Intrauterine devices.
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Biomedical subjects
Publications and source records attributed to D R Mishell.
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OBJECTIVE: To evaluate the safety and efficacy of the copper T380A intrauterine device (IUD) in women with type II, non-insulin-dependent diabetes mellitus. METHODS: From June 1988, 176 women with type II diabetes, in whom the copper T380A IUD was inserted, were followed prospectively until: study closure (June 1993); termination for pregnancy, expulsion, or removal for medical or personal reasons; or termination for loss to follow-up. RESULTS: Sixteen women never returned after initial insertion, leaving 160 women who were followed a total of 3066 months, with 117 continuing follow-up after their reexamination visit 6-12 weeks after insertion. None developed acute salpingitis. The overall removal rates per 100 woman-years were as follows: for pregnancy, 1.57; for expulsion, 1.96; for discontinuation because of medical reasons (including pain and bleeding), 4.31; and for personal reasons, 3.91. The continuation rate at the end of 3 years after insertion was 70%. CONCLUSION: The copper T380A IUD appears to be safe and effective in women with type II diabetes when standard criteria for IUD insertion are followed.
OBJECTIVES: Our purpose was to evaluate morbidity in patients who underwent conservative therapy, ovarian cystectomy, for adnexal torsion compared with those who underwent salpingo-oophorectomy and to determine predictive factors associated with the ability to perform conservative surgery. STUDY DESIGN: A retrospective review of all women < 40 years old with adnexal torsion treated between May 1, 1989, and Dec. 31, 1991, was performed. All potentially viable adnexa were untwisted, and cystectomies were performed unless the adnexa failed to reperfuse. RESULTS: Ninety-four women were studied, and of these 61 (65%) received ovarian cystectomies and 33 (35%) underwent salpingo-oophorectomy. No thromboembolic complications or increase in postoperative morbidity was seen. Patients requiring salpingo-oophorectomy had more preoperative fevers and leukocytosis, larger masses, and higher degrees of torsion. CONCLUSION: Conservative surgery with untwisting of the adnexa followed by cystectomy can be performed in reproductive-age women with adnexal torsion who have potentially viable adnexa.
OBJECTIVE: Peripartum hysterectomy at Los Angeles County-University of Southern California Medical Center was reviewed and associated risk factors were identified. STUDY DESIGN: Retrospective descriptive and cohort analysis from January 1985 to June 1990 was carried out. Adjusted relative risks for hysterectomy with 95% confidence intervals for identified risk factors were calculated where possible. RESULTS: There were 123 cases of emergency peripartum hysterectomy (incidence of 1.3/1000 births). Indications for hysterectomy were primarily placenta accreta (n = 61), uterine atony (n = 25), unspecified uterine bleeding (n = 19), and uterine rupture (n = 14). The relative risk of emergency hysterectomy was 95.5 (95% confidence interval 66.7 to 136.9) for cesarean delivery, 10.78 (95% confidence interval 7.56 to 15.37) for prior cesarean delivery, and 97.29 (95% confidence interval 70.28 to 134.70) for placenta previa. CONCLUSIONS: Cesarean delivery, prior cesarean delivery, placenta previa, placenta accreta, and uterine atony were identified risk factors for emergency peripartum hysterectomy.
Steroids diffuse through polysiloxone at a constant rate, and steroids placed in the vagina rapidly pass through the vaginal epithelium into the circulation. Combining these principles led to the development of contraceptive vaginal rings (CVR) consisting of various progestins, with and without oestrogen, placed in flexible polysiloxone, doughnut-shaped devices. As occurs with oral contraceptives, the CVRs containing progestin plus oestrogen are left in the vagina for 3 weeks and removed for 1 week to allow withdrawal bleeding, while CVRs releasing a small dose of progestins without oestrogen are left in the vagina continuously for several months. Large-scale, clinical trials were performed with a low dose levonorgestrel-releasing-only CVR by the WHO. At 1 year, continuation rates were about 50 per 100 women with 17.2 per 100 discontinuing for menstrual problems and 4.5 for pregnancy. Two sizes of a CVR containing levonorgestrel and oestradiol were studied in a multinational trial organized by the Population Council. At the end of 1 year, about half the women were continuing with the method, one-quarter had discontinued because of bleeding problems, and pregnancy rates were between 1 and 2 per 100 women. The CVR was well accepted by women and their partners, but because of lowered HDL-cholesterol levels and accelerated atherosclerosis in female monkeys, further development of this formulation was discontinued. Recently, phase II clinical trials with CVRs containing combinations of NET-acetate plus ethinyloestradiol and 3-ketodesogestrel plus ethinyloestradiol have been undertaken. These CVRs provide good bleeding control, inhibit ovulation consistently and do not have an adverse effect on serum lipids. Phase III trials with these two types of CVRs will be initiated shortly.
The noncontraceptive health benefits of oral contraceptives were initially summarized a decade ago. Studies conducted in the last decade confirmed the findings of earlier studies with high-dose oral contraceptives and extended them to low-dose formulations. Among the noncontraceptive health benefits first cited were reductions in menorrhagia, irregular menses, endometrial cancer, ovarian cancer, functional ovarian cysts, benign breast disease, dysmenorrhea, premenstrual tension and iron-deficiency anemia. In addition, women who used oral contraceptives were less likely to develop rheumatoid arthritis or acute salpingitis, particularly moderate or severe forms, than were women using no method of contraception. Despite the fact that such benefits were identified more than 10 years ago and despite their inclusion in oral contraceptive labeling, women today are largely unaware of the noncontraceptive health benefits associated with oral contraceptive use.
OBJECTIVE: To investigate the effect of lactation in the puerperium on glucose and lipid metabolism in women with recent gestational diabetes. METHODS: In women with recent gestational diabetes, we examined the effect of 4-12 weeks of lactation on glucose tolerance (2-hour oral glucose tolerance test) and on fasting serum lipids (total cholesterol, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL] cholesterol, and triglycerides). Of 809 women tested in the puerperium, 404 elected to breast-feed and 405 did not lactate. RESULTS: The mean (+/- standard deviation) maternal age (31.6 +/- 5.9 versus 30.5 +/- 6.3 years), body mass index (28.8 +/- 5.1 versus 28.8 +/- 4.5 kg/m2), and parity (3.0 +/- 1.6 versus 2.8 + 1.7) were not different between the lactating and nonlactating groups, respectively. Glucose metabolism improved in the lactating group, indicated by a significantly lower total area under the glucose tolerance curve (17.0 +/- 4.2 versus 17.9 +/- 5.0 g.minute/dL; P = .01), mean fasting serum glucose (93 +/- 13 versus 98 +/- 17 mg/dL; P = .0001), and mean 2-hour glucose level (124 +/- 41 versus 134 +/- 49 mg/dL; P < .01). These differences were significant after adjusting for maternal age, body mass index (BMI), and the use of insulin in pregnancy. Nursing had no effect on total cholesterol, LDL cholesterol, or triglyceride levels. However, the mean serum HDL cholesterol was elevated in the lactating group after adjusting for maternal age, BMI, and pregnancy insulin use compared with the nonlactating group (48 +/- 11 versus 44 +/- 10 mg/dL; P < .01). CONCLUSIONS: Lactation, even for a short duration, has a beneficial effect on glucose and lipid metabolism in women with gestational diabetes. Breast-feeding may offer a practical, low-cost intervention that helps reduce or delay the risk of subsequent diabetes in women with prior gestational diabetes.
Recurrent spontaneous abortion affects about 0.5% of women. The causes of recurrent abortion are fetal and maternal. Most fetal causes are genetic or chromosomal abnormalities. Most maternal causes are congenital or acquired uterine abnormalities. Controversy exists regarding the possible etiology of immunologic factors and lupus anticoagulant activity as causes of recurrent abortion. Performance of histocompatibility locus antigen typing and immunotherapy do not appear to be cost effective or necessary in couples with recurrent abortion. The use of treatment for the presence of lupus anticoagulant or anticardiolipin antibodies has not been found to be superior to no treatment and must be regarded as investigational.
Mifepristone (RU486) should be useful for inducing menstrual bleeding in women with menses delayed up to 10 days. We evaluated this potential use for "menstrual regulation" in a randomized clinical trial with 16 women, half of whom received a single 600 mg dose and half of whom received a placebo. Four of eight women in each treatment group proved to be pregnant. Seven of eight who received mifepristone were not pregnant at two-week follow-up, in contrast to four of eight who received the placebo (p = 0.15). Mifepristone may hold promise for "menstrual regulation" for women who do not have access to medical confirmation of pregnancy or who choose not to have this determination made.
OBJECTIVES: The objectives were to measure rates of planned pregnancy and factors affecting these rates after use of very-long-acting contraceptive methods (Norplant or Norplant II implants, a levonorgestrel-releasing intrauterine contraceptive device, or the copper T (model TCu 380Ag) intrauterine contraceptive device. STUDY DESIGN: The design was a concurrent, multicenter prospective study of 372 women who stopped contraception for planned pregnancy. Analysis was by life-table, log-rank, and standard chi 2 methods. RESULTS: Pregnancy rates 12 and 24 months after cessation of contraceptive use were 82 and 89 per 100, respectively. Age at removal and family planning intentions at initiation of contraception were both significantly correlated with pregnancy rates (p less than 0.05), but former contraceptive regimen and duration of contraceptive use were not. Pregnancy outcomes did not deviate from normal limits and did not differ by contraceptive formerly used. CONCLUSION: Contraceptive implants releasing 30 micrograms/day of levonorgestrel or intrauterine contraceptive devices releasing 20 micrograms/day of levonorgestrel or having copper surface areas of 380 mm2 are associated with normal fertility after use for women seeking pregnancy at termination. Durations of use do not affect pregnancy rates.
Oral contraceptives (OCs) were initially approved for unrestricted use in 1960 in the United States and have been used and studied extensively for 30 years. The initial formulations contained a fixed dose of estrogen and progestogen ingested for 21 days, with a seven-day pill-free interval. Subsequent formulations contained a sequential estrogen dose, a progestogen alone given daily, and variable doses of both progestogen and estrogen. Although the estrogen and progestogen doses employed in currently marketed OCs are markedly lower than those used in the OCs of the 1960s and 1970s, the excellent contraceptive efficacy of these compounds has not been compromised. The estrogen component produces a dose-related increase in serum globulin concentrations, triglycerides, and high-density lipoprotein (HDL) cholesterol, along with a decrease in low-density lipoprotein (LDL) cholesterol, while the progestogen component causes peripheral insulin resistance, a decrease in HDL cholesterol, an increase in LDL cholesterol, and various androgenic effects. The effect of nicotine on thromboxane release acts synergistically with the elevated serum clotting factors to increase the incidence of both arterial and venous thrombotic events, particularly in women smokers over 35 years of age. However, there is no evidence of increased risk of myocardial infarction or stroke in healthy, nonsmoking women of any age who use OCs containing less than 50 micrograms estrogen. Likewise, the lower-dose estrogen/progestogen formulations do not have a clinically significant effect on glucose metabolism and have a neutral effect on lipoprotein metabolism. In addition, the many noncontraceptive health benefits associated with OCs are maintained with the lower-dose formulations. Thus, the low-dose formulations should improve the overall health of healthy, nonsmoking women as well as effectively prevent unwanted pregnancy.
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The purpose of this study was to examine the bleeding patterns of 234 Norplant users during 5 years of use and to identify the bleeding patterns of users who conceived. During the first year of use, 26.6% of users had regular bleeding cycles, 66.3% had irregular cycles, and 7.1% were amenorrheic. By the fifth year of use, 62.5% of users had regular cycles, 37.5% had irregular cycles, and none had amenorrhea. Of the ten users who became pregnant, eight had regular menstrual cycles in the 6 months before the diagnosis of pregnancy, one had an irregular pattern, and one did not keep a bleeding record. None had amenorrhea. The 5-years cumulative pregnancy rate for patients with regular cycles was 17.4%; this was significantly higher (P less than .05) than the 5-year cumulative rates of 4.4% in users with irregular cycles and 0% in users with amenorrhea. This study indicates that during the first year of Norplant use, only 26.6% of users have regular cycles, but after the first year, 50-60% of users develop regular cycles. The bleeding patterns of women using Norplant improve after the first year of use, and those with regular cycles are at greatest risk for method failure.
Oral contraceptives (OCs) were initially approved for unrestricted use in 1960 in the United States and have been used and studied extensively for 30 years. The initial formulations contained a fixed dose of estrogen and progestogen ingested for 21 days, with a seven-day pill-free interval. Subsequent formulations contained a sequential estrogen dose, a progestogen alone given daily, and variable doses of both progestogen and estrogen. Although the estrogen and progestogen doses employed in currently marketed OCs are markedly lower than those used in the OCs of the 1960s and 1970s, the excellent contraceptive efficacy of these compounds has not been compromised. The estrogen component produces a dose-related increase in serum globulin concentrations, triglycerides, and high-density lipoprotein (HDL) cholesterol, along with a decrease in low-density lipoprotein (LDL) cholesterol, while the progestogen component causes peripheral insulin resistance, a decrease in HDL cholesterol, an increase in LDL cholesterol, and various androgenic effects. The effect of nicotine on thromboxane release acts synergistically with the elevated serum clotting factors to increase the incidence of both arterial and venous thrombotic events, particularly in women smokers over 35 years of age. However, there is no evidence of increased risk of myocardial infarction or stroke in healthy, nonsmoking women of any age who use OCs containing less than 50 micrograms estrogen. Likewise, the lower-dose estrogen/progestogen formulations do not have a clinically significant effect on glucose metabolism and have a neutral effect on lipoprotein metabolism. In addition, the many noncontraceptive health benefits associated with OCs are maintained with the lower-dose formulations. Thus, the low-dose formulations should improve the overall health of healthy, nonsmoking women as well as effectively prevent unwanted pregnancy.
Daily transvaginal ultrasound (US) scanning of the ovaries to assess follicular development and daily blood sampling were performed on 19 Norplant (Leiras, Turku, Finland) subdermal contraceptive implant users who had regular menstrual cycles and on 10 normally cycling women. Three groups were identified in the implant users based on US finding. Six (31.6%) of the implant users had US findings that were consistent with a normal ovulatory pattern. However, their mean peak luteinizing hormone levels and peak midluteal phase progesterone (P) levels were significantly lower than control values. Eleven (57.9%) users had persistent follicles, and 2 users (10.5%) had no follicular development. These data suggest that after 2 to 4 years of use, about one third of Norplant users with regular bleeding patterns may ovulate but most have deficient luteal P levels. In this small study, the presence of persistent follicular enlargement in implant users was common.