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Tissue response to the STOP microcoil transcervical permanent contraceptive device: results from a prehysterectomy study.

OBJECTIVE: The present study examines the safety, effectiveness, and local tissue response for a new transcervical fallopian tube permanent contraceptive device, the STOP device (Conceptus, Inc., San Carlos, CA). DESIGN: Nonrandomized prospective evaluation of tubal occlusion and histologic response. SETTING: Inpatient, university and university-affiliated medical centers in the United States and Mexico. PATIENT(S): Premenopausal and perimenopausal women with benign indications for hysterectomy who were able to defer their hysterectomy for 1 to 13 weeks. INTERVENTION(S): A transcervically placed microcoil (STOP device) was inserted into the fallopian tubes of women who were scheduled for hysterectomy, and the device was worn for 1 to 12 weeks. At hysterectomy, hysterosalpingography was done to determine tubal occlusion; subsequently, the tubes containing the STOP devices were processed, sectioned, and evaluated to determine the histologic response. MAIN OUTCOME MEASURE(S): Ability to place a device and evaluate tubal occlusion and tissue response. RESULT(S): Devices were placed in 33 women, representing 57 tubes; the women wore the devices from 1 day to 30 weeks. Histology on 27 women (47 tubes) showed an acute inflammatory and fibrotic response in the short term that, over time, became a chronic inflammatory response with extensive fibrosis. CONCLUSION(S): The localized tissue response and notable absence of any normal tubal architecture in the segment of the fallopian tube containing the STOP device supports the postulated mechanisms of action of the device. Prehysterectomy study findings suggest the usefulness of the STOP device for pregnancy prevention, this is being evaluated in long-term safety and effectiveness studies.

Fallopian Tubes↗

Microbiology of vaginitis associated with the intrauterine contraceptive device.

A malodorous, homogeneous, grey, thin and non-purulent discharge, which resembles non-specific vaginitis occurs in 20% of women with an intrauterine contraceptive device (IUCD); four times more common than in non-users. The aim of this investigation was to study the bacteriological aetiology of this IUCD-associated vaginal discharge, and to assess whether the infection was ascendent. No specific microbiological aetiology was found, but the normal, Lactobacillus-dominated microbial vaginal flora was replaced by Gardnerella vaginalis and certain anaerobic species in IUCD-users with the discharge. Clue cells, pepper-salt phenomenon and curved rods and/or fusiform-shaped rods demonstrated by microscopy, were typical of symptomatic patients. The endometrium and the IUCD were infected with these species in the symptomatic group more often than in IUCD-users who had no symptoms or in the control women who did not use the IUCD.

Bacteria↗

Comparison between antifibrinolytic and antiprostaglandin treatment in the reduction of increased menstrual blood loss in women with intrauterine contraceptive devices.

The effects of a fibrinolysis inhibitor (tranexamic acid, TA) and prostaglandin synthesis inhibitor (diclofenac sodium, DS) were compared in the reduction of excessive menstrual blood loss in 19 women with an intrauterine contraceptive device (IUCD). These women (mean blood loss before treatment to 135.1 +/- 18.9 SE ml, range 70-294 ml) were treated in random order with TA (1.5 g three times daily for 5 days starting on the first day of menstruation for two periods), and with DS (50 mg three times on the first day followed by 25 mg three times daily for 4 days, for two periods), or with placebo (one period) in a double-blind trial. The placebo treatment did not change menstrual blood loss (128.3 +/- 15.6 ml). The TA treatment decreased blood loss to 59.4 +/- 7.7 ml (P less than 0.001) and the DS treatment to 102.1 +/- 13.6 ml (P less than 0.01). Neither treatment abolished pelvic discomfort during menstruation or shortened its duration. Various side-effects were noted by 12 women during 19 TA treatments and by five women during six DS treatments. Thus, while TA is generally far more effective, DS gave pronounced decreases in menstrual bleeding in some women and had less frequent side-effects.

Adult↗

Intra-uterine contraceptive devices (IUDs) in relation to uterine histology and microbiology.

Histological and microbiological examinations were made of 90 uteri taken in association with abdominal hysterectomy. Thirty-one women had an intra-uterine contraceptive device (IUD) in utero at the time of operation, 16 women had previously used an IUD, while 43 had never used one. A chronic inflammatory reaction was seen significantly more often in the fallopian tubes of women with an IUD in situ (21/31, 68%) than in those who had never used an IUD (7/43, 16%). In contrast, non-active post-inflammatory tubal changes were found less frequently in women with an IUD in situ (6%) than in women who had never used an IUD (16%). All tubes were sterile, expect for two with apathogenic microbes. An endometrial inflammatory reaction was found in 4 women with an IUD in situ and in one woman who had never used an IUD. The possibility of tubal infertility must be borne in mind when planning IUD contraception.

Adult↗

Anti-prostglandin therapy in prevention of side-effects of intrauterine contraceptive devices.

The efficacy of an anti-prostaglandin, tolfenamic acid (T.A.), in the prevention of side-effects after insertion of a copper-T200 intrauterine contraceptive device (I.U.D.) was evaluated in a double-blind trial in 160 women. T.A. relieved pain and reduced bleeding after insertion and during three subsequent menstruations without serious side-effects. A scoring system for the assessment of I.U.D. side-effects showed that the acceptability of I.U.D. was significantly better in women treated with T.A. than in those given placebo.

Clinical Trials as Topic↗

Compliance and user satisfaction with the intra-uterine contraceptive device in Family Planning Service: the results of a survey in Fife, Scotland, August 2004.

OBJECTIVES: The study was designed to assess user satisfaction and duration of use of intrauterine contraceptive device (IUD) in Fife. METHODS: A questionnaire was given to 254 women attending a Fife Family Planning Clinic, in whom an IUD had been fitted over 3 years ago, with a 71% response rate. RESULTS: The majority of respondents were over age 30 years (81%) and parous (91%). The most frequently used IUD was the levonorgestrel-releasing intrauterine system (LNG-IUS: 39%), with the rest of the coils being an assortment of copper-medicated coils. Side effects were common, occurring in 92% of users and compliance was low, with 23% using for less than 1 year. Comparisons between LNG-IUS and other IUD-users showed similar side-effects, although mood disorders were higher with LNG-IUS. CONCLUSIONS: Overall satisfaction rates with the family planning service were high. Methods to improve IUD uptake and compliance are needed, particularly in younger women and nulliparous women.

Adolescent↗

The effects of intrauterine contraceptive devices on the ultrastructure of the endometrium in relation to bleeding complications.

The effects of inert (Lippes Loop D and Dalkon Shields) and medicated (copper 7, copper T, and Progestasert) intrauterine contraceptive devices (IUDs) on the ultrastructure of the endometrium were studied in intact human uteri. The most striking morphologic changes induced by the inert and copper-bearing devices were erosion of the surface epithelium and extensive microthrombosis in stromal capillaries of the endometrium in contact with the device. These abnormalities were associated with extravascular thrombi, erythrocytes, and fibrin deposition in the adjacent stroma. Capillary microthrombosis and leukocyte infiltration into the uterine cavity were most extensive around the active part of the copper-bearing devices. With the Progestasert erosion of surface epithelium was rarely seen, but the intact epithelial lining had fewer ciliated cells with flattened and shortened cilia. Large dilated venules were a common finding below the surface epithelium adjacent to the active part of the Progestasert; capillary microthrombosis was found only below the inert arms of the Progestasert. The vascular response of the endometrium to IUDs appears, therefore, to be directly related to the type and proximity of the device. The morphologic changes induced in both surface epithelium and the microvasculature of the endometrium are the likely explanation of the uterine bleeding problems associated with IUDs but are probably intrinsic to the mode of action of the IUD in interfering with implantation.

Adult↗

Pelvicobdominal actinomycosis associated with an intrauterine contraceptive device. A case of liver dissemination mimicking metastatic ovarian cancer.

A rare case of pelvicoabdominal actinomycosis with liver dissemination is reported in a patient with an intrauterine contraceptive device (IUCD) in place for 10 years. Her initial preoperative diagnosis of metastatic ovarian cancer emphasizes the slow indolent destructive nature of actinomycosis mimicking a malignancy. A history of an indwelling IUCD for several years along with a pelvic mass should prompt consideration of actinomycosis as a possible etiology.

Actinomycosis↗

Evidence of prior pelvic inflammatory disease and its relationship to Chlamydia trachomatis antibody and intrauterine contraceptive device use in infertile women.

A total of 204 infertile women attending the Infertility Clinic of the Medical Center Hospital of Vermont were studied for the possible role of Chlamydia trachomatis and intrauterine contraceptive device (IUCD) use as factors related to their infertility. All patients had had at least 1 year of involuntary infertility. All but one woman had negative cultures for C. trachomatis, but a highly significant correlation (p less than 0.001) was evident between evidence of prior pelvic inflammatory disease (PPID) as documented by hysterosalpingograms and/or laparoscopy and the prevalence of chlamydial antibody. Furthermore, a significant (p = 0.01) correlation could be shown between the prevalence of the antibodies and adnexal adhesions. IUCD use could also be shown between the prevalence of the antibodies and adnexal adhesions. IUCD use could also be shown to correlate significantly (p less than 0.001) with PPID, and a detailed statistical analysis indicated that the two factors, antibody to C. trachomatis and a history of IUCD use, were independently related to PPID. Only about one third of the patients with PPID could ever recall having had an illness consistent with PID. Subsequent to the infertility workup, 76 of these women became pregnant and there was a significant (p less than 0.001) correlation between the occurrence of ectopic pregnancy and antibody to C. trachomatis. A significant (p = 0.01) correlation was also noted between a history of IUCD use and subsequent ectopic pregnancy. From these data it appears that antecedent infection with C. trachomatis, as measured by antibody prevalence, and a history of IUCD use are important factors in infertility of tubal origin and are also related to ectopic pregnancy.

Adult↗

Cervical bacterial flora in women fitted with a copper-releasing intra-uterine contraceptive device (IUD).

A bacterial culture was taken from the cervix in 85 sexually active women before, and 3 and 6 months after, insertion of either a copper-releasing or an inert intra-uterine contraceptive device (IUD). Sixty had a Copper-T (TCu-200) and 25 a Lippes loop D. Although in more than a quarter of the patients the bacterial flora increased slightly in diversity and abundance after IUD insertion, there was no difference in effect between the TCu-200 and Lippes loop D.

Adult↗

Frameless intra-uterine contraceptive device (GyneFix).

Modern copper-containing contraceptive intra-uterine devices (IUDs) typically comprise a solid plastic frame loaded with copper wire and/or copper sleeves. Although they are very effective (annual pregnancy rates generally below 1%), some women discontinue their use within a year after insertion because of excessive bleeding and/or painful periods (4-15%), or because the device has been spontaneously expelled (2-8%). GyneFix (Contrel) is a new IUD approved for up to 5 years of use. Its manufacturer claims that the device produces fewer unwanted effects, and is less likely to be expelled, than conventional IUDs because it does not have a plastic frame (a frameless device). Here we assess these claims.

Costs and Cost Analysis↗

Actinomyces in cervical smears of women using intrauterine contraceptive devices.

Cervical smears from 1,784 women who attended the family planning clinics of the Institute for Research in Reproduction were examined for the presence of Actinomyces-like organisms. Among 815 intrauterine contraceptive device (IUD) users, the repeat smears from 57 women were positive for Actinomyces-like organisms, giving a prevalence rate of 6.99%. Immunofluorescent staining using specific antisera confirmed the presence of A. israelii in all 57 women. Forty IUD users whose smears were positive for Actinomyces-like organisms underwent bacteriologic culture studies; A. israelii was isolated in 23 of these cases. The clinical findings at the time of smear collection in the 57 IUD users were within normal limits. The initial cervical smears of all IUD users and both the initial and repeat smears of all nonusers were negative for Actinomyces-like organisms. The data indicate that prolonged use (greater than 2 years) of an inert or copper intrauterine device promotes the overgrowth of Actinomyces in the vagina and that this can be detected by routine cervical cytology.

Actinomyces↗

Actinomyces in the vaginas of women with and without intrauterine contraceptive devices.

Either Actinomyces israeli, A. naeslundii, or Arachnia propionica was found, by immunofluorescence studies, in cervicovaginal mucus from 36% of 50 women. One or more of these organisms were found in a surprising 27% of those with neither intrauterine contraceptive devices (IUDs) nor intravaginal foreign bodies. The only common finding was abundant vaginal mucus, and no clinical features were more serious than vaginal itching, odor, or vague discomfort. Among those women who harbored actinomycetes, the average duration of continuous IUD use was 5.3 years; the comparable figure for those with no infection was 2.1 years.

Actinomyces↗

The effect of a progesterone-releasing intrauterine contraceptive device on uterine secretion of prostaglandin F2alpha and life-span of corpora lutea in the ewe.

Two studies were conducted to investigate the effect of a progesterone-releasing intrauterine contraceptive device (IUD) on uterine secretion of prostaglandin (PG) F2alpha associated with IUD-induced luteolysis in sheep. In bilaterally ovulating ewes receiving an IUD on day 3 (estrus = day 0) intrauterine release of progesterone (90 microgram per day) by the device did not prevent premature luteolysis or the increased concentration of PGF2alpha in uterine venous plasma on day 5 caused by conventional IUD's. In the second study a progesterone-releasing IUD (645 microgram per day) inserted adjacent to the intact ovary at unilateral ovariectomy on day 14 inhibited early luteolysis in the subsequent estrous cycle and reduced the uterine secretion of PGF2alpha on day 5, without affecting concentrations of progesterone in the peripheral circulation at the intervening estrus. It is suggested that locally delivered intrauterine progesterone can inhibit IUD-induced luteolysis in the ewe by suppressing the uterine secretion of PGF2alpha.

Animals↗

Ectopic pregnancy and intrauterine contraceptive devices: new perspectives. The Women's Health Study.

In the period 1965 through 1977 the number of ectopic pregnancies in the United States tripled. A collaborative multicenter case-control study was set up to examine ectopic pregnancy as well as several other suspected complications related to use of an intrauterine contraceptive device (IUD). To determine to what extent IUD use might be related to this increase, the authors analyzed 615 women who had had an ectopic pregnancy and 3453 controls. Most important, women who had never used an IUD were equally likely to have an ectopic pregnancy as women who had used an IUD. Looking at the comparative risks for current contraceptive users, all current users, including IUD users, were less likely to have had an ectopic pregnancy than women not currently using contraceptives. Likelihood of ectopic pregnancy was the same regardless of whether a copper-containing or an inert plastic IUD was used. Among current IUD users, those who had used an IUD for a long time (25 months or more) were 2.6 times as likely to have had an ectopic pregnancy as short-term (less than 25 months) users. This difference between long- and short-term IUD users persisted for some time (not longer than 1 year) after removal of the IUD. Use of the IUD probably did not play a role in the recent tripling of ectopic pregnancies in the United States.

Adolescent↗