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Investigational Prenatal Test Uses Endocervical Mucus
COPENHAGEN — An investigational prenatal diagnostic test that uses fetal cells taken from maternal endocervical mucus could offer all the advantages of chorionic villus sampling, according to a study sponsored by Biocept Inc., the San Diego company that's developing the test.
“This is a completely noninvasive diagnostic test that you can do in the first trimester. It's not just a screening test, which is what the other noninvasive tests are,” said study investigator Farideh Bischoff, Ph.D., of Baylor College of Medicine in Houston.
The idea of analyzing trophoblast cells taken from maternal blood or cervical mucus has been pursued for some time. However, inefficient endocervical sampling procedures and the scarcity of trophoblasts in maternal blood have hampered attempts to develop a reliable prenatal test.
The Biocept test involves collecting maternal endocervical mucus with a brush similar to that used to collect samples for Pap smears. A cell capture device is used to isolate fetal trophoblasts from the mucus. Next, an antibody-based purification system filters out the maternal cells.
In a study she presented at the annual meeting of the European Society of Human Reproduction and Embryology, Dr. Bischoff described immunohistochemical staining and fluorescence in situ hybridization testing on purified cells from 100 women.
The initial endocervical mucus sample contains very small numbers of trophoblasts and following the purification technique can strengthen the concentration to a purity of 85%–95%.
Diagnostic testing of the remaining trophoblast cells is then possible to detect chromosomal aneuploidies, she said.
“If you run a panel of probes you can detect trisomies. Alternatively, you can do DNA testing on the cells to screen for mutations. It basically allows you to do the same tests that investigators are doing with preimplantation embryos,” she said.
Dr. Bischoff said Biocept is running a clinical evaluation study at centers nationwide to compare the results of the test with those of standard chorionic villus sampling in a group of pregnant women.
COPENHAGEN — An investigational prenatal diagnostic test that uses fetal cells taken from maternal endocervical mucus could offer all the advantages of chorionic villus sampling, according to a study sponsored by Biocept Inc., the San Diego company that's developing the test.
“This is a completely noninvasive diagnostic test that you can do in the first trimester. It's not just a screening test, which is what the other noninvasive tests are,” said study investigator Farideh Bischoff, Ph.D., of Baylor College of Medicine in Houston.
The idea of analyzing trophoblast cells taken from maternal blood or cervical mucus has been pursued for some time. However, inefficient endocervical sampling procedures and the scarcity of trophoblasts in maternal blood have hampered attempts to develop a reliable prenatal test.
The Biocept test involves collecting maternal endocervical mucus with a brush similar to that used to collect samples for Pap smears. A cell capture device is used to isolate fetal trophoblasts from the mucus. Next, an antibody-based purification system filters out the maternal cells.
In a study she presented at the annual meeting of the European Society of Human Reproduction and Embryology, Dr. Bischoff described immunohistochemical staining and fluorescence in situ hybridization testing on purified cells from 100 women.
The initial endocervical mucus sample contains very small numbers of trophoblasts and following the purification technique can strengthen the concentration to a purity of 85%–95%.
Diagnostic testing of the remaining trophoblast cells is then possible to detect chromosomal aneuploidies, she said.
“If you run a panel of probes you can detect trisomies. Alternatively, you can do DNA testing on the cells to screen for mutations. It basically allows you to do the same tests that investigators are doing with preimplantation embryos,” she said.
Dr. Bischoff said Biocept is running a clinical evaluation study at centers nationwide to compare the results of the test with those of standard chorionic villus sampling in a group of pregnant women.
COPENHAGEN — An investigational prenatal diagnostic test that uses fetal cells taken from maternal endocervical mucus could offer all the advantages of chorionic villus sampling, according to a study sponsored by Biocept Inc., the San Diego company that's developing the test.
“This is a completely noninvasive diagnostic test that you can do in the first trimester. It's not just a screening test, which is what the other noninvasive tests are,” said study investigator Farideh Bischoff, Ph.D., of Baylor College of Medicine in Houston.
The idea of analyzing trophoblast cells taken from maternal blood or cervical mucus has been pursued for some time. However, inefficient endocervical sampling procedures and the scarcity of trophoblasts in maternal blood have hampered attempts to develop a reliable prenatal test.
The Biocept test involves collecting maternal endocervical mucus with a brush similar to that used to collect samples for Pap smears. A cell capture device is used to isolate fetal trophoblasts from the mucus. Next, an antibody-based purification system filters out the maternal cells.
In a study she presented at the annual meeting of the European Society of Human Reproduction and Embryology, Dr. Bischoff described immunohistochemical staining and fluorescence in situ hybridization testing on purified cells from 100 women.
The initial endocervical mucus sample contains very small numbers of trophoblasts and following the purification technique can strengthen the concentration to a purity of 85%–95%.
Diagnostic testing of the remaining trophoblast cells is then possible to detect chromosomal aneuploidies, she said.
“If you run a panel of probes you can detect trisomies. Alternatively, you can do DNA testing on the cells to screen for mutations. It basically allows you to do the same tests that investigators are doing with preimplantation embryos,” she said.
Dr. Bischoff said Biocept is running a clinical evaluation study at centers nationwide to compare the results of the test with those of standard chorionic villus sampling in a group of pregnant women.
Prenatal Diagnostic Test Uses Endocervical Mucus
COPENHAGEN — An investigational prenatal diagnostic test that uses fetal cells taken from maternal endocervical mucus could offer all the advantages of chorionic villus sampling, according to a study sponsored by Biocept Inc., the San Diego company that's developing the test.
“This is a completely noninvasive diagnostic test that you can do in the first trimester. It's not just a screening test, which is what the other noninvasive tests are,” said study investigator Farideh Bischoff, Ph.D., of Baylor College of Medicine in Houston.
The idea of analyzing trophoblast cells taken from either maternal blood or cervical mucus has been pursued for some time. However, inefficient endocervical sampling procedures and the scarcity of trophoblasts in maternal blood have hampered previous attempts to develop a reliable prenatal test.
The Biocept test involves collecting maternal endocervical mucus with a brush similar to that used to collect samples for Pap smears. A cell capture device is used to isolate fetal trophoblasts from the mucus. Next, an antibody-based purification system filters out the maternal cells.
In a study she presented at the annual meeting of the European Society of Human Reproduction and Embryology, Dr. Bischoff described immunohistochemical staining and fluorescence in situ hybridization testing on the purified cells from 100 women.
The initial endocervical mucus sample contains very small numbers of trophoblasts and following the purification technique can strengthen the concentration to a purity of 85%–95%.
Diagnostic testing of the remaining trophoblast cells is then possible to detect chromosomal aneuploidies, she said.
“If you run a panel of probes you can detect trisomies. Alternatively, you can do DNA testing on the cells to screen for mutations. It basically allows you to do the same tests that investigators are doing with preimplantation embryos,” she said.
Dr. Bischoff said Biocept is currently running a clinical evaluation study at a number of centers across the United States to compare the results of the test with those of standard chorionic villus sampling in a group of pregnant women.
COPENHAGEN — An investigational prenatal diagnostic test that uses fetal cells taken from maternal endocervical mucus could offer all the advantages of chorionic villus sampling, according to a study sponsored by Biocept Inc., the San Diego company that's developing the test.
“This is a completely noninvasive diagnostic test that you can do in the first trimester. It's not just a screening test, which is what the other noninvasive tests are,” said study investigator Farideh Bischoff, Ph.D., of Baylor College of Medicine in Houston.
The idea of analyzing trophoblast cells taken from either maternal blood or cervical mucus has been pursued for some time. However, inefficient endocervical sampling procedures and the scarcity of trophoblasts in maternal blood have hampered previous attempts to develop a reliable prenatal test.
The Biocept test involves collecting maternal endocervical mucus with a brush similar to that used to collect samples for Pap smears. A cell capture device is used to isolate fetal trophoblasts from the mucus. Next, an antibody-based purification system filters out the maternal cells.
In a study she presented at the annual meeting of the European Society of Human Reproduction and Embryology, Dr. Bischoff described immunohistochemical staining and fluorescence in situ hybridization testing on the purified cells from 100 women.
The initial endocervical mucus sample contains very small numbers of trophoblasts and following the purification technique can strengthen the concentration to a purity of 85%–95%.
Diagnostic testing of the remaining trophoblast cells is then possible to detect chromosomal aneuploidies, she said.
“If you run a panel of probes you can detect trisomies. Alternatively, you can do DNA testing on the cells to screen for mutations. It basically allows you to do the same tests that investigators are doing with preimplantation embryos,” she said.
Dr. Bischoff said Biocept is currently running a clinical evaluation study at a number of centers across the United States to compare the results of the test with those of standard chorionic villus sampling in a group of pregnant women.
COPENHAGEN — An investigational prenatal diagnostic test that uses fetal cells taken from maternal endocervical mucus could offer all the advantages of chorionic villus sampling, according to a study sponsored by Biocept Inc., the San Diego company that's developing the test.
“This is a completely noninvasive diagnostic test that you can do in the first trimester. It's not just a screening test, which is what the other noninvasive tests are,” said study investigator Farideh Bischoff, Ph.D., of Baylor College of Medicine in Houston.
The idea of analyzing trophoblast cells taken from either maternal blood or cervical mucus has been pursued for some time. However, inefficient endocervical sampling procedures and the scarcity of trophoblasts in maternal blood have hampered previous attempts to develop a reliable prenatal test.
The Biocept test involves collecting maternal endocervical mucus with a brush similar to that used to collect samples for Pap smears. A cell capture device is used to isolate fetal trophoblasts from the mucus. Next, an antibody-based purification system filters out the maternal cells.
In a study she presented at the annual meeting of the European Society of Human Reproduction and Embryology, Dr. Bischoff described immunohistochemical staining and fluorescence in situ hybridization testing on the purified cells from 100 women.
The initial endocervical mucus sample contains very small numbers of trophoblasts and following the purification technique can strengthen the concentration to a purity of 85%–95%.
Diagnostic testing of the remaining trophoblast cells is then possible to detect chromosomal aneuploidies, she said.
“If you run a panel of probes you can detect trisomies. Alternatively, you can do DNA testing on the cells to screen for mutations. It basically allows you to do the same tests that investigators are doing with preimplantation embryos,” she said.
Dr. Bischoff said Biocept is currently running a clinical evaluation study at a number of centers across the United States to compare the results of the test with those of standard chorionic villus sampling in a group of pregnant women.
Eating Disorders Common in Girls With Diabetes
MONTREAL — Eating disorders occur twice as often in adolescent girls and young women with type 1 diabetes mellitus, compared with their nondiabetic peers, and prepubertal diabetic girls should be screened for these disorders routinely, experts said at an international conference sponsored by the Academy for Eating Disorders.
Studies show that full-syndrome eating disorders are present in 10%, and subthreshold disorders in 14%, of adolescent girls with diabetes, compared with 4% and 8%, respectively, in healthy age-matched controls, said Patricia Colton, M.D., of the University of Toronto. Her own work in diabetic girls aged 9–14 years found an 8% prevalence of subthreshold eating disorders, compared with 1% in nondiabetic controls (Diabetes Care 2004;27:1654–9).
Such disturbed eating has been linked with poor metabolic control and increased rates of diabetes-related complications—in particular, a threefold risk of diabetic retinopathy, she said. Thus, early detection and treatment of eating disorders can have long-term benefits.
It has been suggested that a collection of multiple, interacting factors contributes to the development of eating disorders in patients with diabetes, Dr. Colton said.
Before their diagnosis, many diabetic girls tend to lose weight, which can often return to above baseline after treatment begins. Insulin therapy can cause weight gain, particularly during puberty, and episodes of hypoglycemia, so common in diabetes, can trigger binge eating, which has been reported in 45%–80% of women with diabetes. “Low blood sugar is an incredibly strong biological trigger to eat,” she noted.
All these factors may contribute to feelings of body dissatisfaction and efforts to control weight, including one method unique to diabetes—the omission of insulin therapy, reported by 12%–40% of this population.
But overlying these concerns are such daily management concerns as self-monitoring, dietary restraint, and preoccupation with food, which can give rise to issues of control and rebellion, especially in the adolescent population, she said.
“Dealing with a chronic medical condition can have significant effects on the child and the family. Depression and anxiety disorders are doubled or tripled in individuals with diabetes,” she said, adding that depressive symptoms have also been linked with hyperglycemia.
Established treatments for eating disorders appear effective in patients with diabetes, but tailoring these treatments more closely to diabetes-specific issues may enhance their value for this population, said Marion Olmsted, Ph.D., who is also with the University of Toronto and is director of ambulatory care for eating disorders at the University Health Network, Toronto General Hospital.
Psychoeducational interventions can improve weight and body-shape attitudes in teenaged girls who do not have full-blown eating disorders. Cognitive-behavioral strategies can be used to address issues such as blood sugar monitoring, insulin underdosing or omission, and eating patterns. And psychotherapy can address issues of rebellion, control, anger, and depression. More intensive approaches, such as day hospital treatment, are required in some cases, she explained.
Research by Dr. Olmsted and her colleagues at the University of Toronto has shown that diabetic girls with eating disturbances report less support, poorer communication, and less trust in their relationships with their parents than do diabetic girls without eating disturbances (J. Psychosom. Res. 1998;44:479–90).
In one study, mothers who were videotaped interacting with their daughters who had diabetes and eating disturbances showed less empathy, affective engagement, and support for their child's age-appropriate autonomy, compared with mothers of diabetic daughters without eating disturbances (J. Consult Clin. Psychol. 2001;69:950–8).
“Mothers of diabetic girls with eating disturbances appear to be less able to balance their teenage daughters' complementary needs for independence and supportive guidance,” Dr. Olmsted and her associates said in a literature review (J. Psychosom. Res. 2002;53:943–9).
Evidence shows that as adolescence progresses, behaviors such as insulin omission and binge eating become more common in young women, they reported.
MONTREAL — Eating disorders occur twice as often in adolescent girls and young women with type 1 diabetes mellitus, compared with their nondiabetic peers, and prepubertal diabetic girls should be screened for these disorders routinely, experts said at an international conference sponsored by the Academy for Eating Disorders.
Studies show that full-syndrome eating disorders are present in 10%, and subthreshold disorders in 14%, of adolescent girls with diabetes, compared with 4% and 8%, respectively, in healthy age-matched controls, said Patricia Colton, M.D., of the University of Toronto. Her own work in diabetic girls aged 9–14 years found an 8% prevalence of subthreshold eating disorders, compared with 1% in nondiabetic controls (Diabetes Care 2004;27:1654–9).
Such disturbed eating has been linked with poor metabolic control and increased rates of diabetes-related complications—in particular, a threefold risk of diabetic retinopathy, she said. Thus, early detection and treatment of eating disorders can have long-term benefits.
It has been suggested that a collection of multiple, interacting factors contributes to the development of eating disorders in patients with diabetes, Dr. Colton said.
Before their diagnosis, many diabetic girls tend to lose weight, which can often return to above baseline after treatment begins. Insulin therapy can cause weight gain, particularly during puberty, and episodes of hypoglycemia, so common in diabetes, can trigger binge eating, which has been reported in 45%–80% of women with diabetes. “Low blood sugar is an incredibly strong biological trigger to eat,” she noted.
All these factors may contribute to feelings of body dissatisfaction and efforts to control weight, including one method unique to diabetes—the omission of insulin therapy, reported by 12%–40% of this population.
But overlying these concerns are such daily management concerns as self-monitoring, dietary restraint, and preoccupation with food, which can give rise to issues of control and rebellion, especially in the adolescent population, she said.
“Dealing with a chronic medical condition can have significant effects on the child and the family. Depression and anxiety disorders are doubled or tripled in individuals with diabetes,” she said, adding that depressive symptoms have also been linked with hyperglycemia.
Established treatments for eating disorders appear effective in patients with diabetes, but tailoring these treatments more closely to diabetes-specific issues may enhance their value for this population, said Marion Olmsted, Ph.D., who is also with the University of Toronto and is director of ambulatory care for eating disorders at the University Health Network, Toronto General Hospital.
Psychoeducational interventions can improve weight and body-shape attitudes in teenaged girls who do not have full-blown eating disorders. Cognitive-behavioral strategies can be used to address issues such as blood sugar monitoring, insulin underdosing or omission, and eating patterns. And psychotherapy can address issues of rebellion, control, anger, and depression. More intensive approaches, such as day hospital treatment, are required in some cases, she explained.
Research by Dr. Olmsted and her colleagues at the University of Toronto has shown that diabetic girls with eating disturbances report less support, poorer communication, and less trust in their relationships with their parents than do diabetic girls without eating disturbances (J. Psychosom. Res. 1998;44:479–90).
In one study, mothers who were videotaped interacting with their daughters who had diabetes and eating disturbances showed less empathy, affective engagement, and support for their child's age-appropriate autonomy, compared with mothers of diabetic daughters without eating disturbances (J. Consult Clin. Psychol. 2001;69:950–8).
“Mothers of diabetic girls with eating disturbances appear to be less able to balance their teenage daughters' complementary needs for independence and supportive guidance,” Dr. Olmsted and her associates said in a literature review (J. Psychosom. Res. 2002;53:943–9).
Evidence shows that as adolescence progresses, behaviors such as insulin omission and binge eating become more common in young women, they reported.
MONTREAL — Eating disorders occur twice as often in adolescent girls and young women with type 1 diabetes mellitus, compared with their nondiabetic peers, and prepubertal diabetic girls should be screened for these disorders routinely, experts said at an international conference sponsored by the Academy for Eating Disorders.
Studies show that full-syndrome eating disorders are present in 10%, and subthreshold disorders in 14%, of adolescent girls with diabetes, compared with 4% and 8%, respectively, in healthy age-matched controls, said Patricia Colton, M.D., of the University of Toronto. Her own work in diabetic girls aged 9–14 years found an 8% prevalence of subthreshold eating disorders, compared with 1% in nondiabetic controls (Diabetes Care 2004;27:1654–9).
Such disturbed eating has been linked with poor metabolic control and increased rates of diabetes-related complications—in particular, a threefold risk of diabetic retinopathy, she said. Thus, early detection and treatment of eating disorders can have long-term benefits.
It has been suggested that a collection of multiple, interacting factors contributes to the development of eating disorders in patients with diabetes, Dr. Colton said.
Before their diagnosis, many diabetic girls tend to lose weight, which can often return to above baseline after treatment begins. Insulin therapy can cause weight gain, particularly during puberty, and episodes of hypoglycemia, so common in diabetes, can trigger binge eating, which has been reported in 45%–80% of women with diabetes. “Low blood sugar is an incredibly strong biological trigger to eat,” she noted.
All these factors may contribute to feelings of body dissatisfaction and efforts to control weight, including one method unique to diabetes—the omission of insulin therapy, reported by 12%–40% of this population.
But overlying these concerns are such daily management concerns as self-monitoring, dietary restraint, and preoccupation with food, which can give rise to issues of control and rebellion, especially in the adolescent population, she said.
“Dealing with a chronic medical condition can have significant effects on the child and the family. Depression and anxiety disorders are doubled or tripled in individuals with diabetes,” she said, adding that depressive symptoms have also been linked with hyperglycemia.
Established treatments for eating disorders appear effective in patients with diabetes, but tailoring these treatments more closely to diabetes-specific issues may enhance their value for this population, said Marion Olmsted, Ph.D., who is also with the University of Toronto and is director of ambulatory care for eating disorders at the University Health Network, Toronto General Hospital.
Psychoeducational interventions can improve weight and body-shape attitudes in teenaged girls who do not have full-blown eating disorders. Cognitive-behavioral strategies can be used to address issues such as blood sugar monitoring, insulin underdosing or omission, and eating patterns. And psychotherapy can address issues of rebellion, control, anger, and depression. More intensive approaches, such as day hospital treatment, are required in some cases, she explained.
Research by Dr. Olmsted and her colleagues at the University of Toronto has shown that diabetic girls with eating disturbances report less support, poorer communication, and less trust in their relationships with their parents than do diabetic girls without eating disturbances (J. Psychosom. Res. 1998;44:479–90).
In one study, mothers who were videotaped interacting with their daughters who had diabetes and eating disturbances showed less empathy, affective engagement, and support for their child's age-appropriate autonomy, compared with mothers of diabetic daughters without eating disturbances (J. Consult Clin. Psychol. 2001;69:950–8).
“Mothers of diabetic girls with eating disturbances appear to be less able to balance their teenage daughters' complementary needs for independence and supportive guidance,” Dr. Olmsted and her associates said in a literature review (J. Psychosom. Res. 2002;53:943–9).
Evidence shows that as adolescence progresses, behaviors such as insulin omission and binge eating become more common in young women, they reported.
Sibling Donor Oocytes Linked to Fewer Problems
COPENHAGEN — The higher rate of obstetric complications documented in donor oocyte pregnancies is confined to those pregnancies in which the oocyte donor is not related to the recipient, according to Korean researchers.
In fact, pregnancies achieved through in vitro fertilization procedures involving oocytes donated by a sibling have a complication rate similar to that of in vitro fertilization pregnancies that do not involve donor oocytes, reported S.H. Cha, M.D., in a study that was directed by M.K. Koong, M.D., from Samsung Cheil Hospital, Sungkyunkwan University, Seoul.
This is the first report linking different degrees of oocyte allogenicity to obstetric complications, suggesting that this phenomenon could be due to immunologic factors, Dr. Cha said during the annual meeting of the European Society for Human Reproduction and Embryology.
It has been well documented that pregnancies achieved using donor oocytes demonstrate increased rates of pregnancy-induced hypertension and first-trimester bleeding, Dr. Cha said. Possible explanations for these findings include primiparity, the higher rate of multiple pregnancies, and the increased maternal age of this obstetric population.
Dr. Cha's study compared 61 pregnancies resulting from oocyte donation and 127 pregnancies from standard, nondonor in vitro fertilization (controls). Of the donor pregnancies, 36 involved oocytes from siblings and 25 involved oocytes from nonsiblings.
As expected, the donor group had a much higher rate of early pregnancy loss (34% vs. 13%), second-trimester bleeding (13% vs. 1%), and pregnancy-induced hypertension (12.5% vs. 4%), compared with the controls.
But when the donor group was subdivided into sibling and nonsibling donors, the complications were largely concentrated in the nonsibling donor group. The sibling donor group showed a complication rate that was only slightly (and not statistically significantly) higher than that of the controls, Dr. Cha said. (See table.)
“These data suggest that PIH [pregnancy-induced hypertension] appears to occur more often in pregnancies following oocyte donation from immunologically unrelated donors. Therefore, women who become pregnant after oocyte donation from immunologically unrelated donors should be considered as high risk,” she noted.
COPENHAGEN — The higher rate of obstetric complications documented in donor oocyte pregnancies is confined to those pregnancies in which the oocyte donor is not related to the recipient, according to Korean researchers.
In fact, pregnancies achieved through in vitro fertilization procedures involving oocytes donated by a sibling have a complication rate similar to that of in vitro fertilization pregnancies that do not involve donor oocytes, reported S.H. Cha, M.D., in a study that was directed by M.K. Koong, M.D., from Samsung Cheil Hospital, Sungkyunkwan University, Seoul.
This is the first report linking different degrees of oocyte allogenicity to obstetric complications, suggesting that this phenomenon could be due to immunologic factors, Dr. Cha said during the annual meeting of the European Society for Human Reproduction and Embryology.
It has been well documented that pregnancies achieved using donor oocytes demonstrate increased rates of pregnancy-induced hypertension and first-trimester bleeding, Dr. Cha said. Possible explanations for these findings include primiparity, the higher rate of multiple pregnancies, and the increased maternal age of this obstetric population.
Dr. Cha's study compared 61 pregnancies resulting from oocyte donation and 127 pregnancies from standard, nondonor in vitro fertilization (controls). Of the donor pregnancies, 36 involved oocytes from siblings and 25 involved oocytes from nonsiblings.
As expected, the donor group had a much higher rate of early pregnancy loss (34% vs. 13%), second-trimester bleeding (13% vs. 1%), and pregnancy-induced hypertension (12.5% vs. 4%), compared with the controls.
But when the donor group was subdivided into sibling and nonsibling donors, the complications were largely concentrated in the nonsibling donor group. The sibling donor group showed a complication rate that was only slightly (and not statistically significantly) higher than that of the controls, Dr. Cha said. (See table.)
“These data suggest that PIH [pregnancy-induced hypertension] appears to occur more often in pregnancies following oocyte donation from immunologically unrelated donors. Therefore, women who become pregnant after oocyte donation from immunologically unrelated donors should be considered as high risk,” she noted.
COPENHAGEN — The higher rate of obstetric complications documented in donor oocyte pregnancies is confined to those pregnancies in which the oocyte donor is not related to the recipient, according to Korean researchers.
In fact, pregnancies achieved through in vitro fertilization procedures involving oocytes donated by a sibling have a complication rate similar to that of in vitro fertilization pregnancies that do not involve donor oocytes, reported S.H. Cha, M.D., in a study that was directed by M.K. Koong, M.D., from Samsung Cheil Hospital, Sungkyunkwan University, Seoul.
This is the first report linking different degrees of oocyte allogenicity to obstetric complications, suggesting that this phenomenon could be due to immunologic factors, Dr. Cha said during the annual meeting of the European Society for Human Reproduction and Embryology.
It has been well documented that pregnancies achieved using donor oocytes demonstrate increased rates of pregnancy-induced hypertension and first-trimester bleeding, Dr. Cha said. Possible explanations for these findings include primiparity, the higher rate of multiple pregnancies, and the increased maternal age of this obstetric population.
Dr. Cha's study compared 61 pregnancies resulting from oocyte donation and 127 pregnancies from standard, nondonor in vitro fertilization (controls). Of the donor pregnancies, 36 involved oocytes from siblings and 25 involved oocytes from nonsiblings.
As expected, the donor group had a much higher rate of early pregnancy loss (34% vs. 13%), second-trimester bleeding (13% vs. 1%), and pregnancy-induced hypertension (12.5% vs. 4%), compared with the controls.
But when the donor group was subdivided into sibling and nonsibling donors, the complications were largely concentrated in the nonsibling donor group. The sibling donor group showed a complication rate that was only slightly (and not statistically significantly) higher than that of the controls, Dr. Cha said. (See table.)
“These data suggest that PIH [pregnancy-induced hypertension] appears to occur more often in pregnancies following oocyte donation from immunologically unrelated donors. Therefore, women who become pregnant after oocyte donation from immunologically unrelated donors should be considered as high risk,” she noted.
Investigational OC May Decrease PMDD Symptoms : Regimen of 24 days of low-dose drospirenone tied to fewer symptoms during the pill-free interval.
SAN FRANCISCO — A new drospirenone-based OC awaiting approval by the Food and Drug Administration is effective in relieving premenstrual symptoms because it is given in a low dose and for an extended regimen, according to new research.
Drospirenone is a progestin derived from spironolactone and thus has a diuretic effect that other progestins do not, Gloria Bachmann, M.D., reported at the annual meeting of the American College of Obstetricians and Gynecologists.
Drospirenone is used in an FDA-approved OC (Yasmin, manufactured by Berlex) in a formulation of 30 mcg of ethinyl estradiol (EE) and 3 mg of drospirenone given in the typical OC regimen of 21 days, followed by 7 hormone-free days.
But the newer low-dose formulation (20 mcg of EE/3 mg drospirenone) given over a 24-day period with only 4 hormone-free days can significantly reduce symptoms of premenstrual dysphoric disorder (PMDD), compared with placebo, said Dr. Bachmann, associate dean for women's health and professor of obstetrics and gynecology at Robert Wood Johnson Medical School, New Brunswick, N.J.
“In the usual OC cycle of 21 hormone days and 7 days off, women begin to get symptomatic even before the pill-free interval because their ovaries are not totally suppressed,” she said in an interview. “By giving an extended number of days of hormone, you have better ovarian suppression and thus fewer symptoms during the shorter pill-free interval.”
Dr. Bachmann presented a double-blind study, sponsored by Berlex, in which 83 women with PMDD were randomized to either the low-dose drospirenone-based extended OC regimen (42 women) or placebo (41 women) for three cycles of treatment followed by a washout cycle. The women then crossed over to the other arm of treatment for another three cycles.
PMDD symptoms were assessed using the Daily Record of Severity of Problems (DRSP) scale, which includes 21 symptoms and 3 measures of functional impairment.
Active treatment was significantly more effective than placebo in relieving emotional and physical symptoms of PMDD, and the effects were similar to those seen when PMDD is treated with selective serotonin reuptake inhibitors (SSRIs), Dr. Bachmann commented during the meeting.
“If you're deciding between an SSRI and an OC [to treat women with PMDD], you have the added benefit of birth control. You're actually improving the gynecologic health of women as well, so it's a win-win situation,” she said.
SAN FRANCISCO — A new drospirenone-based OC awaiting approval by the Food and Drug Administration is effective in relieving premenstrual symptoms because it is given in a low dose and for an extended regimen, according to new research.
Drospirenone is a progestin derived from spironolactone and thus has a diuretic effect that other progestins do not, Gloria Bachmann, M.D., reported at the annual meeting of the American College of Obstetricians and Gynecologists.
Drospirenone is used in an FDA-approved OC (Yasmin, manufactured by Berlex) in a formulation of 30 mcg of ethinyl estradiol (EE) and 3 mg of drospirenone given in the typical OC regimen of 21 days, followed by 7 hormone-free days.
But the newer low-dose formulation (20 mcg of EE/3 mg drospirenone) given over a 24-day period with only 4 hormone-free days can significantly reduce symptoms of premenstrual dysphoric disorder (PMDD), compared with placebo, said Dr. Bachmann, associate dean for women's health and professor of obstetrics and gynecology at Robert Wood Johnson Medical School, New Brunswick, N.J.
“In the usual OC cycle of 21 hormone days and 7 days off, women begin to get symptomatic even before the pill-free interval because their ovaries are not totally suppressed,” she said in an interview. “By giving an extended number of days of hormone, you have better ovarian suppression and thus fewer symptoms during the shorter pill-free interval.”
Dr. Bachmann presented a double-blind study, sponsored by Berlex, in which 83 women with PMDD were randomized to either the low-dose drospirenone-based extended OC regimen (42 women) or placebo (41 women) for three cycles of treatment followed by a washout cycle. The women then crossed over to the other arm of treatment for another three cycles.
PMDD symptoms were assessed using the Daily Record of Severity of Problems (DRSP) scale, which includes 21 symptoms and 3 measures of functional impairment.
Active treatment was significantly more effective than placebo in relieving emotional and physical symptoms of PMDD, and the effects were similar to those seen when PMDD is treated with selective serotonin reuptake inhibitors (SSRIs), Dr. Bachmann commented during the meeting.
“If you're deciding between an SSRI and an OC [to treat women with PMDD], you have the added benefit of birth control. You're actually improving the gynecologic health of women as well, so it's a win-win situation,” she said.
SAN FRANCISCO — A new drospirenone-based OC awaiting approval by the Food and Drug Administration is effective in relieving premenstrual symptoms because it is given in a low dose and for an extended regimen, according to new research.
Drospirenone is a progestin derived from spironolactone and thus has a diuretic effect that other progestins do not, Gloria Bachmann, M.D., reported at the annual meeting of the American College of Obstetricians and Gynecologists.
Drospirenone is used in an FDA-approved OC (Yasmin, manufactured by Berlex) in a formulation of 30 mcg of ethinyl estradiol (EE) and 3 mg of drospirenone given in the typical OC regimen of 21 days, followed by 7 hormone-free days.
But the newer low-dose formulation (20 mcg of EE/3 mg drospirenone) given over a 24-day period with only 4 hormone-free days can significantly reduce symptoms of premenstrual dysphoric disorder (PMDD), compared with placebo, said Dr. Bachmann, associate dean for women's health and professor of obstetrics and gynecology at Robert Wood Johnson Medical School, New Brunswick, N.J.
“In the usual OC cycle of 21 hormone days and 7 days off, women begin to get symptomatic even before the pill-free interval because their ovaries are not totally suppressed,” she said in an interview. “By giving an extended number of days of hormone, you have better ovarian suppression and thus fewer symptoms during the shorter pill-free interval.”
Dr. Bachmann presented a double-blind study, sponsored by Berlex, in which 83 women with PMDD were randomized to either the low-dose drospirenone-based extended OC regimen (42 women) or placebo (41 women) for three cycles of treatment followed by a washout cycle. The women then crossed over to the other arm of treatment for another three cycles.
PMDD symptoms were assessed using the Daily Record of Severity of Problems (DRSP) scale, which includes 21 symptoms and 3 measures of functional impairment.
Active treatment was significantly more effective than placebo in relieving emotional and physical symptoms of PMDD, and the effects were similar to those seen when PMDD is treated with selective serotonin reuptake inhibitors (SSRIs), Dr. Bachmann commented during the meeting.
“If you're deciding between an SSRI and an OC [to treat women with PMDD], you have the added benefit of birth control. You're actually improving the gynecologic health of women as well, so it's a win-win situation,” she said.
Newer Version of Endometrial Ablation Technique Said to Boost Satisfaction
LONDON — A newer version of the Thermachoice endometrial ablation system shows better efficacy and patient satisfaction than one of its predecessors, according to data presented at the annual congress of the International Society for Gynecologic Endoscopy.
New clinical efficacy data on the Thermachoice III balloon ablation system, which was approved in 2003 by the Food and Drug Administration, suggest it is an improvement on the first Thermachoice system, said Fiona Marsh, M.D., who presented two studies that were partially funded by Gynecare, which makes the product.
Thermachoice was launched in the United States in 1998, and Thermachoice II, a revised version of the system, had its U.S. launch in 2000. Thermachoice II was not marketed in England, where Dr. Marsh practices. The two studies she presented at the meeting focused on Thermachoice III.
“My results on patient satisfaction and symptom reduction with Thermachoice III do look better than results that have been published for Thermachoice I,” she told this newspaper.
“These are also the first data on the feasibility of performing Thermachoice III in the outpatient setting—information which is imperative for clinicians to be able to counsel women appropriately,” she said.
Gynecare data suggest that Thermachoice III achieves greater thermal effect and depth of necrosis than the original version, but to date there have been no studies assessing symptom reduction or pain with the procedure, said Dr. Marsh, a clinical research fellow at St. James's Hospital, Leeds, England.
Her first study found improved patient satisfaction with the treatment in both the office and hospital outpatient settings—with improvements in dysmenorrhea in 87%, improvements in irregular menstruation in 66%, and improvements in quality of life in 84% of the 44 women in the study. Overall, 87% of the women said they were satisfied with the effects of the treatment—an improvement over previous studies showing a 67% satisfaction rate with the original Thermachoice, Dr. Marsh said.
The second study assessed intraoperative pain with Thermachoice III in patients treated in the office setting without local analgesia or intravenous sedation.
“Since Thermachoice III provides deeper and wider endometrial coverage, compared with the earlier version, we wanted to see if this had an effect on intraoperative pain scores” in patients treated in the office, Dr. Marsh said.
A total of 38 women with menorrhagia were included in the study. For pain prevention, they were given high-dose ibuprofen (800 mg) orally the night before the procedure and again 1 hour before undergoing endometrial ablation.
Intraoperatively, the women were offered rescue analgesia in the form of inhaled nitrous oxide, and after surgery they had the option of having tramadol 100 mg.
A total of 32 women (87%) were able to complete the 8-minute treatment, with 5 requesting it be stopped because of pain. Using a visual analog scale, with 10 describing the worst pain possible, 15% women reported scores of at least 7, including 3 reporting a score of 10.
Twenty-nine percent of the patients requested rescue analgesia, compared with the 12% rate in her unit when the original version of the system was used.
“Performing Thermachoice III in the [office] setting is tolerable for the vast majority of patients, and pretreatment with ibuprofen meant most patients did not need intraoperative rescue analgesia,” Dr. Marsh said.
“This provides women with an [in-office] option, if they would prefer to avoid general anesthesia,” she said.
Most of the patients went home about a half hour after they finished the treatment session.
“None of them came back with complications, and 5% called about cramping. Most of them used ibuprofen for 2–3 days after the procedure,” Dr. Marsh said.
LONDON — A newer version of the Thermachoice endometrial ablation system shows better efficacy and patient satisfaction than one of its predecessors, according to data presented at the annual congress of the International Society for Gynecologic Endoscopy.
New clinical efficacy data on the Thermachoice III balloon ablation system, which was approved in 2003 by the Food and Drug Administration, suggest it is an improvement on the first Thermachoice system, said Fiona Marsh, M.D., who presented two studies that were partially funded by Gynecare, which makes the product.
Thermachoice was launched in the United States in 1998, and Thermachoice II, a revised version of the system, had its U.S. launch in 2000. Thermachoice II was not marketed in England, where Dr. Marsh practices. The two studies she presented at the meeting focused on Thermachoice III.
“My results on patient satisfaction and symptom reduction with Thermachoice III do look better than results that have been published for Thermachoice I,” she told this newspaper.
“These are also the first data on the feasibility of performing Thermachoice III in the outpatient setting—information which is imperative for clinicians to be able to counsel women appropriately,” she said.
Gynecare data suggest that Thermachoice III achieves greater thermal effect and depth of necrosis than the original version, but to date there have been no studies assessing symptom reduction or pain with the procedure, said Dr. Marsh, a clinical research fellow at St. James's Hospital, Leeds, England.
Her first study found improved patient satisfaction with the treatment in both the office and hospital outpatient settings—with improvements in dysmenorrhea in 87%, improvements in irregular menstruation in 66%, and improvements in quality of life in 84% of the 44 women in the study. Overall, 87% of the women said they were satisfied with the effects of the treatment—an improvement over previous studies showing a 67% satisfaction rate with the original Thermachoice, Dr. Marsh said.
The second study assessed intraoperative pain with Thermachoice III in patients treated in the office setting without local analgesia or intravenous sedation.
“Since Thermachoice III provides deeper and wider endometrial coverage, compared with the earlier version, we wanted to see if this had an effect on intraoperative pain scores” in patients treated in the office, Dr. Marsh said.
A total of 38 women with menorrhagia were included in the study. For pain prevention, they were given high-dose ibuprofen (800 mg) orally the night before the procedure and again 1 hour before undergoing endometrial ablation.
Intraoperatively, the women were offered rescue analgesia in the form of inhaled nitrous oxide, and after surgery they had the option of having tramadol 100 mg.
A total of 32 women (87%) were able to complete the 8-minute treatment, with 5 requesting it be stopped because of pain. Using a visual analog scale, with 10 describing the worst pain possible, 15% women reported scores of at least 7, including 3 reporting a score of 10.
Twenty-nine percent of the patients requested rescue analgesia, compared with the 12% rate in her unit when the original version of the system was used.
“Performing Thermachoice III in the [office] setting is tolerable for the vast majority of patients, and pretreatment with ibuprofen meant most patients did not need intraoperative rescue analgesia,” Dr. Marsh said.
“This provides women with an [in-office] option, if they would prefer to avoid general anesthesia,” she said.
Most of the patients went home about a half hour after they finished the treatment session.
“None of them came back with complications, and 5% called about cramping. Most of them used ibuprofen for 2–3 days after the procedure,” Dr. Marsh said.
LONDON — A newer version of the Thermachoice endometrial ablation system shows better efficacy and patient satisfaction than one of its predecessors, according to data presented at the annual congress of the International Society for Gynecologic Endoscopy.
New clinical efficacy data on the Thermachoice III balloon ablation system, which was approved in 2003 by the Food and Drug Administration, suggest it is an improvement on the first Thermachoice system, said Fiona Marsh, M.D., who presented two studies that were partially funded by Gynecare, which makes the product.
Thermachoice was launched in the United States in 1998, and Thermachoice II, a revised version of the system, had its U.S. launch in 2000. Thermachoice II was not marketed in England, where Dr. Marsh practices. The two studies she presented at the meeting focused on Thermachoice III.
“My results on patient satisfaction and symptom reduction with Thermachoice III do look better than results that have been published for Thermachoice I,” she told this newspaper.
“These are also the first data on the feasibility of performing Thermachoice III in the outpatient setting—information which is imperative for clinicians to be able to counsel women appropriately,” she said.
Gynecare data suggest that Thermachoice III achieves greater thermal effect and depth of necrosis than the original version, but to date there have been no studies assessing symptom reduction or pain with the procedure, said Dr. Marsh, a clinical research fellow at St. James's Hospital, Leeds, England.
Her first study found improved patient satisfaction with the treatment in both the office and hospital outpatient settings—with improvements in dysmenorrhea in 87%, improvements in irregular menstruation in 66%, and improvements in quality of life in 84% of the 44 women in the study. Overall, 87% of the women said they were satisfied with the effects of the treatment—an improvement over previous studies showing a 67% satisfaction rate with the original Thermachoice, Dr. Marsh said.
The second study assessed intraoperative pain with Thermachoice III in patients treated in the office setting without local analgesia or intravenous sedation.
“Since Thermachoice III provides deeper and wider endometrial coverage, compared with the earlier version, we wanted to see if this had an effect on intraoperative pain scores” in patients treated in the office, Dr. Marsh said.
A total of 38 women with menorrhagia were included in the study. For pain prevention, they were given high-dose ibuprofen (800 mg) orally the night before the procedure and again 1 hour before undergoing endometrial ablation.
Intraoperatively, the women were offered rescue analgesia in the form of inhaled nitrous oxide, and after surgery they had the option of having tramadol 100 mg.
A total of 32 women (87%) were able to complete the 8-minute treatment, with 5 requesting it be stopped because of pain. Using a visual analog scale, with 10 describing the worst pain possible, 15% women reported scores of at least 7, including 3 reporting a score of 10.
Twenty-nine percent of the patients requested rescue analgesia, compared with the 12% rate in her unit when the original version of the system was used.
“Performing Thermachoice III in the [office] setting is tolerable for the vast majority of patients, and pretreatment with ibuprofen meant most patients did not need intraoperative rescue analgesia,” Dr. Marsh said.
“This provides women with an [in-office] option, if they would prefer to avoid general anesthesia,” she said.
Most of the patients went home about a half hour after they finished the treatment session.
“None of them came back with complications, and 5% called about cramping. Most of them used ibuprofen for 2–3 days after the procedure,” Dr. Marsh said.
Reroute Laparoscopic Entry in Select Patients : Subumbilical adhesions from previous surgeries are a major cause of complications and visceral injury.
LONDON — Physicians attempting laparoscopic entry in patients who have had previous abdominal surgery should consider an alternative to the traditional umbilical entry port, recommended Colin Davis, M.D., associate clinical director of gynecology at St. Bartholomew's Hospital.
Subumbilical adhesions from previous surgeries are a major cause of laparoscopic entry-related complications and can lead to visceral injury secondary to Veress needle or trocar insertion, he said at the annual congress of the International Society for Gynecologic Endoscopy.
“This is an uncommon, but serious complication of laparoscopic surgery and a major cause of [medicolegal] claims,” he said, adding that the Palmer's point entry in the left upper quadrant avoids blind entry in the umbilicus—the area most likely to contain adhesions from previous surgery.
“We should all become familiar with an alternative entry point for patients with a history of previous abdominal surgery,” he said, specifying that this would include patients who've had one previous Pfannenstiel, suprapubic, transverse, or midline laparotomy.
This approach also should be considered in patients who are overweight and in patients with whom entry through the umbilicus is difficult, he said.
Dr. Davis' group assessed the prevalence of subumbilical adhesions in a prospective study of 96 women undergoing Palmer's point entry procedures.
Subumbilical adhesions were seen in 57% of those with a history of one Pfannenstiel laparotomy and 66% among those who'd had two previous Pfannenstiels. Women with a previous midline incision had a 92% risk of subumbilical adhesions.
Overall, 32% of adhesions contained bowel, he reported. There were no subumbilical adhesions in women who were considered low risk for adhesions but who underwent Palmer's point entry due to difficult initial insufflation, large ovarian cysts extending to the umbilicus, or patient preference to avoid an umbilical scar.
According to Dr. Davis, Palmer's point entry is well described, but it is not routinely used in high-risk patients, even though it is easy to learn.
To perform the entry, a Veress needle is introduced 3 cm below the subcostal line on the left, and the peritoneal cavity is insufflated.
Then a 5-mm trocar is introduced, followed by the laparoscope, and the secondary points are then made under direct vision.
“The main disadvantage is a slightly altered perspective of the pelvis because you are looking at it from a different angle,” he said.
In addition, physicians should be prepared to have to push slightly further to gain entry into the peritoneal cavity, since the tissue is slightly thicker than it is at the umbilicus.
LONDON — Physicians attempting laparoscopic entry in patients who have had previous abdominal surgery should consider an alternative to the traditional umbilical entry port, recommended Colin Davis, M.D., associate clinical director of gynecology at St. Bartholomew's Hospital.
Subumbilical adhesions from previous surgeries are a major cause of laparoscopic entry-related complications and can lead to visceral injury secondary to Veress needle or trocar insertion, he said at the annual congress of the International Society for Gynecologic Endoscopy.
“This is an uncommon, but serious complication of laparoscopic surgery and a major cause of [medicolegal] claims,” he said, adding that the Palmer's point entry in the left upper quadrant avoids blind entry in the umbilicus—the area most likely to contain adhesions from previous surgery.
“We should all become familiar with an alternative entry point for patients with a history of previous abdominal surgery,” he said, specifying that this would include patients who've had one previous Pfannenstiel, suprapubic, transverse, or midline laparotomy.
This approach also should be considered in patients who are overweight and in patients with whom entry through the umbilicus is difficult, he said.
Dr. Davis' group assessed the prevalence of subumbilical adhesions in a prospective study of 96 women undergoing Palmer's point entry procedures.
Subumbilical adhesions were seen in 57% of those with a history of one Pfannenstiel laparotomy and 66% among those who'd had two previous Pfannenstiels. Women with a previous midline incision had a 92% risk of subumbilical adhesions.
Overall, 32% of adhesions contained bowel, he reported. There were no subumbilical adhesions in women who were considered low risk for adhesions but who underwent Palmer's point entry due to difficult initial insufflation, large ovarian cysts extending to the umbilicus, or patient preference to avoid an umbilical scar.
According to Dr. Davis, Palmer's point entry is well described, but it is not routinely used in high-risk patients, even though it is easy to learn.
To perform the entry, a Veress needle is introduced 3 cm below the subcostal line on the left, and the peritoneal cavity is insufflated.
Then a 5-mm trocar is introduced, followed by the laparoscope, and the secondary points are then made under direct vision.
“The main disadvantage is a slightly altered perspective of the pelvis because you are looking at it from a different angle,” he said.
In addition, physicians should be prepared to have to push slightly further to gain entry into the peritoneal cavity, since the tissue is slightly thicker than it is at the umbilicus.
LONDON — Physicians attempting laparoscopic entry in patients who have had previous abdominal surgery should consider an alternative to the traditional umbilical entry port, recommended Colin Davis, M.D., associate clinical director of gynecology at St. Bartholomew's Hospital.
Subumbilical adhesions from previous surgeries are a major cause of laparoscopic entry-related complications and can lead to visceral injury secondary to Veress needle or trocar insertion, he said at the annual congress of the International Society for Gynecologic Endoscopy.
“This is an uncommon, but serious complication of laparoscopic surgery and a major cause of [medicolegal] claims,” he said, adding that the Palmer's point entry in the left upper quadrant avoids blind entry in the umbilicus—the area most likely to contain adhesions from previous surgery.
“We should all become familiar with an alternative entry point for patients with a history of previous abdominal surgery,” he said, specifying that this would include patients who've had one previous Pfannenstiel, suprapubic, transverse, or midline laparotomy.
This approach also should be considered in patients who are overweight and in patients with whom entry through the umbilicus is difficult, he said.
Dr. Davis' group assessed the prevalence of subumbilical adhesions in a prospective study of 96 women undergoing Palmer's point entry procedures.
Subumbilical adhesions were seen in 57% of those with a history of one Pfannenstiel laparotomy and 66% among those who'd had two previous Pfannenstiels. Women with a previous midline incision had a 92% risk of subumbilical adhesions.
Overall, 32% of adhesions contained bowel, he reported. There were no subumbilical adhesions in women who were considered low risk for adhesions but who underwent Palmer's point entry due to difficult initial insufflation, large ovarian cysts extending to the umbilicus, or patient preference to avoid an umbilical scar.
According to Dr. Davis, Palmer's point entry is well described, but it is not routinely used in high-risk patients, even though it is easy to learn.
To perform the entry, a Veress needle is introduced 3 cm below the subcostal line on the left, and the peritoneal cavity is insufflated.
Then a 5-mm trocar is introduced, followed by the laparoscope, and the secondary points are then made under direct vision.
“The main disadvantage is a slightly altered perspective of the pelvis because you are looking at it from a different angle,” he said.
In addition, physicians should be prepared to have to push slightly further to gain entry into the peritoneal cavity, since the tissue is slightly thicker than it is at the umbilicus.
Don't Discount Gynecologic Surgeries for Elderly : Risk of major procedures could be reduced by attending to group's specific perioperative needs.
SAN FRANCISCO — Elderly women should not be denied major gynecologic surgery solely on the basis of their presumed age-based operative risk, according to Lindsay M. Mains, M.D.
In a study she presented at the annual meeting of the American College of Obstetricians and Gynecologists, Dr. Mains showed morbidity and mortality among elderly women undergoing major gynecologic surgery is high, compared with rates in younger women undergoing this surgery. But attention to specific perioperative needs of the elderly might reduce this risk, said Dr. Mains of the Ochsner Clinic Foundation in New Orleans.
Dr. Mains' study reviewed data from 110 major gynecologic surgeries on women aged 80–90 years old. All patients received preoperative medical clearance, except one who required emergent surgery.
Although half of the patients were overweight or obese, 61% had no serious medical history otherwise, and 96% had an American Society of Anesthesiologists' (ASA) score of 3 or less.
Most procedures (77%) were performed to remove cancer or a benign mass; the rest were undertaken to treat pelvic organ prolapse and/or urinary incontinence. Almost all patients (95.5%) received general endotracheal anesthesia.
An abdominal procedure was performed in 65% of patients, while 32.5% underwent laparoscopy. A total of 4.5% had a vaginal procedure.
Dr. Mains reported an intraoperative complication rate of 4% and a postoperative complication rate of 45%. Eight percent of the total study group had major life-threatening complications, including death in 3.6% of patients.
The most common postoperative complications were ileus, which occurred in 14% of patients, infection in 14% (urinary tract infection in 6%, wound infection in 5%, and death due to sepsis in 3%), cardiopulmonary events in 13%, and fever of unknown origin in 11%.
There were four fatalities—one due to myocardial infarction and three due to sepsis and intravascular coagulation.
“Our mortality rate was lower than other studies on elderly patients, which include men and women and have shown mortality rates up to 13%. This is an interesting finding and warrants further study,” she said.
One of the mortalities occurred on postoperative day 10 in the only patient who had undergone emergent surgery to do intra-abdominal hemorrhage, she noted.
Dr. Mains suggested that some of the complications in the subjects might be specific to the elderly population, and attention to these issues could help in reducing risk.
For example, half of the 14% of patients who experienced postoperative ileus were readmitted for this problem.
“We could attribute the slow return of bowel function in our subjects to their general decreased mobility and increased sensitivity to narcotics. Emphasis on early ambulation and physical therapy as well as reduction in narcotic use in these patients may help reduce these complications,” she said.
Similarly, a high rate of infection in this population might indicate an increased need for perioperative prophylactic antibiotics. And she speculated that because of an increased rate of pulmonary problems in these patients, greater use of incentive spirometers and bronchodilators perioperatively would likely be beneficial.
Finally, almost one-quarter of the patients received blood transfusions although only 16% had blood loss in excess of 500 cc. This may be an indication of an inability of elderly patients to compensate for perioperative blood loss, she said.
“Aggressive correction of preoperative anemia and dehydration in these patients could benefit their surgical outcome.”
Dr. Mains suggested that elderly women should be advised there is a 5%–10% risk of serious morbidity associated with major gynecologic surgery in their age-group.
However, with attention to the specific perioperative needs of the elderly, this risk might be further reduced.
She said that physicians consider that many elderly patients are willing to accept greater risks for smaller benefits. “The decision about a patient's operability should weigh her risks and benefits. Therefore, as physicians, we must have a clear understanding of these risks and their incidence when counseling patients,” she said.
SAN FRANCISCO — Elderly women should not be denied major gynecologic surgery solely on the basis of their presumed age-based operative risk, according to Lindsay M. Mains, M.D.
In a study she presented at the annual meeting of the American College of Obstetricians and Gynecologists, Dr. Mains showed morbidity and mortality among elderly women undergoing major gynecologic surgery is high, compared with rates in younger women undergoing this surgery. But attention to specific perioperative needs of the elderly might reduce this risk, said Dr. Mains of the Ochsner Clinic Foundation in New Orleans.
Dr. Mains' study reviewed data from 110 major gynecologic surgeries on women aged 80–90 years old. All patients received preoperative medical clearance, except one who required emergent surgery.
Although half of the patients were overweight or obese, 61% had no serious medical history otherwise, and 96% had an American Society of Anesthesiologists' (ASA) score of 3 or less.
Most procedures (77%) were performed to remove cancer or a benign mass; the rest were undertaken to treat pelvic organ prolapse and/or urinary incontinence. Almost all patients (95.5%) received general endotracheal anesthesia.
An abdominal procedure was performed in 65% of patients, while 32.5% underwent laparoscopy. A total of 4.5% had a vaginal procedure.
Dr. Mains reported an intraoperative complication rate of 4% and a postoperative complication rate of 45%. Eight percent of the total study group had major life-threatening complications, including death in 3.6% of patients.
The most common postoperative complications were ileus, which occurred in 14% of patients, infection in 14% (urinary tract infection in 6%, wound infection in 5%, and death due to sepsis in 3%), cardiopulmonary events in 13%, and fever of unknown origin in 11%.
There were four fatalities—one due to myocardial infarction and three due to sepsis and intravascular coagulation.
“Our mortality rate was lower than other studies on elderly patients, which include men and women and have shown mortality rates up to 13%. This is an interesting finding and warrants further study,” she said.
One of the mortalities occurred on postoperative day 10 in the only patient who had undergone emergent surgery to do intra-abdominal hemorrhage, she noted.
Dr. Mains suggested that some of the complications in the subjects might be specific to the elderly population, and attention to these issues could help in reducing risk.
For example, half of the 14% of patients who experienced postoperative ileus were readmitted for this problem.
“We could attribute the slow return of bowel function in our subjects to their general decreased mobility and increased sensitivity to narcotics. Emphasis on early ambulation and physical therapy as well as reduction in narcotic use in these patients may help reduce these complications,” she said.
Similarly, a high rate of infection in this population might indicate an increased need for perioperative prophylactic antibiotics. And she speculated that because of an increased rate of pulmonary problems in these patients, greater use of incentive spirometers and bronchodilators perioperatively would likely be beneficial.
Finally, almost one-quarter of the patients received blood transfusions although only 16% had blood loss in excess of 500 cc. This may be an indication of an inability of elderly patients to compensate for perioperative blood loss, she said.
“Aggressive correction of preoperative anemia and dehydration in these patients could benefit their surgical outcome.”
Dr. Mains suggested that elderly women should be advised there is a 5%–10% risk of serious morbidity associated with major gynecologic surgery in their age-group.
However, with attention to the specific perioperative needs of the elderly, this risk might be further reduced.
She said that physicians consider that many elderly patients are willing to accept greater risks for smaller benefits. “The decision about a patient's operability should weigh her risks and benefits. Therefore, as physicians, we must have a clear understanding of these risks and their incidence when counseling patients,” she said.
SAN FRANCISCO — Elderly women should not be denied major gynecologic surgery solely on the basis of their presumed age-based operative risk, according to Lindsay M. Mains, M.D.
In a study she presented at the annual meeting of the American College of Obstetricians and Gynecologists, Dr. Mains showed morbidity and mortality among elderly women undergoing major gynecologic surgery is high, compared with rates in younger women undergoing this surgery. But attention to specific perioperative needs of the elderly might reduce this risk, said Dr. Mains of the Ochsner Clinic Foundation in New Orleans.
Dr. Mains' study reviewed data from 110 major gynecologic surgeries on women aged 80–90 years old. All patients received preoperative medical clearance, except one who required emergent surgery.
Although half of the patients were overweight or obese, 61% had no serious medical history otherwise, and 96% had an American Society of Anesthesiologists' (ASA) score of 3 or less.
Most procedures (77%) were performed to remove cancer or a benign mass; the rest were undertaken to treat pelvic organ prolapse and/or urinary incontinence. Almost all patients (95.5%) received general endotracheal anesthesia.
An abdominal procedure was performed in 65% of patients, while 32.5% underwent laparoscopy. A total of 4.5% had a vaginal procedure.
Dr. Mains reported an intraoperative complication rate of 4% and a postoperative complication rate of 45%. Eight percent of the total study group had major life-threatening complications, including death in 3.6% of patients.
The most common postoperative complications were ileus, which occurred in 14% of patients, infection in 14% (urinary tract infection in 6%, wound infection in 5%, and death due to sepsis in 3%), cardiopulmonary events in 13%, and fever of unknown origin in 11%.
There were four fatalities—one due to myocardial infarction and three due to sepsis and intravascular coagulation.
“Our mortality rate was lower than other studies on elderly patients, which include men and women and have shown mortality rates up to 13%. This is an interesting finding and warrants further study,” she said.
One of the mortalities occurred on postoperative day 10 in the only patient who had undergone emergent surgery to do intra-abdominal hemorrhage, she noted.
Dr. Mains suggested that some of the complications in the subjects might be specific to the elderly population, and attention to these issues could help in reducing risk.
For example, half of the 14% of patients who experienced postoperative ileus were readmitted for this problem.
“We could attribute the slow return of bowel function in our subjects to their general decreased mobility and increased sensitivity to narcotics. Emphasis on early ambulation and physical therapy as well as reduction in narcotic use in these patients may help reduce these complications,” she said.
Similarly, a high rate of infection in this population might indicate an increased need for perioperative prophylactic antibiotics. And she speculated that because of an increased rate of pulmonary problems in these patients, greater use of incentive spirometers and bronchodilators perioperatively would likely be beneficial.
Finally, almost one-quarter of the patients received blood transfusions although only 16% had blood loss in excess of 500 cc. This may be an indication of an inability of elderly patients to compensate for perioperative blood loss, she said.
“Aggressive correction of preoperative anemia and dehydration in these patients could benefit their surgical outcome.”
Dr. Mains suggested that elderly women should be advised there is a 5%–10% risk of serious morbidity associated with major gynecologic surgery in their age-group.
However, with attention to the specific perioperative needs of the elderly, this risk might be further reduced.
She said that physicians consider that many elderly patients are willing to accept greater risks for smaller benefits. “The decision about a patient's operability should weigh her risks and benefits. Therefore, as physicians, we must have a clear understanding of these risks and their incidence when counseling patients,” she said.
Fibroid Embolization Pays Off for Radiologists, Insurers
SAN FRANCISCO — Compared with hysterectomy and myomectomy, uterine fibroid embolization actually bolsters rather than bleeds the health care system, Anne Bussard, M.D., reported.
“Fibroid embolization is financially advantageous for the health care system, the insurer, and the radiologist. The only economic loser is the gynecologist, who loses a $1,000 surgical fee every time a woman chooses an embolization over a myomectomy or hysterectomy,” said Dr. Bussard of the Jefferson Fibroid Center at Jefferson Medical College, Philadelphia.
The study, which she presented at the annual meeting of the American College of Obstetricians and Gynecologists, analyzed the costs and reimbursements associated with 299 women at her center who underwent abdominal hysterectomy, 105 who had abdominal myomectomy, and 136 who had uterine fibroid embolization (UFE) for symptomatic fibroids.
The baseline characteristics of all patients did not differ significantly except for their mean age, which was oldest in the hysterectomy group (48 years), followed by the UFE group (44 years) and then the myomectomy group (37 years).
The study looked at direct costs (such as nursing costs and operating room time), indirect costs (such as administrative costs) and hospital and physician reimbursements for each procedure and then calculated a net hospital income. “This is the first study of these treatments of which we are aware that calculated the net hospital income, defined as the total reimbursement from the insurance company minus the total cost,” Dr. Bussard said.
Although the insurer's reimbursement was less for UFE procedures ($2,764) than for hysterectomies ($5,135) or myomectomies ($4,961), total hospital costs, direct and indirect, were significantly less for UFE, at $2,707 versus $5,676 for myomectomy and $5,707 for hysterectomy.
As a result, the hospital lost money on both hysterectomies and myomectomies ($572 and $715, respectively), while it made an average of $57 on each UFE.
“Uterine fibroid embolization makes money—and in terms of professional costs, radiologists are reimbursed better than ob.gyns. For a short, same-day procedure, radiologists make $1,306 per embolization, and for a hysterectomy or myomectomy, which can take several hours and 2–3 days of postoperative care, ob.gyns. make $979 to $1,078,” said Dr. Bussard, a resident in obstetrics and gynecology.
One study found the cost of UFE to be higher than that of hysterectomy ($8,223 vs. $6,046), but two other studies favor UFE. One comparing UFE with myomectomy found while hospital costs were lower for UFE, compared with myomectomy ($3,193 vs. $5,598) and physician costs were higher ($2,220 vs. $1,611), the overall costs were less for UFE ($6,708 vs. $7,630).
Another study comparing UFE with abdominal myomectomy, total vaginal hysterectomy, or total abdominal hysterectomy found UFE had the lowest cost.
SAN FRANCISCO — Compared with hysterectomy and myomectomy, uterine fibroid embolization actually bolsters rather than bleeds the health care system, Anne Bussard, M.D., reported.
“Fibroid embolization is financially advantageous for the health care system, the insurer, and the radiologist. The only economic loser is the gynecologist, who loses a $1,000 surgical fee every time a woman chooses an embolization over a myomectomy or hysterectomy,” said Dr. Bussard of the Jefferson Fibroid Center at Jefferson Medical College, Philadelphia.
The study, which she presented at the annual meeting of the American College of Obstetricians and Gynecologists, analyzed the costs and reimbursements associated with 299 women at her center who underwent abdominal hysterectomy, 105 who had abdominal myomectomy, and 136 who had uterine fibroid embolization (UFE) for symptomatic fibroids.
The baseline characteristics of all patients did not differ significantly except for their mean age, which was oldest in the hysterectomy group (48 years), followed by the UFE group (44 years) and then the myomectomy group (37 years).
The study looked at direct costs (such as nursing costs and operating room time), indirect costs (such as administrative costs) and hospital and physician reimbursements for each procedure and then calculated a net hospital income. “This is the first study of these treatments of which we are aware that calculated the net hospital income, defined as the total reimbursement from the insurance company minus the total cost,” Dr. Bussard said.
Although the insurer's reimbursement was less for UFE procedures ($2,764) than for hysterectomies ($5,135) or myomectomies ($4,961), total hospital costs, direct and indirect, were significantly less for UFE, at $2,707 versus $5,676 for myomectomy and $5,707 for hysterectomy.
As a result, the hospital lost money on both hysterectomies and myomectomies ($572 and $715, respectively), while it made an average of $57 on each UFE.
“Uterine fibroid embolization makes money—and in terms of professional costs, radiologists are reimbursed better than ob.gyns. For a short, same-day procedure, radiologists make $1,306 per embolization, and for a hysterectomy or myomectomy, which can take several hours and 2–3 days of postoperative care, ob.gyns. make $979 to $1,078,” said Dr. Bussard, a resident in obstetrics and gynecology.
One study found the cost of UFE to be higher than that of hysterectomy ($8,223 vs. $6,046), but two other studies favor UFE. One comparing UFE with myomectomy found while hospital costs were lower for UFE, compared with myomectomy ($3,193 vs. $5,598) and physician costs were higher ($2,220 vs. $1,611), the overall costs were less for UFE ($6,708 vs. $7,630).
Another study comparing UFE with abdominal myomectomy, total vaginal hysterectomy, or total abdominal hysterectomy found UFE had the lowest cost.
SAN FRANCISCO — Compared with hysterectomy and myomectomy, uterine fibroid embolization actually bolsters rather than bleeds the health care system, Anne Bussard, M.D., reported.
“Fibroid embolization is financially advantageous for the health care system, the insurer, and the radiologist. The only economic loser is the gynecologist, who loses a $1,000 surgical fee every time a woman chooses an embolization over a myomectomy or hysterectomy,” said Dr. Bussard of the Jefferson Fibroid Center at Jefferson Medical College, Philadelphia.
The study, which she presented at the annual meeting of the American College of Obstetricians and Gynecologists, analyzed the costs and reimbursements associated with 299 women at her center who underwent abdominal hysterectomy, 105 who had abdominal myomectomy, and 136 who had uterine fibroid embolization (UFE) for symptomatic fibroids.
The baseline characteristics of all patients did not differ significantly except for their mean age, which was oldest in the hysterectomy group (48 years), followed by the UFE group (44 years) and then the myomectomy group (37 years).
The study looked at direct costs (such as nursing costs and operating room time), indirect costs (such as administrative costs) and hospital and physician reimbursements for each procedure and then calculated a net hospital income. “This is the first study of these treatments of which we are aware that calculated the net hospital income, defined as the total reimbursement from the insurance company minus the total cost,” Dr. Bussard said.
Although the insurer's reimbursement was less for UFE procedures ($2,764) than for hysterectomies ($5,135) or myomectomies ($4,961), total hospital costs, direct and indirect, were significantly less for UFE, at $2,707 versus $5,676 for myomectomy and $5,707 for hysterectomy.
As a result, the hospital lost money on both hysterectomies and myomectomies ($572 and $715, respectively), while it made an average of $57 on each UFE.
“Uterine fibroid embolization makes money—and in terms of professional costs, radiologists are reimbursed better than ob.gyns. For a short, same-day procedure, radiologists make $1,306 per embolization, and for a hysterectomy or myomectomy, which can take several hours and 2–3 days of postoperative care, ob.gyns. make $979 to $1,078,” said Dr. Bussard, a resident in obstetrics and gynecology.
One study found the cost of UFE to be higher than that of hysterectomy ($8,223 vs. $6,046), but two other studies favor UFE. One comparing UFE with myomectomy found while hospital costs were lower for UFE, compared with myomectomy ($3,193 vs. $5,598) and physician costs were higher ($2,220 vs. $1,611), the overall costs were less for UFE ($6,708 vs. $7,630).
Another study comparing UFE with abdominal myomectomy, total vaginal hysterectomy, or total abdominal hysterectomy found UFE had the lowest cost.
Bone Loss Recoverable After Stopping DMPA
SAN FRANCISCO — The bone loss associated with injectable depot medroxyprogesterone acetate can be partially recovered within a few years of the patient's discontinuation, Andrew M. Kaunitz, M.D., reported at the annual meeting of the American College of Obstetricians and Gynecologists.
Moreover, the use of this agent does not warrant regular bone scans for patients receiving it, said Dr. Kaunitz, professor of obstetrics and gynecology at the University of Florida Health Sciences Center in Jacksonville.
“I am hearing that many clinicians are ordering bone mineral density studies on DMPA users, and this is analogous to ordering BMD studies in women because they are breast-feeding,” said Dr. Kaunitz, who presented the study (funded by Pfizer Inc.) at the meeting.
“We don't know how to interpret DEXA [dual-energy x-ray absorptiometry] scans in young women, and we should not be ordering them, whether they are using DMPA or not,” he said.
Concerns about bone loss and use of DMPA (Depo-Provera) peaked last November when the Food and Drug Administration (FDA) added a black box warning to DMPA, advising that “prolonged use of the drug may result in significant loss of bone density.”
The warning also stated that “this bone density loss may not be completely reversible after discontinuation of the drug.”
Dr. Kauntiz's study, which was requested by the FDA, included women aged 25–35 years. It followed 41 DMPA users for almost 5 years of treatment plus almost 2 years after discontinuation of treatment and compared their BMD with that of 66 women who were not using hormonal contraception.
Women who had used DMPA for 5 years showed as much as a 5% decrease in the BMD as measured at the spine and hip compared with their pretreatment baseline. In comparison, BMD decreased no more than 0.4% among the women who were not using the agent.
However, there was substantial recovery in BMD, although not to baseline levels, at 1.8 years after discontinuation: BMD was 1.2% less than baseline in DMPA users almost 2 years after discontinuation of use, compared with 0.5% less than baseline in nonusers.
Dr. Kaunitz said a number of studies with longer follow-up have documented complete recovery of BMD after DMPA discontinuation.
“My speculation is that if we had been able to follow BMD for 3 or more years following DMPA discontinuation, it is likely that complete recovery would have been documented,” he said during an interview with FAMILY PRACTICE NEWS.
He compared the hypoestrogenemia associated with use of DMPA to the similar hormonal state during lactation. “Nursing moms also lose BMD—and not the 1%–2% annually that we see with DMPA use, but 4%–5% in the first year of the baby's life,” he said. “After weaning, just as after discontinuation of DMPA, BMD recovers. And we know from many studies that breast-feeding is not a long-term risk factor for osteoporosis or fractures.”
He said he is also concerned that many physicians may be interpreting the FDA's black box warning as an indication that patients should discontinue DMPA after 2 years.
“In my practice, if the patient continues to be a good candidate after 2 years of use, she certainly can and should continue to use this safe, effective method of contraception,” he said.
For the older patient in whom there is concern about use of DMPA continuing straight into menopause, giving no opportunity for BMD to recover, he said estrogen add-back therapy can prevent BMD decline.
“Am I calling for routine add-back therapy? Absolutely not. But could there be a role for it in some select patients? Certainly,” he said.
SAN FRANCISCO — The bone loss associated with injectable depot medroxyprogesterone acetate can be partially recovered within a few years of the patient's discontinuation, Andrew M. Kaunitz, M.D., reported at the annual meeting of the American College of Obstetricians and Gynecologists.
Moreover, the use of this agent does not warrant regular bone scans for patients receiving it, said Dr. Kaunitz, professor of obstetrics and gynecology at the University of Florida Health Sciences Center in Jacksonville.
“I am hearing that many clinicians are ordering bone mineral density studies on DMPA users, and this is analogous to ordering BMD studies in women because they are breast-feeding,” said Dr. Kaunitz, who presented the study (funded by Pfizer Inc.) at the meeting.
“We don't know how to interpret DEXA [dual-energy x-ray absorptiometry] scans in young women, and we should not be ordering them, whether they are using DMPA or not,” he said.
Concerns about bone loss and use of DMPA (Depo-Provera) peaked last November when the Food and Drug Administration (FDA) added a black box warning to DMPA, advising that “prolonged use of the drug may result in significant loss of bone density.”
The warning also stated that “this bone density loss may not be completely reversible after discontinuation of the drug.”
Dr. Kauntiz's study, which was requested by the FDA, included women aged 25–35 years. It followed 41 DMPA users for almost 5 years of treatment plus almost 2 years after discontinuation of treatment and compared their BMD with that of 66 women who were not using hormonal contraception.
Women who had used DMPA for 5 years showed as much as a 5% decrease in the BMD as measured at the spine and hip compared with their pretreatment baseline. In comparison, BMD decreased no more than 0.4% among the women who were not using the agent.
However, there was substantial recovery in BMD, although not to baseline levels, at 1.8 years after discontinuation: BMD was 1.2% less than baseline in DMPA users almost 2 years after discontinuation of use, compared with 0.5% less than baseline in nonusers.
Dr. Kaunitz said a number of studies with longer follow-up have documented complete recovery of BMD after DMPA discontinuation.
“My speculation is that if we had been able to follow BMD for 3 or more years following DMPA discontinuation, it is likely that complete recovery would have been documented,” he said during an interview with FAMILY PRACTICE NEWS.
He compared the hypoestrogenemia associated with use of DMPA to the similar hormonal state during lactation. “Nursing moms also lose BMD—and not the 1%–2% annually that we see with DMPA use, but 4%–5% in the first year of the baby's life,” he said. “After weaning, just as after discontinuation of DMPA, BMD recovers. And we know from many studies that breast-feeding is not a long-term risk factor for osteoporosis or fractures.”
He said he is also concerned that many physicians may be interpreting the FDA's black box warning as an indication that patients should discontinue DMPA after 2 years.
“In my practice, if the patient continues to be a good candidate after 2 years of use, she certainly can and should continue to use this safe, effective method of contraception,” he said.
For the older patient in whom there is concern about use of DMPA continuing straight into menopause, giving no opportunity for BMD to recover, he said estrogen add-back therapy can prevent BMD decline.
“Am I calling for routine add-back therapy? Absolutely not. But could there be a role for it in some select patients? Certainly,” he said.
SAN FRANCISCO — The bone loss associated with injectable depot medroxyprogesterone acetate can be partially recovered within a few years of the patient's discontinuation, Andrew M. Kaunitz, M.D., reported at the annual meeting of the American College of Obstetricians and Gynecologists.
Moreover, the use of this agent does not warrant regular bone scans for patients receiving it, said Dr. Kaunitz, professor of obstetrics and gynecology at the University of Florida Health Sciences Center in Jacksonville.
“I am hearing that many clinicians are ordering bone mineral density studies on DMPA users, and this is analogous to ordering BMD studies in women because they are breast-feeding,” said Dr. Kaunitz, who presented the study (funded by Pfizer Inc.) at the meeting.
“We don't know how to interpret DEXA [dual-energy x-ray absorptiometry] scans in young women, and we should not be ordering them, whether they are using DMPA or not,” he said.
Concerns about bone loss and use of DMPA (Depo-Provera) peaked last November when the Food and Drug Administration (FDA) added a black box warning to DMPA, advising that “prolonged use of the drug may result in significant loss of bone density.”
The warning also stated that “this bone density loss may not be completely reversible after discontinuation of the drug.”
Dr. Kauntiz's study, which was requested by the FDA, included women aged 25–35 years. It followed 41 DMPA users for almost 5 years of treatment plus almost 2 years after discontinuation of treatment and compared their BMD with that of 66 women who were not using hormonal contraception.
Women who had used DMPA for 5 years showed as much as a 5% decrease in the BMD as measured at the spine and hip compared with their pretreatment baseline. In comparison, BMD decreased no more than 0.4% among the women who were not using the agent.
However, there was substantial recovery in BMD, although not to baseline levels, at 1.8 years after discontinuation: BMD was 1.2% less than baseline in DMPA users almost 2 years after discontinuation of use, compared with 0.5% less than baseline in nonusers.
Dr. Kaunitz said a number of studies with longer follow-up have documented complete recovery of BMD after DMPA discontinuation.
“My speculation is that if we had been able to follow BMD for 3 or more years following DMPA discontinuation, it is likely that complete recovery would have been documented,” he said during an interview with FAMILY PRACTICE NEWS.
He compared the hypoestrogenemia associated with use of DMPA to the similar hormonal state during lactation. “Nursing moms also lose BMD—and not the 1%–2% annually that we see with DMPA use, but 4%–5% in the first year of the baby's life,” he said. “After weaning, just as after discontinuation of DMPA, BMD recovers. And we know from many studies that breast-feeding is not a long-term risk factor for osteoporosis or fractures.”
He said he is also concerned that many physicians may be interpreting the FDA's black box warning as an indication that patients should discontinue DMPA after 2 years.
“In my practice, if the patient continues to be a good candidate after 2 years of use, she certainly can and should continue to use this safe, effective method of contraception,” he said.
For the older patient in whom there is concern about use of DMPA continuing straight into menopause, giving no opportunity for BMD to recover, he said estrogen add-back therapy can prevent BMD decline.
“Am I calling for routine add-back therapy? Absolutely not. But could there be a role for it in some select patients? Certainly,” he said.