ACOG 2012

SAN DIEGO – A year of using the experimental drug ospemifene for vulvar and vaginal atrophy produced no clinically significant estrogenic or adverse endometrial effects, compared with placebo in a study of 180 women.

Patients from an initial 12-week efficacy and safety study at 51 sites continued on the same blinded courses of 30 mg or 60 mg of ospemifene or placebo daily for up to 52 weeks in the long-term safety extension study.

After a year, endometrial thickness decreased slightly in the placebo group and increased slightly in the ospemifene groups by approximately 1 mm on average, Dr. Steven R. Goldstein and his associates reported at the annual meeting of the American College of Obstetricians and Gynecologists.

Endometrial biopsies in the 30-mg ospemifene group after 1 year showed atrophic, inactive, or insufficient endometrial tissue in approximately 95% of patients; weakly proliferative tissue in 2%; and atypical epithelial proliferation in 2%. In the 60-mg ospemifene group, 96% had atrophic, inactive, or insufficient endometrial tissue; 2% had weakly proliferative tissue; and 2% showed atrophic-type polyps. All biopsies in the placebo group showed atrophic, inactive, or insufficient endometrial tissue, said Dr. Goldstein, professor of ob.gyn. at New York University Langone Medical Center.

The category of "weakly proliferative" basically represents inactive atrophic endometrium with a few mitotic figures, and can be considered clinically to be in a category with atrophic, inactive, or insufficient tissue, he said.

Two patients in the 30-mg group and one in the 60-mg group developed vaginal bleeding or spotting. One had intermittent spotting, one had 2 days of bleeding, and the third had 4 days of bleeding. Endometrial biopsy results for all three were reported as atrophic.

The patients had no endometrial pathology at baseline biopsy. Forty patients discontinued treatment before 1 year, including 17% of the 60-mg group, 21% of the 30-mg group, and 31% of the placebo group, usually because of withdrawal of patient consent to continue. "This probably represents people who were upset with failure of efficacy" on placebo or low-dose ospemifene, he said.

There were no cases of endometrial hyperplasia or carcinoma. Although 2% of endometrial biopsy results were proliferative in the drug treatment groups, "the overwhelming majority of all endometrial tissue was atrophic or inactive," Dr. Goldstein said.

The findings echo results from a similar previous study in Europe that also found minimal endometrial impact – a 2% incidence of proliferative endometrium after 1 year, he noted (Menopause 2010;17:642-53).

Ospemifene is an investigational selective estrogen-receptor modulator (SERM). The incidence of proliferation with ospemifene (2%) compares favorably with a 3% rate of proliferation seen after 1 year in studies of raloxifene, another SERM, he said.

Only estrogens are approved in the United States for the treatment of moderate to severe vulvar or vaginal atrophy. The package insert for one clinically available low-dose estrogen vaginal tablet (Vagifem 10 mcg) lists the incidences of endometrial carcinoma and complex hyperplasia as approximately 1% each, he said.

Different SERMs have been shown to have different effects on the endometrium. Previous studies have reported estrogenic action in the vaginal epithelium from ospemifene use, prompting the current study.

Dr. Goldstein reported financial associations with Shionogi, which has applied for Food and Drug Administration approval for ospemifene, and with Amgen, Bayer, Cook Ob.Gyn., Eli Lilly, Novo Nordisk, Merck, Pfizer, Philips Ultrasound, and Warner Chilcott.

SAN DIEGO – A year of using the experimental drug ospemifene for vulvar and vaginal atrophy produced no clinically significant estrogenic or adverse endometrial effects, compared with placebo in a study of 180 women.

Patients from an initial 12-week efficacy and safety study at 51 sites continued on the same blinded courses of 30 mg or 60 mg of ospemifene or placebo daily for up to 52 weeks in the long-term safety extension study.

After a year, endometrial thickness decreased slightly in the placebo group and increased slightly in the ospemifene groups by approximately 1 mm on average, Dr. Steven R. Goldstein and his associates reported at the annual meeting of the American College of Obstetricians and Gynecologists.

Endometrial biopsies in the 30-mg ospemifene group after 1 year showed atrophic, inactive, or insufficient endometrial tissue in approximately 95% of patients; weakly proliferative tissue in 2%; and atypical epithelial proliferation in 2%. In the 60-mg ospemifene group, 96% had atrophic, inactive, or insufficient endometrial tissue; 2% had weakly proliferative tissue; and 2% showed atrophic-type polyps. All biopsies in the placebo group showed atrophic, inactive, or insufficient endometrial tissue, said Dr. Goldstein, professor of ob.gyn. at New York University Langone Medical Center.

The category of "weakly proliferative" basically represents inactive atrophic endometrium with a few mitotic figures, and can be considered clinically to be in a category with atrophic, inactive, or insufficient tissue, he said.

Two patients in the 30-mg group and one in the 60-mg group developed vaginal bleeding or spotting. One had intermittent spotting, one had 2 days of bleeding, and the third had 4 days of bleeding. Endometrial biopsy results for all three were reported as atrophic.

The patients had no endometrial pathology at baseline biopsy. Forty patients discontinued treatment before 1 year, including 17% of the 60-mg group, 21% of the 30-mg group, and 31% of the placebo group, usually because of withdrawal of patient consent to continue. "This probably represents people who were upset with failure of efficacy" on placebo or low-dose ospemifene, he said.

There were no cases of endometrial hyperplasia or carcinoma. Although 2% of endometrial biopsy results were proliferative in the drug treatment groups, "the overwhelming majority of all endometrial tissue was atrophic or inactive," Dr. Goldstein said.

The findings echo results from a similar previous study in Europe that also found minimal endometrial impact – a 2% incidence of proliferative endometrium after 1 year, he noted (Menopause 2010;17:642-53).

Ospemifene is an investigational selective estrogen-receptor modulator (SERM). The incidence of proliferation with ospemifene (2%) compares favorably with a 3% rate of proliferation seen after 1 year in studies of raloxifene, another SERM, he said.

Only estrogens are approved in the United States for the treatment of moderate to severe vulvar or vaginal atrophy. The package insert for one clinically available low-dose estrogen vaginal tablet (Vagifem 10 mcg) lists the incidences of endometrial carcinoma and complex hyperplasia as approximately 1% each, he said.

Different SERMs have been shown to have different effects on the endometrium. Previous studies have reported estrogenic action in the vaginal epithelium from ospemifene use, prompting the current study.

Dr. Goldstein reported financial associations with Shionogi, which has applied for Food and Drug Administration approval for ospemifene, and with Amgen, Bayer, Cook Ob.Gyn., Eli Lilly, Novo Nordisk, Merck, Pfizer, Philips Ultrasound, and Warner Chilcott.

SAN DIEGO – A year of using the experimental drug ospemifene for vulvar and vaginal atrophy produced no clinically significant estrogenic or adverse endometrial effects, compared with placebo in a study of 180 women.

Patients from an initial 12-week efficacy and safety study at 51 sites continued on the same blinded courses of 30 mg or 60 mg of ospemifene or placebo daily for up to 52 weeks in the long-term safety extension study.

After a year, endometrial thickness decreased slightly in the placebo group and increased slightly in the ospemifene groups by approximately 1 mm on average, Dr. Steven R. Goldstein and his associates reported at the annual meeting of the American College of Obstetricians and Gynecologists.

Endometrial biopsies in the 30-mg ospemifene group after 1 year showed atrophic, inactive, or insufficient endometrial tissue in approximately 95% of patients; weakly proliferative tissue in 2%; and atypical epithelial proliferation in 2%. In the 60-mg ospemifene group, 96% had atrophic, inactive, or insufficient endometrial tissue; 2% had weakly proliferative tissue; and 2% showed atrophic-type polyps. All biopsies in the placebo group showed atrophic, inactive, or insufficient endometrial tissue, said Dr. Goldstein, professor of ob.gyn. at New York University Langone Medical Center.

The category of "weakly proliferative" basically represents inactive atrophic endometrium with a few mitotic figures, and can be considered clinically to be in a category with atrophic, inactive, or insufficient tissue, he said.

Two patients in the 30-mg group and one in the 60-mg group developed vaginal bleeding or spotting. One had intermittent spotting, one had 2 days of bleeding, and the third had 4 days of bleeding. Endometrial biopsy results for all three were reported as atrophic.

The patients had no endometrial pathology at baseline biopsy. Forty patients discontinued treatment before 1 year, including 17% of the 60-mg group, 21% of the 30-mg group, and 31% of the placebo group, usually because of withdrawal of patient consent to continue. "This probably represents people who were upset with failure of efficacy" on placebo or low-dose ospemifene, he said.

There were no cases of endometrial hyperplasia or carcinoma. Although 2% of endometrial biopsy results were proliferative in the drug treatment groups, "the overwhelming majority of all endometrial tissue was atrophic or inactive," Dr. Goldstein said.

The findings echo results from a similar previous study in Europe that also found minimal endometrial impact – a 2% incidence of proliferative endometrium after 1 year, he noted (Menopause 2010;17:642-53).

Ospemifene is an investigational selective estrogen-receptor modulator (SERM). The incidence of proliferation with ospemifene (2%) compares favorably with a 3% rate of proliferation seen after 1 year in studies of raloxifene, another SERM, he said.

Only estrogens are approved in the United States for the treatment of moderate to severe vulvar or vaginal atrophy. The package insert for one clinically available low-dose estrogen vaginal tablet (Vagifem 10 mcg) lists the incidences of endometrial carcinoma and complex hyperplasia as approximately 1% each, he said.

Different SERMs have been shown to have different effects on the endometrium. Previous studies have reported estrogenic action in the vaginal epithelium from ospemifene use, prompting the current study.

Dr. Goldstein reported financial associations with Shionogi, which has applied for Food and Drug Administration approval for ospemifene, and with Amgen, Bayer, Cook Ob.Gyn., Eli Lilly, Novo Nordisk, Merck, Pfizer, Philips Ultrasound, and Warner Chilcott.

SAN DIEGO – Biometric findings on third-trimester ultrasound predicted increased risk for shoulder dystocia at term in a chart review of 132 pregnancies in women without diabetes.

The risk of shoulder dystocia doubled with every unit deviation from the mean for the ratio of femur length to head circumference and the ratio of head circumference to abdominal circumference, Dr. Stephanie M. Melka and her associates reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.

Other factors that independently predicted a statistically significant 4%-17% increased risk for shoulder dystocia at term included estimated fetal weight, femur length, abdominal circumference, and the ratio of femur length to biparietal diameter, reported Dr. Melka of Mount Sinai School of Medicine, New York.

The only standard measurements and ratios on prenatal ultrasound that were not significantly associated with increased risk for shoulder dystocia were head circumference and the ratio of femur length to abdominal circumference.

Several previous studies have shown that prenatal sonographic findings can predict shoulder dystocia at term in diabetic mothers, but this appears to be the first study of elective third-trimester sonography in low-risk nondiabetic women, the investigators noted.

The study identified 44 cases of shoulder dystocia during vaginal delivery at Mount Sinai in 2008-2009 in which the mothers underwent ultrasound examination early in the third trimester prior to 37 weeks. Each case was matched with two women who had a third-trimester ultrasound on the same day, for a total of 88 women in the control group.

The ratio of femur length to head circumference averaged 21 in the control group and 21.6 in the shoulder dystocia group. The ratio of head circumference to abdominal circumference averaged 1.05 in the control group and 1 in the dystocia group.

Biometric measurements and estimated fetal weight ascertained from third-trimester prenatal ultrasound can be used to counsel mothers on the risk for shoulder dystocia, the investigators concluded.

Other, classic risk factors for shoulder dystocia include maternal diabetes, obesity, a history of shoulder dystocia, and excessive weight gain during pregnancy.

The study did not control for the effects of obesity or weight gain on the risk for shoulder dystocia. It also did not assess the influence of differences in gestational age at the time of the sonograms.

Shoulder dystocia occurs in approximately 1% of all deliveries. Half of cases have been thought to be unpredictable.

Dr. Melka reported having no relevant financial disclosures.

SAN DIEGO – Biometric findings on third-trimester ultrasound predicted increased risk for shoulder dystocia at term in a chart review of 132 pregnancies in women without diabetes.

The risk of shoulder dystocia doubled with every unit deviation from the mean for the ratio of femur length to head circumference and the ratio of head circumference to abdominal circumference, Dr. Stephanie M. Melka and her associates reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.

Other factors that independently predicted a statistically significant 4%-17% increased risk for shoulder dystocia at term included estimated fetal weight, femur length, abdominal circumference, and the ratio of femur length to biparietal diameter, reported Dr. Melka of Mount Sinai School of Medicine, New York.

The only standard measurements and ratios on prenatal ultrasound that were not significantly associated with increased risk for shoulder dystocia were head circumference and the ratio of femur length to abdominal circumference.

Several previous studies have shown that prenatal sonographic findings can predict shoulder dystocia at term in diabetic mothers, but this appears to be the first study of elective third-trimester sonography in low-risk nondiabetic women, the investigators noted.

The study identified 44 cases of shoulder dystocia during vaginal delivery at Mount Sinai in 2008-2009 in which the mothers underwent ultrasound examination early in the third trimester prior to 37 weeks. Each case was matched with two women who had a third-trimester ultrasound on the same day, for a total of 88 women in the control group.

The ratio of femur length to head circumference averaged 21 in the control group and 21.6 in the shoulder dystocia group. The ratio of head circumference to abdominal circumference averaged 1.05 in the control group and 1 in the dystocia group.

Biometric measurements and estimated fetal weight ascertained from third-trimester prenatal ultrasound can be used to counsel mothers on the risk for shoulder dystocia, the investigators concluded.

Other, classic risk factors for shoulder dystocia include maternal diabetes, obesity, a history of shoulder dystocia, and excessive weight gain during pregnancy.

The study did not control for the effects of obesity or weight gain on the risk for shoulder dystocia. It also did not assess the influence of differences in gestational age at the time of the sonograms.

Shoulder dystocia occurs in approximately 1% of all deliveries. Half of cases have been thought to be unpredictable.

Dr. Melka reported having no relevant financial disclosures.

SAN DIEGO – Biometric findings on third-trimester ultrasound predicted increased risk for shoulder dystocia at term in a chart review of 132 pregnancies in women without diabetes.

The risk of shoulder dystocia doubled with every unit deviation from the mean for the ratio of femur length to head circumference and the ratio of head circumference to abdominal circumference, Dr. Stephanie M. Melka and her associates reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.

Other factors that independently predicted a statistically significant 4%-17% increased risk for shoulder dystocia at term included estimated fetal weight, femur length, abdominal circumference, and the ratio of femur length to biparietal diameter, reported Dr. Melka of Mount Sinai School of Medicine, New York.

The only standard measurements and ratios on prenatal ultrasound that were not significantly associated with increased risk for shoulder dystocia were head circumference and the ratio of femur length to abdominal circumference.

Several previous studies have shown that prenatal sonographic findings can predict shoulder dystocia at term in diabetic mothers, but this appears to be the first study of elective third-trimester sonography in low-risk nondiabetic women, the investigators noted.

The study identified 44 cases of shoulder dystocia during vaginal delivery at Mount Sinai in 2008-2009 in which the mothers underwent ultrasound examination early in the third trimester prior to 37 weeks. Each case was matched with two women who had a third-trimester ultrasound on the same day, for a total of 88 women in the control group.

The ratio of femur length to head circumference averaged 21 in the control group and 21.6 in the shoulder dystocia group. The ratio of head circumference to abdominal circumference averaged 1.05 in the control group and 1 in the dystocia group.

Biometric measurements and estimated fetal weight ascertained from third-trimester prenatal ultrasound can be used to counsel mothers on the risk for shoulder dystocia, the investigators concluded.

Other, classic risk factors for shoulder dystocia include maternal diabetes, obesity, a history of shoulder dystocia, and excessive weight gain during pregnancy.

The study did not control for the effects of obesity or weight gain on the risk for shoulder dystocia. It also did not assess the influence of differences in gestational age at the time of the sonograms.

Shoulder dystocia occurs in approximately 1% of all deliveries. Half of cases have been thought to be unpredictable.

Dr. Melka reported having no relevant financial disclosures.

SAN DIEGO – Focusing routine screening for Chlamydia trachomatis infection on women younger than 25 years may be inappropriate in some states in which older women are at significant risk for infection, an analysis of data from 326,601 tests suggest.

The 2010 guidelines on STDs by the Centers for Disease Control and Prevention recommend routine annual screening for chlamydia in sexually active females younger than 25 years and selective screening in older nonpregnant women with increased risk for infection, such as those with new or multiple sexual partners (MMWR 2010;59 [No. RR-12]).

Sherry Boschert/IMNG Medical Media

U.S. Preventive Services Task Force guidelines are similar, and recommend against routine screening in women aged 25 years or older unless they have risk factors for infection (Ann. Intern. Med. 2007;147:128-34).

Those guidelines emphasize age because infection rates drop off steeply after age 24 years, but chlamydia rates also vary significantly by region, race, and socioeconomic status, Dr. Mark G. Martens said at the annual meeting of the American College of Obstetricians and Gynecologists.

A retrospective analysis of routine screening tests sent to one microbiology laboratory found that seven states had infection rates of at least 2% in women aged 25 years and older, reported Dr. Martens of Jersey Shore University Medical Center, Neptune, N.J. and his associates.

Meanwhile, prevalence rates for females younger than 25 years were less than 2% in eight states (California, Connecticut, Idaho, Kansas, Maine, New Hampshire, North Carolina, and Washington) and Puerto Rico.

"Perhaps screening by age isn’t the best answer," he said. "Perhaps we should be screening women who are over 25 years of age in some states, but not in others." That may be difficult to do but warranted, he added.

Two percent of all the tests in the analysis were positive for C. trachomatis. The tests were submitted to Bio-Reference Laboratories from January 2010 through June 2011 from 40 states, Washington, and Puerto Rico. The patients tested consisted mainly of middle-class women seen in insured office practices.

Approximately 5% of the 105,921 tests in females under 25 years old were positive, compared with 1% of the 220,680 tests in older women. Those results are similar to findings from the studies on which the federal guidelines are based.

In women aged 25 years or older in the current study, at least 2% of tests were positive in Arkansas, Delaware, Minnesota, New Hampshire, New Mexico, Oregon, and Wisconsin – a rate twice as high as the 1% "cut-off" that federal guidelines used to decide against routine screening in this age group, Dr. Martens noted.

Positivity rates in those same states varied greatly for women younger than 25 years, ranging from 0% in New Hampshire to more than 11% in Arkansas.

The three states with the highest rates of C. trachomatis infection rates in females younger than 25 years were Arkansas (11.4% positive), Louisiana (10.5%) and Mississippi (10.5%).

Chlamydia is one of the most common sexually transmitted infections, with approximately 4 million U.S. cases per year. More than 50% of infected women are asymptomatic, with an ongoing reservoir for infection. If untreated, approximately 30% of infected women will develop pelvic inflammatory disease with upper genital tract involvement and serious sequelae such as chronic abdominal pain, ectopic pregnancy, and infertility. Recurrent and persistent chlamydia infections are common.

Dr. Martens has been a speaker and adviser for Bio-Reference Laboratories, which conducted the tests.

SAN DIEGO – Focusing routine screening for Chlamydia trachomatis infection on women younger than 25 years may be inappropriate in some states in which older women are at significant risk for infection, an analysis of data from 326,601 tests suggest.

The 2010 guidelines on STDs by the Centers for Disease Control and Prevention recommend routine annual screening for chlamydia in sexually active females younger than 25 years and selective screening in older nonpregnant women with increased risk for infection, such as those with new or multiple sexual partners (MMWR 2010;59 [No. RR-12]).

Sherry Boschert/IMNG Medical Media

U.S. Preventive Services Task Force guidelines are similar, and recommend against routine screening in women aged 25 years or older unless they have risk factors for infection (Ann. Intern. Med. 2007;147:128-34).

Those guidelines emphasize age because infection rates drop off steeply after age 24 years, but chlamydia rates also vary significantly by region, race, and socioeconomic status, Dr. Mark G. Martens said at the annual meeting of the American College of Obstetricians and Gynecologists.

A retrospective analysis of routine screening tests sent to one microbiology laboratory found that seven states had infection rates of at least 2% in women aged 25 years and older, reported Dr. Martens of Jersey Shore University Medical Center, Neptune, N.J. and his associates.

Meanwhile, prevalence rates for females younger than 25 years were less than 2% in eight states (California, Connecticut, Idaho, Kansas, Maine, New Hampshire, North Carolina, and Washington) and Puerto Rico.

"Perhaps screening by age isn’t the best answer," he said. "Perhaps we should be screening women who are over 25 years of age in some states, but not in others." That may be difficult to do but warranted, he added.

Two percent of all the tests in the analysis were positive for C. trachomatis. The tests were submitted to Bio-Reference Laboratories from January 2010 through June 2011 from 40 states, Washington, and Puerto Rico. The patients tested consisted mainly of middle-class women seen in insured office practices.

Approximately 5% of the 105,921 tests in females under 25 years old were positive, compared with 1% of the 220,680 tests in older women. Those results are similar to findings from the studies on which the federal guidelines are based.

In women aged 25 years or older in the current study, at least 2% of tests were positive in Arkansas, Delaware, Minnesota, New Hampshire, New Mexico, Oregon, and Wisconsin – a rate twice as high as the 1% "cut-off" that federal guidelines used to decide against routine screening in this age group, Dr. Martens noted.

Positivity rates in those same states varied greatly for women younger than 25 years, ranging from 0% in New Hampshire to more than 11% in Arkansas.

The three states with the highest rates of C. trachomatis infection rates in females younger than 25 years were Arkansas (11.4% positive), Louisiana (10.5%) and Mississippi (10.5%).

Chlamydia is one of the most common sexually transmitted infections, with approximately 4 million U.S. cases per year. More than 50% of infected women are asymptomatic, with an ongoing reservoir for infection. If untreated, approximately 30% of infected women will develop pelvic inflammatory disease with upper genital tract involvement and serious sequelae such as chronic abdominal pain, ectopic pregnancy, and infertility. Recurrent and persistent chlamydia infections are common.

Dr. Martens has been a speaker and adviser for Bio-Reference Laboratories, which conducted the tests.

SAN DIEGO – Focusing routine screening for Chlamydia trachomatis infection on women younger than 25 years may be inappropriate in some states in which older women are at significant risk for infection, an analysis of data from 326,601 tests suggest.

The 2010 guidelines on STDs by the Centers for Disease Control and Prevention recommend routine annual screening for chlamydia in sexually active females younger than 25 years and selective screening in older nonpregnant women with increased risk for infection, such as those with new or multiple sexual partners (MMWR 2010;59 [No. RR-12]).

Sherry Boschert/IMNG Medical Media

U.S. Preventive Services Task Force guidelines are similar, and recommend against routine screening in women aged 25 years or older unless they have risk factors for infection (Ann. Intern. Med. 2007;147:128-34).

Those guidelines emphasize age because infection rates drop off steeply after age 24 years, but chlamydia rates also vary significantly by region, race, and socioeconomic status, Dr. Mark G. Martens said at the annual meeting of the American College of Obstetricians and Gynecologists.

A retrospective analysis of routine screening tests sent to one microbiology laboratory found that seven states had infection rates of at least 2% in women aged 25 years and older, reported Dr. Martens of Jersey Shore University Medical Center, Neptune, N.J. and his associates.

Meanwhile, prevalence rates for females younger than 25 years were less than 2% in eight states (California, Connecticut, Idaho, Kansas, Maine, New Hampshire, North Carolina, and Washington) and Puerto Rico.

"Perhaps screening by age isn’t the best answer," he said. "Perhaps we should be screening women who are over 25 years of age in some states, but not in others." That may be difficult to do but warranted, he added.

Two percent of all the tests in the analysis were positive for C. trachomatis. The tests were submitted to Bio-Reference Laboratories from January 2010 through June 2011 from 40 states, Washington, and Puerto Rico. The patients tested consisted mainly of middle-class women seen in insured office practices.

Approximately 5% of the 105,921 tests in females under 25 years old were positive, compared with 1% of the 220,680 tests in older women. Those results are similar to findings from the studies on which the federal guidelines are based.

In women aged 25 years or older in the current study, at least 2% of tests were positive in Arkansas, Delaware, Minnesota, New Hampshire, New Mexico, Oregon, and Wisconsin – a rate twice as high as the 1% "cut-off" that federal guidelines used to decide against routine screening in this age group, Dr. Martens noted.

Positivity rates in those same states varied greatly for women younger than 25 years, ranging from 0% in New Hampshire to more than 11% in Arkansas.

The three states with the highest rates of C. trachomatis infection rates in females younger than 25 years were Arkansas (11.4% positive), Louisiana (10.5%) and Mississippi (10.5%).

Chlamydia is one of the most common sexually transmitted infections, with approximately 4 million U.S. cases per year. More than 50% of infected women are asymptomatic, with an ongoing reservoir for infection. If untreated, approximately 30% of infected women will develop pelvic inflammatory disease with upper genital tract involvement and serious sequelae such as chronic abdominal pain, ectopic pregnancy, and infertility. Recurrent and persistent chlamydia infections are common.

Dr. Martens has been a speaker and adviser for Bio-Reference Laboratories, which conducted the tests.

SAN DIEGO – Mandating circumcision in the United States would prevent 24 more cases of HIV than does the traditional optional approach to circumcision, but would increase costs by approximately $389 million, making it far less cost effective, an analysis of published data suggests.

The investigators assumed that the overall incidence of HIV in the United States is 27 cases/100,000 people and the lifetime cost of care for someone with HIV is $119,000, based on published data from government statistics and peer-reviewed studies. Using the $392 cost of a circumcision at their institution, they developed computer-generated estimates of the cost-effectiveness of mandatory or traditional circumcision strategies for various populations, said Dr. Sarah E. Drennan, a third-year resident in ob.gyn. at Ochsner Medical Center, New Orleans.

Sherry Boschert/IMNG Medical Media

For the overall U.S. population, mandatory circumcision would prevent 494 cases of HIV at a cost of approximately $790 million. Traditional circumcision – in which the parents choose whether or not to circumcise a newborn – would prevent 470 cases of HIV at a cost of approximately $401 million, she reported at the annual meeting of the American College of Obstetricians and Gynecologists.

The idea of mandatory circumcision policies in the United States has come up because of randomized, controlled trials in Africa showing that male circumcision reduces the risk of female-to-male transmission of HIV by 50%-60%, Dr. Drennan said.

She and coinvestigator Dr. Rajiv Gala, also of the Ochsner Medical Center, conducted the current analysis to account for key differences between the two geographical regions. HIV is spread mainly through heterosexual contact in Africa and by intravenous drug use or men having sex with men in the United States. The prevalence of HIV is 5% in sub-Saharan Africa and 0.6% in North America

The study also compared the two strategies in the United States among African American and Hispanic populations, who have lower rates of circumcision and a higher prevalence of HIV, compared with the population as a whole. Traditional circumcision was the more cost-effective strategy in those subgroups too, although not as strongly as in the population as a whole, she said.

For African Americans, mandatory circumcision would prevent 1,878 cases of HIV at a cost of approximately $816 million. Traditional circumcision would prevent 1,807 cases of HIV at a cost of approximately $613 million.

For Hispanics, mandatory circumcision would prevent 472 cases of HIV at a cost of approximately $792 million. Traditional circumcision would prevent 435 cases of HIV at a cost of approximately $342 million.

"Given the U.S. incidence of HIV, recommendations for mandatory circumcision are not supported" and require more U.S. studies on the role of circumcision in HIV prevention, Dr. Drennan said.

Circumcision would have to cost a mere $2.90 for the two strategies to be equally cost effective in the overall population, she said. The price of circumcision would need to be no more than $3.80 for Hispanics or $15.50 for African Americans for the two strategies to be equally cost effective in those subgroups.

Alternatively, the lifetime cost of HIV would need to be $15 million/case for the two circumcision strategies to be equally cost effective in the general population.

The topic has generated controversy in recent years as the Centers for Disease Control and Prevention was said to be considering recommendations promoting routine circumcision for HIV prevention. The CDC still is considering what might be recommended, but any recommendations will be voluntary in nature, according to the CDC website.

The analysis was limited by a lack of data from randomized clinical trials and by the subjective nature of measuring behavioral risk, she said. The study also did not consider adverse events associated with circumcision or other health benefits other than prevention of HIV.

Dr. Drennan reported having no relevant financial disclosures.

SAN DIEGO – Mandating circumcision in the United States would prevent 24 more cases of HIV than does the traditional optional approach to circumcision, but would increase costs by approximately $389 million, making it far less cost effective, an analysis of published data suggests.

The investigators assumed that the overall incidence of HIV in the United States is 27 cases/100,000 people and the lifetime cost of care for someone with HIV is $119,000, based on published data from government statistics and peer-reviewed studies. Using the $392 cost of a circumcision at their institution, they developed computer-generated estimates of the cost-effectiveness of mandatory or traditional circumcision strategies for various populations, said Dr. Sarah E. Drennan, a third-year resident in ob.gyn. at Ochsner Medical Center, New Orleans.

Sherry Boschert/IMNG Medical Media

For the overall U.S. population, mandatory circumcision would prevent 494 cases of HIV at a cost of approximately $790 million. Traditional circumcision – in which the parents choose whether or not to circumcise a newborn – would prevent 470 cases of HIV at a cost of approximately $401 million, she reported at the annual meeting of the American College of Obstetricians and Gynecologists.

The idea of mandatory circumcision policies in the United States has come up because of randomized, controlled trials in Africa showing that male circumcision reduces the risk of female-to-male transmission of HIV by 50%-60%, Dr. Drennan said.

She and coinvestigator Dr. Rajiv Gala, also of the Ochsner Medical Center, conducted the current analysis to account for key differences between the two geographical regions. HIV is spread mainly through heterosexual contact in Africa and by intravenous drug use or men having sex with men in the United States. The prevalence of HIV is 5% in sub-Saharan Africa and 0.6% in North America

The study also compared the two strategies in the United States among African American and Hispanic populations, who have lower rates of circumcision and a higher prevalence of HIV, compared with the population as a whole. Traditional circumcision was the more cost-effective strategy in those subgroups too, although not as strongly as in the population as a whole, she said.

For African Americans, mandatory circumcision would prevent 1,878 cases of HIV at a cost of approximately $816 million. Traditional circumcision would prevent 1,807 cases of HIV at a cost of approximately $613 million.

For Hispanics, mandatory circumcision would prevent 472 cases of HIV at a cost of approximately $792 million. Traditional circumcision would prevent 435 cases of HIV at a cost of approximately $342 million.

"Given the U.S. incidence of HIV, recommendations for mandatory circumcision are not supported" and require more U.S. studies on the role of circumcision in HIV prevention, Dr. Drennan said.

Circumcision would have to cost a mere $2.90 for the two strategies to be equally cost effective in the overall population, she said. The price of circumcision would need to be no more than $3.80 for Hispanics or $15.50 for African Americans for the two strategies to be equally cost effective in those subgroups.

Alternatively, the lifetime cost of HIV would need to be $15 million/case for the two circumcision strategies to be equally cost effective in the general population.

The topic has generated controversy in recent years as the Centers for Disease Control and Prevention was said to be considering recommendations promoting routine circumcision for HIV prevention. The CDC still is considering what might be recommended, but any recommendations will be voluntary in nature, according to the CDC website.

The analysis was limited by a lack of data from randomized clinical trials and by the subjective nature of measuring behavioral risk, she said. The study also did not consider adverse events associated with circumcision or other health benefits other than prevention of HIV.

Dr. Drennan reported having no relevant financial disclosures.

SAN DIEGO – Mandating circumcision in the United States would prevent 24 more cases of HIV than does the traditional optional approach to circumcision, but would increase costs by approximately $389 million, making it far less cost effective, an analysis of published data suggests.

The investigators assumed that the overall incidence of HIV in the United States is 27 cases/100,000 people and the lifetime cost of care for someone with HIV is $119,000, based on published data from government statistics and peer-reviewed studies. Using the $392 cost of a circumcision at their institution, they developed computer-generated estimates of the cost-effectiveness of mandatory or traditional circumcision strategies for various populations, said Dr. Sarah E. Drennan, a third-year resident in ob.gyn. at Ochsner Medical Center, New Orleans.

Sherry Boschert/IMNG Medical Media

For the overall U.S. population, mandatory circumcision would prevent 494 cases of HIV at a cost of approximately $790 million. Traditional circumcision – in which the parents choose whether or not to circumcise a newborn – would prevent 470 cases of HIV at a cost of approximately $401 million, she reported at the annual meeting of the American College of Obstetricians and Gynecologists.

The idea of mandatory circumcision policies in the United States has come up because of randomized, controlled trials in Africa showing that male circumcision reduces the risk of female-to-male transmission of HIV by 50%-60%, Dr. Drennan said.

She and coinvestigator Dr. Rajiv Gala, also of the Ochsner Medical Center, conducted the current analysis to account for key differences between the two geographical regions. HIV is spread mainly through heterosexual contact in Africa and by intravenous drug use or men having sex with men in the United States. The prevalence of HIV is 5% in sub-Saharan Africa and 0.6% in North America

The study also compared the two strategies in the United States among African American and Hispanic populations, who have lower rates of circumcision and a higher prevalence of HIV, compared with the population as a whole. Traditional circumcision was the more cost-effective strategy in those subgroups too, although not as strongly as in the population as a whole, she said.

For African Americans, mandatory circumcision would prevent 1,878 cases of HIV at a cost of approximately $816 million. Traditional circumcision would prevent 1,807 cases of HIV at a cost of approximately $613 million.

For Hispanics, mandatory circumcision would prevent 472 cases of HIV at a cost of approximately $792 million. Traditional circumcision would prevent 435 cases of HIV at a cost of approximately $342 million.

"Given the U.S. incidence of HIV, recommendations for mandatory circumcision are not supported" and require more U.S. studies on the role of circumcision in HIV prevention, Dr. Drennan said.

Circumcision would have to cost a mere $2.90 for the two strategies to be equally cost effective in the overall population, she said. The price of circumcision would need to be no more than $3.80 for Hispanics or $15.50 for African Americans for the two strategies to be equally cost effective in those subgroups.

Alternatively, the lifetime cost of HIV would need to be $15 million/case for the two circumcision strategies to be equally cost effective in the general population.

The topic has generated controversy in recent years as the Centers for Disease Control and Prevention was said to be considering recommendations promoting routine circumcision for HIV prevention. The CDC still is considering what might be recommended, but any recommendations will be voluntary in nature, according to the CDC website.

The analysis was limited by a lack of data from randomized clinical trials and by the subjective nature of measuring behavioral risk, she said. The study also did not consider adverse events associated with circumcision or other health benefits other than prevention of HIV.

Dr. Drennan reported having no relevant financial disclosures.

SAN DIEGO – The risk of C-section doubled in women undergoing induction of labor who received an epidural before 4 -cm dilation, compared with later epidural administration, a retrospective study found.

In 281 singleton pregnancies at gestational ages greater than 36 weeks that underwent induction of labor from 2008 to 2009 at one institution, 83% of mothers received an epidural. The C-section rate was significantly higher among the 233 women who received an epidural, compared with the 48 women who did not get an epidural – 30% vs. 8%.

In unadjusted results for women who got an epidural, "early" administration before 4-cm dilation was associated with a 38% chance of C-section, compared with a 24% C-section rate with "late" epidural administration when dilation reached at least 4 cm, Monica Rincon and her associates reported at the annual meeting of the American College of Obstetricians and Gynecologists.

After adjusting for the effects of age, race, body mass index (BMI), parity, and Bishop score, the risk for C-section was doubled with early vs. late epidural, said Ms. Rincon, a senior research assistant in the women’s health research unit at Oregon Health and Science University, Portland.

A non-reassuring fetal heart tracing was significantly more likely to be an indication for C-section in the early epidural group (18%), compared with the late epidural group (9%). Arrest of labor was the indication for C-section in 25% of the early epidural group and 21% of the late epidural group, which was not a statistically significant difference, she said.

Women in the early epidural group were significantly more likely to be white (80%), compared with the late epidural group (66%).

Several other factors besides timing of the epidural were associated with significantly increased risk for C-section after adjusting for confounders. The risk doubled with a Bishop score less than 5 at the time of admission, compared with higher Bishop scores. Maternal age of at least 35 years tripled the risk for C-section, compared with younger age. The risk for C-section quadrupled with a body mass index of at least 30 kg/m², compared with lower BMI. Nonwhite women had a fivefold increased risk for C-section, compared with white women. Nulliparous women had a 13-fold increased risk for C-section, compared with multiparous women.

The early and late epidural groups did not differ significantly by age, BMI, gestational age, birth weight, reason for induction of labor, or the proportions of women who were nulliparous or who had a Bishop score greater than 5 at admission.

Among all 281 deliveries (including those without an epidural), 68% were spontaneous vaginal deliveries, 6% were assisted vaginal deliveries, 8% were C-sections for non-reassuring fetal heart tracings, and 18% were C-sections because of arrest of labor.

Approximately 22% of U.S. labors in 2006 were induced, Ms. Rincon said. Previous studies of nulliparous women have shown a higher rate of C-section after labor induction, compared with spontaneous labor. Studies of multiparous women with induced labor provide conflicting results for the risk of C-section, with some reporting no increase in risk of C-section and others reporting increased C-section rates.

Among 2,231 deliveries in 2011 at Oregon Health and Science University, 41% involved labor induction, 56% used an epidural, and 27% were C-section deliveries, she said.

The current study excluded twin deliveries, vaginal births after C-section deliveries, and patients whose epidural status was unknown.

Ms. Rincon reported having no financial disclosures.

SAN DIEGO – The risk of C-section doubled in women undergoing induction of labor who received an epidural before 4 -cm dilation, compared with later epidural administration, a retrospective study found.

In 281 singleton pregnancies at gestational ages greater than 36 weeks that underwent induction of labor from 2008 to 2009 at one institution, 83% of mothers received an epidural. The C-section rate was significantly higher among the 233 women who received an epidural, compared with the 48 women who did not get an epidural – 30% vs. 8%.

In unadjusted results for women who got an epidural, "early" administration before 4-cm dilation was associated with a 38% chance of C-section, compared with a 24% C-section rate with "late" epidural administration when dilation reached at least 4 cm, Monica Rincon and her associates reported at the annual meeting of the American College of Obstetricians and Gynecologists.

After adjusting for the effects of age, race, body mass index (BMI), parity, and Bishop score, the risk for C-section was doubled with early vs. late epidural, said Ms. Rincon, a senior research assistant in the women’s health research unit at Oregon Health and Science University, Portland.

A non-reassuring fetal heart tracing was significantly more likely to be an indication for C-section in the early epidural group (18%), compared with the late epidural group (9%). Arrest of labor was the indication for C-section in 25% of the early epidural group and 21% of the late epidural group, which was not a statistically significant difference, she said.

Women in the early epidural group were significantly more likely to be white (80%), compared with the late epidural group (66%).

Several other factors besides timing of the epidural were associated with significantly increased risk for C-section after adjusting for confounders. The risk doubled with a Bishop score less than 5 at the time of admission, compared with higher Bishop scores. Maternal age of at least 35 years tripled the risk for C-section, compared with younger age. The risk for C-section quadrupled with a body mass index of at least 30 kg/m², compared with lower BMI. Nonwhite women had a fivefold increased risk for C-section, compared with white women. Nulliparous women had a 13-fold increased risk for C-section, compared with multiparous women.

The early and late epidural groups did not differ significantly by age, BMI, gestational age, birth weight, reason for induction of labor, or the proportions of women who were nulliparous or who had a Bishop score greater than 5 at admission.

Among all 281 deliveries (including those without an epidural), 68% were spontaneous vaginal deliveries, 6% were assisted vaginal deliveries, 8% were C-sections for non-reassuring fetal heart tracings, and 18% were C-sections because of arrest of labor.

Approximately 22% of U.S. labors in 2006 were induced, Ms. Rincon said. Previous studies of nulliparous women have shown a higher rate of C-section after labor induction, compared with spontaneous labor. Studies of multiparous women with induced labor provide conflicting results for the risk of C-section, with some reporting no increase in risk of C-section and others reporting increased C-section rates.

Among 2,231 deliveries in 2011 at Oregon Health and Science University, 41% involved labor induction, 56% used an epidural, and 27% were C-section deliveries, she said.

The current study excluded twin deliveries, vaginal births after C-section deliveries, and patients whose epidural status was unknown.

Ms. Rincon reported having no financial disclosures.

SAN DIEGO – The risk of C-section doubled in women undergoing induction of labor who received an epidural before 4 -cm dilation, compared with later epidural administration, a retrospective study found.

In 281 singleton pregnancies at gestational ages greater than 36 weeks that underwent induction of labor from 2008 to 2009 at one institution, 83% of mothers received an epidural. The C-section rate was significantly higher among the 233 women who received an epidural, compared with the 48 women who did not get an epidural – 30% vs. 8%.

In unadjusted results for women who got an epidural, "early" administration before 4-cm dilation was associated with a 38% chance of C-section, compared with a 24% C-section rate with "late" epidural administration when dilation reached at least 4 cm, Monica Rincon and her associates reported at the annual meeting of the American College of Obstetricians and Gynecologists.

After adjusting for the effects of age, race, body mass index (BMI), parity, and Bishop score, the risk for C-section was doubled with early vs. late epidural, said Ms. Rincon, a senior research assistant in the women’s health research unit at Oregon Health and Science University, Portland.

A non-reassuring fetal heart tracing was significantly more likely to be an indication for C-section in the early epidural group (18%), compared with the late epidural group (9%). Arrest of labor was the indication for C-section in 25% of the early epidural group and 21% of the late epidural group, which was not a statistically significant difference, she said.

Women in the early epidural group were significantly more likely to be white (80%), compared with the late epidural group (66%).

Several other factors besides timing of the epidural were associated with significantly increased risk for C-section after adjusting for confounders. The risk doubled with a Bishop score less than 5 at the time of admission, compared with higher Bishop scores. Maternal age of at least 35 years tripled the risk for C-section, compared with younger age. The risk for C-section quadrupled with a body mass index of at least 30 kg/m², compared with lower BMI. Nonwhite women had a fivefold increased risk for C-section, compared with white women. Nulliparous women had a 13-fold increased risk for C-section, compared with multiparous women.

The early and late epidural groups did not differ significantly by age, BMI, gestational age, birth weight, reason for induction of labor, or the proportions of women who were nulliparous or who had a Bishop score greater than 5 at admission.

Among all 281 deliveries (including those without an epidural), 68% were spontaneous vaginal deliveries, 6% were assisted vaginal deliveries, 8% were C-sections for non-reassuring fetal heart tracings, and 18% were C-sections because of arrest of labor.

Approximately 22% of U.S. labors in 2006 were induced, Ms. Rincon said. Previous studies of nulliparous women have shown a higher rate of C-section after labor induction, compared with spontaneous labor. Studies of multiparous women with induced labor provide conflicting results for the risk of C-section, with some reporting no increase in risk of C-section and others reporting increased C-section rates.

Among 2,231 deliveries in 2011 at Oregon Health and Science University, 41% involved labor induction, 56% used an epidural, and 27% were C-section deliveries, she said.

The current study excluded twin deliveries, vaginal births after C-section deliveries, and patients whose epidural status was unknown.

Ms. Rincon reported having no financial disclosures.

SAN DIEGO – Oral tranexamic acid tablets at a dose of up to 3.9 g/day reduced blood loss by a mean of at least 60-65 mL per menstrual period in women aged 30 or older with heavy menstrual bleeding, a pooled analysis of two pivotal trials found.

Dr. Jeffrey B. Baker and his associates analyzed data for 383 women from the two randomized, double-blind, placebo-controlled studies who were randomized to either a 3.9-g/day group or placebo. One study also included a treatment arm using 1.95 g/day of tranexamic acid (Lysteda), but that dosage did not reduce menstrual bleeding by at least 50 mL, the minimum required by the Food and Drug Administration to show a significant difference, he said at the annual meeting of the American College of Obstetricians and Gynecologists.

In November 2010, the FDA approved the 3.9 g/day dosage of Lysteda to treat heavy menstrual bleeding based on results from the pivotal trials (Obstet. Gynecol. 2010;116:865-75; Am. J. Obstet. Gynecol. 2011;205:319.e1-7).

Women who were randomized to the 3.9 g/day groups took the drug for up to 5 days per menstrual cycle for either three or six menstrual cycles, depending on the study. They could decide to take it for no days or for up to 5 days in any one cycle; they averaged 2.5 days of the medication per cycle.

In the current analysis of data pooled from both studies, reductions in menstrual blood loss tended to be greater with increasing patient age. Women younger than 30 years had a mean reduction in menstrual blood loss of approximately 40 mL, below the desired 50-mL threshold. A 60- to 65-mL reduction in bleeding was seen in women in age groups of 30-34 years, 35-39 years, and 40-49 years. The reduction in blood loss in women aged 45 years or older averaged more than 80 mL per period, said Dr. Baker, an ob.gyn. and clinical researcher in private practice in Idaho Falls, Idaho.

For women on placebo in those age groups, the mean change in menstrual blood loss ranged from an approximately 10-mL reduction to slight increases in blood loss.

"What tranexamic acid offers to clinicians and patients is another tool amongst the many tools that are available for heavy menstrual bleeding," he said.

Some of the available hormonal treatments for heavy menstrual bleeding, such as the Mirena IUD, also act as contraceptives. Lysteda is a nonhormonal lysine analog that acts as a competitive plasmin inhibitor; it is not a contraceptive. The studies excluded the use of any hormonal products that might compromise the effectiveness of Lysteda, so women used barrier techniques, tubal ligations, or vasectomies for birth control, he said.

Women with fibroids saw a slightly greater reduction in menstrual blood loss, compared with those without fibroids (approximately 75 mL and 60 mL, respectively). Women with a body mass index less than 25 kg/m² had an approximately 75-mL reduction in blood loss, compared with approximately 65-mL reductions for women in two other BMI categories (25-29, or 30 or greater).

Treatment-emergent serious adverse events in the 3.9-g/day groups included tachycardia in one woman, low blood sugar in one woman, severe ovarian torsion in one woman, and complaints of severe dyspepsia, severe gastritis, and severe chest pain in one woman. The investigators considered these to be unrelated to treatment.

Four women in the 3.9-g/day groups withdrew from the studies. The reasons given were mild myalgias, elevated FSH level, rash, or palpitations, each of which resolved by the time of the follow-up visit.

The most common adverse events in the Lysteda groups were upper respiratory infection (7%), musculoskeletal pain (5%), and myalgia (5%) in one study, and headache (11%), nausea (10%), and menstrual discomfort (8%) in the other study. Most adverse events were mild to moderate in severity. The Lysteda and placebo groups did not differ significantly in treatment-emergent adverse events.

In response to a question from the audience, Dr. Baker said that the studies did not screen patients for underlying thrombophilias.

The studies included adult women with no abnormal findings on pelvic examination as well as normal cervical cytology results and normal findings on transvaginal ultrasound. Women with fibroids or simple ovarian cysts were allowed to participate. The studies excluded women with severe anemia or other identifiable causes of abnormal menstrual bleeding.

Two previous studies found that tranexamic acid reduced menstrual blood loss in women with heavy menstrual bleeding, Dr. Baker noted (Acta Obstet. Gynecol. Scand. 1994;73:274-7; Drugs 2003;63:1417-33).

Ferring Pharmaceuticals, which markets Lysteda, funded the study. Dr. Baker has been a speaker and advisor for Ferring. One of his coinvestigators is an employee of Ferring, and the other has been a speaker and advisor for Ferring and a consultant or researcher for multiple other companies.

SAN DIEGO – Oral tranexamic acid tablets at a dose of up to 3.9 g/day reduced blood loss by a mean of at least 60-65 mL per menstrual period in women aged 30 or older with heavy menstrual bleeding, a pooled analysis of two pivotal trials found.

Dr. Jeffrey B. Baker and his associates analyzed data for 383 women from the two randomized, double-blind, placebo-controlled studies who were randomized to either a 3.9-g/day group or placebo. One study also included a treatment arm using 1.95 g/day of tranexamic acid (Lysteda), but that dosage did not reduce menstrual bleeding by at least 50 mL, the minimum required by the Food and Drug Administration to show a significant difference, he said at the annual meeting of the American College of Obstetricians and Gynecologists.

In November 2010, the FDA approved the 3.9 g/day dosage of Lysteda to treat heavy menstrual bleeding based on results from the pivotal trials (Obstet. Gynecol. 2010;116:865-75; Am. J. Obstet. Gynecol. 2011;205:319.e1-7).

Women who were randomized to the 3.9 g/day groups took the drug for up to 5 days per menstrual cycle for either three or six menstrual cycles, depending on the study. They could decide to take it for no days or for up to 5 days in any one cycle; they averaged 2.5 days of the medication per cycle.

In the current analysis of data pooled from both studies, reductions in menstrual blood loss tended to be greater with increasing patient age. Women younger than 30 years had a mean reduction in menstrual blood loss of approximately 40 mL, below the desired 50-mL threshold. A 60- to 65-mL reduction in bleeding was seen in women in age groups of 30-34 years, 35-39 years, and 40-49 years. The reduction in blood loss in women aged 45 years or older averaged more than 80 mL per period, said Dr. Baker, an ob.gyn. and clinical researcher in private practice in Idaho Falls, Idaho.

For women on placebo in those age groups, the mean change in menstrual blood loss ranged from an approximately 10-mL reduction to slight increases in blood loss.

"What tranexamic acid offers to clinicians and patients is another tool amongst the many tools that are available for heavy menstrual bleeding," he said.

Some of the available hormonal treatments for heavy menstrual bleeding, such as the Mirena IUD, also act as contraceptives. Lysteda is a nonhormonal lysine analog that acts as a competitive plasmin inhibitor; it is not a contraceptive. The studies excluded the use of any hormonal products that might compromise the effectiveness of Lysteda, so women used barrier techniques, tubal ligations, or vasectomies for birth control, he said.

Women with fibroids saw a slightly greater reduction in menstrual blood loss, compared with those without fibroids (approximately 75 mL and 60 mL, respectively). Women with a body mass index less than 25 kg/m² had an approximately 75-mL reduction in blood loss, compared with approximately 65-mL reductions for women in two other BMI categories (25-29, or 30 or greater).

Treatment-emergent serious adverse events in the 3.9-g/day groups included tachycardia in one woman, low blood sugar in one woman, severe ovarian torsion in one woman, and complaints of severe dyspepsia, severe gastritis, and severe chest pain in one woman. The investigators considered these to be unrelated to treatment.

Four women in the 3.9-g/day groups withdrew from the studies. The reasons given were mild myalgias, elevated FSH level, rash, or palpitations, each of which resolved by the time of the follow-up visit.

The most common adverse events in the Lysteda groups were upper respiratory infection (7%), musculoskeletal pain (5%), and myalgia (5%) in one study, and headache (11%), nausea (10%), and menstrual discomfort (8%) in the other study. Most adverse events were mild to moderate in severity. The Lysteda and placebo groups did not differ significantly in treatment-emergent adverse events.

In response to a question from the audience, Dr. Baker said that the studies did not screen patients for underlying thrombophilias.

The studies included adult women with no abnormal findings on pelvic examination as well as normal cervical cytology results and normal findings on transvaginal ultrasound. Women with fibroids or simple ovarian cysts were allowed to participate. The studies excluded women with severe anemia or other identifiable causes of abnormal menstrual bleeding.

Two previous studies found that tranexamic acid reduced menstrual blood loss in women with heavy menstrual bleeding, Dr. Baker noted (Acta Obstet. Gynecol. Scand. 1994;73:274-7; Drugs 2003;63:1417-33).

Ferring Pharmaceuticals, which markets Lysteda, funded the study. Dr. Baker has been a speaker and advisor for Ferring. One of his coinvestigators is an employee of Ferring, and the other has been a speaker and advisor for Ferring and a consultant or researcher for multiple other companies.

SAN DIEGO – Oral tranexamic acid tablets at a dose of up to 3.9 g/day reduced blood loss by a mean of at least 60-65 mL per menstrual period in women aged 30 or older with heavy menstrual bleeding, a pooled analysis of two pivotal trials found.

Dr. Jeffrey B. Baker and his associates analyzed data for 383 women from the two randomized, double-blind, placebo-controlled studies who were randomized to either a 3.9-g/day group or placebo. One study also included a treatment arm using 1.95 g/day of tranexamic acid (Lysteda), but that dosage did not reduce menstrual bleeding by at least 50 mL, the minimum required by the Food and Drug Administration to show a significant difference, he said at the annual meeting of the American College of Obstetricians and Gynecologists.

In November 2010, the FDA approved the 3.9 g/day dosage of Lysteda to treat heavy menstrual bleeding based on results from the pivotal trials (Obstet. Gynecol. 2010;116:865-75; Am. J. Obstet. Gynecol. 2011;205:319.e1-7).

Women who were randomized to the 3.9 g/day groups took the drug for up to 5 days per menstrual cycle for either three or six menstrual cycles, depending on the study. They could decide to take it for no days or for up to 5 days in any one cycle; they averaged 2.5 days of the medication per cycle.

In the current analysis of data pooled from both studies, reductions in menstrual blood loss tended to be greater with increasing patient age. Women younger than 30 years had a mean reduction in menstrual blood loss of approximately 40 mL, below the desired 50-mL threshold. A 60- to 65-mL reduction in bleeding was seen in women in age groups of 30-34 years, 35-39 years, and 40-49 years. The reduction in blood loss in women aged 45 years or older averaged more than 80 mL per period, said Dr. Baker, an ob.gyn. and clinical researcher in private practice in Idaho Falls, Idaho.

For women on placebo in those age groups, the mean change in menstrual blood loss ranged from an approximately 10-mL reduction to slight increases in blood loss.

"What tranexamic acid offers to clinicians and patients is another tool amongst the many tools that are available for heavy menstrual bleeding," he said.

Some of the available hormonal treatments for heavy menstrual bleeding, such as the Mirena IUD, also act as contraceptives. Lysteda is a nonhormonal lysine analog that acts as a competitive plasmin inhibitor; it is not a contraceptive. The studies excluded the use of any hormonal products that might compromise the effectiveness of Lysteda, so women used barrier techniques, tubal ligations, or vasectomies for birth control, he said.

Women with fibroids saw a slightly greater reduction in menstrual blood loss, compared with those without fibroids (approximately 75 mL and 60 mL, respectively). Women with a body mass index less than 25 kg/m² had an approximately 75-mL reduction in blood loss, compared with approximately 65-mL reductions for women in two other BMI categories (25-29, or 30 or greater).

Treatment-emergent serious adverse events in the 3.9-g/day groups included tachycardia in one woman, low blood sugar in one woman, severe ovarian torsion in one woman, and complaints of severe dyspepsia, severe gastritis, and severe chest pain in one woman. The investigators considered these to be unrelated to treatment.

Four women in the 3.9-g/day groups withdrew from the studies. The reasons given were mild myalgias, elevated FSH level, rash, or palpitations, each of which resolved by the time of the follow-up visit.

The most common adverse events in the Lysteda groups were upper respiratory infection (7%), musculoskeletal pain (5%), and myalgia (5%) in one study, and headache (11%), nausea (10%), and menstrual discomfort (8%) in the other study. Most adverse events were mild to moderate in severity. The Lysteda and placebo groups did not differ significantly in treatment-emergent adverse events.

In response to a question from the audience, Dr. Baker said that the studies did not screen patients for underlying thrombophilias.

The studies included adult women with no abnormal findings on pelvic examination as well as normal cervical cytology results and normal findings on transvaginal ultrasound. Women with fibroids or simple ovarian cysts were allowed to participate. The studies excluded women with severe anemia or other identifiable causes of abnormal menstrual bleeding.

Two previous studies found that tranexamic acid reduced menstrual blood loss in women with heavy menstrual bleeding, Dr. Baker noted (Acta Obstet. Gynecol. Scand. 1994;73:274-7; Drugs 2003;63:1417-33).

Ferring Pharmaceuticals, which markets Lysteda, funded the study. Dr. Baker has been a speaker and advisor for Ferring. One of his coinvestigators is an employee of Ferring, and the other has been a speaker and advisor for Ferring and a consultant or researcher for multiple other companies.

SAN DIEGO – Women expelled 54% of intrauterine devices placed immediately after giving birth, compared with a 6% expulsion rate after conventional placement at 6 weeks post partum or later, a study of an indigent population found.

The expulsion rate in the immediate-placement group (12 of 22 women) was significantly higher than when the levonorgestrel-containing intrauterine device (the Mirena IUD) was placed 6 weeks postpartum or later (1 of 18 women). The finding suggests that the immediate-placement strategy is prohibitively expensive, Dr. Tiffany D. Justice and her associates reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.

Photo courtesy Mirena-US.com

Immediate placement after delivery might be acceptable for women who are nearly certain to not return for follow-up visits after delivery, but even in those cases, a different long-acting reversible contraceptive such as a progesterone-containing implant might make more sense, said Dr. Justice, an ob.gyn. specializing in reproductive endocrinology and infertility at the University of Louisville, Ky.

The study randomized women who desired contraception after delivery in a university-based prenatal obstetrics clinic that primarily serves the indigent. In the immediate-placement group, women received the IUD within 10 minutes after placental delivery.

Among 32 women randomized to immediate IUD placement, 9 patients did not receive one due to cesarean section delivery (5 patients), infection in 2 patients, and a change of mind by 2 patients. One patient who got immediate placement was lost to follow-up and 22 returned at 6 weeks post partum for a repeat ultrasound to confirm placement.

Among 34 women randomized to standard-interval IUD placement, 5 were disqualified due to cesarean section (2), infection (1), or a change of mind (1). Eleven of the remaining 29 patients did not return as planned for IUD placement 6 weeks post partum or later (38%), a high rate of patients being lost to follow-up in this group, Dr. Justice said.

Despite the poor follow-up rate in the standard-interval group, 59% had an IUD in place at 6 months post partum, significantly greater than the 46% of patients in the immediate placement group who were still using their original IUD at 6 months.

In general, 60% of women in the university-based system who choose an IUD for postpartum contraception never return for placement, she said. Ovulation resumes very quickly after delivery in all women and especially in those who do not breastfeed, creating a risk for repeat conception as soon as 4 weeks after delivery. Unintended pregnancies are a huge problem affecting nearly half of all pregnancies.

The comparison groups in the current study did not differ significantly in age, proportion of nulliparous women, gestational age, length of rupture of membranes, infant weight, breastfeeding rate, use of epidurals, race, or rates of infection, perforation, or unintended pregnancy.

Follow-up ultrasounds in the immediate placement group found that some women had the IUD oriented obliquely or upside down at the fundus, but it’s not clear if these abnormal orientations within the uterine cavity had any significance, Dr. Justice said.

A previous study reported a 24% expulsion rate after immediate postpartum placement of an IUD, compared with a 4% expulsion rate after standard interval placement (Obstet. Gynecol. 2010;116:1079-87).

The 54% expulsion rate after immediate placement in the current study "is a closer approximation to the expected experience in general practice and represents a ‘typical use’ in that multiple physicians placed the device over the length of the study," Dr. Justice said.

Studies are underway to assess placement of progesterone-containing implants immediately after delivery, she said.

Dr. Justice reported having no relevant financial disclosures.

SAN DIEGO – Women expelled 54% of intrauterine devices placed immediately after giving birth, compared with a 6% expulsion rate after conventional placement at 6 weeks post partum or later, a study of an indigent population found.

The expulsion rate in the immediate-placement group (12 of 22 women) was significantly higher than when the levonorgestrel-containing intrauterine device (the Mirena IUD) was placed 6 weeks postpartum or later (1 of 18 women). The finding suggests that the immediate-placement strategy is prohibitively expensive, Dr. Tiffany D. Justice and her associates reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.

Photo courtesy Mirena-US.com

Immediate placement after delivery might be acceptable for women who are nearly certain to not return for follow-up visits after delivery, but even in those cases, a different long-acting reversible contraceptive such as a progesterone-containing implant might make more sense, said Dr. Justice, an ob.gyn. specializing in reproductive endocrinology and infertility at the University of Louisville, Ky.

The study randomized women who desired contraception after delivery in a university-based prenatal obstetrics clinic that primarily serves the indigent. In the immediate-placement group, women received the IUD within 10 minutes after placental delivery.

Among 32 women randomized to immediate IUD placement, 9 patients did not receive one due to cesarean section delivery (5 patients), infection in 2 patients, and a change of mind by 2 patients. One patient who got immediate placement was lost to follow-up and 22 returned at 6 weeks post partum for a repeat ultrasound to confirm placement.

Among 34 women randomized to standard-interval IUD placement, 5 were disqualified due to cesarean section (2), infection (1), or a change of mind (1). Eleven of the remaining 29 patients did not return as planned for IUD placement 6 weeks post partum or later (38%), a high rate of patients being lost to follow-up in this group, Dr. Justice said.

Despite the poor follow-up rate in the standard-interval group, 59% had an IUD in place at 6 months post partum, significantly greater than the 46% of patients in the immediate placement group who were still using their original IUD at 6 months.

In general, 60% of women in the university-based system who choose an IUD for postpartum contraception never return for placement, she said. Ovulation resumes very quickly after delivery in all women and especially in those who do not breastfeed, creating a risk for repeat conception as soon as 4 weeks after delivery. Unintended pregnancies are a huge problem affecting nearly half of all pregnancies.

The comparison groups in the current study did not differ significantly in age, proportion of nulliparous women, gestational age, length of rupture of membranes, infant weight, breastfeeding rate, use of epidurals, race, or rates of infection, perforation, or unintended pregnancy.

Follow-up ultrasounds in the immediate placement group found that some women had the IUD oriented obliquely or upside down at the fundus, but it’s not clear if these abnormal orientations within the uterine cavity had any significance, Dr. Justice said.

A previous study reported a 24% expulsion rate after immediate postpartum placement of an IUD, compared with a 4% expulsion rate after standard interval placement (Obstet. Gynecol. 2010;116:1079-87).

The 54% expulsion rate after immediate placement in the current study "is a closer approximation to the expected experience in general practice and represents a ‘typical use’ in that multiple physicians placed the device over the length of the study," Dr. Justice said.

Studies are underway to assess placement of progesterone-containing implants immediately after delivery, she said.

Dr. Justice reported having no relevant financial disclosures.

SAN DIEGO – Women expelled 54% of intrauterine devices placed immediately after giving birth, compared with a 6% expulsion rate after conventional placement at 6 weeks post partum or later, a study of an indigent population found.

The expulsion rate in the immediate-placement group (12 of 22 women) was significantly higher than when the levonorgestrel-containing intrauterine device (the Mirena IUD) was placed 6 weeks postpartum or later (1 of 18 women). The finding suggests that the immediate-placement strategy is prohibitively expensive, Dr. Tiffany D. Justice and her associates reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.

Photo courtesy Mirena-US.com

Immediate placement after delivery might be acceptable for women who are nearly certain to not return for follow-up visits after delivery, but even in those cases, a different long-acting reversible contraceptive such as a progesterone-containing implant might make more sense, said Dr. Justice, an ob.gyn. specializing in reproductive endocrinology and infertility at the University of Louisville, Ky.

The study randomized women who desired contraception after delivery in a university-based prenatal obstetrics clinic that primarily serves the indigent. In the immediate-placement group, women received the IUD within 10 minutes after placental delivery.

Among 32 women randomized to immediate IUD placement, 9 patients did not receive one due to cesarean section delivery (5 patients), infection in 2 patients, and a change of mind by 2 patients. One patient who got immediate placement was lost to follow-up and 22 returned at 6 weeks post partum for a repeat ultrasound to confirm placement.

Among 34 women randomized to standard-interval IUD placement, 5 were disqualified due to cesarean section (2), infection (1), or a change of mind (1). Eleven of the remaining 29 patients did not return as planned for IUD placement 6 weeks post partum or later (38%), a high rate of patients being lost to follow-up in this group, Dr. Justice said.

Despite the poor follow-up rate in the standard-interval group, 59% had an IUD in place at 6 months post partum, significantly greater than the 46% of patients in the immediate placement group who were still using their original IUD at 6 months.

In general, 60% of women in the university-based system who choose an IUD for postpartum contraception never return for placement, she said. Ovulation resumes very quickly after delivery in all women and especially in those who do not breastfeed, creating a risk for repeat conception as soon as 4 weeks after delivery. Unintended pregnancies are a huge problem affecting nearly half of all pregnancies.

The comparison groups in the current study did not differ significantly in age, proportion of nulliparous women, gestational age, length of rupture of membranes, infant weight, breastfeeding rate, use of epidurals, race, or rates of infection, perforation, or unintended pregnancy.

Follow-up ultrasounds in the immediate placement group found that some women had the IUD oriented obliquely or upside down at the fundus, but it’s not clear if these abnormal orientations within the uterine cavity had any significance, Dr. Justice said.

A previous study reported a 24% expulsion rate after immediate postpartum placement of an IUD, compared with a 4% expulsion rate after standard interval placement (Obstet. Gynecol. 2010;116:1079-87).

The 54% expulsion rate after immediate placement in the current study "is a closer approximation to the expected experience in general practice and represents a ‘typical use’ in that multiple physicians placed the device over the length of the study," Dr. Justice said.

Studies are underway to assess placement of progesterone-containing implants immediately after delivery, she said.

Dr. Justice reported having no relevant financial disclosures.

SAN DIEGO – As birth weight increases, progression in labor was slower both in successful trial of labor patients and in patients who ultimately had cesarean deliveries.

The findings come from a retrospective review of electronic data from the Consortium on Safe Labor, an observational study of labor and delivery practices led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institutes of Health (NIH) that was conducted at 12 clinical centers from 2002 to 2008.

Doug Brunk/IMNG Medical Media

"Since the 1950s, obstetricians have been using the Friedman labor curve in order to assist in interpreting normal and abnormal labor patterns," lead study author Heidi K. Leftwich, D.O., said at the annual meeting of the American College of Obstetricians and Gynecologists.

"However, we have [a] very different patient population these days. There is more obesity, less active management of the second stage of labor, we use more epidurals, and we have an older population, with women waiting later to begin their families."

With the cesarean section rate escalating, she continued, "current research has been focusing on variables which might alter the labor curve, and challenging the notion that one labor curve can apply to all women."

The objective of the current study was to examine data from the Consortium on Safe Labor to determine whether birth weight alters the labor pattern in nulliparas and multiparas. Inclusion criteria consisted of patients with cephalic presentation, singleton gestation, gestational age of 34 weeks or more, who had undergone two or more cervical exams. Those patients with fetal anomalies, elective repeat cesarean section, and lacking birth weight data were excluded from the study.

The researchers created five birth weight categories separated by 500 g increments: less than 2,500 g (category 1), 2,500-2,999 g (category 2), 3,000-3,499 g (category 3), 3,500-3,999 g (category 4), and greater than or equal to 4,000 g (category 5). They used interval-censored regression to estimate the duration of labor, or "traverse times," and repeated measures analysis to construct mean labor curves by parity as well as by birth weight categories.

"The traverse times is more of an approximation of the time it takes for the cervix to dilate a centimeter," explained Dr. Leftwich, a fellow of maternal-fetal medicine in the department of obstetrics and gynecology at the University of Illinois at Chicago. "This is stratified by cervical dilation at admission, as well as exams performed in labor."

A total of 146,904 maternal records met inclusion criteria. Cesarean sections occurred in 21% of group 1, 14% of group 2, 14% of group 3, 17% of group 3, and 25% of group 5. Dr. Leftwich reported that in nulliparas, traverse times increased as birth weight increased, for both vaginal and cesarean deliveries (P less than .001). In multiparas, traverse times increased as birth weight increased from 5-8 cm dilation, for both vaginal and cesarean deliveries (P less than .001). "From 8 cm-10 cm, traverse times still increased by birth weight, but this was not statistically significant secondary to minimal cervical exams," Dr. Leftwich said.

A limitation of the study, she noted, was that "rapid progression of labor in multiparas makes traverse times less accurate for the active phase."

The study was supported by a contract from the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and an award from the University of Illinois at Chicago Center for Clinical and Translational Science. Dr. Leftwich said that she had no relevant financial disclosures.

SAN DIEGO – As birth weight increases, progression in labor was slower both in successful trial of labor patients and in patients who ultimately had cesarean deliveries.

The findings come from a retrospective review of electronic data from the Consortium on Safe Labor, an observational study of labor and delivery practices led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institutes of Health (NIH) that was conducted at 12 clinical centers from 2002 to 2008.

Doug Brunk/IMNG Medical Media

"Since the 1950s, obstetricians have been using the Friedman labor curve in order to assist in interpreting normal and abnormal labor patterns," lead study author Heidi K. Leftwich, D.O., said at the annual meeting of the American College of Obstetricians and Gynecologists.

"However, we have [a] very different patient population these days. There is more obesity, less active management of the second stage of labor, we use more epidurals, and we have an older population, with women waiting later to begin their families."

With the cesarean section rate escalating, she continued, "current research has been focusing on variables which might alter the labor curve, and challenging the notion that one labor curve can apply to all women."

The objective of the current study was to examine data from the Consortium on Safe Labor to determine whether birth weight alters the labor pattern in nulliparas and multiparas. Inclusion criteria consisted of patients with cephalic presentation, singleton gestation, gestational age of 34 weeks or more, who had undergone two or more cervical exams. Those patients with fetal anomalies, elective repeat cesarean section, and lacking birth weight data were excluded from the study.

The researchers created five birth weight categories separated by 500 g increments: less than 2,500 g (category 1), 2,500-2,999 g (category 2), 3,000-3,499 g (category 3), 3,500-3,999 g (category 4), and greater than or equal to 4,000 g (category 5). They used interval-censored regression to estimate the duration of labor, or "traverse times," and repeated measures analysis to construct mean labor curves by parity as well as by birth weight categories.

"The traverse times is more of an approximation of the time it takes for the cervix to dilate a centimeter," explained Dr. Leftwich, a fellow of maternal-fetal medicine in the department of obstetrics and gynecology at the University of Illinois at Chicago. "This is stratified by cervical dilation at admission, as well as exams performed in labor."

A total of 146,904 maternal records met inclusion criteria. Cesarean sections occurred in 21% of group 1, 14% of group 2, 14% of group 3, 17% of group 3, and 25% of group 5. Dr. Leftwich reported that in nulliparas, traverse times increased as birth weight increased, for both vaginal and cesarean deliveries (P less than .001). In multiparas, traverse times increased as birth weight increased from 5-8 cm dilation, for both vaginal and cesarean deliveries (P less than .001). "From 8 cm-10 cm, traverse times still increased by birth weight, but this was not statistically significant secondary to minimal cervical exams," Dr. Leftwich said.

A limitation of the study, she noted, was that "rapid progression of labor in multiparas makes traverse times less accurate for the active phase."

The study was supported by a contract from the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and an award from the University of Illinois at Chicago Center for Clinical and Translational Science. Dr. Leftwich said that she had no relevant financial disclosures.

SAN DIEGO – As birth weight increases, progression in labor was slower both in successful trial of labor patients and in patients who ultimately had cesarean deliveries.

The findings come from a retrospective review of electronic data from the Consortium on Safe Labor, an observational study of labor and delivery practices led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institutes of Health (NIH) that was conducted at 12 clinical centers from 2002 to 2008.

Doug Brunk/IMNG Medical Media

"Since the 1950s, obstetricians have been using the Friedman labor curve in order to assist in interpreting normal and abnormal labor patterns," lead study author Heidi K. Leftwich, D.O., said at the annual meeting of the American College of Obstetricians and Gynecologists.

"However, we have [a] very different patient population these days. There is more obesity, less active management of the second stage of labor, we use more epidurals, and we have an older population, with women waiting later to begin their families."

With the cesarean section rate escalating, she continued, "current research has been focusing on variables which might alter the labor curve, and challenging the notion that one labor curve can apply to all women."

The objective of the current study was to examine data from the Consortium on Safe Labor to determine whether birth weight alters the labor pattern in nulliparas and multiparas. Inclusion criteria consisted of patients with cephalic presentation, singleton gestation, gestational age of 34 weeks or more, who had undergone two or more cervical exams. Those patients with fetal anomalies, elective repeat cesarean section, and lacking birth weight data were excluded from the study.

The researchers created five birth weight categories separated by 500 g increments: less than 2,500 g (category 1), 2,500-2,999 g (category 2), 3,000-3,499 g (category 3), 3,500-3,999 g (category 4), and greater than or equal to 4,000 g (category 5). They used interval-censored regression to estimate the duration of labor, or "traverse times," and repeated measures analysis to construct mean labor curves by parity as well as by birth weight categories.

"The traverse times is more of an approximation of the time it takes for the cervix to dilate a centimeter," explained Dr. Leftwich, a fellow of maternal-fetal medicine in the department of obstetrics and gynecology at the University of Illinois at Chicago. "This is stratified by cervical dilation at admission, as well as exams performed in labor."

A total of 146,904 maternal records met inclusion criteria. Cesarean sections occurred in 21% of group 1, 14% of group 2, 14% of group 3, 17% of group 3, and 25% of group 5. Dr. Leftwich reported that in nulliparas, traverse times increased as birth weight increased, for both vaginal and cesarean deliveries (P less than .001). In multiparas, traverse times increased as birth weight increased from 5-8 cm dilation, for both vaginal and cesarean deliveries (P less than .001). "From 8 cm-10 cm, traverse times still increased by birth weight, but this was not statistically significant secondary to minimal cervical exams," Dr. Leftwich said.

A limitation of the study, she noted, was that "rapid progression of labor in multiparas makes traverse times less accurate for the active phase."

The study was supported by a contract from the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and an award from the University of Illinois at Chicago Center for Clinical and Translational Science. Dr. Leftwich said that she had no relevant financial disclosures.

SAN DIEGO – Women with vulvodynia who received one counseling session with a licensed social worker after their diagnosis reported increased knowledge about their condition and less impact of vulvar symptoms on their lives, compared with women who did not receive the session, results from a pilot study showed.

"Several studies have shown a positive effect of individual and group psychosocial therapy programs in women with vulvodynia," a chronic pain syndrome affecting the vulvar area, Dr. Molly B. Moravek said at the annual meeting of the American College of Obstetricians and Gynecologists.

"However, this sort of long-term therapy is not feasible for all women due to time or financial constraints. No studies to date have investigated whether benefit can be derived from a single counseling session performed at the time of diagnosis," she noted.

Reported psychosocial effects from vulvodynia, a condition thought to affect 6%-15% of women seeking gynecologic care, include increased depression, anxiety, emotional distress, irritability, anger, perfectionistic traits, fear of negative evaluation, preoccupation with symptoms, somatization, and catastrophization. "Causation [of vulvodynia] is not known, but theories include neurological, physiological, and psychological etiologies," said Dr. Moravek of the department of obstetrics and gynecology at the University of Michigan Hospitals and Health System, Ann Arbor, who conducted the study along with colleagues in the university’s department of family medicine.

The aims of the current study were to determine the effect of a single session of a psychosexual counseling intervention compared with medical treatment alone on illness perceptions and coping mechanisms among women with vulvodynia, and to assess alterations in sexual function and pain perception after a single session of a psychosocial intervention.

Over a 4-month period, the researchers recruited 31 women from a specialty clinic dedicated to the treatment of vulvar diseases. All study participants were newly diagnosed with vulvodynia and were randomly assigned to receive either a 30- to 45-minute counseling session plus written educational materials or written materials alone (control group).

All patients were asked to complete a survey prior to randomization and at 6 weeks, including basic demographic information, the Female Sexual Function Index (FSFI), the Brief Illness Perception Questionnaire (BIPQ), and questions about knowledge of sexual and vulvar health.

The counseling session intervention was led by a licensed social worker who is certified in sex therapy and was tailored to the particulars of each patient’s psychosocial and medical situation. "The primary aims of the session were to increase knowledge about, and confidence in ability to deal with, vulvodynia; address common psychological effects from vulvodynia; and discuss sexual strategies for women who were having pain with intercourse," Dr. Moravek explained.

The mean age of the 31 women was 39 years; 16 received the intervention and 15 did not. At the 6-week follow-up, women in the intervention group trended toward increased sexual function in each of the six domains of the FSFI (desire, arousal, lubrication, orgasm, satisfaction, and pain), "whereas the controls showed more mixed results, and some even trended toward decreased function at the 6-week follow-up," she said. However, the mean total FSFI significantly favored the intervention group, with a P value of .02.

On the BIPQ, women in both groups reported an increased sense of control over their vulvodynia symptoms that reached statistical significance (P = .007 in controls and P = .006 in the intervention group). However, only women in the intervention group reported statistically significant improvements in their understanding of their illness (P = .011), the impact vulvodynia had on their lives (P = .009), how long they thought their symptoms would continue (P = .04), their concern over their symptoms (P = .003), and the emotional effect of their symptoms (P = .004). Additionally, only women in the intervention group scored significantly better on their self-perceived knowledge of vulvar health (P = .003) and sexual health (P = .025) at the 6-week follow-up.

Although the study is limited by its sample size, "we believe that it justifies a larger study examining the role of a single-session psychosocial intervention for patients with vulvodynia," Dr. Moravek said. "Future studies should also investigate different therapy modalities and durations, and the best way to incorporate a psychosocial intervention into the patient’s medical care."

The study was supported by the Ansbacher Fund for Resident/Fellow Education and Research at the University of Michigan. Dr. Moravek said that she had no relevant financial disclosures.

SAN DIEGO – Women with vulvodynia who received one counseling session with a licensed social worker after their diagnosis reported increased knowledge about their condition and less impact of vulvar symptoms on their lives, compared with women who did not receive the session, results from a pilot study showed.

"Several studies have shown a positive effect of individual and group psychosocial therapy programs in women with vulvodynia," a chronic pain syndrome affecting the vulvar area, Dr. Molly B. Moravek said at the annual meeting of the American College of Obstetricians and Gynecologists.

"However, this sort of long-term therapy is not feasible for all women due to time or financial constraints. No studies to date have investigated whether benefit can be derived from a single counseling session performed at the time of diagnosis," she noted.

Reported psychosocial effects from vulvodynia, a condition thought to affect 6%-15% of women seeking gynecologic care, include increased depression, anxiety, emotional distress, irritability, anger, perfectionistic traits, fear of negative evaluation, preoccupation with symptoms, somatization, and catastrophization. "Causation [of vulvodynia] is not known, but theories include neurological, physiological, and psychological etiologies," said Dr. Moravek of the department of obstetrics and gynecology at the University of Michigan Hospitals and Health System, Ann Arbor, who conducted the study along with colleagues in the university’s department of family medicine.

The aims of the current study were to determine the effect of a single session of a psychosexual counseling intervention compared with medical treatment alone on illness perceptions and coping mechanisms among women with vulvodynia, and to assess alterations in sexual function and pain perception after a single session of a psychosocial intervention.

Over a 4-month period, the researchers recruited 31 women from a specialty clinic dedicated to the treatment of vulvar diseases. All study participants were newly diagnosed with vulvodynia and were randomly assigned to receive either a 30- to 45-minute counseling session plus written educational materials or written materials alone (control group).

All patients were asked to complete a survey prior to randomization and at 6 weeks, including basic demographic information, the Female Sexual Function Index (FSFI), the Brief Illness Perception Questionnaire (BIPQ), and questions about knowledge of sexual and vulvar health.

The counseling session intervention was led by a licensed social worker who is certified in sex therapy and was tailored to the particulars of each patient’s psychosocial and medical situation. "The primary aims of the session were to increase knowledge about, and confidence in ability to deal with, vulvodynia; address common psychological effects from vulvodynia; and discuss sexual strategies for women who were having pain with intercourse," Dr. Moravek explained.

The mean age of the 31 women was 39 years; 16 received the intervention and 15 did not. At the 6-week follow-up, women in the intervention group trended toward increased sexual function in each of the six domains of the FSFI (desire, arousal, lubrication, orgasm, satisfaction, and pain), "whereas the controls showed more mixed results, and some even trended toward decreased function at the 6-week follow-up," she said. However, the mean total FSFI significantly favored the intervention group, with a P value of .02.

On the BIPQ, women in both groups reported an increased sense of control over their vulvodynia symptoms that reached statistical significance (P = .007 in controls and P = .006 in the intervention group). However, only women in the intervention group reported statistically significant improvements in their understanding of their illness (P = .011), the impact vulvodynia had on their lives (P = .009), how long they thought their symptoms would continue (P = .04), their concern over their symptoms (P = .003), and the emotional effect of their symptoms (P = .004). Additionally, only women in the intervention group scored significantly better on their self-perceived knowledge of vulvar health (P = .003) and sexual health (P = .025) at the 6-week follow-up.

Although the study is limited by its sample size, "we believe that it justifies a larger study examining the role of a single-session psychosocial intervention for patients with vulvodynia," Dr. Moravek said. "Future studies should also investigate different therapy modalities and durations, and the best way to incorporate a psychosocial intervention into the patient’s medical care."

The study was supported by the Ansbacher Fund for Resident/Fellow Education and Research at the University of Michigan. Dr. Moravek said that she had no relevant financial disclosures.

SAN DIEGO – Women with vulvodynia who received one counseling session with a licensed social worker after their diagnosis reported increased knowledge about their condition and less impact of vulvar symptoms on their lives, compared with women who did not receive the session, results from a pilot study showed.

"Several studies have shown a positive effect of individual and group psychosocial therapy programs in women with vulvodynia," a chronic pain syndrome affecting the vulvar area, Dr. Molly B. Moravek said at the annual meeting of the American College of Obstetricians and Gynecologists.

"However, this sort of long-term therapy is not feasible for all women due to time or financial constraints. No studies to date have investigated whether benefit can be derived from a single counseling session performed at the time of diagnosis," she noted.

Reported psychosocial effects from vulvodynia, a condition thought to affect 6%-15% of women seeking gynecologic care, include increased depression, anxiety, emotional distress, irritability, anger, perfectionistic traits, fear of negative evaluation, preoccupation with symptoms, somatization, and catastrophization. "Causation [of vulvodynia] is not known, but theories include neurological, physiological, and psychological etiologies," said Dr. Moravek of the department of obstetrics and gynecology at the University of Michigan Hospitals and Health System, Ann Arbor, who conducted the study along with colleagues in the university’s department of family medicine.

The aims of the current study were to determine the effect of a single session of a psychosexual counseling intervention compared with medical treatment alone on illness perceptions and coping mechanisms among women with vulvodynia, and to assess alterations in sexual function and pain perception after a single session of a psychosocial intervention.

Over a 4-month period, the researchers recruited 31 women from a specialty clinic dedicated to the treatment of vulvar diseases. All study participants were newly diagnosed with vulvodynia and were randomly assigned to receive either a 30- to 45-minute counseling session plus written educational materials or written materials alone (control group).

All patients were asked to complete a survey prior to randomization and at 6 weeks, including basic demographic information, the Female Sexual Function Index (FSFI), the Brief Illness Perception Questionnaire (BIPQ), and questions about knowledge of sexual and vulvar health.

The counseling session intervention was led by a licensed social worker who is certified in sex therapy and was tailored to the particulars of each patient’s psychosocial and medical situation. "The primary aims of the session were to increase knowledge about, and confidence in ability to deal with, vulvodynia; address common psychological effects from vulvodynia; and discuss sexual strategies for women who were having pain with intercourse," Dr. Moravek explained.

The mean age of the 31 women was 39 years; 16 received the intervention and 15 did not. At the 6-week follow-up, women in the intervention group trended toward increased sexual function in each of the six domains of the FSFI (desire, arousal, lubrication, orgasm, satisfaction, and pain), "whereas the controls showed more mixed results, and some even trended toward decreased function at the 6-week follow-up," she said. However, the mean total FSFI significantly favored the intervention group, with a P value of .02.

On the BIPQ, women in both groups reported an increased sense of control over their vulvodynia symptoms that reached statistical significance (P = .007 in controls and P = .006 in the intervention group). However, only women in the intervention group reported statistically significant improvements in their understanding of their illness (P = .011), the impact vulvodynia had on their lives (P = .009), how long they thought their symptoms would continue (P = .04), their concern over their symptoms (P = .003), and the emotional effect of their symptoms (P = .004). Additionally, only women in the intervention group scored significantly better on their self-perceived knowledge of vulvar health (P = .003) and sexual health (P = .025) at the 6-week follow-up.

Although the study is limited by its sample size, "we believe that it justifies a larger study examining the role of a single-session psychosocial intervention for patients with vulvodynia," Dr. Moravek said. "Future studies should also investigate different therapy modalities and durations, and the best way to incorporate a psychosocial intervention into the patient’s medical care."

The study was supported by the Ansbacher Fund for Resident/Fellow Education and Research at the University of Michigan. Dr. Moravek said that she had no relevant financial disclosures.

SAN DIEGO – Something as simple as a stamp in a patient’s chart to remind medical providers about vaccinating against human papillomavirus nearly quintupled the percentage of eligible patients being vaccinated in one outpatient office, according to a poster presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The faculty practice was vaccinating only 11% of eligible women before the trial, lower than the 2009 national average vaccination rate of 25%. After the office staff was instructed to place a reminder stamp in the progress notes of all nonpregnant women aged 18-26 years who were scheduled for an appointment with a gynecology provider, the office significantly improved its vaccination rate to 49% of eligible women, Dr. Kerry Rut and her associates reported.

Photo Sherry Boschert/IMNG Medical Mail

The prospective study compared charts for 86 patients who were eligible to receive the Gardasil vaccine for human papillomavirus (HPV) before use of the stamp and 70 patients after implementation of the stamp. Three of the six health care providers in the office (five physicians and a nurse practitioner) significantly increased their vaccinations of patients after the reminder stamp started appearing in progress notes, said Dr. Rut, an ob.gyn. in private practice in Bay Shore, N.Y. She led the study while she was a resident at Winthrop University Hospital, Mineola, N.Y.

The study received top prize among posters presented at the meeting.

Vaccination rates did not seem to be influenced by the reason for the patient’s visit or a history of abnormal Pap smear results. Only the use of the stamp was associated with vaccination rates.

The charts documented that the physician discussed Gardasil in 19 of 86 (22%) cases before use of the stamp and in 63 of 70 (90%) cases after use of the stamp, a significant increase. Still, less than half of eligible patients received the vaccine. When Gardasil was discussed, patients refused vaccination in 34 of 63 (54%) cases. The high refusal rate despite counseling suggests a need to investigate the type of patient education and its content, Dr. Rut suggested.

Patients averaged 23 years of age before use of the stamp and 22 years after the stamp, a statistically significant difference. The two groups did not differ significantly in the type of insurance, the reason for the visit, or the percentage with a previous abnormal Pap smear.

Each of the six medical providers increased their vaccination rates; the increase was statistically significant for three of them. The nurse practitioner had the highest vaccination rate before use of the stamp (4 of 12, or 33%) and after implementation of the stamp (11 of 14, or 79%), a significant increase.

One physician significantly increased vaccination rates from 6% before the stamp (1 of 17 patients) to 62% after the stamp (8 of 13 patients). Another physician significantly improved from vaccinating none of 14 patients before the stamp to 7 of 12 patients after the stamp (58%).

Of the three physicians whose improvement did not reach statistical significance, one went from vaccinating none of 15 patients before the stamp to 1 of 10 patients (10%) after the stamp. Another physician vaccinated 2 of 12 patients at baseline (17%) and 4 of 7 patients after the stamp started (57%). The third physician vaccinated 2 of 16 patients at baseline (13%) and 3 of 14 patients after the stamp (21%).

Overall, the vaccination rate increased from 9 of 86 patients before the stamp (11%) to 34 of 70 patients with use of the stamp (49%), Dr. Rut said.

The stamp included five boxes that the physician could check off: "Start series today," "Series in-progress," "3-vaccine series completed," "Counseled but refuses," and "Other."

As the use of electronic health records increases, perhaps a Gardasil reminder could be incorporated instead of a physical stamp to improve vaccination rates even more, she suggested.

Dr. Rut reported having no relevant financial disclosures.

SAN DIEGO – Something as simple as a stamp in a patient’s chart to remind medical providers about vaccinating against human papillomavirus nearly quintupled the percentage of eligible patients being vaccinated in one outpatient office, according to a poster presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The faculty practice was vaccinating only 11% of eligible women before the trial, lower than the 2009 national average vaccination rate of 25%. After the office staff was instructed to place a reminder stamp in the progress notes of all nonpregnant women aged 18-26 years who were scheduled for an appointment with a gynecology provider, the office significantly improved its vaccination rate to 49% of eligible women, Dr. Kerry Rut and her associates reported.

Photo Sherry Boschert/IMNG Medical Mail

The prospective study compared charts for 86 patients who were eligible to receive the Gardasil vaccine for human papillomavirus (HPV) before use of the stamp and 70 patients after implementation of the stamp. Three of the six health care providers in the office (five physicians and a nurse practitioner) significantly increased their vaccinations of patients after the reminder stamp started appearing in progress notes, said Dr. Rut, an ob.gyn. in private practice in Bay Shore, N.Y. She led the study while she was a resident at Winthrop University Hospital, Mineola, N.Y.

The study received top prize among posters presented at the meeting.

Vaccination rates did not seem to be influenced by the reason for the patient’s visit or a history of abnormal Pap smear results. Only the use of the stamp was associated with vaccination rates.

The charts documented that the physician discussed Gardasil in 19 of 86 (22%) cases before use of the stamp and in 63 of 70 (90%) cases after use of the stamp, a significant increase. Still, less than half of eligible patients received the vaccine. When Gardasil was discussed, patients refused vaccination in 34 of 63 (54%) cases. The high refusal rate despite counseling suggests a need to investigate the type of patient education and its content, Dr. Rut suggested.

Patients averaged 23 years of age before use of the stamp and 22 years after the stamp, a statistically significant difference. The two groups did not differ significantly in the type of insurance, the reason for the visit, or the percentage with a previous abnormal Pap smear.

Each of the six medical providers increased their vaccination rates; the increase was statistically significant for three of them. The nurse practitioner had the highest vaccination rate before use of the stamp (4 of 12, or 33%) and after implementation of the stamp (11 of 14, or 79%), a significant increase.

One physician significantly increased vaccination rates from 6% before the stamp (1 of 17 patients) to 62% after the stamp (8 of 13 patients). Another physician significantly improved from vaccinating none of 14 patients before the stamp to 7 of 12 patients after the stamp (58%).

Of the three physicians whose improvement did not reach statistical significance, one went from vaccinating none of 15 patients before the stamp to 1 of 10 patients (10%) after the stamp. Another physician vaccinated 2 of 12 patients at baseline (17%) and 4 of 7 patients after the stamp started (57%). The third physician vaccinated 2 of 16 patients at baseline (13%) and 3 of 14 patients after the stamp (21%).

Overall, the vaccination rate increased from 9 of 86 patients before the stamp (11%) to 34 of 70 patients with use of the stamp (49%), Dr. Rut said.

The stamp included five boxes that the physician could check off: "Start series today," "Series in-progress," "3-vaccine series completed," "Counseled but refuses," and "Other."

As the use of electronic health records increases, perhaps a Gardasil reminder could be incorporated instead of a physical stamp to improve vaccination rates even more, she suggested.

Dr. Rut reported having no relevant financial disclosures.

SAN DIEGO – Something as simple as a stamp in a patient’s chart to remind medical providers about vaccinating against human papillomavirus nearly quintupled the percentage of eligible patients being vaccinated in one outpatient office, according to a poster presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The faculty practice was vaccinating only 11% of eligible women before the trial, lower than the 2009 national average vaccination rate of 25%. After the office staff was instructed to place a reminder stamp in the progress notes of all nonpregnant women aged 18-26 years who were scheduled for an appointment with a gynecology provider, the office significantly improved its vaccination rate to 49% of eligible women, Dr. Kerry Rut and her associates reported.

Photo Sherry Boschert/IMNG Medical Mail

The prospective study compared charts for 86 patients who were eligible to receive the Gardasil vaccine for human papillomavirus (HPV) before use of the stamp and 70 patients after implementation of the stamp. Three of the six health care providers in the office (five physicians and a nurse practitioner) significantly increased their vaccinations of patients after the reminder stamp started appearing in progress notes, said Dr. Rut, an ob.gyn. in private practice in Bay Shore, N.Y. She led the study while she was a resident at Winthrop University Hospital, Mineola, N.Y.

The study received top prize among posters presented at the meeting.

Vaccination rates did not seem to be influenced by the reason for the patient’s visit or a history of abnormal Pap smear results. Only the use of the stamp was associated with vaccination rates.

The charts documented that the physician discussed Gardasil in 19 of 86 (22%) cases before use of the stamp and in 63 of 70 (90%) cases after use of the stamp, a significant increase. Still, less than half of eligible patients received the vaccine. When Gardasil was discussed, patients refused vaccination in 34 of 63 (54%) cases. The high refusal rate despite counseling suggests a need to investigate the type of patient education and its content, Dr. Rut suggested.

Patients averaged 23 years of age before use of the stamp and 22 years after the stamp, a statistically significant difference. The two groups did not differ significantly in the type of insurance, the reason for the visit, or the percentage with a previous abnormal Pap smear.

Each of the six medical providers increased their vaccination rates; the increase was statistically significant for three of them. The nurse practitioner had the highest vaccination rate before use of the stamp (4 of 12, or 33%) and after implementation of the stamp (11 of 14, or 79%), a significant increase.

One physician significantly increased vaccination rates from 6% before the stamp (1 of 17 patients) to 62% after the stamp (8 of 13 patients). Another physician significantly improved from vaccinating none of 14 patients before the stamp to 7 of 12 patients after the stamp (58%).

Of the three physicians whose improvement did not reach statistical significance, one went from vaccinating none of 15 patients before the stamp to 1 of 10 patients (10%) after the stamp. Another physician vaccinated 2 of 12 patients at baseline (17%) and 4 of 7 patients after the stamp started (57%). The third physician vaccinated 2 of 16 patients at baseline (13%) and 3 of 14 patients after the stamp (21%).

Overall, the vaccination rate increased from 9 of 86 patients before the stamp (11%) to 34 of 70 patients with use of the stamp (49%), Dr. Rut said.

The stamp included five boxes that the physician could check off: "Start series today," "Series in-progress," "3-vaccine series completed," "Counseled but refuses," and "Other."

As the use of electronic health records increases, perhaps a Gardasil reminder could be incorporated instead of a physical stamp to improve vaccination rates even more, she suggested.

Dr. Rut reported having no relevant financial disclosures.