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Randomized clinical trial with intrauterine devices (levonorgestrel intrauterine device (LNG), CuT 380Ag, CuT 220C and CuT 200B). A 36-month study. Indian Council of Medical Research Task Force on IUD.

A total of 1905 subjects were randomly allocated to four types of intrauterine devices (IUDs) and were observed for 45,683 woman-months of use. While no method failure was observed with levonorgestrel (LNG) IUD, 11 women became pregnant with other devices; 4 with Copper T 380Ag, 1 with Copper T 220C, and 6 while using Copper T 200B, indicating method failure rates of 1.0, 0.3 and 1.6, respectively, at 36 months of use. These rates were within acceptable range. Continuation rates were significantly lower with LNG IUD (74.5, 58.7, 38.8 at 1 year, 2 years and 3 years, respectively) as compared to other copper devices, which ranged between 82.4 to 84.4 at 1 year, 66.6 to 69.9 at 2 years and 45.4 to 50.4 at 3 years. The difference in continuation rates was mainly due to menstrual disturbances (e.g. amenorrhoea, irregular bleeding) which were higher with LNG IUD (27.9 per 100 users) as compared to the copper devices (13.4-15.4 per 100 users) at 36 months of use. The risk of expulsion ranged between 8.3 to 10.6 per 100 users and was comparable for all the devices. The observations from the present study based on 36 months of experience with different intrauterine devices do not indicate the need to replace CuT 200, the device currently in use in the National Programme.

Adolescent↗

[Multiload Cu250 intrauterine devices and VCu200 intrauterine devices for women with previous failure of stainless steel ring intrauterine devices: a 5-year randomized clinical trial].

Two hundred rural women with history of stainless steel ring (SSR) intrauterine devices (IUD) failure (i.e. expulsion or pregnancy with IUD-in-situ) were randomly allocated into Multiload Cu250 (MLCu250) or VCu200 group. The follow up rate was 97.5% at the end of 5-year. The 5-year gross cumulative continuation rates per 100 women for MLCu250 and VCu200 were 80.0 and 81.7 respectively. The 5-year cumulative expulsion rate was significantly lower in MLCu250 group (1.0) than that in VCu200 group (8.1) (P < 0.05), while the pregnancy rate was higher in MLCu group (12.0 vs. 4.1) but no statistical significant difference existed between the 2 groups. The removal for bleeding and (or) pain were similar (6.0 and 6.1). There was one ectopic pregnancy in each group and no removal for medical or personal reasons. The expulsion and pregnancy cases in the present study were not associated with their previous failures. It was concluded that both types of copper IUD were effective for women with previous failure of SSR. The study also showed that MLCu250 might be used as long as 5 years. Should surface area of copper be increased, further decreased pregnancy rate would be expected.

Adult↗

Intravesical migration of intrauterine device.

Intrauterine devices have been plagued by many early and late complications, including uterine perforation and migration into adjacent structures. To our knowledge only 18 cases have been reported in the literature of migration of an intrauterine device into the bladder. We report on a 38-year-old woman in whom an intrauterine device eroded from the uterus 3 years after placement. The device remained asymptomatic in the pelvis for an additional 13 years before the patient presented with urinary symptoms. The literature is reviewed.

Adult↗

An unusual cause of vesical stone: a migrant intrauterine device.

Intrauterine contraceptives devices have been in use for many years. Although perforation of the uterus by an intrauterine device is not uncommon, intravesical migration with secondary stone formation is a rare complication. We report on a 32-year-old woman in whom an intrauterine contraceptive device (Copper T) migrated from her uterus into the bladder. She had lower urinary tract symptoms for nearly 2 years but sought no treatment. The onset of hematuria and fear of cancer prompted her to seek treatment. On investigation, a vesical stone was discovered that had formed on a copper T contraceptive device. It was removed via suprapubic cystostomy. In any woman in whom an intrauterine device is fitted and who presents with lower urinary tract symptoms, the possibility of intravesical migration of the device should be included in the differential diagnosis.

Adult↗

Interleukin-6 and tumor necrosis factor-alpha concentrations in the intrauterine cavity of postmenopausal women using an intrauterine delivery system releasing progesterone. A possible mechanism of action of the intrauterine device.

Intrauterine devices (IUD) provide effective contraception. The current study evaluates the concentration of interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha) in the intrauterine fluid of postmenopausal women using an intrauterine delivery system releasing progesterone (IDS-P). Intrauterine fluid was obtained by lavage, and IL-6 and TNF-alpha were analyzed using an enzyme-linked immunosorbent assay (ELISA). Statistical analysis was performed with a one-way analysis of variance (ANOVA). Intrauterine fluid IL-6 levels were 33.6 vs 6.09 pg/sample IDS-P vs no IDS-P (p = 0.0301). Intrauterine TNF-alpha levels for women using the IDS-P were higher than in nonusers, but the differences did not reach statistical significance. IL-6 and TNF-alpha levels were increased in the intrauterine cavity of postmenopausal women with an IDS-P. These data suggest that secreted cytokines could be a potential mechanism of IUD contraceptive efficacy.

Enzyme-Linked Immunosorbent Assay↗

[Severe infectious complications after an excessively long use of intrauterine device].

Intrauterine device (IUD) is a widely used method of contraception in the world. The aim of our study was to examine infectious cases due to a prolonged use of IUD. We present four patients who had carried IUD for about seventeen years. On admission, all cases were presenting symptoms of acute adnexitis. On further examination, we diagnosed tubo-ovarian abscess in two patients. In our article, we carefully describe all cases and focus attention on side effects of abnormally extended period of using IUD. We conclude that the only proper way of informing patients how to use IUD and good gynecological care while using IUD may protect against severe infectious complications of the genital tract.

Abdominal Pain↗

Two cases of uterine septum with intrauterine device.

Intrauterine devices (IUDs) have been used worldwide for contraception for decades. They are easily deployed, inexpensive and one of the most reliable contraceptive methods. Though ease of placement is such that they are frequently placed by midwives in the outpatient setting in developing countries, some complications due to its misplacement occasionally can occur. We present two cases with unknown uterine septum in which IUDs were placed without prior ultrasound examination of the pelvis. We conclude evaluation of the pelvis by ultrasound prior to placement of IUDs in women with a history of breech presentation, preterm labour, or recurrent miscarriage may be helpful in identifying uterine anomalies that make IUD placement unsuitable.

Abortion, Habitual↗

Pharmacokinetic and pharmacodynamic studies of levonorgestrel-releasing intrauterine device.

Intrauterine devices releasing 20 micrograms/day levonorgestrel were inserted in 10 women (ages 25-34). Bleeding and spotting patterns were recorded on a menstrual card during one year of follow-up. Blood samples were collected for radioimmunoassays of LH, estradiol (E2), progesterone (P) and levonorgestrel (LNG) and for sex hormone binding globulin (SHBG) 3 times a week during the 1st month of use, and twice a week during the 6th and 12th treatment months. Among the 10 women, two experienced irregular cycles with prolonged intermenstrual spotting, four had amenorrhea in the latter part of treatment months, while the other four had regular cycles. According to the serum levels of E2 and P, the hormone profiles were divided into four types of reaction: A) anovulatory, B) anovulatory but with high follicular activity, C) ovulatory but with luteal insufficiency, and D) ovulatory. Among the 29 treatment cycles, there were 10 D-type, 3 C-type, 13 B-type and 3 A-type of ovarian reactions: 44.8% of the cycles were ovulatory (C + D) and 55.2% were anovulatory (A + B). In general, serum levels of levonorgestrel were low in ovulatory cycles and were high in anovulatory cycles. The difference was statistically significant. There were marked individual differences. The decline of serum LNG from the 1st (492 pmol/l) to the 6th (320 pmol/l) treatment months was 34.9% on average. The amenorrheic cycles coincided mostly with the hormonal profile of ovulatory types, which indicated that the cause of amenorrhea is due to the local effect of levonorgestrel on the endometrium. The levonorgestrel levels were significantly correlated with serum SHBG, r = 0.8856, p less than 0.001, and with E2, r = 0.4661, p less than 0.05.

Adult↗

Water absorption characteristics of novel Cu/LDPE nanocomposite for use in intrauterine devices.

Intrauterine devices (IUDs), especially the copper-containing IUDs (Cu-IUDs), are one of the worldwide used forms for birth control, owing to their advantages of long-lasting and high efficacy, economy, safety, and reversibility. However, it is not perfect for the existing Cu-IUDs; some shortcomings related to its side effects have not been overcome yet. For this reason, a new Cu-IUDs material, the copper/low-density polyethylene (Cu/LDPE) nanocomposite, has been developed in our research team. The structure and water uptake characteristics of this new Cu-IUDs material have been investigated by using X-ray diffraction (XRD), Scanning electron microscopy (SEM), X-ray energy dispersive spectroscopy (EDS), Fourier transform infrared spectroscopy (FT-IR), and gravimetric analysis in this paper. The results of XRD, SEM, EDS, and FT-IR show three important outcomes associated with the structure of the nanocomposite. First, the nanocomposite is hybrid of the polymer and the copper nanoparticles (nano-Cu). Second, porosities, nano-Cu aggregates, and primary alcohol (R--CH(2)--OH) are existed in the nanocomposite. Third, the nano-Cu aggregates are distributed uniformly in the polymer matrix in general. The results of Gravimetric analysis, which associated with the water uptake characteristics of the nanocomposite, exhibit that the water absorption behavior of the nanocomposite obeys the classical diffusion theory very well, the water uptake of the nanocomposite increases with the increasing of the nano-Cu loading, and that the water uptake ability of the nanocomposite with 15.0 wt % nano-Cu (50 nm in diameter) is about 150 times larger than that of the base resin and about 45 times higher than that of the Cu/LDPE microcomposite with 15.0 wt % copper microparticles (5 microm in diameter). These water uptake characteristics are mainly attributed to the structure of the Cu/LDPE composites and the size effect of the nano-Cu.

Absorption↗

[Effects of long-term installation of intrauterine devices on intrauterine microenvironment].

OBJECTIVES: To study the effect of long-term installation of intrauterine devices (IUD) on the intrauterine microenvironment. METHODS: Eighty-nine healthy 26 - 50-year-old women undergoing physical examination or having their IUD removed were recruited. Among them 62 had used IUDs, including 32 inert IUD (I-IUD) and 30 copper releasing IUD (T-IUD), for 5 - 20 years, and 27 women without installation of IUD were used as controls. In the 3rd to 13th day of menstrual cycle, 3 ml of irrigation of intrauterine cavity were collected to examine the concentrations of tumor necrosis factor-alpha (TNF-alpha), interleukin 2 (IL-2) and secretary IgA (SIgA) by radioimmunoassay (RIA). Hysteroscopy was used to obtain 3 pieces of endometrium at the place where the IUD was attached for each subject. Three pieces of endometrium were curretted from each control during the proliferative stage. Thirty specimens of endometrium, including 10 cases with I-IUD, 10 cases with T-IUD, and 10 control cases were used to examine the distribution of T cell subset by immunohistochemistry. Fifteen specimens of endometrium, including 6 cases with I-IUD, 6 cases with T-IUD, and 3 control cases, were used to examine the endometrial ultrastructure by scanning electron microscopy (SEM) and transmission electron microscopy (TEM). Twenty-five specimens of endometrium, including 10 cases with I-IUD, 10 cases with T-IUD, and 5 control cases, were used to detect the expression and mutation of P16, P53 and K-ras by PCR-SSCP technique. RESULTS: There was no significant difference in TNF-alpha level in the irrigation among the three groups (P > 0.05). IL-2 and SIgA levels (0.39 +/- 0.18) microg/L and (2000 +/- 1224) microg/L respectively) in the T-IUD group were significantly lower than those in the control group (0.96 +/- 0.15) microg/L and (3377 +/- 1906) microg/L respectively, both (P < 0.05). There was a significant difference in the population of T lymphocytes (CD(8)(+) and CD(4)(+) lymphocytes) between the T-IUD group and control group (P < 0.05). SEM and TEM showed no necrosis and atypia in the endometrial cells of I-IUD group and T-IUD group. There was no positive expression of gene p16, p53 and K-ras in the endometrium of the three groups. CONCLUSION: It is safe and effective using I-IUD or T-IUD for a long time, however, T-IUD has some effects on intrauterine local immune function.

Adult↗

Spontaneous bacterial peritonitis associated with an intrauterine device.

Intrauterine contraceptive devices (IUD) have been associated with the induction of chronic anaerobic endometritis as well as superimposition of exogenous sexually transmitted diseases and unilateral tubo-ovarian abscesses. We report an unusual case of spontaneous bacterial peritonitis in a patient with ascites and an IUD. Bacteriological data support the concept that the source of infection was a chronic mixed endometritis induced by prolonged use of an IUD (16 years). In the presence of ascites, a localized endometritis with its reservoir of bacteria provided the medium for systemic disease.

Ascites↗

Hormonal intrauterine devices.

Intrauterine administration of progestogens from an IUD was introduced more than 15 years ago in order to improve the contraceptive efficacy and to reduce side-effects. A device releasing 20 micrograms levonorgestrel daily (Levonova) with a life span of at least 5 years is now available and has been subjected to an extensive study including 1821 women followed during 5 years. The safety and efficacy were evaluated in comparison to Cu-T IUDs. The pregnancy rate (Pearl index) was 0.09. During the first two cycles after insertion intermenstrual bleeding was common, otherwise the frequency of side-effects was low. The results seem to justify the conclusion that intrauterine administration of progestogens represents a further development of IUDs and hormonal contraception. Furthermore, these devices have proven to be effective in treatment of heavy menstrual blood losses. In many menorrhagic women, use of these IUDs can replace more invasive surgical methods such as hysterectomy or endometrial resection. Intrauterine administration of progestogens is also effective in opposing the proliferative effect of oestrogen on the endometrium in women on hormonal replacement therapy.

Adolescent↗

Effect of different types of intrauterine devices on intrauterine activity.

OBJECTIVE: To compare the effects of various IUDs on intrauterine activity. PATIENTS AND METHODS: 57 women volunteers aged 18 to 25 in the outpatient clinic of the Department of Obstetrics and Gynecology at Cerrahpasa Medical Faculty of Istanbul University were included in the study. All were in good health and menstruating normally. The subjects were introduced to different types of IUDs on the fifth to eighth days of their menstrual cycle. Intrauterine activities with and without naproxen were recorded, for at least 20 minutes each time, with a micro-tip transducer before insertion, just after insertion, and 1 month later. RESULTS: Intrauterine activity increased just after insertion of both IUDs and disappeared 1 month later in copper-T wearing women, but persisted in multiload wearers. Naproxen seemed to be useful in preventing intrauterine activity caused by the IUD. CONCLUSIONS: The IUD itself causes an increase in intrauterine activity which is preventable by naproxen, suggesting the possible role of prostaglandins. Persistence of intrauterine activity depends upon the type of device. Optimal designing of IUDs is required to decrease side effects and make them more acceptable.

Adolescent↗

Residues of pelvic inflammatory disease in intrauterine device users: a result of the intrauterine device or Chlamydia trachomatis infection?

It is currently believed that intrauterine devices cause pelvic inflammatory disease and tubal infertility. To investigate this concept further, we evaluated 245 infertile patients for inflammatory residues by laparoscopy or laparotomy; 176 patients had not used an intrauterine device and 69 had used one. Chlamydial antibody titers were performed on all patients. Although users had a higher overall prevalence of inflammatory residues than nonusers, there was no difference in residue prevalence for either group at the same titer level. No specific type of device appeared to be associated with either an increased or decreased residue frequency. "Silent" chlamydial infections occurred with equal frequency in both users and nonusers. We conclude that inflammatory residues and tubal infertility in intrauterine device users are not caused by the intrauterine device but by both overt and silent chlamydial infections.

Adult↗

Immediate post-abortal insertion of intrauterine devices.

OBJECTIVES: To assess the safety and efficacy of IUD insertion immediately after spontaneous or induced abortion. SEARCH STRATEGY: We used Medline, Popline, and EMBASE computer searches, supplemented by review articles and contacts with investigators. SELECTION CRITERIA: We sought all randomized controlled trials that had at least one treatment arm that involved IUD insertion immediately after an induced abortion or after curettage for spontaneous abortion. We identified 12 trials which described random assignment but excluded three from this review. Two of these revealed unethical research conduct, and one used alternate assignment to treatments. DATA COLLECTION AND ANALYSIS: We evaluated the methodological quality of each report and abstracted information onto a data collection form. We focused on gross discontinuation rates (single-decrement life table analysis) for accidental pregnancy, perforation, expulsion, and pelvic inflammatory disease. We entered the data into RevMan 3.1 for analysis of Peto odds ratios. MAIN RESULTS: In large multicenter trials, the TCu 220C device proved superior to either the Lippes Loop D or the Copper 7 IUDs for immediate post-abortal insertion. The Peto OR for discontinuation for pregnancy was 0.4 (95% CI 0.2-0.7) compared with the Lippes Loop D and 0.5 (95% CI 0.3-0.8) compared with the Copper 7. Expulsions were also significantly less common with the TCu 220C than with the other two IUDs. In single-center trials, the Nova T IUD had a signicantly higher discontinuation rate for pregnancy than did the Multiload 250 (OR 4.5; 95% CI 1.0-19.8), while the Nova T had a significantly lower discontinuation rate for pregnancy than did the TCu 200 (OR 0.3; 95% CI 0.1-0.9). Only one trial compared immediate vs. delayed insertion. In this trial, the performance of the Copper 7 IUD inserted immediately after abortion was inferior to that after interval insertion (remote from pregnancy), although the differences were not statistically significant. Addition of copper sleeves to a Lippes Loop D improved its performance, but addition of a topical hydrogel to a Spring Coil did not offer benefit. Overall, rates of perforation and pelvic inflammatory disease were low. REVIEWER'S CONCLUSIONS: Insertion of an IUD immediately after abortion is both safe and practical. This was true for both induced and reported "spontaneous" abortions, many of which may have been induced under clandestine circumstances. IUD expulsion rates were higher after second-trimester abortions than after earlier abortions, so delaying insertion may be advisable after later abortions. Although Copper 7 devices inserted unrelated to pregnancy may perform better than those inserted after abortion, many women who express interest in intrauterine contraception do not return for the scheduled insertion. These women may remain unprotected against unintended pregnancy. However, evidence is inadequate to compare the safety and efficacy of IUD insertion immediately after abortion vs. insertion some weeks later.

Abortion, Induced↗

Two years' experience with two levonorgestrel-releasing intrauterine devices and one copper-releasing intrauterine device: a randomized comparative performance study.

A randomized comparative performance study of two levonorgestrel intrauterine devices (IUDs) and a copper (Nova-T) IUD (Leiras, Turku, Finland) was performed at two clinics in Finland and one in Brazil. The 24-month cumulative event rates per 100 women are reported. Six thousand woman-months of use were recorded with the levonorgestrel IUD and 3000 with the Nova-T device. Pregnancy rates at 2 years of use were 0.6 and 0 with the two levonorgestrel IUDs and 3.3 with the Nova-T IUD. Removal rates because of bleeding and/or pain were low with all three IUDs: 7.5, 7.6, and 7.1, respectively, at 24 months. Recordings of the number of days of bleeding showed significantly fewer days of bleeding during use of the levonorgestrel IUDs than the Nova-T IUD from the second month of use onward, until the end of the second year. No infections were recorded in association with use of the levonorgestrel IUDs, and only one termination because of infection was recorded for the Nova-T IUD. The continuation rates of use at 24 months were 66.6, 60.7, and 71.9 for the two levonorgestrel IUDs and the Nova-T IUD, respectively; the differences were not statistically significant.

Adolescent↗