IDSOG

BERNALILLO, N.M. – Results were mixed in an Italian trial of hyperimmune globulin to block intrauterine transmission of cytomegalovirus, an investigation that was largely an attempt to replicate a well-known but uncontrolled 2005 study in which the agent appeared to do just that.

Thirty percent of women (18/61) with primary cytomegalovirus (CMV) infection given intravenous anti-CMV hyperimmune globulin (Cytotect, Biotest) until gestational week 36 – or CMV-positive amniocentesis – passed the virus on to their fetuses or newborns. The transmission rate was 44% (27/62) in the trial’s saline-placebo arm, but the difference was not statistically significant (95% P = .13).

Hyperimmune globulin–treated women also had a higher incidence of serious obstetric adverse events, including preeclampsia and fetal growth restriction (P =.06). Preterm delivery was the most frequent problem; there was one preterm delivery of an infected infant in the placebo group, but there were seven in the hyperimmune globulin (HIG) group – six noninfected infants and one infected infant.

Courtesy CDC/ Dr. Haraszti

"In some cases, prematurity was rather severe," but the medical records of the women haven’t been reviewed yet to see if they had risk factors for early delivery, said lead investigator Dr. Maria Revello of the IRCCS Policlinico San Matteo in Pavia, Italy.

Overall, "the safety and efficacy of HIG for the prevention of [CMV] transmission remains to be established in phase III studies. The jury is still out," she said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. One such trial is underway in the United States, with an enrollment goal of 800 women.

There were no significant differences in virus antibody kinetics, weeks of gestation at enrollment, blood viral loads, and other factors among women who transmitted the virus in either trial arm. Likewise, there were no significant differences in amniotic viral loads, ultrasound findings, clinical birth outcomes, and other factors between infected fetuses and newborns in the two arms.

The results seem to be at odds with the 2005 project and its finding that HIG decreased intrauterine transmission from 40% to 16% (N. Engl. J. Med. 2005;353:1350-62).

That study "raised a lot of interest and a lot of expectations," but because it wasn’t a randomized controlled trial, the authors called for one in their conclusions. "That’s what we did," Dr. Revello said.

Her team used the same drug at the same dosage, 100 U/kg monthly. About 60 women were in each arm because that was the number needed to demonstrate a significant reduction in transmission from 40% to 16%. Enrollment was limited to those who picked up the infection between 5 and 26 weeks of gestation, because that’s when the rate of transmission is thought to be 40%.

The "results are actually quite encouraging because they do suggest there’s efficacy," said Dr. Stuart Adler, an author on the earlier paper, after hearing Dr. Revello’s presentation.

"Your study was slightly underpowered, but it was not significantly different in terms of efficacy rate. If you do a logistic regression of the two studies, it looks like the efficacy would be about 50%, probably because a lot of those babies were infected prior to receiving Cytotect," said Dr. Adler, a pediatric infectious disease specialist at Virginia Commonwealth University in Richmond.

Even so, until there is a proven treatment to block intrauterine CMV transmission, the best way to prevent it is to identify women who are not infected and teach them how to avoid the virus while pregnant, Dr. Revello said.

The virus is usually picked up during pregnancy through sexual contact or contact with the urine or saliva of young infected children.

Dr. Revello and Dr. Adler reported no relevant financial disclosures. The study was funded by the Italian government.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – Results were mixed in an Italian trial of hyperimmune globulin to block intrauterine transmission of cytomegalovirus, an investigation that was largely an attempt to replicate a well-known but uncontrolled 2005 study in which the agent appeared to do just that.

Thirty percent of women (18/61) with primary cytomegalovirus (CMV) infection given intravenous anti-CMV hyperimmune globulin (Cytotect, Biotest) until gestational week 36 – or CMV-positive amniocentesis – passed the virus on to their fetuses or newborns. The transmission rate was 44% (27/62) in the trial’s saline-placebo arm, but the difference was not statistically significant (95% P = .13).

Hyperimmune globulin–treated women also had a higher incidence of serious obstetric adverse events, including preeclampsia and fetal growth restriction (P =.06). Preterm delivery was the most frequent problem; there was one preterm delivery of an infected infant in the placebo group, but there were seven in the hyperimmune globulin (HIG) group – six noninfected infants and one infected infant.

Courtesy CDC/ Dr. Haraszti

"In some cases, prematurity was rather severe," but the medical records of the women haven’t been reviewed yet to see if they had risk factors for early delivery, said lead investigator Dr. Maria Revello of the IRCCS Policlinico San Matteo in Pavia, Italy.

Overall, "the safety and efficacy of HIG for the prevention of [CMV] transmission remains to be established in phase III studies. The jury is still out," she said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. One such trial is underway in the United States, with an enrollment goal of 800 women.

There were no significant differences in virus antibody kinetics, weeks of gestation at enrollment, blood viral loads, and other factors among women who transmitted the virus in either trial arm. Likewise, there were no significant differences in amniotic viral loads, ultrasound findings, clinical birth outcomes, and other factors between infected fetuses and newborns in the two arms.

The results seem to be at odds with the 2005 project and its finding that HIG decreased intrauterine transmission from 40% to 16% (N. Engl. J. Med. 2005;353:1350-62).

That study "raised a lot of interest and a lot of expectations," but because it wasn’t a randomized controlled trial, the authors called for one in their conclusions. "That’s what we did," Dr. Revello said.

Her team used the same drug at the same dosage, 100 U/kg monthly. About 60 women were in each arm because that was the number needed to demonstrate a significant reduction in transmission from 40% to 16%. Enrollment was limited to those who picked up the infection between 5 and 26 weeks of gestation, because that’s when the rate of transmission is thought to be 40%.

The "results are actually quite encouraging because they do suggest there’s efficacy," said Dr. Stuart Adler, an author on the earlier paper, after hearing Dr. Revello’s presentation.

"Your study was slightly underpowered, but it was not significantly different in terms of efficacy rate. If you do a logistic regression of the two studies, it looks like the efficacy would be about 50%, probably because a lot of those babies were infected prior to receiving Cytotect," said Dr. Adler, a pediatric infectious disease specialist at Virginia Commonwealth University in Richmond.

Even so, until there is a proven treatment to block intrauterine CMV transmission, the best way to prevent it is to identify women who are not infected and teach them how to avoid the virus while pregnant, Dr. Revello said.

The virus is usually picked up during pregnancy through sexual contact or contact with the urine or saliva of young infected children.

Dr. Revello and Dr. Adler reported no relevant financial disclosures. The study was funded by the Italian government.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – Results were mixed in an Italian trial of hyperimmune globulin to block intrauterine transmission of cytomegalovirus, an investigation that was largely an attempt to replicate a well-known but uncontrolled 2005 study in which the agent appeared to do just that.

Thirty percent of women (18/61) with primary cytomegalovirus (CMV) infection given intravenous anti-CMV hyperimmune globulin (Cytotect, Biotest) until gestational week 36 – or CMV-positive amniocentesis – passed the virus on to their fetuses or newborns. The transmission rate was 44% (27/62) in the trial’s saline-placebo arm, but the difference was not statistically significant (95% P = .13).

Hyperimmune globulin–treated women also had a higher incidence of serious obstetric adverse events, including preeclampsia and fetal growth restriction (P =.06). Preterm delivery was the most frequent problem; there was one preterm delivery of an infected infant in the placebo group, but there were seven in the hyperimmune globulin (HIG) group – six noninfected infants and one infected infant.

Courtesy CDC/ Dr. Haraszti

"In some cases, prematurity was rather severe," but the medical records of the women haven’t been reviewed yet to see if they had risk factors for early delivery, said lead investigator Dr. Maria Revello of the IRCCS Policlinico San Matteo in Pavia, Italy.

Overall, "the safety and efficacy of HIG for the prevention of [CMV] transmission remains to be established in phase III studies. The jury is still out," she said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology. One such trial is underway in the United States, with an enrollment goal of 800 women.

There were no significant differences in virus antibody kinetics, weeks of gestation at enrollment, blood viral loads, and other factors among women who transmitted the virus in either trial arm. Likewise, there were no significant differences in amniotic viral loads, ultrasound findings, clinical birth outcomes, and other factors between infected fetuses and newborns in the two arms.

The results seem to be at odds with the 2005 project and its finding that HIG decreased intrauterine transmission from 40% to 16% (N. Engl. J. Med. 2005;353:1350-62).

That study "raised a lot of interest and a lot of expectations," but because it wasn’t a randomized controlled trial, the authors called for one in their conclusions. "That’s what we did," Dr. Revello said.

Her team used the same drug at the same dosage, 100 U/kg monthly. About 60 women were in each arm because that was the number needed to demonstrate a significant reduction in transmission from 40% to 16%. Enrollment was limited to those who picked up the infection between 5 and 26 weeks of gestation, because that’s when the rate of transmission is thought to be 40%.

The "results are actually quite encouraging because they do suggest there’s efficacy," said Dr. Stuart Adler, an author on the earlier paper, after hearing Dr. Revello’s presentation.

"Your study was slightly underpowered, but it was not significantly different in terms of efficacy rate. If you do a logistic regression of the two studies, it looks like the efficacy would be about 50%, probably because a lot of those babies were infected prior to receiving Cytotect," said Dr. Adler, a pediatric infectious disease specialist at Virginia Commonwealth University in Richmond.

Even so, until there is a proven treatment to block intrauterine CMV transmission, the best way to prevent it is to identify women who are not infected and teach them how to avoid the virus while pregnant, Dr. Revello said.

The virus is usually picked up during pregnancy through sexual contact or contact with the urine or saliva of young infected children.

Dr. Revello and Dr. Adler reported no relevant financial disclosures. The study was funded by the Italian government.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – Intravaginal 5-fluorouracil might be a better option than watchful waiting for women with stage II cervical intraepithelial neoplasia, according to a small trial from the University of North Carolina at Chapel Hill.

Twenty-eight women aged 18-29 years with CIN 2 self-administered 2 g of 5% 5-fluorouracil cream (5-FU) intravaginally by applicator every 2 weeks for 16 weeks; 28 others were randomized to observation, the usual approach.

At 6 months, disease had regressed on colposcopic biopsy in 96% (27) of the 5-FU women, and 56% (15/27) were free of cervical human papilloma virus (HPV). Disease regressed in 57% (16) of the control group, and just 26% (7/27) were free of cervical HPV. The findings were statistically significant.

"The results from this study indicate that 5-FU is an effective medical therapy for CIN 2 in young women whose disease is being observed at 6-month intervals. Further investigation in women who are older or with a CIN 3 diagnosis is needed prior to considering this option in lieu of excisional or ablative management strategies," said lead investigator Dr. Lisa Rahangdale of the department of obstetrics and gynecology at the university.

"We need more data to make this a standard of care recommendation, but it has been successful in my practice," she said.

So long as they agree to avoid pregnancy while on the category X drug, "I’ve started offering women this option, particularly if they are not interested in an excisional procedure and are planning on childbearing; they are really excited to have a nonsurgical option. I also use it for women" with positive margins after excision, Dr. Rahangdale said. "Based on [a] previous study of HIV-positive women, this will help reduce their recurrence of disease," she added (Obstet. Gynecol. 1999;94:954-61).

About half of the women in the trial reported side effects, including irritation, discharge, and intermenstrual bleeding. One woman was withdrawn for possible ulceration; another, for vulvar erythema.

Even so, the women said the side effects didn’t interfere with their lives, and most would recommend 5-FU to a friend.

Topical formulations of the old chemotherapy drug were used in the past for genital warts and other HPV problems, but the drug was largely abandoned because of significant side effects with multiple doses per week. "I think our side effect profile is relatively favorable" because the dosing is biweekly, Dr. Rahangdale said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

Most of the study subjects were white, and there were no statistically-significant between-group differences in HPV vaccination history, history of prior dysplasia, contraception or condom use, number of sexual partners, and other parameters. About a third of the treated women and a fifth of the untreated women reported having had at least one dose of HPV vaccine.

Dr. Rahangdale said she had no relevant financial disclosures.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – Intravaginal 5-fluorouracil might be a better option than watchful waiting for women with stage II cervical intraepithelial neoplasia, according to a small trial from the University of North Carolina at Chapel Hill.

Twenty-eight women aged 18-29 years with CIN 2 self-administered 2 g of 5% 5-fluorouracil cream (5-FU) intravaginally by applicator every 2 weeks for 16 weeks; 28 others were randomized to observation, the usual approach.

At 6 months, disease had regressed on colposcopic biopsy in 96% (27) of the 5-FU women, and 56% (15/27) were free of cervical human papilloma virus (HPV). Disease regressed in 57% (16) of the control group, and just 26% (7/27) were free of cervical HPV. The findings were statistically significant.

"The results from this study indicate that 5-FU is an effective medical therapy for CIN 2 in young women whose disease is being observed at 6-month intervals. Further investigation in women who are older or with a CIN 3 diagnosis is needed prior to considering this option in lieu of excisional or ablative management strategies," said lead investigator Dr. Lisa Rahangdale of the department of obstetrics and gynecology at the university.

"We need more data to make this a standard of care recommendation, but it has been successful in my practice," she said.

So long as they agree to avoid pregnancy while on the category X drug, "I’ve started offering women this option, particularly if they are not interested in an excisional procedure and are planning on childbearing; they are really excited to have a nonsurgical option. I also use it for women" with positive margins after excision, Dr. Rahangdale said. "Based on [a] previous study of HIV-positive women, this will help reduce their recurrence of disease," she added (Obstet. Gynecol. 1999;94:954-61).

About half of the women in the trial reported side effects, including irritation, discharge, and intermenstrual bleeding. One woman was withdrawn for possible ulceration; another, for vulvar erythema.

Even so, the women said the side effects didn’t interfere with their lives, and most would recommend 5-FU to a friend.

Topical formulations of the old chemotherapy drug were used in the past for genital warts and other HPV problems, but the drug was largely abandoned because of significant side effects with multiple doses per week. "I think our side effect profile is relatively favorable" because the dosing is biweekly, Dr. Rahangdale said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

Most of the study subjects were white, and there were no statistically-significant between-group differences in HPV vaccination history, history of prior dysplasia, contraception or condom use, number of sexual partners, and other parameters. About a third of the treated women and a fifth of the untreated women reported having had at least one dose of HPV vaccine.

Dr. Rahangdale said she had no relevant financial disclosures.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – Intravaginal 5-fluorouracil might be a better option than watchful waiting for women with stage II cervical intraepithelial neoplasia, according to a small trial from the University of North Carolina at Chapel Hill.

Twenty-eight women aged 18-29 years with CIN 2 self-administered 2 g of 5% 5-fluorouracil cream (5-FU) intravaginally by applicator every 2 weeks for 16 weeks; 28 others were randomized to observation, the usual approach.

At 6 months, disease had regressed on colposcopic biopsy in 96% (27) of the 5-FU women, and 56% (15/27) were free of cervical human papilloma virus (HPV). Disease regressed in 57% (16) of the control group, and just 26% (7/27) were free of cervical HPV. The findings were statistically significant.

"The results from this study indicate that 5-FU is an effective medical therapy for CIN 2 in young women whose disease is being observed at 6-month intervals. Further investigation in women who are older or with a CIN 3 diagnosis is needed prior to considering this option in lieu of excisional or ablative management strategies," said lead investigator Dr. Lisa Rahangdale of the department of obstetrics and gynecology at the university.

"We need more data to make this a standard of care recommendation, but it has been successful in my practice," she said.

So long as they agree to avoid pregnancy while on the category X drug, "I’ve started offering women this option, particularly if they are not interested in an excisional procedure and are planning on childbearing; they are really excited to have a nonsurgical option. I also use it for women" with positive margins after excision, Dr. Rahangdale said. "Based on [a] previous study of HIV-positive women, this will help reduce their recurrence of disease," she added (Obstet. Gynecol. 1999;94:954-61).

About half of the women in the trial reported side effects, including irritation, discharge, and intermenstrual bleeding. One woman was withdrawn for possible ulceration; another, for vulvar erythema.

Even so, the women said the side effects didn’t interfere with their lives, and most would recommend 5-FU to a friend.

Topical formulations of the old chemotherapy drug were used in the past for genital warts and other HPV problems, but the drug was largely abandoned because of significant side effects with multiple doses per week. "I think our side effect profile is relatively favorable" because the dosing is biweekly, Dr. Rahangdale said at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

Most of the study subjects were white, and there were no statistically-significant between-group differences in HPV vaccination history, history of prior dysplasia, contraception or condom use, number of sexual partners, and other parameters. About a third of the treated women and a fifth of the untreated women reported having had at least one dose of HPV vaccine.

Dr. Rahangdale said she had no relevant financial disclosures.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – Intravaginal high-dose metronidazole and miconazole may be better than metronidazole gel for keeping recurrent bacterial vaginosis at bay, according to the results of a small pilot study from Wayne State University in Detroit.

Eighteen women with refractory bacterial vaginosis (BV) were cured there with a 7-day course of the suppository, an ovule containing 750 mg metronidazole – far more than in a typical Metrogel (metronidazole gel) application – and 200 mg miconazole. The women were then switched to a twice-weekly maintenance regimen.

The 10 who returned for a checkup 1 month later were in remission, with no symptoms, no clue cells, a negative amine test result, and no more than one of four Amsel criteria. Nine of the 10 were still in remission at the 3-month checkup, at which time treatment was discontinued, senior author Dr. Jack Sobel reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

Although the regimen wasn’t compared directly with Metrogel maintenance, Dr. Sobel said that based on his earlier work, he’d expect twice-weekly Metrogel maintenance to keep about 6 or 7 women out of 10 in remission (Am. J. Obstet. Gynecol. 2006;194:1283-9).

The team used a product called Neo-Penotran Forte, a combination metronidazole/miconazole ovule not generally available in the United States. However, a similar suppository "can be made up by any compounding company," said Dr. Sobel, chief of Wayne State’s division of infectious diseases. The medication was well tolerated in the study.

Unfortunately and as is often the case with BV, "these patients recurred and recurred rapidly after stopping maintenance therapy," said coauthor and ob.gyn. Tina Aguin, also of Wayne State.

Six of nine patients relapsed within 3 months. "The bottom line is we are able to control people with intravaginal high-dose metronidazole maintenance, but we are not curing anyone," she said.

Dr. Aguin and Dr. Sobel said they had no relevant financial disclosures.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – Intravaginal high-dose metronidazole and miconazole may be better than metronidazole gel for keeping recurrent bacterial vaginosis at bay, according to the results of a small pilot study from Wayne State University in Detroit.

Eighteen women with refractory bacterial vaginosis (BV) were cured there with a 7-day course of the suppository, an ovule containing 750 mg metronidazole – far more than in a typical Metrogel (metronidazole gel) application – and 200 mg miconazole. The women were then switched to a twice-weekly maintenance regimen.

The 10 who returned for a checkup 1 month later were in remission, with no symptoms, no clue cells, a negative amine test result, and no more than one of four Amsel criteria. Nine of the 10 were still in remission at the 3-month checkup, at which time treatment was discontinued, senior author Dr. Jack Sobel reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

Although the regimen wasn’t compared directly with Metrogel maintenance, Dr. Sobel said that based on his earlier work, he’d expect twice-weekly Metrogel maintenance to keep about 6 or 7 women out of 10 in remission (Am. J. Obstet. Gynecol. 2006;194:1283-9).

The team used a product called Neo-Penotran Forte, a combination metronidazole/miconazole ovule not generally available in the United States. However, a similar suppository "can be made up by any compounding company," said Dr. Sobel, chief of Wayne State’s division of infectious diseases. The medication was well tolerated in the study.

Unfortunately and as is often the case with BV, "these patients recurred and recurred rapidly after stopping maintenance therapy," said coauthor and ob.gyn. Tina Aguin, also of Wayne State.

Six of nine patients relapsed within 3 months. "The bottom line is we are able to control people with intravaginal high-dose metronidazole maintenance, but we are not curing anyone," she said.

Dr. Aguin and Dr. Sobel said they had no relevant financial disclosures.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – Intravaginal high-dose metronidazole and miconazole may be better than metronidazole gel for keeping recurrent bacterial vaginosis at bay, according to the results of a small pilot study from Wayne State University in Detroit.

Eighteen women with refractory bacterial vaginosis (BV) were cured there with a 7-day course of the suppository, an ovule containing 750 mg metronidazole – far more than in a typical Metrogel (metronidazole gel) application – and 200 mg miconazole. The women were then switched to a twice-weekly maintenance regimen.

The 10 who returned for a checkup 1 month later were in remission, with no symptoms, no clue cells, a negative amine test result, and no more than one of four Amsel criteria. Nine of the 10 were still in remission at the 3-month checkup, at which time treatment was discontinued, senior author Dr. Jack Sobel reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

Although the regimen wasn’t compared directly with Metrogel maintenance, Dr. Sobel said that based on his earlier work, he’d expect twice-weekly Metrogel maintenance to keep about 6 or 7 women out of 10 in remission (Am. J. Obstet. Gynecol. 2006;194:1283-9).

The team used a product called Neo-Penotran Forte, a combination metronidazole/miconazole ovule not generally available in the United States. However, a similar suppository "can be made up by any compounding company," said Dr. Sobel, chief of Wayne State’s division of infectious diseases. The medication was well tolerated in the study.

Unfortunately and as is often the case with BV, "these patients recurred and recurred rapidly after stopping maintenance therapy," said coauthor and ob.gyn. Tina Aguin, also of Wayne State.

Six of nine patients relapsed within 3 months. "The bottom line is we are able to control people with intravaginal high-dose metronidazole maintenance, but we are not curing anyone," she said.

Dr. Aguin and Dr. Sobel said they had no relevant financial disclosures.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – It’s necessary to use metronidazole in addition to doxycycline and a cephalosporin to cover all the bacteria species associated with pelvic inflammatory disease, according to an analysis of 198 endometrial biopsy isolates from 170 women with the condition.

"The coadministration of a cephalosporin with doxycycline for women with PID provides coverage for all anaerobic pathogens except Prevotella species. The addition of metronidazole is necessary to provide coverage for these anaerobic gram-negative rods," investigators from the University of Pittsburgh concluded.

Twelve percent of the women had Prevotella species in their endometrium that were resistant to both ceftriaxone and doxycycline, but not metronidazole.

The Centers for Disease Control and Prevention currently recommends an injectable cephalosporin and oral doxycycline for outpatient PID, but lets clinicians decide whether to include metronidazole.

"If you are going to cover the spectrum of organisms that are there, you really have to add the metronidazole," said senior investigator Sharon L. Hillier, Ph.D., professor of obstetrics, gynecology, and reproductive sciences in the division of infectious diseases at the university.

But "there’s reticence to prescribe it in addition to doxycycline because of the GI upset and lack of tolerance. The concern is that people might not finish their antimicrobials and get worse. It’s truly a conundrum; we don’t have a good alternative to metronidazole," Dr. Hillier said at the annual meeting of the Infectious Diseases Society of Obstetrics and Gynecology.

Also, "there aren’t longitudinal data yet that show that women with untreated Prevotella have worse outcomes. There haven’t been data suggesting that failure to cover those has long-term infertility sequelae. My own view is that we probably should use metronidazole. The bottom line is that no two antibiotics cover everything," she said.

Biopsies from 65 women – all outpatients 15-40 years old with clinical PID diagnoses – grew out one or more organisms. In all, 17 types or species of bacteria were isolated.

Gardnerella vaginalis, Atopobium vaginae, and Prevotella and Lactobacillus species made up 81% of the isolates.

Ceftriaxone was effective for all of them except the Prevotella, while metronidazole was effective against only the Prevotella. Doxycycline susceptibilities ranged from 47% for A. vaginae to 82% for G. vaginalis.

With the exception of Prevotella, ceftriaxone and doxycycline "are effective against many of the anaerobic and facultative bacteria associated with" PID, the researchers concluded.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – It’s necessary to use metronidazole in addition to doxycycline and a cephalosporin to cover all the bacteria species associated with pelvic inflammatory disease, according to an analysis of 198 endometrial biopsy isolates from 170 women with the condition.

"The coadministration of a cephalosporin with doxycycline for women with PID provides coverage for all anaerobic pathogens except Prevotella species. The addition of metronidazole is necessary to provide coverage for these anaerobic gram-negative rods," investigators from the University of Pittsburgh concluded.

Twelve percent of the women had Prevotella species in their endometrium that were resistant to both ceftriaxone and doxycycline, but not metronidazole.

The Centers for Disease Control and Prevention currently recommends an injectable cephalosporin and oral doxycycline for outpatient PID, but lets clinicians decide whether to include metronidazole.

"If you are going to cover the spectrum of organisms that are there, you really have to add the metronidazole," said senior investigator Sharon L. Hillier, Ph.D., professor of obstetrics, gynecology, and reproductive sciences in the division of infectious diseases at the university.

But "there’s reticence to prescribe it in addition to doxycycline because of the GI upset and lack of tolerance. The concern is that people might not finish their antimicrobials and get worse. It’s truly a conundrum; we don’t have a good alternative to metronidazole," Dr. Hillier said at the annual meeting of the Infectious Diseases Society of Obstetrics and Gynecology.

Also, "there aren’t longitudinal data yet that show that women with untreated Prevotella have worse outcomes. There haven’t been data suggesting that failure to cover those has long-term infertility sequelae. My own view is that we probably should use metronidazole. The bottom line is that no two antibiotics cover everything," she said.

Biopsies from 65 women – all outpatients 15-40 years old with clinical PID diagnoses – grew out one or more organisms. In all, 17 types or species of bacteria were isolated.

Gardnerella vaginalis, Atopobium vaginae, and Prevotella and Lactobacillus species made up 81% of the isolates.

Ceftriaxone was effective for all of them except the Prevotella, while metronidazole was effective against only the Prevotella. Doxycycline susceptibilities ranged from 47% for A. vaginae to 82% for G. vaginalis.

With the exception of Prevotella, ceftriaxone and doxycycline "are effective against many of the anaerobic and facultative bacteria associated with" PID, the researchers concluded.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – It’s necessary to use metronidazole in addition to doxycycline and a cephalosporin to cover all the bacteria species associated with pelvic inflammatory disease, according to an analysis of 198 endometrial biopsy isolates from 170 women with the condition.

"The coadministration of a cephalosporin with doxycycline for women with PID provides coverage for all anaerobic pathogens except Prevotella species. The addition of metronidazole is necessary to provide coverage for these anaerobic gram-negative rods," investigators from the University of Pittsburgh concluded.

Twelve percent of the women had Prevotella species in their endometrium that were resistant to both ceftriaxone and doxycycline, but not metronidazole.

The Centers for Disease Control and Prevention currently recommends an injectable cephalosporin and oral doxycycline for outpatient PID, but lets clinicians decide whether to include metronidazole.

"If you are going to cover the spectrum of organisms that are there, you really have to add the metronidazole," said senior investigator Sharon L. Hillier, Ph.D., professor of obstetrics, gynecology, and reproductive sciences in the division of infectious diseases at the university.

But "there’s reticence to prescribe it in addition to doxycycline because of the GI upset and lack of tolerance. The concern is that people might not finish their antimicrobials and get worse. It’s truly a conundrum; we don’t have a good alternative to metronidazole," Dr. Hillier said at the annual meeting of the Infectious Diseases Society of Obstetrics and Gynecology.

Also, "there aren’t longitudinal data yet that show that women with untreated Prevotella have worse outcomes. There haven’t been data suggesting that failure to cover those has long-term infertility sequelae. My own view is that we probably should use metronidazole. The bottom line is that no two antibiotics cover everything," she said.

Biopsies from 65 women – all outpatients 15-40 years old with clinical PID diagnoses – grew out one or more organisms. In all, 17 types or species of bacteria were isolated.

Gardnerella vaginalis, Atopobium vaginae, and Prevotella and Lactobacillus species made up 81% of the isolates.

Ceftriaxone was effective for all of them except the Prevotella, while metronidazole was effective against only the Prevotella. Doxycycline susceptibilities ranged from 47% for A. vaginae to 82% for G. vaginalis.

With the exception of Prevotella, ceftriaxone and doxycycline "are effective against many of the anaerobic and facultative bacteria associated with" PID, the researchers concluded.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – A score of 6 or greater on a sepsis risk scale specifically for pregnant women had an adjusted odds ratio of 109 for ICU admission, with a 95% confidence interval of 18-661, according to its developers at Brown University in Providence, R.I.

Dubbed the Sepsis in Obstetrics Score (SOS), the scale is based on the Rapid Emergency Medicine Score and the SIRS/Sepsis criteria, but is adjusted to reflect the slightly higher heart rates, lower blood pressures, and elevated white counts associated with pregnancy. Scores range from 0-28, with 0 being normal.

The team applied the scoring system retrospectively to 850 pregnant or recently postpartum women who had gotten blood cultures or influenza swabs in the ED; both were used as surrogate markers for septic presentations.

Forty-eight women had scores of at least 6, and eight were admitted to the ICU. There was one ICU admission among the 802 women with scores less than 6.

In addition to the high odds ratio, which was adjusted for age, race, and body mass index, a score of at least 6 had a sensitivity of 88.9%, a specificity of 95.2%, a negative predictive value of 99.9%, and a positive predictive value of 16.7% for ICU admission within 48 hours of presentation.

"In this population in general, there is a low overall rate of serious morbidity and mortality, resulting in our low positive predictive value; it is, however, significantly higher than other disease severity scoring systems studied in this population," said lead investigator Dr. Catherine Albright, an ob.gyn. resident at Brown.

A score of at least 6 also was independently associated with telemetry unit admission, length of hospital stay, fetal tachycardia, and positive blood cultures; the latter were found in 30.8% of women who met the cutoff, but only 8.5% of women who did not. There was no significant difference in the percentage of women with positive flu swabs, about 14% in each group.

"None of the current disease severity scoring systems included pregnant women in their initial study populations. They uniformly overestimate morbidity and mortality in obstetric populations," whereas SOS "can reliably identify patients" who require ICU treatment, Dr. Albright said. The next step is prospective validation, she added.

However, during the question and answer period, an audience member pointed out that the researchers "used your own cohort to develop the cutoff, and then applied that cutoff to the same cohort, and got a high odds ratio; that’s really not surprising. I think your follow-up of applying this to a different cohort [will be] really important."

"Absolutely," Dr. Albright responded.

The score includes temperature, heart rate, blood pressure, respiratory rate, oxygen saturation, white blood cell count, percentage of immature neutrophils, and lactic acid concentration. With adjustment for pregnancy, a heart rate up to 120 bpm, a WBC count of about 6-17,000 cells/mcL, and a systolic blood pressure down to 90 mm Hg are considered to be in the normal range.

Among higher-scoring women, the most common diagnoses at presentation were pyelonephritis and endometritis. Those with scores below six were most commonly diagnosed with influenzalike illness, Dr. Albright reported at the Infectious Diseases Society for Obstetrics and Gynecology annual meeting

There were no significant differences between the two groups in the presence of hypertension, diabetes, HIV, and other comorbidities. The only significant demographic difference was age, with higher-scoring women a mean of 24 years old, vs. 26.3 in the lower-scoring group, probably a clinically irrelevant finding, she said.

Known or suspected ectopic pregnancies and multiple gestations were among the exclusion criteria.

Dr. Albright said she had no relevant financial disclosures.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – A score of 6 or greater on a sepsis risk scale specifically for pregnant women had an adjusted odds ratio of 109 for ICU admission, with a 95% confidence interval of 18-661, according to its developers at Brown University in Providence, R.I.

Dubbed the Sepsis in Obstetrics Score (SOS), the scale is based on the Rapid Emergency Medicine Score and the SIRS/Sepsis criteria, but is adjusted to reflect the slightly higher heart rates, lower blood pressures, and elevated white counts associated with pregnancy. Scores range from 0-28, with 0 being normal.

The team applied the scoring system retrospectively to 850 pregnant or recently postpartum women who had gotten blood cultures or influenza swabs in the ED; both were used as surrogate markers for septic presentations.

Forty-eight women had scores of at least 6, and eight were admitted to the ICU. There was one ICU admission among the 802 women with scores less than 6.

In addition to the high odds ratio, which was adjusted for age, race, and body mass index, a score of at least 6 had a sensitivity of 88.9%, a specificity of 95.2%, a negative predictive value of 99.9%, and a positive predictive value of 16.7% for ICU admission within 48 hours of presentation.

"In this population in general, there is a low overall rate of serious morbidity and mortality, resulting in our low positive predictive value; it is, however, significantly higher than other disease severity scoring systems studied in this population," said lead investigator Dr. Catherine Albright, an ob.gyn. resident at Brown.

A score of at least 6 also was independently associated with telemetry unit admission, length of hospital stay, fetal tachycardia, and positive blood cultures; the latter were found in 30.8% of women who met the cutoff, but only 8.5% of women who did not. There was no significant difference in the percentage of women with positive flu swabs, about 14% in each group.

"None of the current disease severity scoring systems included pregnant women in their initial study populations. They uniformly overestimate morbidity and mortality in obstetric populations," whereas SOS "can reliably identify patients" who require ICU treatment, Dr. Albright said. The next step is prospective validation, she added.

However, during the question and answer period, an audience member pointed out that the researchers "used your own cohort to develop the cutoff, and then applied that cutoff to the same cohort, and got a high odds ratio; that’s really not surprising. I think your follow-up of applying this to a different cohort [will be] really important."

"Absolutely," Dr. Albright responded.

The score includes temperature, heart rate, blood pressure, respiratory rate, oxygen saturation, white blood cell count, percentage of immature neutrophils, and lactic acid concentration. With adjustment for pregnancy, a heart rate up to 120 bpm, a WBC count of about 6-17,000 cells/mcL, and a systolic blood pressure down to 90 mm Hg are considered to be in the normal range.

Among higher-scoring women, the most common diagnoses at presentation were pyelonephritis and endometritis. Those with scores below six were most commonly diagnosed with influenzalike illness, Dr. Albright reported at the Infectious Diseases Society for Obstetrics and Gynecology annual meeting

There were no significant differences between the two groups in the presence of hypertension, diabetes, HIV, and other comorbidities. The only significant demographic difference was age, with higher-scoring women a mean of 24 years old, vs. 26.3 in the lower-scoring group, probably a clinically irrelevant finding, she said.

Known or suspected ectopic pregnancies and multiple gestations were among the exclusion criteria.

Dr. Albright said she had no relevant financial disclosures.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – A score of 6 or greater on a sepsis risk scale specifically for pregnant women had an adjusted odds ratio of 109 for ICU admission, with a 95% confidence interval of 18-661, according to its developers at Brown University in Providence, R.I.

Dubbed the Sepsis in Obstetrics Score (SOS), the scale is based on the Rapid Emergency Medicine Score and the SIRS/Sepsis criteria, but is adjusted to reflect the slightly higher heart rates, lower blood pressures, and elevated white counts associated with pregnancy. Scores range from 0-28, with 0 being normal.

The team applied the scoring system retrospectively to 850 pregnant or recently postpartum women who had gotten blood cultures or influenza swabs in the ED; both were used as surrogate markers for septic presentations.

Forty-eight women had scores of at least 6, and eight were admitted to the ICU. There was one ICU admission among the 802 women with scores less than 6.

In addition to the high odds ratio, which was adjusted for age, race, and body mass index, a score of at least 6 had a sensitivity of 88.9%, a specificity of 95.2%, a negative predictive value of 99.9%, and a positive predictive value of 16.7% for ICU admission within 48 hours of presentation.

"In this population in general, there is a low overall rate of serious morbidity and mortality, resulting in our low positive predictive value; it is, however, significantly higher than other disease severity scoring systems studied in this population," said lead investigator Dr. Catherine Albright, an ob.gyn. resident at Brown.

A score of at least 6 also was independently associated with telemetry unit admission, length of hospital stay, fetal tachycardia, and positive blood cultures; the latter were found in 30.8% of women who met the cutoff, but only 8.5% of women who did not. There was no significant difference in the percentage of women with positive flu swabs, about 14% in each group.

"None of the current disease severity scoring systems included pregnant women in their initial study populations. They uniformly overestimate morbidity and mortality in obstetric populations," whereas SOS "can reliably identify patients" who require ICU treatment, Dr. Albright said. The next step is prospective validation, she added.

However, during the question and answer period, an audience member pointed out that the researchers "used your own cohort to develop the cutoff, and then applied that cutoff to the same cohort, and got a high odds ratio; that’s really not surprising. I think your follow-up of applying this to a different cohort [will be] really important."

"Absolutely," Dr. Albright responded.

The score includes temperature, heart rate, blood pressure, respiratory rate, oxygen saturation, white blood cell count, percentage of immature neutrophils, and lactic acid concentration. With adjustment for pregnancy, a heart rate up to 120 bpm, a WBC count of about 6-17,000 cells/mcL, and a systolic blood pressure down to 90 mm Hg are considered to be in the normal range.

Among higher-scoring women, the most common diagnoses at presentation were pyelonephritis and endometritis. Those with scores below six were most commonly diagnosed with influenzalike illness, Dr. Albright reported at the Infectious Diseases Society for Obstetrics and Gynecology annual meeting

There were no significant differences between the two groups in the presence of hypertension, diabetes, HIV, and other comorbidities. The only significant demographic difference was age, with higher-scoring women a mean of 24 years old, vs. 26.3 in the lower-scoring group, probably a clinically irrelevant finding, she said.

Known or suspected ectopic pregnancies and multiple gestations were among the exclusion criteria.

Dr. Albright said she had no relevant financial disclosures.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – Women with HIV probably need a booster shot of HPV vaccine within 2 years to maintain efficacy, according to a Canadian study of quadrivalent HPV vaccine (Gardasil) in 136 HIV-positive women.

Antibody response to the vaccine is strong enough at 2 years to protect about 90% of HIV-negative women against HPV [human papillomavirus]. "But in our population, with approximately a year and a half of follow-up, that number decreased to about 63%. There’s a much more rapid decline in antibody levels" among HIV-positive women, "which suggests this population might in fact benefit from a booster," said lead investigator Erin Moses, R.N., a researcher at the Women’s Health Research Institute in Vancouver, B.C.

Cervical specimens from the women were negative for HPV DNA – and their blood was negative for HPV antibodies– both at screening and 3 months later when they received the vaccine. They were then assessed at 6, 12, and 18 months for cervical HPV DNA.

The initial seroconversion rate was high at about 99%, but "we saw nine breakthrough infections" to HPV types targeted by the vaccine "in a short period of follow up. Although we’ve only been monitoring these women for approximately a year and a half, we have already seen five [new] infections of HPV type 18. Of those five, we saw two persistent infections, which means these women had two positive tests 6 months apart for HPV 18," Ms. Moses said at the Infectious Diseases Society for Obstetrics and Gynecology annual meeting.

Women who picked up a new infection had a mean CD4 nadir of 69 cells/mm³; women who did not had a mean nadir of 228 cells/mm³, a significant difference. Women who became infected also were more likely to have a new sexual partner.

"We didn’t see a correlation between viral load" and new infections, "which was odd because typically you would think that if they have an unsuppressed viral load, they would be more at risk, but there was no correlation with that," Ms. Moses said.

The median age in the study was 40 years; about half the women were black, most of the rest were white. The median time since HIV diagnosis was 8 years, and 11% were coinfected with hepatitis C; 92% of the women were on highly active antiretroviral medications, and 69% had undetectable viral loads.

Ms. Moses said she had no relevant financial disclosures. The study was funded by Merck, the maker of Gardasil, and the Canadian Institutes of Health Research.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – Women with HIV probably need a booster shot of HPV vaccine within 2 years to maintain efficacy, according to a Canadian study of quadrivalent HPV vaccine (Gardasil) in 136 HIV-positive women.

Antibody response to the vaccine is strong enough at 2 years to protect about 90% of HIV-negative women against HPV [human papillomavirus]. "But in our population, with approximately a year and a half of follow-up, that number decreased to about 63%. There’s a much more rapid decline in antibody levels" among HIV-positive women, "which suggests this population might in fact benefit from a booster," said lead investigator Erin Moses, R.N., a researcher at the Women’s Health Research Institute in Vancouver, B.C.

Cervical specimens from the women were negative for HPV DNA – and their blood was negative for HPV antibodies– both at screening and 3 months later when they received the vaccine. They were then assessed at 6, 12, and 18 months for cervical HPV DNA.

The initial seroconversion rate was high at about 99%, but "we saw nine breakthrough infections" to HPV types targeted by the vaccine "in a short period of follow up. Although we’ve only been monitoring these women for approximately a year and a half, we have already seen five [new] infections of HPV type 18. Of those five, we saw two persistent infections, which means these women had two positive tests 6 months apart for HPV 18," Ms. Moses said at the Infectious Diseases Society for Obstetrics and Gynecology annual meeting.

Women who picked up a new infection had a mean CD4 nadir of 69 cells/mm³; women who did not had a mean nadir of 228 cells/mm³, a significant difference. Women who became infected also were more likely to have a new sexual partner.

"We didn’t see a correlation between viral load" and new infections, "which was odd because typically you would think that if they have an unsuppressed viral load, they would be more at risk, but there was no correlation with that," Ms. Moses said.

The median age in the study was 40 years; about half the women were black, most of the rest were white. The median time since HIV diagnosis was 8 years, and 11% were coinfected with hepatitis C; 92% of the women were on highly active antiretroviral medications, and 69% had undetectable viral loads.

Ms. Moses said she had no relevant financial disclosures. The study was funded by Merck, the maker of Gardasil, and the Canadian Institutes of Health Research.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – Women with HIV probably need a booster shot of HPV vaccine within 2 years to maintain efficacy, according to a Canadian study of quadrivalent HPV vaccine (Gardasil) in 136 HIV-positive women.

Antibody response to the vaccine is strong enough at 2 years to protect about 90% of HIV-negative women against HPV [human papillomavirus]. "But in our population, with approximately a year and a half of follow-up, that number decreased to about 63%. There’s a much more rapid decline in antibody levels" among HIV-positive women, "which suggests this population might in fact benefit from a booster," said lead investigator Erin Moses, R.N., a researcher at the Women’s Health Research Institute in Vancouver, B.C.

Cervical specimens from the women were negative for HPV DNA – and their blood was negative for HPV antibodies– both at screening and 3 months later when they received the vaccine. They were then assessed at 6, 12, and 18 months for cervical HPV DNA.

The initial seroconversion rate was high at about 99%, but "we saw nine breakthrough infections" to HPV types targeted by the vaccine "in a short period of follow up. Although we’ve only been monitoring these women for approximately a year and a half, we have already seen five [new] infections of HPV type 18. Of those five, we saw two persistent infections, which means these women had two positive tests 6 months apart for HPV 18," Ms. Moses said at the Infectious Diseases Society for Obstetrics and Gynecology annual meeting.

Women who picked up a new infection had a mean CD4 nadir of 69 cells/mm³; women who did not had a mean nadir of 228 cells/mm³, a significant difference. Women who became infected also were more likely to have a new sexual partner.

"We didn’t see a correlation between viral load" and new infections, "which was odd because typically you would think that if they have an unsuppressed viral load, they would be more at risk, but there was no correlation with that," Ms. Moses said.

The median age in the study was 40 years; about half the women were black, most of the rest were white. The median time since HIV diagnosis was 8 years, and 11% were coinfected with hepatitis C; 92% of the women were on highly active antiretroviral medications, and 69% had undetectable viral loads.

Ms. Moses said she had no relevant financial disclosures. The study was funded by Merck, the maker of Gardasil, and the Canadian Institutes of Health Research.

aotto@frontlinemedcom.com

SANTA ANA PUEBLO, N.M. – Only certain classes of antibiotics increased the risk of yeast infections in a study of 650 women followed for 18 months to see what factors were associated with new-onset vulvovaginal candidiasis.

Penicillins increased the risk the most (adjusted hazard ratio, 4.1), followed by cephalosporins (aHR, 3.3) and metronidazole (aHR, 2.8), compared with women who did not report antibiotic use. Other classes of antibiotics were not associated with yeast infections.

"Many women and physicians believe that if you take an antibiotic, you’re just bound to get yeast. The message is that not all antibiotics are associated with yeast vaginitis; it’s certain classes of antibiotics that carry the highest risk," said senior investigator Sharon L. Hillier, Ph.D., a professor of obstetrics and gynecology and reproductive sciences at the University of Pittsburgh.

"When women are given antibiotics, I think it’s useful to help them understand they have some likelihood of getting a yeast infection with these three, and less so with quinolones or tetracyclines or something else," she said at the annual scientific meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

The 650 subjects – 18-40 years old, not pregnant, and with no signs or symptoms of yeast at baseline – were followed at 2-month intervals during the investigation, and had a total of 4,934 follow-up office visits. Each time, they were asked what antibiotics they had been on, if any, among other questions.

There were 82 clinical yeast vaginitis diagnoses and 58 self-diagnosed infections with documented antifungal use. The results were largely similar when the team limited analysis to just clinically diagnosed cases.

A total of 312 women used an antibiotic at least once. Macrolides, metronidazole, and penicillins were used most often among the nine classes of reported antibiotics. The most common indications were upper respiratory tract infections, bacterial vaginosis, urinary tract infections, and sexually transmitted infections.

Having two or more male sexual partners was also a strong predictor of yeast vaginitis (aHR, 5.0), "and that was something that was a little bit surprising because it’s not a sexually transmitted infection. It’s useful maybe to tell women that limiting their numbers of sex partners will also decrease their risk," Dr. Hillier said.

Using depot medroxyprogesterone acetate (Depo-Provera), meanwhile, had a protective effect (aHR, 0.3), compared with women not using hormonal contraceptives. "Depo-Provera has a very strong progestin; some women who get the shot actually have estrogen depletion in the vaginal epithelium. The finding suggests that when you remove the estrogen from the [vaginal] epithelium, it can reduce your risk for yeast vaginitis," Dr. Hillier said.

Other forms of hormonal contraception were not associated with yeast vaginitis. Although "many women believe oral contraceptives and other hormonal methods increase the risk, there was no evidence of increased risk in this study," she said.

Dr. Hillier said she had no disclosures. The work was funded by the National Institutes of Health.

aotto@frontlinemedcom.com

SANTA ANA PUEBLO, N.M. – Only certain classes of antibiotics increased the risk of yeast infections in a study of 650 women followed for 18 months to see what factors were associated with new-onset vulvovaginal candidiasis.

Penicillins increased the risk the most (adjusted hazard ratio, 4.1), followed by cephalosporins (aHR, 3.3) and metronidazole (aHR, 2.8), compared with women who did not report antibiotic use. Other classes of antibiotics were not associated with yeast infections.

"Many women and physicians believe that if you take an antibiotic, you’re just bound to get yeast. The message is that not all antibiotics are associated with yeast vaginitis; it’s certain classes of antibiotics that carry the highest risk," said senior investigator Sharon L. Hillier, Ph.D., a professor of obstetrics and gynecology and reproductive sciences at the University of Pittsburgh.

"When women are given antibiotics, I think it’s useful to help them understand they have some likelihood of getting a yeast infection with these three, and less so with quinolones or tetracyclines or something else," she said at the annual scientific meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

The 650 subjects – 18-40 years old, not pregnant, and with no signs or symptoms of yeast at baseline – were followed at 2-month intervals during the investigation, and had a total of 4,934 follow-up office visits. Each time, they were asked what antibiotics they had been on, if any, among other questions.

There were 82 clinical yeast vaginitis diagnoses and 58 self-diagnosed infections with documented antifungal use. The results were largely similar when the team limited analysis to just clinically diagnosed cases.

A total of 312 women used an antibiotic at least once. Macrolides, metronidazole, and penicillins were used most often among the nine classes of reported antibiotics. The most common indications were upper respiratory tract infections, bacterial vaginosis, urinary tract infections, and sexually transmitted infections.

Having two or more male sexual partners was also a strong predictor of yeast vaginitis (aHR, 5.0), "and that was something that was a little bit surprising because it’s not a sexually transmitted infection. It’s useful maybe to tell women that limiting their numbers of sex partners will also decrease their risk," Dr. Hillier said.

Using depot medroxyprogesterone acetate (Depo-Provera), meanwhile, had a protective effect (aHR, 0.3), compared with women not using hormonal contraceptives. "Depo-Provera has a very strong progestin; some women who get the shot actually have estrogen depletion in the vaginal epithelium. The finding suggests that when you remove the estrogen from the [vaginal] epithelium, it can reduce your risk for yeast vaginitis," Dr. Hillier said.

Other forms of hormonal contraception were not associated with yeast vaginitis. Although "many women believe oral contraceptives and other hormonal methods increase the risk, there was no evidence of increased risk in this study," she said.

Dr. Hillier said she had no disclosures. The work was funded by the National Institutes of Health.

aotto@frontlinemedcom.com

SANTA ANA PUEBLO, N.M. – Only certain classes of antibiotics increased the risk of yeast infections in a study of 650 women followed for 18 months to see what factors were associated with new-onset vulvovaginal candidiasis.

Penicillins increased the risk the most (adjusted hazard ratio, 4.1), followed by cephalosporins (aHR, 3.3) and metronidazole (aHR, 2.8), compared with women who did not report antibiotic use. Other classes of antibiotics were not associated with yeast infections.

"Many women and physicians believe that if you take an antibiotic, you’re just bound to get yeast. The message is that not all antibiotics are associated with yeast vaginitis; it’s certain classes of antibiotics that carry the highest risk," said senior investigator Sharon L. Hillier, Ph.D., a professor of obstetrics and gynecology and reproductive sciences at the University of Pittsburgh.

"When women are given antibiotics, I think it’s useful to help them understand they have some likelihood of getting a yeast infection with these three, and less so with quinolones or tetracyclines or something else," she said at the annual scientific meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

The 650 subjects – 18-40 years old, not pregnant, and with no signs or symptoms of yeast at baseline – were followed at 2-month intervals during the investigation, and had a total of 4,934 follow-up office visits. Each time, they were asked what antibiotics they had been on, if any, among other questions.

There were 82 clinical yeast vaginitis diagnoses and 58 self-diagnosed infections with documented antifungal use. The results were largely similar when the team limited analysis to just clinically diagnosed cases.

A total of 312 women used an antibiotic at least once. Macrolides, metronidazole, and penicillins were used most often among the nine classes of reported antibiotics. The most common indications were upper respiratory tract infections, bacterial vaginosis, urinary tract infections, and sexually transmitted infections.

Having two or more male sexual partners was also a strong predictor of yeast vaginitis (aHR, 5.0), "and that was something that was a little bit surprising because it’s not a sexually transmitted infection. It’s useful maybe to tell women that limiting their numbers of sex partners will also decrease their risk," Dr. Hillier said.

Using depot medroxyprogesterone acetate (Depo-Provera), meanwhile, had a protective effect (aHR, 0.3), compared with women not using hormonal contraceptives. "Depo-Provera has a very strong progestin; some women who get the shot actually have estrogen depletion in the vaginal epithelium. The finding suggests that when you remove the estrogen from the [vaginal] epithelium, it can reduce your risk for yeast vaginitis," Dr. Hillier said.

Other forms of hormonal contraception were not associated with yeast vaginitis. Although "many women believe oral contraceptives and other hormonal methods increase the risk, there was no evidence of increased risk in this study," she said.

Dr. Hillier said she had no disclosures. The work was funded by the National Institutes of Health.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – A personal one-on-one recommendation from a woman’s obstetrician is what’s most likely to convince a woman to get flu and Tdap shots during pregnancy, according to an e-mail survey of 274 women from nine private obstetrics practices in Colorado.

Women were almost four times more likely to get Tdap during pregnancy and have at least one close contact get the shot – a practice known as cocooning – if their obstetricians recommended it (adjusted odds ratio [aOR], 3.67), and almost twice as likely to cocoon with the flu shot (aOR, 1.89). Recommendations from office staff, written material, and other sources didn’t work.

And yet only about half of the respondents said that their obstetrician recommended the flu vaccine, and that about two-thirds recommended Tdap vaccine; the survey was done after Tdap was recommended for all pregnant women in the fall of 2012. "The practice may have provided written material or the nurse may have said [something], but their [obstetrician] didn’t sit down with them and recommend it. We are not doing a great job of recommending cocooning for our patients," said Dr. Meghan Donnelly, an ob.gyn. specializing in maternal and fetal medicine at the University of Colorado Hospital in Aurora.

"You can’t just be lazy and put the ACOG [American College of Obstetricians and Gynecologists] pamphlet in your office," she said.

Just 61% of women reported cocooning for Tdap or flu vaccines. Perceived benefit – gauged by questions such as "getting myself vaccinated will help keep my baby from getting pertussis" – and perceived susceptibility to infection also made cocooning more likely; negative beliefs about vaccines made it less likely. Hispanic women also were less likely to get the shots than white women (aOR, 0.26).

In addition to patient education, the solution is "to educate providers" that they need "to mention [the shots] specifically in the office visit" and that it’s possible to give the shots without slowing down their practices or losing money, Dr. Donnelly said at the Infectious Diseases Society for Obstetrics and Gynecology annual meeting.

She and her colleagues are working to get the word out; the survey was part of an ongoing, randomized Centers for Disease Control and Prevention–funded trial to compare vaccine uptake rates between practices that are taught those things and those that are not.

Vaccine supply specialists are meeting with offices in the intervention group to teach them how to predict the needs of their patients, and effectively order, properly store, and bill for vaccines so they don’t lose money.

"We are [also] helping them create a vaccine champion program so that there’s one person who takes ownership of the [issue]. We are providing education to every level of staff about the importance of this, how to record a vaccination history, and how you identify who you need to talk to about vaccination, because it’s not every person and you don’t need to ask every time. We are [also] creating flow maps of practices to come up with the most efficient way to increase vaccine uptake [without] taking more time per patient," she said.

"In some practices, we created a standing order set where a nurse could identify who needs the flu vaccine and administer it without a doctor seeing the patient or writing a separate order. In some clinics, nurses did not feel comfortable with that approach, whereas other clinics thought it was a really great idea and embraced it enthusiastically," Dr. Donnelly said.

"It is harder to do interventions in some practices than others, mainly if their medical record system isn’t electronic. We’ve had to adjust interventions differently for each practice," she said.

Dr. Donnelly said she had no relevant financial disclosures.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – A personal one-on-one recommendation from a woman’s obstetrician is what’s most likely to convince a woman to get flu and Tdap shots during pregnancy, according to an e-mail survey of 274 women from nine private obstetrics practices in Colorado.

Women were almost four times more likely to get Tdap during pregnancy and have at least one close contact get the shot – a practice known as cocooning – if their obstetricians recommended it (adjusted odds ratio [aOR], 3.67), and almost twice as likely to cocoon with the flu shot (aOR, 1.89). Recommendations from office staff, written material, and other sources didn’t work.

And yet only about half of the respondents said that their obstetrician recommended the flu vaccine, and that about two-thirds recommended Tdap vaccine; the survey was done after Tdap was recommended for all pregnant women in the fall of 2012. "The practice may have provided written material or the nurse may have said [something], but their [obstetrician] didn’t sit down with them and recommend it. We are not doing a great job of recommending cocooning for our patients," said Dr. Meghan Donnelly, an ob.gyn. specializing in maternal and fetal medicine at the University of Colorado Hospital in Aurora.

"You can’t just be lazy and put the ACOG [American College of Obstetricians and Gynecologists] pamphlet in your office," she said.

Just 61% of women reported cocooning for Tdap or flu vaccines. Perceived benefit – gauged by questions such as "getting myself vaccinated will help keep my baby from getting pertussis" – and perceived susceptibility to infection also made cocooning more likely; negative beliefs about vaccines made it less likely. Hispanic women also were less likely to get the shots than white women (aOR, 0.26).

In addition to patient education, the solution is "to educate providers" that they need "to mention [the shots] specifically in the office visit" and that it’s possible to give the shots without slowing down their practices or losing money, Dr. Donnelly said at the Infectious Diseases Society for Obstetrics and Gynecology annual meeting.

She and her colleagues are working to get the word out; the survey was part of an ongoing, randomized Centers for Disease Control and Prevention–funded trial to compare vaccine uptake rates between practices that are taught those things and those that are not.

Vaccine supply specialists are meeting with offices in the intervention group to teach them how to predict the needs of their patients, and effectively order, properly store, and bill for vaccines so they don’t lose money.

"We are [also] helping them create a vaccine champion program so that there’s one person who takes ownership of the [issue]. We are providing education to every level of staff about the importance of this, how to record a vaccination history, and how you identify who you need to talk to about vaccination, because it’s not every person and you don’t need to ask every time. We are [also] creating flow maps of practices to come up with the most efficient way to increase vaccine uptake [without] taking more time per patient," she said.

"In some practices, we created a standing order set where a nurse could identify who needs the flu vaccine and administer it without a doctor seeing the patient or writing a separate order. In some clinics, nurses did not feel comfortable with that approach, whereas other clinics thought it was a really great idea and embraced it enthusiastically," Dr. Donnelly said.

"It is harder to do interventions in some practices than others, mainly if their medical record system isn’t electronic. We’ve had to adjust interventions differently for each practice," she said.

Dr. Donnelly said she had no relevant financial disclosures.

aotto@frontlinemedcom.com

BERNALILLO, N.M. – A personal one-on-one recommendation from a woman’s obstetrician is what’s most likely to convince a woman to get flu and Tdap shots during pregnancy, according to an e-mail survey of 274 women from nine private obstetrics practices in Colorado.

Women were almost four times more likely to get Tdap during pregnancy and have at least one close contact get the shot – a practice known as cocooning – if their obstetricians recommended it (adjusted odds ratio [aOR], 3.67), and almost twice as likely to cocoon with the flu shot (aOR, 1.89). Recommendations from office staff, written material, and other sources didn’t work.

And yet only about half of the respondents said that their obstetrician recommended the flu vaccine, and that about two-thirds recommended Tdap vaccine; the survey was done after Tdap was recommended for all pregnant women in the fall of 2012. "The practice may have provided written material or the nurse may have said [something], but their [obstetrician] didn’t sit down with them and recommend it. We are not doing a great job of recommending cocooning for our patients," said Dr. Meghan Donnelly, an ob.gyn. specializing in maternal and fetal medicine at the University of Colorado Hospital in Aurora.

"You can’t just be lazy and put the ACOG [American College of Obstetricians and Gynecologists] pamphlet in your office," she said.

Just 61% of women reported cocooning for Tdap or flu vaccines. Perceived benefit – gauged by questions such as "getting myself vaccinated will help keep my baby from getting pertussis" – and perceived susceptibility to infection also made cocooning more likely; negative beliefs about vaccines made it less likely. Hispanic women also were less likely to get the shots than white women (aOR, 0.26).

In addition to patient education, the solution is "to educate providers" that they need "to mention [the shots] specifically in the office visit" and that it’s possible to give the shots without slowing down their practices or losing money, Dr. Donnelly said at the Infectious Diseases Society for Obstetrics and Gynecology annual meeting.

She and her colleagues are working to get the word out; the survey was part of an ongoing, randomized Centers for Disease Control and Prevention–funded trial to compare vaccine uptake rates between practices that are taught those things and those that are not.

Vaccine supply specialists are meeting with offices in the intervention group to teach them how to predict the needs of their patients, and effectively order, properly store, and bill for vaccines so they don’t lose money.

"We are [also] helping them create a vaccine champion program so that there’s one person who takes ownership of the [issue]. We are providing education to every level of staff about the importance of this, how to record a vaccination history, and how you identify who you need to talk to about vaccination, because it’s not every person and you don’t need to ask every time. We are [also] creating flow maps of practices to come up with the most efficient way to increase vaccine uptake [without] taking more time per patient," she said.

"In some practices, we created a standing order set where a nurse could identify who needs the flu vaccine and administer it without a doctor seeing the patient or writing a separate order. In some clinics, nurses did not feel comfortable with that approach, whereas other clinics thought it was a really great idea and embraced it enthusiastically," Dr. Donnelly said.

"It is harder to do interventions in some practices than others, mainly if their medical record system isn’t electronic. We’ve had to adjust interventions differently for each practice," she said.

Dr. Donnelly said she had no relevant financial disclosures.

aotto@frontlinemedcom.com