contraception for adolescents with headaches, but most adolescents don’t have the types of headaches that are of concern, Dr. Kives of the University of Toronto said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

 

Fuse/ThinkStockPhotos.com

owever, it is important to get a good characterization of the headaches, keeping in mind that teens may have difficulty relating their symptoms, she said.

“It’s important to understand what the headache actually is. Is it a tension headache, which is by far the most common headache you will see in adolescents?” she said, noting that menstrual migraines and classical migraines are less common in adolescents.

Menstrual migraines account for about 7%-8% of migraines, occur 2-3 days before menses, can last throughout the period, don’t occur any other time of the month, and can be quite debilitating. They usually are secondary to estrogen withdrawal, Dr. Kives said, adding that a decade ago, add-back estrogen was commonly given during the week off of oral contraceptives in those with menstrual headaches.

 

Dr. Sari Kives

Now it is common practice to use continuous pills or extended-cycle pills, she said, explaining that eliminating the estrogen fluctuation improves the headaches.

Classical migraines also occur commonly in adolescent girls. Some may include focal neurological symptoms that may be triggered by hormonal changes, stress, certain foods and beverages, certain scents or fumes, fatigue, hunger, or trauma.

It is important to ask about such symptoms, Dr. Kives said.

“And that’s probably the most important question you can ask. For me, a focal neurological symptom is, ‘I go blind in my left eye. I lose sensation in my right arm,’ ” she said, providing examples.

Some symptoms are characteristic of “atypical aura,” and some are associated with “typical aura” – an important distinction when determining whether combined OCs are safe for a given patient.

Atypical aura usually has sudden unilateral onset and lasts more than 30-60 minutes. Headache may or may not be present, and visual symptoms may include loss of vision, amaurosis fugax (painless transient monocular visual loss), and visual field anomaly. Sensory and motor symptoms can include lower limb anesthesia or hypoesthesia (decrease in sensation).

Typical aura has more progressive onset, lasts less than an hour, and precedes migraine. Patients may experience bilateral scintillating scotoma, fortification spectra, and blurred vision. These are usually limited to visual symptoms, Dr. Kives said, but sensory and motor symptoms can occur. They tend to occur in relation to the visual symptoms, and may affect the upper limbs, mouth, and tongue – causing tingling or pinching sensations.

Individuals who have migraine with aura account for only about 20% of those with migraine headaches, and the vast majority are going to have visual aura.

“They can have sensory and motor symptoms, but the visual ones are the ones where you have to be very specific,” she said, noting that in her experience, 99% of cases are visual.

“If it’s a short visual aura, less than an hour, and it’s not repetitive, I will consider an oral contraceptive pill in this group of patients, but you have to balance it against what their history sounds like,” she said.

Typically, combined OCs are contraindicated in patients with migraine with aura because of an increased risk of cerebrovascular accident, but in Canada, guidelines provide allowances for this “unique group of individuals with migraines with aura that are limited to visual symptoms and that last less than 1 hour,” she said.

Remember that photophobia, phonophobia, nausea and vomiting, visual blurring, and generalized visual spots/flashing lights do not constitute aura, she said.

This is important, because using too stringent a definition of “migraine with aura” will leave a substantial number of individuals with limited contraceptive options, particularly options that are effective and promote cycle control and compliance, she said.

Although there is a definite risk associated with combined OCs in those with migraine with aura – with an added risk in those who smoke, the risks are low in adolescents, compared with older patients.

“The adult women who walks in with hypertension, or who is a smoker who gets oral contraception – that is a very different patient than the 14-year-old who says, ‘I may get flashing lights before my headache, but not on a regular basis.’ Those are completely different entity patients, in my opinion,” Dr. Kives said.

 

 

If she does prescribe combined OCs for an adolescent with migraines, she advises the patient to stop the pills if the headaches get worse, she said. In many cases, however, headaches improve, because they were menstrual migraines and not classical migraines, she said, adding that “improvement in headaches is a reassuring sign.” The bottom line, Dr. Kives said, is that migraine without aura doesn’t preclude prescribing of any contraceptive options in adolescents, and that migraine with aura is a relative contraindication; low-dose combined oral contraceptive pills are safe for those with migraine with aura that primarily includes visual symptoms lasting less than an hour.

However, the risk of cerebrovascular accidents is increased in those with migraines, so other risk factors, such as family history, obesity, hypertension, and smoking, should be considered.

“If they have no other risk factors, their risk probably is quite low,” Dr. Kives said.

She reported having no relevant financial disclosures.

[email protected]

ORLANDO– Most adolescent girls who report having headaches – including some of those who report migraines with aura – can safely use combined oral contraceptive pills, according to Dr. Sari Kives.

The available literature suggests that there is some resistance to prescribing such contraception for adolescents with headaches, but most adolescents don’t have the types of headaches that are of concern, Dr. Kives of the University of Toronto said at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

 

Fuse/ThinkStockPhotos.com

owever, it is important to get a good characterization of the headaches, keeping in mind that teens may have difficulty relating their symptoms, she said.

“It’s important to understand what the headache actually is. Is it a tension headache, which is by far the most common headache you will see in adolescents?” she said, noting that menstrual migraines and classical migraines are less common in adolescents.

Menstrual migraines account for about 7%-8% of migraines, occur 2-3 days before menses, can last throughout the period, don’t occur any other time of the month, and can be quite debilitating. They usually are secondary to estrogen withdrawal, Dr. Kives said, adding that a decade ago, add-back estrogen was commonly given during the week off of oral contraceptives in those with menstrual headaches.

 

Dr. Sari Kives

Now it is common practice to use continuous pills or extended-cycle pills, she said, explaining that eliminating the estrogen fluctuation improves the headaches.

Classical migraines also occur commonly in adolescent girls. Some may include focal neurological symptoms that may be triggered by hormonal changes, stress, certain foods and beverages, certain scents or fumes, fatigue, hunger, or trauma.

It is important to ask about such symptoms, Dr. Kives said.

“And that’s probably the most important question you can ask. For me, a focal neurological symptom is, ‘I go blind in my left eye. I lose sensation in my right arm,’ ” she said, providing examples.

Some symptoms are characteristic of “atypical aura,” and some are associated with “typical aura” – an important distinction when determining whether combined OCs are safe for a given patient.

Atypical aura usually has sudden unilateral onset and lasts more than 30-60 minutes. Headache may or may not be present, and visual symptoms may include loss of vision, amaurosis fugax (painless transient monocular visual loss), and visual field anomaly. Sensory and motor symptoms can include lower limb anesthesia or hypoesthesia (decrease in sensation).

Typical aura has more progressive onset, lasts less than an hour, and precedes migraine. Patients may experience bilateral scintillating scotoma, fortification spectra, and blurred vision. These are usually limited to visual symptoms, Dr. Kives said, but sensory and motor symptoms can occur. They tend to occur in relation to the visual symptoms, and may affect the upper limbs, mouth, and tongue – causing tingling or pinching sensations.

Individuals who have migraine with aura account for only about 20% of those with migraine headaches, and the vast majority are going to have visual aura.

“They can have sensory and motor symptoms, but the visual ones are the ones where you have to be very specific,” she said, noting that in her experience, 99% of cases are visual.

“If it’s a short visual aura, less than an hour, and it’s not repetitive, I will consider an oral contraceptive pill in this group of patients, but you have to balance it against what their history sounds like,” she said.

Typically, combined OCs are contraindicated in patients with migraine with aura because of an increased risk of cerebrovascular accident, but in Canada, guidelines provide allowances for this “unique group of individuals with migraines with aura that are limited to visual symptoms and that last less than 1 hour,” she said.

Remember that photophobia, phonophobia, nausea and vomiting, visual blurring, and generalized visual spots/flashing lights do not constitute aura, she said.

This is important, because using too stringent a definition of “migraine with aura” will leave a substantial number of individuals with limited contraceptive options, particularly options that are effective and promote cycle control and compliance, she said.

Although there is a definite risk associated with combined OCs in those with migraine with aura – with an added risk in those who smoke, the risks are low in adolescents, compared with older patients.

“The adult women who walks in with hypertension, or who is a smoker who gets oral contraception – that is a very different patient than the 14-year-old who says, ‘I may get flashing lights before my headache, but not on a regular basis.’ Those are completely different entity patients, in my opinion,” Dr. Kives said.

 

 

If she does prescribe combined OCs for an adolescent with migraines, she advises the patient to stop the pills if the headaches get worse, she said. In many cases, however, headaches improve, because they were menstrual migraines and not classical migraines, she said, adding that “improvement in headaches is a reassuring sign.” The bottom line, Dr. Kives said, is that migraine without aura doesn’t preclude prescribing of any contraceptive options in adolescents, and that migraine with aura is a relative contraindication; low-dose combined oral contraceptive pills are safe for those with migraine with aura that primarily includes visual symptoms lasting less than an hour.

However, the risk of cerebrovascular accidents is increased in those with migraines, so other risk factors, such as family history, obesity, hypertension, and smoking, should be considered.

“If they have no other risk factors, their risk probably is quite low,” Dr. Kives said.

She reported having no relevant financial disclosures.

[email protected]

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NASPAG: Parity, postpartum status predict adolescent LARC use

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ORLANDO – The decision to use long-acting reversible contraception appears largely reactionary among adolescent girls, as the only factors significantly associated with the decision in a recent cross-sectional study were increased parity and postpartum status.

The findings could help with future efforts to identify and remove barriers to long-acting reversible contraceptive (LARC) use among adolescents, according to Dr. Lisa Moon, a third-year resident at the University of Oklahoma, Oklahoma City.

©istock/Thinkstock.com

Of 209 adolescents included in the study, 66 used oral contraceptive (OC) pills, and 143 used LARC methods. Levonorgestrel intrauterine devices were used most often (77 subjects), followed by etonogestrel implants (61 subjects). Five of the adolescents used a copper intrauterine device (IUD), Dr. Moon reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

A breakdown of the findings by age showed that with the exception of those aged 15 years, LARC use increased with increasing age; 1 subject was aged 14 years, and she used OCs; 5 were aged 15 years, and all used a LARC; 15 were aged 16 years, and 9 (60%) used a LARC; 44 were aged 17 years, and 28 (64%) used a LARC; 62 were aged 18 years and 44 (71%) used a LARC; and 82 were aged 19 years, and 57 (70%) used a LARC.

Multivariate analysis showed that having previously given birth and postpartum status were significant predictors of LARC vs. OC use (odds ratios, 3.5 and 3.9, respectively). Age, race, marital status, and documented citizenship were not associated with choice of contraception.

The vast majority of adolescent pregnancies – about 82% – are unplanned, and 50% of teens with unplanned pregnancies report having used some form of contraception at the time of pregnancy. LARC methods have the potential to improve teen pregnancy rates because non-LARC methods have been reported to have a more than 20-fold greater risk of failure; that risk was almost doubled in adolescents, but while 8.5% of U.S. women use such methods, 4.5% of those aged 15-19 years do so, Dr. Moon said (N. Engl. J. Med. 2012;366:1998-2007).

Lack of familiarity with LARCs, misperceptions, cost, lack of access, health care provider concerns, and confidentiality concerns are possible barriers to increased LARC use, she noted.

Confusion about recommendations for LARC use also may play a role, she said, noting that as recently as 2004, a World Health Organization report stated that “While there are no restrictions based on age or parity for IUDs, many adolescents still will not qualify as candidates, because of the risk of exposure to STIs [sexually transmitted infections]. Ideal candidates for IUDs are in long-term mutually monogamous relationships, are parous, and do not have unexplained vaginal bleeding,”

That view has changed. In 2012, both the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists released recommendations promoting LARC use among adolescents, and a 2013 WHO report stated that “LARC methods are appropriate for most women, including adolescent and nulliparous women.”

The ACOG recommendation specifically notes that LARC methods should be first line for all women (Obstet. Gynecol. 2012;120:983-8).

“It takes a little bit of time for that information to percolate out to our community clinics, which is where we get a little bit behind sometimes in our recommendations,” Dr. Moon noted.

That is concerning, given that a 2010 survey of physicians showed that 30.7% agreed that IUDs were appropriate for teenagers, 49.6% said they would offer an IUD to an unmarried teenager with one child, and 19% said they would offer an IUD to a nulliparous unmarried teenager (Contraception 2010;81:112-6).

“There’s kind of this disconnect between what we know is effective and reliable for preventing pregnancy in our teen population, and what we recommend to them,” Dr. Moon said.

The findings have prompted a deeper look into barriers to adolescent LARC use in Oklahoma, which ranks 48th in the nation for teen pregnancy rates among 15- to 17-year olds (22.8 births per 1,000 vs. 14.1 nationally), 50th for unplanned pregnancies among 18- and 19-year olds (83.1 per 1,000 vs. 51.4 nationally), and 49th overall (MMWR 2013;62:249-55).

“What’s most staggering to me is that 20% of those are to teens who are already parents, which highlights this unmet need that we have in our state,” she said.

The current findings demonstrate that parity and postpartum status predict LARC choice, but they don’t explain why that is, Dr. Moon said.

To characterize barriers to LARC use, as well as biases on the part of both patients and physicians, researchers are currently meeting with focus groups of primary care practitioners to identify provider biases, and focus groups of adolescent are planned, she said.

 

 

“Our hope is that with education and identifying some of those barriers, we can catch these people – before they get pregnant – and get them the contraception that they need,” she said.

Dr. Moon reported having no relevant financial disclosures.

[email protected]

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ORLANDO – The decision to use long-acting reversible contraception appears largely reactionary among adolescent girls, as the only factors significantly associated with the decision in a recent cross-sectional study were increased parity and postpartum status.

The findings could help with future efforts to identify and remove barriers to long-acting reversible contraceptive (LARC) use among adolescents, according to Dr. Lisa Moon, a third-year resident at the University of Oklahoma, Oklahoma City.

©istock/Thinkstock.com

Of 209 adolescents included in the study, 66 used oral contraceptive (OC) pills, and 143 used LARC methods. Levonorgestrel intrauterine devices were used most often (77 subjects), followed by etonogestrel implants (61 subjects). Five of the adolescents used a copper intrauterine device (IUD), Dr. Moon reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

A breakdown of the findings by age showed that with the exception of those aged 15 years, LARC use increased with increasing age; 1 subject was aged 14 years, and she used OCs; 5 were aged 15 years, and all used a LARC; 15 were aged 16 years, and 9 (60%) used a LARC; 44 were aged 17 years, and 28 (64%) used a LARC; 62 were aged 18 years and 44 (71%) used a LARC; and 82 were aged 19 years, and 57 (70%) used a LARC.

Multivariate analysis showed that having previously given birth and postpartum status were significant predictors of LARC vs. OC use (odds ratios, 3.5 and 3.9, respectively). Age, race, marital status, and documented citizenship were not associated with choice of contraception.

The vast majority of adolescent pregnancies – about 82% – are unplanned, and 50% of teens with unplanned pregnancies report having used some form of contraception at the time of pregnancy. LARC methods have the potential to improve teen pregnancy rates because non-LARC methods have been reported to have a more than 20-fold greater risk of failure; that risk was almost doubled in adolescents, but while 8.5% of U.S. women use such methods, 4.5% of those aged 15-19 years do so, Dr. Moon said (N. Engl. J. Med. 2012;366:1998-2007).

Lack of familiarity with LARCs, misperceptions, cost, lack of access, health care provider concerns, and confidentiality concerns are possible barriers to increased LARC use, she noted.

Confusion about recommendations for LARC use also may play a role, she said, noting that as recently as 2004, a World Health Organization report stated that “While there are no restrictions based on age or parity for IUDs, many adolescents still will not qualify as candidates, because of the risk of exposure to STIs [sexually transmitted infections]. Ideal candidates for IUDs are in long-term mutually monogamous relationships, are parous, and do not have unexplained vaginal bleeding,”

That view has changed. In 2012, both the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists released recommendations promoting LARC use among adolescents, and a 2013 WHO report stated that “LARC methods are appropriate for most women, including adolescent and nulliparous women.”

The ACOG recommendation specifically notes that LARC methods should be first line for all women (Obstet. Gynecol. 2012;120:983-8).

“It takes a little bit of time for that information to percolate out to our community clinics, which is where we get a little bit behind sometimes in our recommendations,” Dr. Moon noted.

That is concerning, given that a 2010 survey of physicians showed that 30.7% agreed that IUDs were appropriate for teenagers, 49.6% said they would offer an IUD to an unmarried teenager with one child, and 19% said they would offer an IUD to a nulliparous unmarried teenager (Contraception 2010;81:112-6).

“There’s kind of this disconnect between what we know is effective and reliable for preventing pregnancy in our teen population, and what we recommend to them,” Dr. Moon said.

The findings have prompted a deeper look into barriers to adolescent LARC use in Oklahoma, which ranks 48th in the nation for teen pregnancy rates among 15- to 17-year olds (22.8 births per 1,000 vs. 14.1 nationally), 50th for unplanned pregnancies among 18- and 19-year olds (83.1 per 1,000 vs. 51.4 nationally), and 49th overall (MMWR 2013;62:249-55).

“What’s most staggering to me is that 20% of those are to teens who are already parents, which highlights this unmet need that we have in our state,” she said.

The current findings demonstrate that parity and postpartum status predict LARC choice, but they don’t explain why that is, Dr. Moon said.

To characterize barriers to LARC use, as well as biases on the part of both patients and physicians, researchers are currently meeting with focus groups of primary care practitioners to identify provider biases, and focus groups of adolescent are planned, she said.

 

 

“Our hope is that with education and identifying some of those barriers, we can catch these people – before they get pregnant – and get them the contraception that they need,” she said.

Dr. Moon reported having no relevant financial disclosures.

[email protected]

ORLANDO – The decision to use long-acting reversible contraception appears largely reactionary among adolescent girls, as the only factors significantly associated with the decision in a recent cross-sectional study were increased parity and postpartum status.

The findings could help with future efforts to identify and remove barriers to long-acting reversible contraceptive (LARC) use among adolescents, according to Dr. Lisa Moon, a third-year resident at the University of Oklahoma, Oklahoma City.

©istock/Thinkstock.com

Of 209 adolescents included in the study, 66 used oral contraceptive (OC) pills, and 143 used LARC methods. Levonorgestrel intrauterine devices were used most often (77 subjects), followed by etonogestrel implants (61 subjects). Five of the adolescents used a copper intrauterine device (IUD), Dr. Moon reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

A breakdown of the findings by age showed that with the exception of those aged 15 years, LARC use increased with increasing age; 1 subject was aged 14 years, and she used OCs; 5 were aged 15 years, and all used a LARC; 15 were aged 16 years, and 9 (60%) used a LARC; 44 were aged 17 years, and 28 (64%) used a LARC; 62 were aged 18 years and 44 (71%) used a LARC; and 82 were aged 19 years, and 57 (70%) used a LARC.

Multivariate analysis showed that having previously given birth and postpartum status were significant predictors of LARC vs. OC use (odds ratios, 3.5 and 3.9, respectively). Age, race, marital status, and documented citizenship were not associated with choice of contraception.

The vast majority of adolescent pregnancies – about 82% – are unplanned, and 50% of teens with unplanned pregnancies report having used some form of contraception at the time of pregnancy. LARC methods have the potential to improve teen pregnancy rates because non-LARC methods have been reported to have a more than 20-fold greater risk of failure; that risk was almost doubled in adolescents, but while 8.5% of U.S. women use such methods, 4.5% of those aged 15-19 years do so, Dr. Moon said (N. Engl. J. Med. 2012;366:1998-2007).

Lack of familiarity with LARCs, misperceptions, cost, lack of access, health care provider concerns, and confidentiality concerns are possible barriers to increased LARC use, she noted.

Confusion about recommendations for LARC use also may play a role, she said, noting that as recently as 2004, a World Health Organization report stated that “While there are no restrictions based on age or parity for IUDs, many adolescents still will not qualify as candidates, because of the risk of exposure to STIs [sexually transmitted infections]. Ideal candidates for IUDs are in long-term mutually monogamous relationships, are parous, and do not have unexplained vaginal bleeding,”

That view has changed. In 2012, both the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists released recommendations promoting LARC use among adolescents, and a 2013 WHO report stated that “LARC methods are appropriate for most women, including adolescent and nulliparous women.”

The ACOG recommendation specifically notes that LARC methods should be first line for all women (Obstet. Gynecol. 2012;120:983-8).

“It takes a little bit of time for that information to percolate out to our community clinics, which is where we get a little bit behind sometimes in our recommendations,” Dr. Moon noted.

That is concerning, given that a 2010 survey of physicians showed that 30.7% agreed that IUDs were appropriate for teenagers, 49.6% said they would offer an IUD to an unmarried teenager with one child, and 19% said they would offer an IUD to a nulliparous unmarried teenager (Contraception 2010;81:112-6).

“There’s kind of this disconnect between what we know is effective and reliable for preventing pregnancy in our teen population, and what we recommend to them,” Dr. Moon said.

The findings have prompted a deeper look into barriers to adolescent LARC use in Oklahoma, which ranks 48th in the nation for teen pregnancy rates among 15- to 17-year olds (22.8 births per 1,000 vs. 14.1 nationally), 50th for unplanned pregnancies among 18- and 19-year olds (83.1 per 1,000 vs. 51.4 nationally), and 49th overall (MMWR 2013;62:249-55).

“What’s most staggering to me is that 20% of those are to teens who are already parents, which highlights this unmet need that we have in our state,” she said.

The current findings demonstrate that parity and postpartum status predict LARC choice, but they don’t explain why that is, Dr. Moon said.

To characterize barriers to LARC use, as well as biases on the part of both patients and physicians, researchers are currently meeting with focus groups of primary care practitioners to identify provider biases, and focus groups of adolescent are planned, she said.

 

 

“Our hope is that with education and identifying some of those barriers, we can catch these people – before they get pregnant – and get them the contraception that they need,” she said.

Dr. Moon reported having no relevant financial disclosures.

[email protected]

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Key clinical point: LARC methods are underutilized in adolescents.

Major finding: Significant predictors of LARC vs. OC use were previous childbirth and postpartum status (odds ratios, 3.5 and 3.9, respectively).

Data source: A cross-sectional study of 209 adolescents.

Disclosures: Dr. Moon reported having no relevant financial disclosures.

NASPAG: Teens largely support OTC oral contraceptive access

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ORLANDO – Most adolescents expressed interest in and support for access to over-the-counter oral contraceptives, a survey found.

Data from a separate cross-sectional study showed that adolescents are skilled at self-screening for contraindications to combined OCs, demonstrating preliminary support for the safety of over-the-counter access.

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Of 348 girls aged 14-17 years who completed the survey in the first study, 73% reported supporting over-the-counter (OTC) OC access for teens, and 61% reported being likely to use OCs if they were available OTC. Significant associations were found between support for OTC access and having used birth control and having had sex. An association was also found between the likelihood of OTC use and having used birth control, having had sex, and being white, Ruth Manski of the Jane Fonda Center for Adolescent Reproductive Health, Atlanta, reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Those who had never been tested for sexually transmitted infections were more likely to support OTC access (91% vs. 76%).

Support for, and the likelihood of, using OTC OCs were not influenced by age, geographic region, rural/urban location, health insurance status, or pregnancy history. Race played a factor in that white participants were more likely than nonwhite participants to be interested in OTC access. The study also showed that participants understood an average of 7.1 of 8 key product-labeling concepts, and that most would be willing to pay up to $20 per month for OTC OCs, with the largest percentage (42%) willing to pay between $11 and $20. About a third said they would pay $21 or more.

Survey respondents were girls recruited via Facebook advertisements in 2014. Nearly a third (32%) were aged 17 years, 31% were aged 16 years, 24% were aged 15, and 13% were aged 14. Most (79%) were white, Ms. Manski said, adding that the respondents represented 44 states, 53% lived in a suburban area, 41% had private health insurance, and 33% had public health insurance.

About 90% reported having used contraception, and 44% reported having had sex. Of those who had sex, 60% reported having had unprotected sex, 58% used OCs, and 12% reported having been pregnant.

“So results from this study show that participants are supportive of over-the-counter access and that they’re interested in obtaining oral contraceptives over the counter. The findings also suggest that teenagers understand how to use oral contraceptives based on independent label review, which offers some evidence in response to concerns raised in other studies about teenagers’ ability to understand how to use over-the-counter products,” Ms. Manski said.

The findings suggest that while cost is a concern for teens and could impact their contraceptive choices, making OCs available OTC without age restrictions may help increase adolescents’ contraceptive access and use, she said, noting that this is important given the unique barriers that adolescents face with respect to accessing contraception.

The high levels of interest, and the perception of benefit, highlight the potential of this strategy to increase contraceptive access and reduce unintended pregnancy, she added.

Although some respondents expressed concerns about safety and the potential impact on sexual behavior, the evidence with respect to currently available OTC emergency contraception demonstrates that easier access does not increase sexual risk taking, and that teens can safely use OTC emergency contraception, she said.

However, the behavioral effects of OTC OC availability are not known and should be evaluated in actual use studies, Ms. Manski added.

Concerns about the safety of OTC OC access were specifically addressed in the second study, which sought to determine whether adolescents are capable of self-screening for contraindications to OC use.

Prior studies have shown that adults are able to self-screen adequately, but little is known about adolescents’ ability to do so, Dr. Rebekah L. Williams of Riley Hospital for Children, Indianapolis, said at the meeting.

Findings in the first 61 teens aged 14-21 years enrolled in the study showed that the teens were actually more likely than their providers to report potential contraindications.

The teens completed screening questionnaires prior to their office visit, and the provider completed the medical history questionnaire after the visit.

Perfectly concordant responses between providers and patients were seen for six potential contraindications: diabetes (which was present in two cases) and heavy smoking, breastfeeding, wheelchair use, surgery within 4 weeks, and current HIV medication use (which were not present in any cases). Discordant responses were seen for the remaining potential contraindications, including breast cancer, liver disease, medication interactions, smoking, migraine, hypertension, gallbladder disease, thromboembolism/heart disease, having a first-degree relative with thromboembolism, weight over 200 pounds, and having been told/having the perception that OCs should not be used.

 

 

Potential contraindications reported only by the participant were breast cancer, liver disease, medication interaction, any smoking, hypertension, personal history of thromboembolism or heart disease, and having a first-degree relative with thromboembolism.

Participants were adolescents with a mean age of 17 years from a primary care medicine clinic in a Midwest urban setting. Of the 61 subjects, 62% were black, 62% reported having ever used contraceptives, 44% were currently using contraceptives, and 62% said they would be interested in OTC OC access. Among the 38 who reported having penile/vaginal sex, 87% had ever used OCs, and 60% were currently using them.

“In summary, adolescent women are interested in over-the-counter access to combined oral contraceptive pills, they’re skilled at self-screening, and they’re mostly more likely than providers to report potential contraindications. So these data really provide some preliminary support for the over-the-counter provision of oral contraceptive pills to adolescents,” Dr. Williams said, noting that additional research is needed to assess adolescents’ ability to use combined oral contraceptive pills correctly.

In addition, larger studies in groups with a higher prevalence of contraindications are needed, as are studies with recruitment from nonclinical settings and more diverse populations, she said.

Ms. Manski and Dr. Williams both reported having no relevant financial disclosures.

[email protected]

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ORLANDO – Most adolescents expressed interest in and support for access to over-the-counter oral contraceptives, a survey found.

Data from a separate cross-sectional study showed that adolescents are skilled at self-screening for contraindications to combined OCs, demonstrating preliminary support for the safety of over-the-counter access.

Fuse/ThinkStockPhotos.com

Of 348 girls aged 14-17 years who completed the survey in the first study, 73% reported supporting over-the-counter (OTC) OC access for teens, and 61% reported being likely to use OCs if they were available OTC. Significant associations were found between support for OTC access and having used birth control and having had sex. An association was also found between the likelihood of OTC use and having used birth control, having had sex, and being white, Ruth Manski of the Jane Fonda Center for Adolescent Reproductive Health, Atlanta, reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Those who had never been tested for sexually transmitted infections were more likely to support OTC access (91% vs. 76%).

Support for, and the likelihood of, using OTC OCs were not influenced by age, geographic region, rural/urban location, health insurance status, or pregnancy history. Race played a factor in that white participants were more likely than nonwhite participants to be interested in OTC access. The study also showed that participants understood an average of 7.1 of 8 key product-labeling concepts, and that most would be willing to pay up to $20 per month for OTC OCs, with the largest percentage (42%) willing to pay between $11 and $20. About a third said they would pay $21 or more.

Survey respondents were girls recruited via Facebook advertisements in 2014. Nearly a third (32%) were aged 17 years, 31% were aged 16 years, 24% were aged 15, and 13% were aged 14. Most (79%) were white, Ms. Manski said, adding that the respondents represented 44 states, 53% lived in a suburban area, 41% had private health insurance, and 33% had public health insurance.

About 90% reported having used contraception, and 44% reported having had sex. Of those who had sex, 60% reported having had unprotected sex, 58% used OCs, and 12% reported having been pregnant.

“So results from this study show that participants are supportive of over-the-counter access and that they’re interested in obtaining oral contraceptives over the counter. The findings also suggest that teenagers understand how to use oral contraceptives based on independent label review, which offers some evidence in response to concerns raised in other studies about teenagers’ ability to understand how to use over-the-counter products,” Ms. Manski said.

The findings suggest that while cost is a concern for teens and could impact their contraceptive choices, making OCs available OTC without age restrictions may help increase adolescents’ contraceptive access and use, she said, noting that this is important given the unique barriers that adolescents face with respect to accessing contraception.

The high levels of interest, and the perception of benefit, highlight the potential of this strategy to increase contraceptive access and reduce unintended pregnancy, she added.

Although some respondents expressed concerns about safety and the potential impact on sexual behavior, the evidence with respect to currently available OTC emergency contraception demonstrates that easier access does not increase sexual risk taking, and that teens can safely use OTC emergency contraception, she said.

However, the behavioral effects of OTC OC availability are not known and should be evaluated in actual use studies, Ms. Manski added.

Concerns about the safety of OTC OC access were specifically addressed in the second study, which sought to determine whether adolescents are capable of self-screening for contraindications to OC use.

Prior studies have shown that adults are able to self-screen adequately, but little is known about adolescents’ ability to do so, Dr. Rebekah L. Williams of Riley Hospital for Children, Indianapolis, said at the meeting.

Findings in the first 61 teens aged 14-21 years enrolled in the study showed that the teens were actually more likely than their providers to report potential contraindications.

The teens completed screening questionnaires prior to their office visit, and the provider completed the medical history questionnaire after the visit.

Perfectly concordant responses between providers and patients were seen for six potential contraindications: diabetes (which was present in two cases) and heavy smoking, breastfeeding, wheelchair use, surgery within 4 weeks, and current HIV medication use (which were not present in any cases). Discordant responses were seen for the remaining potential contraindications, including breast cancer, liver disease, medication interactions, smoking, migraine, hypertension, gallbladder disease, thromboembolism/heart disease, having a first-degree relative with thromboembolism, weight over 200 pounds, and having been told/having the perception that OCs should not be used.

 

 

Potential contraindications reported only by the participant were breast cancer, liver disease, medication interaction, any smoking, hypertension, personal history of thromboembolism or heart disease, and having a first-degree relative with thromboembolism.

Participants were adolescents with a mean age of 17 years from a primary care medicine clinic in a Midwest urban setting. Of the 61 subjects, 62% were black, 62% reported having ever used contraceptives, 44% were currently using contraceptives, and 62% said they would be interested in OTC OC access. Among the 38 who reported having penile/vaginal sex, 87% had ever used OCs, and 60% were currently using them.

“In summary, adolescent women are interested in over-the-counter access to combined oral contraceptive pills, they’re skilled at self-screening, and they’re mostly more likely than providers to report potential contraindications. So these data really provide some preliminary support for the over-the-counter provision of oral contraceptive pills to adolescents,” Dr. Williams said, noting that additional research is needed to assess adolescents’ ability to use combined oral contraceptive pills correctly.

In addition, larger studies in groups with a higher prevalence of contraindications are needed, as are studies with recruitment from nonclinical settings and more diverse populations, she said.

Ms. Manski and Dr. Williams both reported having no relevant financial disclosures.

[email protected]

ORLANDO – Most adolescents expressed interest in and support for access to over-the-counter oral contraceptives, a survey found.

Data from a separate cross-sectional study showed that adolescents are skilled at self-screening for contraindications to combined OCs, demonstrating preliminary support for the safety of over-the-counter access.

Fuse/ThinkStockPhotos.com

Of 348 girls aged 14-17 years who completed the survey in the first study, 73% reported supporting over-the-counter (OTC) OC access for teens, and 61% reported being likely to use OCs if they were available OTC. Significant associations were found between support for OTC access and having used birth control and having had sex. An association was also found between the likelihood of OTC use and having used birth control, having had sex, and being white, Ruth Manski of the Jane Fonda Center for Adolescent Reproductive Health, Atlanta, reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Those who had never been tested for sexually transmitted infections were more likely to support OTC access (91% vs. 76%).

Support for, and the likelihood of, using OTC OCs were not influenced by age, geographic region, rural/urban location, health insurance status, or pregnancy history. Race played a factor in that white participants were more likely than nonwhite participants to be interested in OTC access. The study also showed that participants understood an average of 7.1 of 8 key product-labeling concepts, and that most would be willing to pay up to $20 per month for OTC OCs, with the largest percentage (42%) willing to pay between $11 and $20. About a third said they would pay $21 or more.

Survey respondents were girls recruited via Facebook advertisements in 2014. Nearly a third (32%) were aged 17 years, 31% were aged 16 years, 24% were aged 15, and 13% were aged 14. Most (79%) were white, Ms. Manski said, adding that the respondents represented 44 states, 53% lived in a suburban area, 41% had private health insurance, and 33% had public health insurance.

About 90% reported having used contraception, and 44% reported having had sex. Of those who had sex, 60% reported having had unprotected sex, 58% used OCs, and 12% reported having been pregnant.

“So results from this study show that participants are supportive of over-the-counter access and that they’re interested in obtaining oral contraceptives over the counter. The findings also suggest that teenagers understand how to use oral contraceptives based on independent label review, which offers some evidence in response to concerns raised in other studies about teenagers’ ability to understand how to use over-the-counter products,” Ms. Manski said.

The findings suggest that while cost is a concern for teens and could impact their contraceptive choices, making OCs available OTC without age restrictions may help increase adolescents’ contraceptive access and use, she said, noting that this is important given the unique barriers that adolescents face with respect to accessing contraception.

The high levels of interest, and the perception of benefit, highlight the potential of this strategy to increase contraceptive access and reduce unintended pregnancy, she added.

Although some respondents expressed concerns about safety and the potential impact on sexual behavior, the evidence with respect to currently available OTC emergency contraception demonstrates that easier access does not increase sexual risk taking, and that teens can safely use OTC emergency contraception, she said.

However, the behavioral effects of OTC OC availability are not known and should be evaluated in actual use studies, Ms. Manski added.

Concerns about the safety of OTC OC access were specifically addressed in the second study, which sought to determine whether adolescents are capable of self-screening for contraindications to OC use.

Prior studies have shown that adults are able to self-screen adequately, but little is known about adolescents’ ability to do so, Dr. Rebekah L. Williams of Riley Hospital for Children, Indianapolis, said at the meeting.

Findings in the first 61 teens aged 14-21 years enrolled in the study showed that the teens were actually more likely than their providers to report potential contraindications.

The teens completed screening questionnaires prior to their office visit, and the provider completed the medical history questionnaire after the visit.

Perfectly concordant responses between providers and patients were seen for six potential contraindications: diabetes (which was present in two cases) and heavy smoking, breastfeeding, wheelchair use, surgery within 4 weeks, and current HIV medication use (which were not present in any cases). Discordant responses were seen for the remaining potential contraindications, including breast cancer, liver disease, medication interactions, smoking, migraine, hypertension, gallbladder disease, thromboembolism/heart disease, having a first-degree relative with thromboembolism, weight over 200 pounds, and having been told/having the perception that OCs should not be used.

 

 

Potential contraindications reported only by the participant were breast cancer, liver disease, medication interaction, any smoking, hypertension, personal history of thromboembolism or heart disease, and having a first-degree relative with thromboembolism.

Participants were adolescents with a mean age of 17 years from a primary care medicine clinic in a Midwest urban setting. Of the 61 subjects, 62% were black, 62% reported having ever used contraceptives, 44% were currently using contraceptives, and 62% said they would be interested in OTC OC access. Among the 38 who reported having penile/vaginal sex, 87% had ever used OCs, and 60% were currently using them.

“In summary, adolescent women are interested in over-the-counter access to combined oral contraceptive pills, they’re skilled at self-screening, and they’re mostly more likely than providers to report potential contraindications. So these data really provide some preliminary support for the over-the-counter provision of oral contraceptive pills to adolescents,” Dr. Williams said, noting that additional research is needed to assess adolescents’ ability to use combined oral contraceptive pills correctly.

In addition, larger studies in groups with a higher prevalence of contraindications are needed, as are studies with recruitment from nonclinical settings and more diverse populations, she said.

Ms. Manski and Dr. Williams both reported having no relevant financial disclosures.

[email protected]

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AT THE NASPAG ANNUAL MEETING

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Key clinical point: Adolescents have an interest in access to over-the-counter OCs and appear capable of using them safely.

Major finding: 73% reported supporting OTC access for teens.

Data source: A survey of 348 subjects and a cross-sectional study involving 61 subjects.

Disclosures: Ms. Manski and Dr. Williams both reported having no relevant financial disclosures.

NASPAG: Hormonal add-back prevents GnRH-A–related bone loss in adolescents

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NASPAG: Hormonal add-back prevents GnRH-A–related bone loss in adolescents

ORLANDO – Hormonal add-back therapy using combination norethindrone acetate and conjugated equine estrogens was effective and better than norethindrone acetate plus placebo for preserving bone health and improving quality of life in adolescents receiving treatment with gonadotropin-releasing hormone agonists (GnRH-A) for endometriosis in a randomized, double-blind, placebo-controlled study.

Of 51 adolescents aged 15-22 years who were initiating GnRH-A therapy for endometriosis, 25 were randomized to receive add-back therapy with 5 mg daily oral norethindrone acetate (NA) plus 0.625 mg oral daily conjugated equine estrogens (CEE), and 26 were randomized to receive NA plus placebo; 18 and 16, respectively, completed the study.

Those in the combination-therapy group experienced significant increases over 12 months in both total body bone mineral content (BMC) and bone mineral density (BMD), compared with those who received NA plus placebo. BMC increased by nearly 40 g/unit scanned in the combination-therapy group, compared with about 12 g in the NA plus placebo group, and BMD increased more than 0.01 g/cm2, compared with no change in the NA plus placebo group, Dr. Amy D. DiVasta reported at the North American Society for Pediatric and Adolescent Gynecology annual meeting.

No losses of total hip or lumbar spine BMC or BMD occurred, said Dr. DiVasta of Boston Children’s Hospital.

Further, lean mass increased in the combination-therapy group at 12 months – by about 1.4 kg, compared with no change in the placebo group. No differences were seen between the groups in change in fat mass.

As for quality of life measures, overall physical health scores at baseline were significantly below the U.S. mean in both groups, and overall mental health scores were above the U.S. mean in both groups. Both groups improved over time on both measures; the increase in the Physical Component Summary scale scores on the SF-36 (Short Form 36 Health Survey) was significantly greater with combination-therapy group (increase from about 40 to 50 out of 100 ), compared with NA plus placebo (increase from about 40 to 45), but the increases on the Mental Component Summary scale scores were not statistically significant in either group, or between the groups.

The study subjects, who were treated for 12 months between 2008 and 2012, were at least 2 years post menarche at baseline and had a surgical diagnosis of endometriosis. The two treatment groups were similar with respect to baseline characteristics, including age, BMD Z score, and disease severity. No significant side effects were observed in either the combination or NA plus placebo group, Dr. DiVasta said, noting that laboratory tests included liver function tests and lipid levels.

Areal BMD, BMC, and body composition were measured by dual-energy X-ray absorptiometry (DXA) at baseline, 6 months, and 12 months. Anthropometrics, quality of life measures, and laboratory studies were conducted at 1, 3, 6, and 12 months.

GnRH-A are commonly utilized for endometriosis patients who fail primary therapy, such as NSAIDs or combined oral contraceptives, but long-term use is associated with deleterious effects on bone mineralization; adults have been shown to lose 5%-8% of BMD after 3-6 months of treatment, Dr. DiVasta noted.

Hormonal add-back therapy is a promising adjunct to counteract these effects and could be an important tool for protecting adolescents, who are at the greatest risk for the deleterious effects of GnRH-A therapy, she said.

In the current study, hormonal add-back did successfully protect bone health and improve quality of life for adolescents with endometriosis who were treated with 12 months of GnRH-A. Combination therapy with NA and CEE appears to be more effective for increasing total body BMC and BMD, lean mass, and physical health-related quality of life, as compared with NA monotherapy, she said.

The findings are limited by the inclusion of only skeletally mature young women, as the results may not be generalizable to growing girls. Also, DXA measures provide two-dimensional measures of bone mineral density, and do not yield information regarding skeletal strength or bone microarchitecture, she noted.

“Given the prevalence of endometriosis, our data suggest norethindrone plus estrogens to be a useful adjunctive therapy to prevent bone loss in these young women while they receive appropriate medical treatment for their underlying disease,” she concluded, noting that future work will explore the effects of add-back on the peripheral skeleton and bone strength.

This study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the McCarthy Family Foundation, Thrasher Research Fund, and Boston Children’s Hospital department of medicine. Medications were provided by Abbott, Duramed Pharmaceuticals, and Wyeth Pharmaceuticals. Dr. DiVasta reported having no relevant financial disclosures.

 

 

[email protected]

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ORLANDO – Hormonal add-back therapy using combination norethindrone acetate and conjugated equine estrogens was effective and better than norethindrone acetate plus placebo for preserving bone health and improving quality of life in adolescents receiving treatment with gonadotropin-releasing hormone agonists (GnRH-A) for endometriosis in a randomized, double-blind, placebo-controlled study.

Of 51 adolescents aged 15-22 years who were initiating GnRH-A therapy for endometriosis, 25 were randomized to receive add-back therapy with 5 mg daily oral norethindrone acetate (NA) plus 0.625 mg oral daily conjugated equine estrogens (CEE), and 26 were randomized to receive NA plus placebo; 18 and 16, respectively, completed the study.

Those in the combination-therapy group experienced significant increases over 12 months in both total body bone mineral content (BMC) and bone mineral density (BMD), compared with those who received NA plus placebo. BMC increased by nearly 40 g/unit scanned in the combination-therapy group, compared with about 12 g in the NA plus placebo group, and BMD increased more than 0.01 g/cm2, compared with no change in the NA plus placebo group, Dr. Amy D. DiVasta reported at the North American Society for Pediatric and Adolescent Gynecology annual meeting.

No losses of total hip or lumbar spine BMC or BMD occurred, said Dr. DiVasta of Boston Children’s Hospital.

Further, lean mass increased in the combination-therapy group at 12 months – by about 1.4 kg, compared with no change in the placebo group. No differences were seen between the groups in change in fat mass.

As for quality of life measures, overall physical health scores at baseline were significantly below the U.S. mean in both groups, and overall mental health scores were above the U.S. mean in both groups. Both groups improved over time on both measures; the increase in the Physical Component Summary scale scores on the SF-36 (Short Form 36 Health Survey) was significantly greater with combination-therapy group (increase from about 40 to 50 out of 100 ), compared with NA plus placebo (increase from about 40 to 45), but the increases on the Mental Component Summary scale scores were not statistically significant in either group, or between the groups.

The study subjects, who were treated for 12 months between 2008 and 2012, were at least 2 years post menarche at baseline and had a surgical diagnosis of endometriosis. The two treatment groups were similar with respect to baseline characteristics, including age, BMD Z score, and disease severity. No significant side effects were observed in either the combination or NA plus placebo group, Dr. DiVasta said, noting that laboratory tests included liver function tests and lipid levels.

Areal BMD, BMC, and body composition were measured by dual-energy X-ray absorptiometry (DXA) at baseline, 6 months, and 12 months. Anthropometrics, quality of life measures, and laboratory studies were conducted at 1, 3, 6, and 12 months.

GnRH-A are commonly utilized for endometriosis patients who fail primary therapy, such as NSAIDs or combined oral contraceptives, but long-term use is associated with deleterious effects on bone mineralization; adults have been shown to lose 5%-8% of BMD after 3-6 months of treatment, Dr. DiVasta noted.

Hormonal add-back therapy is a promising adjunct to counteract these effects and could be an important tool for protecting adolescents, who are at the greatest risk for the deleterious effects of GnRH-A therapy, she said.

In the current study, hormonal add-back did successfully protect bone health and improve quality of life for adolescents with endometriosis who were treated with 12 months of GnRH-A. Combination therapy with NA and CEE appears to be more effective for increasing total body BMC and BMD, lean mass, and physical health-related quality of life, as compared with NA monotherapy, she said.

The findings are limited by the inclusion of only skeletally mature young women, as the results may not be generalizable to growing girls. Also, DXA measures provide two-dimensional measures of bone mineral density, and do not yield information regarding skeletal strength or bone microarchitecture, she noted.

“Given the prevalence of endometriosis, our data suggest norethindrone plus estrogens to be a useful adjunctive therapy to prevent bone loss in these young women while they receive appropriate medical treatment for their underlying disease,” she concluded, noting that future work will explore the effects of add-back on the peripheral skeleton and bone strength.

This study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the McCarthy Family Foundation, Thrasher Research Fund, and Boston Children’s Hospital department of medicine. Medications were provided by Abbott, Duramed Pharmaceuticals, and Wyeth Pharmaceuticals. Dr. DiVasta reported having no relevant financial disclosures.

 

 

[email protected]

ORLANDO – Hormonal add-back therapy using combination norethindrone acetate and conjugated equine estrogens was effective and better than norethindrone acetate plus placebo for preserving bone health and improving quality of life in adolescents receiving treatment with gonadotropin-releasing hormone agonists (GnRH-A) for endometriosis in a randomized, double-blind, placebo-controlled study.

Of 51 adolescents aged 15-22 years who were initiating GnRH-A therapy for endometriosis, 25 were randomized to receive add-back therapy with 5 mg daily oral norethindrone acetate (NA) plus 0.625 mg oral daily conjugated equine estrogens (CEE), and 26 were randomized to receive NA plus placebo; 18 and 16, respectively, completed the study.

Those in the combination-therapy group experienced significant increases over 12 months in both total body bone mineral content (BMC) and bone mineral density (BMD), compared with those who received NA plus placebo. BMC increased by nearly 40 g/unit scanned in the combination-therapy group, compared with about 12 g in the NA plus placebo group, and BMD increased more than 0.01 g/cm2, compared with no change in the NA plus placebo group, Dr. Amy D. DiVasta reported at the North American Society for Pediatric and Adolescent Gynecology annual meeting.

No losses of total hip or lumbar spine BMC or BMD occurred, said Dr. DiVasta of Boston Children’s Hospital.

Further, lean mass increased in the combination-therapy group at 12 months – by about 1.4 kg, compared with no change in the placebo group. No differences were seen between the groups in change in fat mass.

As for quality of life measures, overall physical health scores at baseline were significantly below the U.S. mean in both groups, and overall mental health scores were above the U.S. mean in both groups. Both groups improved over time on both measures; the increase in the Physical Component Summary scale scores on the SF-36 (Short Form 36 Health Survey) was significantly greater with combination-therapy group (increase from about 40 to 50 out of 100 ), compared with NA plus placebo (increase from about 40 to 45), but the increases on the Mental Component Summary scale scores were not statistically significant in either group, or between the groups.

The study subjects, who were treated for 12 months between 2008 and 2012, were at least 2 years post menarche at baseline and had a surgical diagnosis of endometriosis. The two treatment groups were similar with respect to baseline characteristics, including age, BMD Z score, and disease severity. No significant side effects were observed in either the combination or NA plus placebo group, Dr. DiVasta said, noting that laboratory tests included liver function tests and lipid levels.

Areal BMD, BMC, and body composition were measured by dual-energy X-ray absorptiometry (DXA) at baseline, 6 months, and 12 months. Anthropometrics, quality of life measures, and laboratory studies were conducted at 1, 3, 6, and 12 months.

GnRH-A are commonly utilized for endometriosis patients who fail primary therapy, such as NSAIDs or combined oral contraceptives, but long-term use is associated with deleterious effects on bone mineralization; adults have been shown to lose 5%-8% of BMD after 3-6 months of treatment, Dr. DiVasta noted.

Hormonal add-back therapy is a promising adjunct to counteract these effects and could be an important tool for protecting adolescents, who are at the greatest risk for the deleterious effects of GnRH-A therapy, she said.

In the current study, hormonal add-back did successfully protect bone health and improve quality of life for adolescents with endometriosis who were treated with 12 months of GnRH-A. Combination therapy with NA and CEE appears to be more effective for increasing total body BMC and BMD, lean mass, and physical health-related quality of life, as compared with NA monotherapy, she said.

The findings are limited by the inclusion of only skeletally mature young women, as the results may not be generalizable to growing girls. Also, DXA measures provide two-dimensional measures of bone mineral density, and do not yield information regarding skeletal strength or bone microarchitecture, she noted.

“Given the prevalence of endometriosis, our data suggest norethindrone plus estrogens to be a useful adjunctive therapy to prevent bone loss in these young women while they receive appropriate medical treatment for their underlying disease,” she concluded, noting that future work will explore the effects of add-back on the peripheral skeleton and bone strength.

This study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the McCarthy Family Foundation, Thrasher Research Fund, and Boston Children’s Hospital department of medicine. Medications were provided by Abbott, Duramed Pharmaceuticals, and Wyeth Pharmaceuticals. Dr. DiVasta reported having no relevant financial disclosures.

 

 

[email protected]

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AT THE NASPAG ANNUAL MEETING

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Inside the Article

Vitals

Key clinical point: Add-back therapy could allow for safe long-term GnRH-A therapy in adolescents with endometriosis.

Major finding: Bone mineral content increased nearly 40 g/unit scanned in the combination therapy group vs. about 12 g in the norethindrone acetate plus placebo group.

Data source: A randomized, placebo-controlled study of 51 adolescents.

Disclosures: This study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the McCarthy Family Foundation, Thrasher Research Fund, and Boston Children’s Hospital department of medicine. Medications were provided by Abbott, Duramed Pharmaceuticals, and Wyeth Pharmaceuticals. Dr. DiVasta reported having no relevant financial disclosures.

Most accidental genital trauma cases manageable in ED

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Most accidental genital trauma cases manageable in ED

ORLANDO – Most cases of accidental genital trauma in girls are caused by straddle injury and are isolated to the labia, and most can be managed expectantly or treated in the emergency department, according to findings from a retrospective cohort study.

Penetrating injuries, however, should be considered an indication for management in the operating room, Dr. Tazim Dowlut-McElroy reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

A review of 359 cases showed that the vast majority – 82% – were minor and managed expectantly.

“Only 18% required surgical management. Of those, 37% required general anesthesia in the OR, but 63% were adequately evaluated and treated in the ED,”said Dr. Dowlut-McElroy of Children’s Mercy Hospitals and Clinics, Kansas City.

About 2/3 (64%) of the patients presented during the day, and 36% presented at night. The most common presenting complaint was bleeding and pain (89% of cases), followed by voiding issues in 8% of cases. No presenting complaint was recorded in the remaining patient charts.

The most common mechanism of injury was straddle injury (73% of cases), followed by non-straddle blunt trauma in 15% of cases, and penetrating injury in the remaining cases, Dr. Dowlut-McElroy said.

Injuries included lacerations in 86% of cases, abrasions or contusions in 7%, and hematomas in 3%.

Factors associated with a need for treatment in the OR included greater mean age (mean age was 8 vs. 6 years for OR vs. ED cases), transfer from another institution (77% of OR cases vs. 31% of ED cases), penetrating injury (54% of OR cases vs. 8% of ED cases), injury to the urethra or anus (46% of OR cases vs. 7% of ED cases) and lesion size greater than 3 cm (63% of OR cases vs. 7% of ED cases), she noted.

Logistic regression analysis showed that factors significantly associated with treatment in the OR under general anesthesia were lesion size greater than 3 cm (odds ratio 5.5), and transfer from another hospital (odds ratio 4.1). Presentation at night approached significance (odds ratio 3.2).

Pediatric genital injuries comprise 0.2% to 8% of reported childhood trauma, and despite public health efforts to reduce injuries, the number of such pediatric injuries continues to rise, Dr. Dowlut-McElroy said.

As was the case in the current study, straddle injuries are the most common cause of accidental genital trauma (AGT), and most injuries are external and isolated to the labia.

However, genital bleeding, which is the most common presenting symptom after blunt genital trauma, usually requires a thorough evaluation of the location and severity of injury and may require surgical repair, she said.

Injuries may not consistently result in external bleeding, and without careful examination, injuries to the urogenital tract can be missed and result in delays in repair that can lead to urethral and vaginal stenosis and chronic fissures and fistulas, she said.

“Therefore, a key question is whether all patients should undergo examination under anesthesia in the operating room rather than undergoing evaluation and treatment in the emergency department,” she said, citing reports of discordant examination for the severity and extent of injury after AGT between an initial assessment in the ED and treatment in the OR, which have led some authors to recommend that all patients with AGT be evaluated under general anesthesia.

In one retrospective review of 22 patients with AGT, the most common mechanism of injury was straddle injury, and every patient was initially evaluated in the ED by an emergency physician and then by a pediatric surgeon. All were taken to the OR, and the findings on examination under anesthesia in the OR demonstrated significant disagreement with the findings in the ED, Dr. Dowlut-McElroy said.

In fact, 76% of patients had more significant injury than determined by the ED evaluation; 27% had complete disruption of the perianal sphincter, and 95% required surgical repair (Ped. Emerg. Care. 1995; 11:372-5).

In contrast to those findings, a 2008 review showed that only 19% of 105 cases - also due mainly to straddle injury - required examination under anesthesia in the OR, while 7% underwent conscious sedation in the ED. Only 21% of subjects required surgical repair (Ped. Emerg. Care 2008;24:831-5).

Conflicting reports such as these have results in considerable variation in recommendations for managing AGT, Dr. Dowlut-McElroy said.

“We sought to determine the characteristics of those managed in ED vs. those requiring treatment in the OR,” she added.

Patients included in the current review were identified by a medical database query from January 2000 to July 2014. They were aged 0-18 years and had been treated in the ED for genital trauma; those with obstetrical injuries were excluded.

 

 

Though limited by the retrospective and single center design, as well as by errors associated with misclassification of variables and missing data, the finding suggest that with adequate sedation, most girls with AGT, with the exception of those who experience penetrating injury, can undergo a thorough examination and repair in the ED, she concluded.

Dr. Dowlut-McElroy reported having no disclosures. One of her co-authors, Dr. Julie Strickland, is a Nexplanon trainer for Merck.

[email protected]

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ORLANDO – Most cases of accidental genital trauma in girls are caused by straddle injury and are isolated to the labia, and most can be managed expectantly or treated in the emergency department, according to findings from a retrospective cohort study.

Penetrating injuries, however, should be considered an indication for management in the operating room, Dr. Tazim Dowlut-McElroy reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

A review of 359 cases showed that the vast majority – 82% – were minor and managed expectantly.

“Only 18% required surgical management. Of those, 37% required general anesthesia in the OR, but 63% were adequately evaluated and treated in the ED,”said Dr. Dowlut-McElroy of Children’s Mercy Hospitals and Clinics, Kansas City.

About 2/3 (64%) of the patients presented during the day, and 36% presented at night. The most common presenting complaint was bleeding and pain (89% of cases), followed by voiding issues in 8% of cases. No presenting complaint was recorded in the remaining patient charts.

The most common mechanism of injury was straddle injury (73% of cases), followed by non-straddle blunt trauma in 15% of cases, and penetrating injury in the remaining cases, Dr. Dowlut-McElroy said.

Injuries included lacerations in 86% of cases, abrasions or contusions in 7%, and hematomas in 3%.

Factors associated with a need for treatment in the OR included greater mean age (mean age was 8 vs. 6 years for OR vs. ED cases), transfer from another institution (77% of OR cases vs. 31% of ED cases), penetrating injury (54% of OR cases vs. 8% of ED cases), injury to the urethra or anus (46% of OR cases vs. 7% of ED cases) and lesion size greater than 3 cm (63% of OR cases vs. 7% of ED cases), she noted.

Logistic regression analysis showed that factors significantly associated with treatment in the OR under general anesthesia were lesion size greater than 3 cm (odds ratio 5.5), and transfer from another hospital (odds ratio 4.1). Presentation at night approached significance (odds ratio 3.2).

Pediatric genital injuries comprise 0.2% to 8% of reported childhood trauma, and despite public health efforts to reduce injuries, the number of such pediatric injuries continues to rise, Dr. Dowlut-McElroy said.

As was the case in the current study, straddle injuries are the most common cause of accidental genital trauma (AGT), and most injuries are external and isolated to the labia.

However, genital bleeding, which is the most common presenting symptom after blunt genital trauma, usually requires a thorough evaluation of the location and severity of injury and may require surgical repair, she said.

Injuries may not consistently result in external bleeding, and without careful examination, injuries to the urogenital tract can be missed and result in delays in repair that can lead to urethral and vaginal stenosis and chronic fissures and fistulas, she said.

“Therefore, a key question is whether all patients should undergo examination under anesthesia in the operating room rather than undergoing evaluation and treatment in the emergency department,” she said, citing reports of discordant examination for the severity and extent of injury after AGT between an initial assessment in the ED and treatment in the OR, which have led some authors to recommend that all patients with AGT be evaluated under general anesthesia.

In one retrospective review of 22 patients with AGT, the most common mechanism of injury was straddle injury, and every patient was initially evaluated in the ED by an emergency physician and then by a pediatric surgeon. All were taken to the OR, and the findings on examination under anesthesia in the OR demonstrated significant disagreement with the findings in the ED, Dr. Dowlut-McElroy said.

In fact, 76% of patients had more significant injury than determined by the ED evaluation; 27% had complete disruption of the perianal sphincter, and 95% required surgical repair (Ped. Emerg. Care. 1995; 11:372-5).

In contrast to those findings, a 2008 review showed that only 19% of 105 cases - also due mainly to straddle injury - required examination under anesthesia in the OR, while 7% underwent conscious sedation in the ED. Only 21% of subjects required surgical repair (Ped. Emerg. Care 2008;24:831-5).

Conflicting reports such as these have results in considerable variation in recommendations for managing AGT, Dr. Dowlut-McElroy said.

“We sought to determine the characteristics of those managed in ED vs. those requiring treatment in the OR,” she added.

Patients included in the current review were identified by a medical database query from January 2000 to July 2014. They were aged 0-18 years and had been treated in the ED for genital trauma; those with obstetrical injuries were excluded.

 

 

Though limited by the retrospective and single center design, as well as by errors associated with misclassification of variables and missing data, the finding suggest that with adequate sedation, most girls with AGT, with the exception of those who experience penetrating injury, can undergo a thorough examination and repair in the ED, she concluded.

Dr. Dowlut-McElroy reported having no disclosures. One of her co-authors, Dr. Julie Strickland, is a Nexplanon trainer for Merck.

[email protected]

ORLANDO – Most cases of accidental genital trauma in girls are caused by straddle injury and are isolated to the labia, and most can be managed expectantly or treated in the emergency department, according to findings from a retrospective cohort study.

Penetrating injuries, however, should be considered an indication for management in the operating room, Dr. Tazim Dowlut-McElroy reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

A review of 359 cases showed that the vast majority – 82% – were minor and managed expectantly.

“Only 18% required surgical management. Of those, 37% required general anesthesia in the OR, but 63% were adequately evaluated and treated in the ED,”said Dr. Dowlut-McElroy of Children’s Mercy Hospitals and Clinics, Kansas City.

About 2/3 (64%) of the patients presented during the day, and 36% presented at night. The most common presenting complaint was bleeding and pain (89% of cases), followed by voiding issues in 8% of cases. No presenting complaint was recorded in the remaining patient charts.

The most common mechanism of injury was straddle injury (73% of cases), followed by non-straddle blunt trauma in 15% of cases, and penetrating injury in the remaining cases, Dr. Dowlut-McElroy said.

Injuries included lacerations in 86% of cases, abrasions or contusions in 7%, and hematomas in 3%.

Factors associated with a need for treatment in the OR included greater mean age (mean age was 8 vs. 6 years for OR vs. ED cases), transfer from another institution (77% of OR cases vs. 31% of ED cases), penetrating injury (54% of OR cases vs. 8% of ED cases), injury to the urethra or anus (46% of OR cases vs. 7% of ED cases) and lesion size greater than 3 cm (63% of OR cases vs. 7% of ED cases), she noted.

Logistic regression analysis showed that factors significantly associated with treatment in the OR under general anesthesia were lesion size greater than 3 cm (odds ratio 5.5), and transfer from another hospital (odds ratio 4.1). Presentation at night approached significance (odds ratio 3.2).

Pediatric genital injuries comprise 0.2% to 8% of reported childhood trauma, and despite public health efforts to reduce injuries, the number of such pediatric injuries continues to rise, Dr. Dowlut-McElroy said.

As was the case in the current study, straddle injuries are the most common cause of accidental genital trauma (AGT), and most injuries are external and isolated to the labia.

However, genital bleeding, which is the most common presenting symptom after blunt genital trauma, usually requires a thorough evaluation of the location and severity of injury and may require surgical repair, she said.

Injuries may not consistently result in external bleeding, and without careful examination, injuries to the urogenital tract can be missed and result in delays in repair that can lead to urethral and vaginal stenosis and chronic fissures and fistulas, she said.

“Therefore, a key question is whether all patients should undergo examination under anesthesia in the operating room rather than undergoing evaluation and treatment in the emergency department,” she said, citing reports of discordant examination for the severity and extent of injury after AGT between an initial assessment in the ED and treatment in the OR, which have led some authors to recommend that all patients with AGT be evaluated under general anesthesia.

In one retrospective review of 22 patients with AGT, the most common mechanism of injury was straddle injury, and every patient was initially evaluated in the ED by an emergency physician and then by a pediatric surgeon. All were taken to the OR, and the findings on examination under anesthesia in the OR demonstrated significant disagreement with the findings in the ED, Dr. Dowlut-McElroy said.

In fact, 76% of patients had more significant injury than determined by the ED evaluation; 27% had complete disruption of the perianal sphincter, and 95% required surgical repair (Ped. Emerg. Care. 1995; 11:372-5).

In contrast to those findings, a 2008 review showed that only 19% of 105 cases - also due mainly to straddle injury - required examination under anesthesia in the OR, while 7% underwent conscious sedation in the ED. Only 21% of subjects required surgical repair (Ped. Emerg. Care 2008;24:831-5).

Conflicting reports such as these have results in considerable variation in recommendations for managing AGT, Dr. Dowlut-McElroy said.

“We sought to determine the characteristics of those managed in ED vs. those requiring treatment in the OR,” she added.

Patients included in the current review were identified by a medical database query from January 2000 to July 2014. They were aged 0-18 years and had been treated in the ED for genital trauma; those with obstetrical injuries were excluded.

 

 

Though limited by the retrospective and single center design, as well as by errors associated with misclassification of variables and missing data, the finding suggest that with adequate sedation, most girls with AGT, with the exception of those who experience penetrating injury, can undergo a thorough examination and repair in the ED, she concluded.

Dr. Dowlut-McElroy reported having no disclosures. One of her co-authors, Dr. Julie Strickland, is a Nexplanon trainer for Merck.

[email protected]

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Most accidental genital trauma cases manageable in ED
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Most accidental genital trauma cases manageable in ED
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AT THE NASPAG ANNUAL MEETING

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Inside the Article

Vitals

Key clinical point: With adequate sedation, most girls with AGT requiring treatment can undergo evaluation and repair in the ED.

Major finding: 82% of cases reviewed were minor and managed expectantly.

Data source: A retrospective medical records review of 359 cases of AGT.

Disclosures: Dr. Dowlut-McElroy reported having no disclosures. One of her co-authors, Dr. Julie Strickland, is a Nexplanon trainer for Merck.

Lower DMPA dose provides comparable efficacy, tolerability in adolescents

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Lower DMPA dose provides comparable efficacy, tolerability in adolescents

ORLANDO – Depot medroxyprogesterone acetate (DMPA) given at a dose of 75 mg provided effective contraception with rates of weight gain and unscheduled bleeding in adolescent girls that were comparable to higher doses in a small randomized controlled trial.

Of 27 girls who completed the study, 8 were treated with a 150 mg dose, 9 were treated with 104 mg, and 10 were treated with 75 mg. Weight gain was greatest with the 75 mg dose, with 28.6% of girls in that group experiencing greater than 5% weight gain, compared with 12.5% and 22.2% of those in the 150 mg and 104 mg groups, respectively. The differences between groups did not reach statistical significance, however, Dr. Andrea E. Bonny reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

The combined number of days of bleeding or spotting during days 0 to 24 was lowest for those on the 75 mg dose (about 44 days vs. about 45 and 70 days for the 150 mg and 104 mg groups, respectively). These differences also failed to reach statistical significance, although the difference between the 104 mg and 75 mg groups trended toward significance, said Dr. Bonny of Nationwide Children’s Hospital, Columbus, Ohio.

Study subjects were healthy postmenarcheal females aged 12 to 21 years (mean of 18.5 years) who were initiating DMPA. Assigned doses were administered by intramuscular injection every 12 weeks. Subjects were assessed for weight/adiposity at baseline and at 12 and 24 weeks, and for serum MPA, estradiol, and progesterone weekly from 0-12 weeks, and also at 16, 20, and 24 weeks. Doses were escalated if MPA concentration was below 0.3 ng/ml, which is triple the previously demonstrated efficacy threshold of 0.1 ng/ml, Dr. Bonny said.

Doses were also escalated if progesterone concentration was 2 ng/ml or greater (which is suggestive of ovulation) at the time of an assessment. Escalations were required in 3 of the 10 girls in the 75 mg dose group, indicating 70% efficacy, but it is important to note that 98% of the measures of MPA concentration were above the standard 0.01 threshold for efficacy, she said.

All subjects kept a diary to track the number of days of spotting and bleeding.

An analysis of pharmacokinetic measures, including maximum MPA concentration, time needed to reach maximum MPA concentration, MPA elimination rate, and area under the concentration time curve from 0-12 weeks, showed a trend for an inverse relationship between MPA exposure and weight gain. The analysis also showed that time to maximum MPA concentration was a better predictor of unscheduled bleeding than was MPA dose; the time to maximum concentration was highly inversely correlated with the number of days of bleeding, Dr. Bonny said.

“The longer the time to get up to max concentration, the less bleeding they had,” she said.

Single intramuscular doses of 25, 50, and 100 mg have been shown to inhibit ovulation for at least 3 months in most individuals, but the relationship between exposure and side effects has been unclear, she said.

“We know that weight gain and unscheduled bleeding are highly variable among adolescents on DMPA, and despite a wide variety of studies examining predictors of DMPA-associated side effects, understanding of who is at risk is still limited,” she said, adding that pharmacokinetics also vary widely among patients.

“We found the 75 mg DMPA dose provided effective contraception in 70% of subjects, but that was using our very conservative cutoff of 0.03 ng/ml, and if we actually used the historical cutoff of 0.1, it would have reached 98%,” she said

The finding of a trend toward increased weight gain with the lowest dose seems counterintuitive, but has also been seen in at least one other cohort, she noted.

Aside from demonstrating the efficacy of the 75 mg dose of DMPA, this study demonstrated that adolescents “really can be enrolled in rigorous contraceptive trials,” she said, explaining that such studies rarely include individuals under age 18 years, and almost never include those under age 16 years.

“We had subjects who were 12 years old ... who were very compliant,” she said.

She also noted that the findings would be much more clinically useful if a simple clinical marker of pharmacokinetics were available.

“To that end, we have collected whole blood, and we will be analyzing it for genetic variants of the primary enzyme responsible for metabolizing DMPA to see if we can find a marker that can predict [time to maximum concentration] or some other pharmacokinetic measure,” she said.

 

 

This study was funded by a Society of Family Planning research grant and a Clinical and Translational Science Awards grant. Dr. Bonny reported having no disclosures.

[email protected]

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ORLANDO – Depot medroxyprogesterone acetate (DMPA) given at a dose of 75 mg provided effective contraception with rates of weight gain and unscheduled bleeding in adolescent girls that were comparable to higher doses in a small randomized controlled trial.

Of 27 girls who completed the study, 8 were treated with a 150 mg dose, 9 were treated with 104 mg, and 10 were treated with 75 mg. Weight gain was greatest with the 75 mg dose, with 28.6% of girls in that group experiencing greater than 5% weight gain, compared with 12.5% and 22.2% of those in the 150 mg and 104 mg groups, respectively. The differences between groups did not reach statistical significance, however, Dr. Andrea E. Bonny reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

The combined number of days of bleeding or spotting during days 0 to 24 was lowest for those on the 75 mg dose (about 44 days vs. about 45 and 70 days for the 150 mg and 104 mg groups, respectively). These differences also failed to reach statistical significance, although the difference between the 104 mg and 75 mg groups trended toward significance, said Dr. Bonny of Nationwide Children’s Hospital, Columbus, Ohio.

Study subjects were healthy postmenarcheal females aged 12 to 21 years (mean of 18.5 years) who were initiating DMPA. Assigned doses were administered by intramuscular injection every 12 weeks. Subjects were assessed for weight/adiposity at baseline and at 12 and 24 weeks, and for serum MPA, estradiol, and progesterone weekly from 0-12 weeks, and also at 16, 20, and 24 weeks. Doses were escalated if MPA concentration was below 0.3 ng/ml, which is triple the previously demonstrated efficacy threshold of 0.1 ng/ml, Dr. Bonny said.

Doses were also escalated if progesterone concentration was 2 ng/ml or greater (which is suggestive of ovulation) at the time of an assessment. Escalations were required in 3 of the 10 girls in the 75 mg dose group, indicating 70% efficacy, but it is important to note that 98% of the measures of MPA concentration were above the standard 0.01 threshold for efficacy, she said.

All subjects kept a diary to track the number of days of spotting and bleeding.

An analysis of pharmacokinetic measures, including maximum MPA concentration, time needed to reach maximum MPA concentration, MPA elimination rate, and area under the concentration time curve from 0-12 weeks, showed a trend for an inverse relationship between MPA exposure and weight gain. The analysis also showed that time to maximum MPA concentration was a better predictor of unscheduled bleeding than was MPA dose; the time to maximum concentration was highly inversely correlated with the number of days of bleeding, Dr. Bonny said.

“The longer the time to get up to max concentration, the less bleeding they had,” she said.

Single intramuscular doses of 25, 50, and 100 mg have been shown to inhibit ovulation for at least 3 months in most individuals, but the relationship between exposure and side effects has been unclear, she said.

“We know that weight gain and unscheduled bleeding are highly variable among adolescents on DMPA, and despite a wide variety of studies examining predictors of DMPA-associated side effects, understanding of who is at risk is still limited,” she said, adding that pharmacokinetics also vary widely among patients.

“We found the 75 mg DMPA dose provided effective contraception in 70% of subjects, but that was using our very conservative cutoff of 0.03 ng/ml, and if we actually used the historical cutoff of 0.1, it would have reached 98%,” she said

The finding of a trend toward increased weight gain with the lowest dose seems counterintuitive, but has also been seen in at least one other cohort, she noted.

Aside from demonstrating the efficacy of the 75 mg dose of DMPA, this study demonstrated that adolescents “really can be enrolled in rigorous contraceptive trials,” she said, explaining that such studies rarely include individuals under age 18 years, and almost never include those under age 16 years.

“We had subjects who were 12 years old ... who were very compliant,” she said.

She also noted that the findings would be much more clinically useful if a simple clinical marker of pharmacokinetics were available.

“To that end, we have collected whole blood, and we will be analyzing it for genetic variants of the primary enzyme responsible for metabolizing DMPA to see if we can find a marker that can predict [time to maximum concentration] or some other pharmacokinetic measure,” she said.

 

 

This study was funded by a Society of Family Planning research grant and a Clinical and Translational Science Awards grant. Dr. Bonny reported having no disclosures.

[email protected]

ORLANDO – Depot medroxyprogesterone acetate (DMPA) given at a dose of 75 mg provided effective contraception with rates of weight gain and unscheduled bleeding in adolescent girls that were comparable to higher doses in a small randomized controlled trial.

Of 27 girls who completed the study, 8 were treated with a 150 mg dose, 9 were treated with 104 mg, and 10 were treated with 75 mg. Weight gain was greatest with the 75 mg dose, with 28.6% of girls in that group experiencing greater than 5% weight gain, compared with 12.5% and 22.2% of those in the 150 mg and 104 mg groups, respectively. The differences between groups did not reach statistical significance, however, Dr. Andrea E. Bonny reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

The combined number of days of bleeding or spotting during days 0 to 24 was lowest for those on the 75 mg dose (about 44 days vs. about 45 and 70 days for the 150 mg and 104 mg groups, respectively). These differences also failed to reach statistical significance, although the difference between the 104 mg and 75 mg groups trended toward significance, said Dr. Bonny of Nationwide Children’s Hospital, Columbus, Ohio.

Study subjects were healthy postmenarcheal females aged 12 to 21 years (mean of 18.5 years) who were initiating DMPA. Assigned doses were administered by intramuscular injection every 12 weeks. Subjects were assessed for weight/adiposity at baseline and at 12 and 24 weeks, and for serum MPA, estradiol, and progesterone weekly from 0-12 weeks, and also at 16, 20, and 24 weeks. Doses were escalated if MPA concentration was below 0.3 ng/ml, which is triple the previously demonstrated efficacy threshold of 0.1 ng/ml, Dr. Bonny said.

Doses were also escalated if progesterone concentration was 2 ng/ml or greater (which is suggestive of ovulation) at the time of an assessment. Escalations were required in 3 of the 10 girls in the 75 mg dose group, indicating 70% efficacy, but it is important to note that 98% of the measures of MPA concentration were above the standard 0.01 threshold for efficacy, she said.

All subjects kept a diary to track the number of days of spotting and bleeding.

An analysis of pharmacokinetic measures, including maximum MPA concentration, time needed to reach maximum MPA concentration, MPA elimination rate, and area under the concentration time curve from 0-12 weeks, showed a trend for an inverse relationship between MPA exposure and weight gain. The analysis also showed that time to maximum MPA concentration was a better predictor of unscheduled bleeding than was MPA dose; the time to maximum concentration was highly inversely correlated with the number of days of bleeding, Dr. Bonny said.

“The longer the time to get up to max concentration, the less bleeding they had,” she said.

Single intramuscular doses of 25, 50, and 100 mg have been shown to inhibit ovulation for at least 3 months in most individuals, but the relationship between exposure and side effects has been unclear, she said.

“We know that weight gain and unscheduled bleeding are highly variable among adolescents on DMPA, and despite a wide variety of studies examining predictors of DMPA-associated side effects, understanding of who is at risk is still limited,” she said, adding that pharmacokinetics also vary widely among patients.

“We found the 75 mg DMPA dose provided effective contraception in 70% of subjects, but that was using our very conservative cutoff of 0.03 ng/ml, and if we actually used the historical cutoff of 0.1, it would have reached 98%,” she said

The finding of a trend toward increased weight gain with the lowest dose seems counterintuitive, but has also been seen in at least one other cohort, she noted.

Aside from demonstrating the efficacy of the 75 mg dose of DMPA, this study demonstrated that adolescents “really can be enrolled in rigorous contraceptive trials,” she said, explaining that such studies rarely include individuals under age 18 years, and almost never include those under age 16 years.

“We had subjects who were 12 years old ... who were very compliant,” she said.

She also noted that the findings would be much more clinically useful if a simple clinical marker of pharmacokinetics were available.

“To that end, we have collected whole blood, and we will be analyzing it for genetic variants of the primary enzyme responsible for metabolizing DMPA to see if we can find a marker that can predict [time to maximum concentration] or some other pharmacokinetic measure,” she said.

 

 

This study was funded by a Society of Family Planning research grant and a Clinical and Translational Science Awards grant. Dr. Bonny reported having no disclosures.

[email protected]

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Lower DMPA dose provides comparable efficacy, tolerability in adolescents
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Lower DMPA dose provides comparable efficacy, tolerability in adolescents
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AT THE NASPAG ANNUAL MEETING

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Inside the Article

Vitals

Key clinical point: A 75 mg DMPA dose provides effective contraception with comparable bleeding and weight gain.

Major finding: Using a very conservative cutoff, a 75 mg DMPA dose provided effective contraception in 70% of subjects.

Data source: A randomized controlled trial involving 27 girls.

Disclosures: This study was funded by a Society of Family Planning research grant and a Clinical and Translational Science Awards grant. Dr. Bonny reported having no disclosures.