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Intrauterine devices: medicated and nonmedicated.

The main benefits of intrauterine devices (IUDs) are a lack of adverse systemic effects, excellent effectiveness, high continuation rates and the single act of motivation required for use. First year failure rates range from 2% to 3%, but decline steadily thereafter to a cumulative annual failure rate of less than 1% after six years. The risks of IUDs include increased blood loss, uterine perforation, pelvic infection and pregnancy-related complications. The incidence of perforation of the uterine fundus ranges from 1:1000 to 1:2500 insertions, while that of cervical perforation with the copper devices ranges from 1:600 to 1:1000. IUD use is associated with about a three-fold increased incidence of developing acute salpingitis in comparison with use of oral contraceptives and diaphragms. If pregnancy occurs with an IUD in place, there is a three-fold increased risk of spontaneous abortion, a ten-fold increased risk of ectopic pregnancy (5% of all IUD pregnancies) and a possible increased incidence of sepsis during the pregnancy.

Abortion, Septic↗

Management of a perforated levonorgestrel-medicated intrauterine device--a pharmacokinetic study: case report.

Intrauterine contraception is a widely used, highly effective method of birth control. Uterine perforation is a serious albeit rare complication with the use of an intrauterine device (IUD). Although uterine perforation by the levonorgestrel-releasing intrauterine system (LNG-IUS) has already been described, no plasma LNG concentrations in this setting were reported. Neither has the management of LNG-IUS been commented on to date. Two months after insertion of an LNG-IUS into a 33-year-old woman, it was noted to be in the peritoneal cavity. Laparoscopy for IUD removal was conducted 5 months after insertion. LNG and sex hormone-binding globulin plasma concentrations were measured prior to and following the laparoscopic removal of the IUD. Intra-peritoneal dislocated LNG-IUS resulted in plasma LNG levels 10 times higher (4.7 nmol/l) than the plasma level of LNG observed with LNG-IUS placed in utero. This high plasma LNG level suppresses ovulation. Therefore a misplaced LNG-IUS should be removed when pregnancy is desired.

Adult↗

[Study of pH values of uterine fluid in users of medicated intrauterine devices].

A study was made of the pH value of uterine secretion in 100 women at the age of 18-50 years and with a normal menstrual cycle (28 +/- 2 days). Fifty women had inserted medicated IUDs (Copper T and Multiload Cu 250) and 50 women served as a control group. In the proliferation phase of menstrual cycle 22 women were with the IUDs (of whom 14 had group II and 8 women group III vaginal secretion) and 21 women without any IUD of whom 8 had group II and 13 women group III vaginal secretion. In the secretion phase 28 women were with IUDs, (8 had group II and 20 women group III vaginal secretion) and 29 women from the control group, of whom 17 had group II and 12 women had group III. For the sampling of the intrauterine fluid the aspiration method and for the pH determination the colorimetric method were used. It can be seen that there is no correlation between the group of vaginal secretion and the pH of the uterine fluid, that the presence of a medicated IUD induced an insignificant change in the intrauterine pH, and that the pH value of the uterine fluid ranges from 3.0-9.0 which may be an important factor in the elucidation of certain mechanisms that occur in the uterus in the presence of intrauterine devices.

Adolescent↗

Medicated intrauterine devices to improve bleeding events.

In an attempt to find an IUD that will cause a minimum amount of blood loss, while continuing to be effective and easily retained, we are studying 4 medicated IUDs: a copper-bearing Lipps Loop, a Copper-T-200, a progesterone-releasing U-coil, and a tranexamic-acid-releasing Lippes Loop. Inert devices of the same shape and size are used as controls. This is a comparison of the findings on menstrual blood loss and loss and changes in bleeding patterns for patients using the plain and copper-bearing Lippes Loops. Preliminary results for the progesterone-bearing U-coil and the tranexamic-acid-releasing Lippes Loop are also given, but studies of these devices are not yet complete.

Female↗

Experience with two different medicated intrauterine devices: a comparative study of the Progestasert and Nova-T.

A comparative study of the Progestasert (UPS) and the Nova-T in 326 randomly selected women was carried out. The observation period was 1 year. The over-all continuation rates for the two types of intrauterine devices (IUDs) were similar. The expulsion rate for the Nova-T (9.2%) was considerably higher (P = 0.001) than that for the UPS (1.2%). Medical removals for bleeding/pain were more frequent (P = 0.028) for the UPS (15.4%) as compared with the Nova-T (6.1%). The pregnancy rate for the UPS (Pearl index = 4.8) was insignificantly higher than that for the Nova-T (Pearl index = 2.8). Two of the pregnancies in the UPS group were ectopic. No significant changes in the reactive immunoglobulins (IgA, IgG, or IgM) were observed in either of the groups. Our results indicate that neither of these two IUDs is preferable to the already existing medicated IUDs, such as the Copper T or the Copper 7.

Adult↗

[The histological reaction of the endometrium to gestagens applied locally].

To study the histologic changes produced by a new type of progesterone-medicated intrauterine device we examined the endometria of six hysterectomy specimens and one complete curettage. After being in place for 1 month the device induced a mild perifocal "arrested secretion" of the upper layers of the endometrium; after 3 months the change was pronounced, with decidually transformed stromal cells and atrophic glands. After 12 months these changes had partially progressed to fibrous atrophy. The endometrium underlying the perifocal-arrested secretion showed either proliferative or secretory changes almost like those of the lower functionalis of a normal menstrual cycle. A generalized atrophy of glands developed only when the patient had used oral contraceptive agents before the device was inserted. The perifocal arrested secretion thus differs from the generalized arrested secretion of the endometrium that follows use of oral or injected gestagens and from the decidualization produced mechanically by the local effect of an intrauterine device. The contraceptive effectiveness of the medicated intrauterine device, as compared with that of a simple device, is increased by the glandular atrophy of the arrested secretion. It avoids the dangers of the generalized effects of progestational agents by limiting the changes to the upper layers of the endometrium which are so important for implantation.

Administration, Topical↗

New interventional techniques for adenomyosis.

This chapter demonstrates that new interventional techniques have been introduced over recent years in order to find an adequate non-invasive therapy for adenomyosis. There is no evidence-based medicine to guide us in the treatment of adenomyosis with minimally invasive therapy. In fact, most data regarding adenomyosis and these evolving therapies comes from the inadvertent treatment of adenomyosis in studies designed to treat uterine leiomyomas. Essentially, all data are from case reports or small case series. The problem is compounded by the fact that there is no agreed imaging definition of adenomyosis, and so therapies that do not excise the uterus have no 'gold standard' for comparison. Nonetheless, there are some reports suggesting that there may be efficacy in techniques such as medicated intrauterine devices, uterine artery embolization, and MRI-guided focused ultrasound surgery. Larger studies specifically treating adenomyosis are clearly required. As with every new approach, the widespread success of these techniques will depend on the general adoption of adequate diagnostic solutions and improvements in the technical parameters of these new regimens. Since the techniques presented in this chapter are new, they have not yet undergone the necessary thorough scientific scrutiny and discussion that is needed for their general acceptance. In the past, adenomyosis was mainly a 'post-factum' pathological diagnosis after extensive surgery. Based on the evidence presented in this chapter it seems that adenomyosis has become an entity that might be treatable by new, minimally invasive or non-invasive treatments.

Adult↗

Therapies for the treatment of abnormal uterine bleeding.

Abnormal uterine bleeding (AUB) is one of the most common disorders encountered by the gynecologist. Several drugs have been demonstrated to decrease menstrual bleeding in patients with menorrhagia. Non-steroidal anti-inflammatory drugs will decrease bleeding by 30% to 50%. Oral contraceptives may be useful to stop acute bleeding and will decrease menstrual flow by approximately 50%. Tranexamic acid, a plasminogen inhibitor approved for the treatment of hemophilia, will also decrease flow by approximately 50%. Danazol and GnRH analogues both have been used for the treatment of menorrhagia. However, side effects make them unsuitable for long-term use. There are currently two medicated intrauterine devices (IUDs) available in the United States. These IUDs reduce menstrual blood loss by 65% to 85%. Several minimally invasive surgical procedures, including endometrial resection and ablation, may treat menorrhagia in select patients. More recently, various office-based ablation instruments have been developed. These machines conform to the endometrial cavity and may obviate the need for hysteroscopy.

Anti-Inflammatory Agents, Non-Steroidal↗

Menstrual bleeding pattern and iron status in women fitted with copper and non-medicated intrauterine contraceptive devices.

A prospective study of the menstrual bleeding pattern and iron status was conducted in 42 healthy Nigerian women volunteers before and after being fitted with either a medicated, copper T (TCu.200B) (n = 20) or a non-medicated, Lippes loop (n = 22) intrauterine contraceptive device (IUD). After about six months of use, the mean fasting serum iron and packed cell volume (PCV) were significantly higher (+32% and +6% respectively), mean serum ferritin was significantly decreased (-14%) compared to the pre-insertion levels in the copper T IUD users. In the Lippes loop IUD users, mean fasting serum iron was significantly lower (-11%), mean PCV was higher (+5%). The changes observed in the mean levels of serum ferritin and the duration of menstrual bleeding did not reach a statistical significant level. Among the two groups, only the changes in the mean fasting serum iron was significant (P < 0.01). In all, only the women fitted with Lippes loop IUDs had a decrease in the levels of both serum iron and body iron stores (ferritin), however, no clinical anaemia was observed at six months of use.

Adult↗

Health during prolonged use of levonorgestrel 20 micrograms/d and the copper TCu 380Ag intrauterine contraceptive devices: a multicenter study. International Committee for Contraception Research (ICCR).

OBJECTIVES: To measure and compare the incidence of adverse events during use of two medicated intrauterine devices (IUDs). DESIGN: A multicenter prospective 7-year randomized study. SETTING: Family planning clinics, primarily in developing countries. SUBJECTS: Women age 18 to 38 years at admission, desiring contraception and without contraindications to IUDs. MAIN OUTCOME MEASURES: Incidence of complaints, conditions, and rates of specific termination for each IUD. METHODS: Subjects recorded menstrual events, and clinical staff registered all complaints and conditions found on examination at four first-year clinic visits and at semiannual visits thereafter. Difference in rates were analyzed by chi 2 statistics. RESULTS: Annual pregnancy rates for each IUD averaged 0.2/100 women whereas upper genital tract infection occurred at rates of 0.6 to 0.7 per 100 years of use. The levonorgestrel-releasing IUD significantly decreased bleeding and spotting days in comparison with historical data for noncontraceptors and with the copper-medicated IUD. Dysmenorrhea, vaginitis, and myoma in women with the levonorgestrel IUD were markedly decreased in comparison with the experience of copper IUD users. Significantly higher rates of amenorrhea, delayed ovarian follicular atresia, skin and hair conditions, and headache were observed with the steroid IUD than with the copper-releasing IUD. Rates of reported adverse effects for either IUD were highest in the first 2 years of use and among women under age 25. CONCLUSIONS: Long-term use of copper or levonorgestrel IUDs is characterized by very low rates of pregnancy and by a low and declining annual incidence of side effects, including pelvic infection and borderline anemia. The levonorgestrel-releasing IUD reduced the incidence of bleeding and, in the long term, of myoma and myoma-related surgery in comparison with the copper T IUD. Both IUDs proved highly acceptable and had few unanticipated side effects.

Adolescent↗

Effects of the etonogestrel-releasing contraceptive implant (Implanon on parameters of breastfeeding compared to those of an intrauterine device.

Eighty healthy single births born at a gestational age of 259-294 days were studied in an open, non-randomized, group comparative fashion. The mothers were on average 6 weeks postpartum, healthy, and fully breastfeeding at the start of treatment. Forty-two mothers elected to use the etonogestrel-releasing implant, Implanon, while 38 chose use of a non-hormone medicated intrauterine device (IUD). One month after implant placement, the dose of etonogestrel ingested by the infants via breast milk was 19.86 ng/kg/day, which decreased to 10.45 ng/kg/day at the end of the study period (month 4). The volume of breast milk production was not affected by the use of Implanon. There were no significant differences between groups in milk content of total fat, total protein, and lactose. The timing and quantity of supplementary feedings did not differ between the two groups. Growth of the infants was analyzed by treatment and gender. For the girls, no differences between groups were seen for body weight, body length, and head circumference. The same applied to the boys except for a somewhat larger, although not statistically significant, increase in body weight for boys whose mother used Implanon. There was a low incidence of intercurrent illnesses in the infants of both groups. None of the conditions was of a serious nature. From the present study, we conclude that Implanon did not change the volume and composition of breast milk. The low concentration of etonogestrel ingested by the infant was not associated with adverse effects.

Adult↗

[Medicated stainless steel ring-165, medicated gamma-intrauterine devices and TCu220C: a multicenter comparative study].

OBJECTIVE: A five-year multicenter comparative study was conducted to observe the clinical efficacy, side effects, and menstrual blood loss (MBL) of medicated stainless steel ring 165 (MSSR-165), medicated gamma-Intrauterine devices (gamma-IUD) (both containing indomethacin and copper) and TCu220C for exploring new kinds of IUD to reduce MBL after IUD insertion. METHODS: MSSR-165 and medicated gamma-IUD, with TCu220C as a control, were randomly inserted (one thousand in each group) in women 12 hospitals nation wide in October 1988. Follow-ups were performed at the time of 3, 6, 12, 24, 36, 48 and 60 months after IUD insertion. The efficacy of the IUDs was calculated with life table method. A quantitative comparison of MBL was made before and 3, 6, 12, 24, 36 and 60 months after the IUD insertion in 20 volunteers. RESULTS: At the end of 5 years, the pregnancy rates of MSSR-165, medicated gamma-IUD and TCu220C were 3.2, 2.7 and 3.2. The expulsion rates were 7.7, 2.3 and 2.4, while the removal rates for medical reasons were 5.0, 3.8 and 6.4. The cumulative continuation rates were 79.8, 88.7 and 84.9 per 100 women respectively. The average total bleeding time in the first year of MSSR-165 was 22 days, the shortest one among the three IUDs. The quantitative comparison of MBL showed that the gamma-IUD reduced the MBL and the TCu220C increased the MBL apparently. CONCLUSION: With good clinical efficacy, short menstrual bleeding time, as well as the same appearance and insertion technic as stainless steel ring, the MSSR-165 will be easily accepted at the grass root level. The gamma-IUD had good clinical efficacy and higher continuation rate, whereas the side effect of bleeding was not obvious. Both medicated SSR165 and gamma-IUD could be recommended for promotion.

Adult↗

Delivery options for contraceptives.

Although a steady increase in contraceptive use has been observed in developed and less-developed countries, the contraceptive needs of a significant proportion of couples have not yet been met, resulting in an increase in unplanned pregnancies. Several new contraceptive products have reached the market during the past few years. Among these are new implants, a medicated intrauterine device, contraceptive vaginal rings, transdermal patches and several new regimen of combined oral contraceptives. These new or improved methods have been developed to expand the contraceptive choices available to women and men as well as to respond to the unmet need for contraceptives with long-term activity. New targets are being identified both in the ovary and the testes for a more specific non-hormonal contraception. This futuristic approach still keeps in mind the need for better access to existing contraceptive methods, as well as the discovery of new contraceptives that are simple to use, safe, reversible and inexpensive. In recent years, there has been great interest in agents that provide dual protection against pregnancy and sexually transmitted infections (STI), especially human immunodeficiency virus (HIV). A contraceptive method providing dual medical benefits might increase motivation for consistent use, thus reducing contraceptive failures and unwanted pregnancies.

Contraception↗

Bone mineral density during long-term use of the progestagen contraceptive implant Implanon compared to a non-hormonal method of contraception.

An open, prospective, comparative study was done in healthy women, aged between 18 and 40 years, to study the effects of long-term etonogestrel treatment on bone mineral density (BMD). The control group used a non-hormone-medicated intrauterine device (IUD). The BMD was measured using a dual energy X-ray absorptiometry instrument. Measurements included the lumbar spine (L(2)-L(4)), the proximal femur (femoral neck, Ward's triangle, trochanter) and distal radius. The period of treatment was 2 years and 44 women in the Implanon group and 29 in the IUD group provided data. Groups were comparable at baseline with respect to age, weight, body mass index, BMD and 17beta-oestradiol status. Changes from baseline in BMD in the Implanon group were not essentially different from those in the IUD group. There was no relationship between 17beta-oestradiol concentrations and changes in BMD in this study population. The results of the present study indicate that Implanon((R)) can safely be used in young women who have not yet achieved their peak bone mass.

Absorptiometry, Photon↗