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At least 19 recordsLinked to original sources

The intra-uterine contraceptive device--contraceptive or abortifacient?

Further to the investigation of the possible mode of action of the intra-uterine contraceptive device (IUCD), an assay for the beta-specific subunit of human chorionic gonadotrophin (HCG) has detected endogenous chorionic activity 21 days after menstruation. In 22 proven ovulatory cycles, 7 patients wearing an IUCD had demonstrable serum HCG levels in 45% of these cycles. Abnormal menstruation was associated with the majority of cycles in which there was HCG in the serum. Subsequent luteolysis occurred in all cases. The results of this study may support the hypothesis that IUCD exerts its effect on the fertilized, implanted blastocyst, thus causing possible 'micro-abortion'. Caution should be exercised in the interpretation of HCG values in the follow-up of patients with hydatidiform mole or choriocarcinoma who are bearing IUCDs, since positive HCG levels may be due to an early, fertilized and implanted blastocyst and not to invasive tissue.

Adult↗

Antibiotic prophylaxis for intrauterine contraceptive device insertion.

BACKGROUND: Concern about the risk of upper genital tract infection (pelvic inflammatory disease) often limits use of the IUD, a highly effective contraceptive. Prophylactic antibiotic administration around the time of induced abortion significantly reduces the risk of postoperative endometritis.(Sawaya, 1996) Since the risk of IUD-related infection is limited to the first few weeks to months after insertion,(Lee, 1983; Farley, 1992) contamination of the endometrial cavity at the time of insertion(Mishell, 1966) appears to be the mechanism, rather than the IUD or string itself. Thus, antibiotic administration before IUD insertion might reduce the risk of upper genital tract infection from passive introduction of bacteria at insertion. OBJECTIVES: To assess the effectiveness of prophylactic antibiotic administration before IUD insertion in reducing IUD-related complications and discontinuations within three months of insertion. The primary outcome was pelvic inflammatory disease (four reports) or early removals of the device (two reports). SEARCH STRATEGY: We searched both MEDLINE and EMBASE, handsearches of journals through CENTRAL, and lists of references. We also wrote to international experts in the field to identify unpublished studies. SELECTION CRITERIA: We included randomized controlled trials using any antibiotic compared with a placebo. We found four such trials; two had pilot study data available. DATA COLLECTION AND ANALYSIS DATA EXTRACTION: We used searches of MEDLINE, EMBASE, and handsearches of journals available through CENTRAL. We also reviewed lists of references in original research and in review articles. We wrote to experts to identify unpublished trials and made telephone calls to authors to supply missing information. Two independent reviewers abstracted data. We assessed the validity of each study using methods suggested in the Cochrane Handbook. DATA SYNTHESIS: We generated 2x2 tables for the principal outcome measures. We used the Peto modified Mantel-Haenszel technique to calculate odds ratios and assessed statistical heterogeneity between studies. MAIN RESULTS: The odds ratios for pelvic inflammatory disease associated with use of prophylactic doxycycline or azithromycin compared with placebo or no treatment was 0.89 (95%CI 0.53-1.51). Use of prophylaxis was associated with a small reduction in unscheduled vists to the provider (OR 0.82; 95% CI 0.70-0.98). Use of doxycycline or azithromycin had little effect on the likelihood of removal of the IUD within 90 days of insertion (OR 1.05; 95% CI 0.68-1.63). Significant heterogeneity did not exist between studies. REVIEWER'S CONCLUSIONS: Use of either doxycycline 200 mg or azithromycin 500 mg by mouth before IUD insertion confers little benefit. While the reduction in unscheduled visits to the provider was marginally significant, the cost-effectiveness of routine prophylaxis remains questionable. A uniform finding in these trials was the low risk of IUD-associated infection, with or without use of antibiotic prophylaxis.

Antibiotic Prophylaxis↗

Interactions between intrauterine contraceptive device use and breast-feeding status at time of intrauterine contraceptive device insertion: analysis of TCu-380A acceptors in developing countries.

OBJECTIVE: This paper is a reassessment of earlier findings from a preliminary analysis of data from a multicenter international trial regimen on breast-feeding and non-breast-feeding women in which events related to insertion, expulsion, and removal of the TCu-380A intrauterine contraceptive device (ParaGard 380) were investigated. STUDY DESIGN: Performance of the TCu-380A through 12 months after insertion was compared with life-table rate analysis, chi 2, Fisher exact test, or Student's t test. Variables were events reported during intrauterine contraceptive device insertion and events throughout the 12 months of study participation by breast-feeding status. RESULTS: Breast-feeding among intrauterine contraceptive device users was associated with fewer insertion-related complaints and lower removal rates for bleeding and pain. No uterine perforations were reported throughout the study. CONCLUSION: Differences in the performance of the TCu-380A intrauterine contraceptive device suggest physiologic effects associated with lactational amenorrhea. The TCu-380A intrauterine contraceptive device is a viable option for women breast-feeding at the time of intrauterine contraceptive device insertion.

Adult↗

Bacteriological colonisation of uterine cavity: role of tailed intrauterine contraceptive device.

Intrauterine contraceptive devices (IUCDs) are thought to cause pelvic inflammatory disease by allowing vaginal bacteria to pass into the uterus along the tail of the device. In this study the uterine cavities of 22 women using an IUCD were examined by a multiple biopsy technique. All five uteruses with a tailless IUCD were sterile but 15 out of 17 with a tailed device contained bacteria. The bacteria had not reached the fundus and most were commensals. The bacteria were not introduced by insertion of the IUCD as bacteria were present in several cases long after insertion. No differences in bacterial count were found between monofilamentous and multifilamentous devices. Bacteria were cultured from only four devices, which suggested that the bacteria adhere to the endometrium and not to the device. The bacteria in the cavity represent interference by the tail with the protective mechanisms of the uterus, which explains the increase in pelvic inflammatory disease in IUCD users.

Adult↗

Production of fibrinolytic enzymes by macrophages on intrauterine contraceptive devices.

Intrauterine contraceptive devices (IUCDs) were removed from 44 patients with a variety of clinical conditions, and incubated in culture media. Following incubation for up to 96 hours the total numbers of macrophages on each device were counted. The Lippes loop and Saf-T- Coil had higher counts than the Copper 7. The counts on all devices were higher at mid-cycle and during menstruation and significantly higher in patients with menorrhagia and intermenstrual bleeding (P less than 0.0005). Samples of culture media were taken on a number of occasions for up to 96 hours for fibrinolytic studies, and fibrinolytic activity increased with time in 10 of 16 cases where fibrinolytic activity was detected. There was a weak positive correlation between the number of cells on each of the 10 devices which produced a rise in fibrinolytic activity and the highest level of activity produced by each of the devices (r = +0.59; P less than 0.05). Plasminogen activator activity was maximum early in the incubation period, while plasmin-like activity predominated in later samples. The possible role of macrophages in IUCDs in causing menorrhagia is discussed.

Cell Count↗

A reanalysis of the Cu-7 intrauterine contraceptive device clinical trial and the incidence of pelvic inflammatory disease: a paradigm for assessing intrauterine contraceptive device safety.

OBJECTIVE: We calculated and compared the incidence of pelvic inflammatory disease in a 10% random sample of the Cu-7 intrauterine contraceptive device (G.D. Searle & Co., Skokie, Ill.) clinical trial with the rates reported to the Food and Drug Administration and those in subsequent trials published in the world literature. STUDY DESIGN: A 10% random sample of the Cu-7 clinical trial was examined because calculations had demonstrated this random sample to be sufficient in size (n = 1614) to detect a difference in rates of pelvic inflammatory disease from those reported to the Food and Drug Administration. An audit of a subset of the patient files, compared with the original files in Skokie, Illinois, confirmed that the files available for analysis were complete. Standard definitions were used to identify cases of pelvic inflammatory disease and to calculate rates of pelvic inflammatory disease. The world literature on Cu-7 clinical trials was reviewed. RESULTS: The calculated crude and Pearl index rates of pelvic inflammatory disease were consistent with those rates previously reported to the Food and Drug Administration and published in the medical literature. Life-table pelvic inflammatory disease rates were not different between nulliparous and parous women and pelvic inflammatory disease did not differ from basal annual rates in fecund women. CONCLUSION: On the basis of the analysis of this 10% sample, the pelvic inflammatory disease patient rates reported to the Food and Drug Administration for the entire Cu-7 clinical trial are accurate and are similar to those published in the world literature.

Adult↗

Hormone-releasing silicone-rubber intrauterine contraceptive devices. Effect of incorporation of various compounds on intrauterine contraceptive devices in rats.

Intrauterine devices (IUD's) containing 0, 5, or 10 per cent by weight of progesterone, melengestrol acetate (MGA), norethindrone, norgestrel, medroxyprogesterone acetate, isoxsuprine, or R2323 or wound with fine copper wire were placed in one or both horns of cycling female rats. All the progestins improved retention of the silicone-rubber IUD's to some degree. The effects of these compounds on the estrous cycle, mating, ovulation, fertilization, tubal transport, and implantation varied among the compounds. Effects were local or systemic, depending upon the amount and the drug. Uterine motility studies showed clearly that 5 per cent MGA decreased uterine motility; however, no consistent results could be obtained using the other compounds in the same in vivo system.

Acetates↗

The mechanism of action of hormonal contraceptives and intrauterine contraceptive devices.

Modern hormonal contraceptives and intrauterine contraceptive devices have multiple biologic effects. Some of them may be the primary mechanism of contraceptive action, whereas others are secondary. For combined oral contraceptives and progestin-only methods, the main mechanisms are ovulation inhibition and changes in the cervical mucus that inhibit sperm penetration. The hormonal methods, particularly the low-dose progestin-only products and emergency contraceptive pills, have effects on the endometrium that, theoretically, could affect implantation. However, no scientific evidence indicates that prevention of implantation actually results from the use of these methods. Once pregnancy begins, none of these methods has an abortifacient action. The precise mechanism of intrauterine contraceptive devices is unclear. Current evidence indicates they exert their primary effect before fertilization, reducing the opportunity of sperm to fertilize an ovum.

Abortifacient Agents↗

The intrauterine contraceptive device: an often-forgotten and maligned method of contraception.

Although 90% of women at risk for unintended pregnancy in the United States use contraception, <1% of these women use the intrauterine contraceptive device. The mechanism of action of intrauterine contraceptive devices has been controversial, but several studies suggest that interference with sperm migration or function and with fertilization may be the most likely mechanisms. More important, there is lack of compelling evidence that the intrauterine contraceptive device acts as an abortifacient. The risk for pelvic inflammatory disease among users now appears to be extremely low, primarily as a result of better selection of candidates. A levonorgestrel-releasing intrauterine contraceptive device may offer some new therapeutic approaches for the treatment of certain gynecologic disorders. Although women who are not at risk for pelvic inflammatory disease or sexually transmitted diseases are appropriate candidates for the intrauterine contraceptive device, it appears that use can be expanded to selected nulliparous women and women with certain medical conditions.

Contraceptive Agents, Female↗

[Follow-up of intrauterine contraceptive devices].

The intrauterine contraceptive device (IUCD) is the most popular, reversible contraceptive method, worldwide. Leaving an IUCD in-utero even beyond the time recommended by the manufacturer has been found both safe, and effective in terms of contraceptive ability. In 1995 we screened the medical records of the gynecologic infirmaries of 4 agricultural settlements (kibbutzim) and found 78 women who had worn an IUCD continuously for more than 5 years. All had been regularly examined every 6 months. Most of the IUCDs (63, 80.7%) were copper-containing. Mean IUCD wear was 7.9+/- 2.6 years (range, 5-17 years). At the time of the study, 38 (48.7%) of the IUCDs were still in utero. Related complications were 3 cases of dysmenorrhea (3.8%) and 20 of metrorrhagia. No pregnancies or pelvic infections were recorded. This study also shows that wearing an IUCD beyond the time recommended by the manufacturer is not associated with loss of contraceptive effectiveness. Furthermore, the rate of IUCD-related complications after 5 years of wear was not higher than during the first 5 years. To support these findings further studies with larger samples are needed.

Female↗

Pain reduction during and after insertion of an intrauterine contraceptive device.

The intrauterine contraceptive device (IUD) is an established method of fertility regulation despite certain problems. The major problems relating to IUD use are unwanted pregnancy, excessive bleeding, genital infection, occasional uterine perforation, device translocation, and pelvic pain. All fertility regulation personnel are aware that a very large number of potential IUD acceptors are concerned about the possibility of pain before, during and after device insertion. Pain is recognized as one of the major reasons for termination of the use of the IUD. Despite this, and unlike other IUD problems, IUD-related pain has been very poorly studied. At a recent workshop on intrauterine contraception there was not one presentation on this topic. The reason for this is that IUD-related pain is difficult to study, requiring careful analysis of subjective rather than objective data. Nevertheless a thorough understanding of the mechanisms, causes, prevention and treatment of IUD-related pain is important for fertility regulators in both developed and developing countries.

Analgesia↗

Thermoreversible gel formulation containing sodium lauryl sulfate as a potential contraceptive device.

The contraceptive properties of a gel formulation containing sodium lauryl sulfate were investigated in both in vitro and in vivo models. Results showed that sodium lauryl sulfate inhibited, in a concentration-dependent manner, the activity of sheep testicular hyaluronidase. Sodium lauryl sulfate also completely inhibited human sperm motility as evaluated by the 30-sec Sander-Cramer test. The acid-buffering capacity of gel formulations containing sodium lauryl sulfate increased with the molarity of the citrate buffers used for their preparations. Furthermore, experiments in which semen was mixed with undiluted gel formulations in different proportions confirmed their physiologically relevant buffering capacity. Intravaginal application of the gel formulation containing sodium lauryl sulfate to rabbits before their artificial insemination with freshly ejaculated semen completely prevented egg fertilization. The gel formulation containing sodium lauryl sulfate was fully compatible with nonlubricated latex condoms. Taken together, these results suggest that the gel formulation containing sodium lauryl sulfate could represent a potential candidate for use as a topical vaginal spermicidal formulation to provide fertility control in women.

Animals↗

Clinical experience with the Margulies intrauterine contraceptive device.

There has been renewed interest in recent years in the use of intrauterine devices for contraception. The Margulies intrauterine device was inserted in 303 patients. Of 301 patients subsequently evaluated, 24 expelled the device spontaneously; in 21 others the device was removed for various reasons. No pregnancies occurred in the first 920 patient-months. There were no serious complications in the patients using the coil. From this experience we estimate that not more than 80% of patients will accept this technique. Intrauterine contraceptive devices are, however, a satisfactory addition to the various methods of birth control.

Canada↗

Low-level, progestogen-releasing vaginal contraceptive devices.

Silicone rubber vaginal contraceptive devices of four different formulations, which release predetermined, controlled doses of three progestogens at four distinct levels, were designed and fabricated, and tested in 90-day clinical trials. Data obtained with 70 of the devices indicated that in vivo release rates (microgram/day +/- S.D.) for the formulations were: progesterone, 1400 +/- 30; norethindrone (two levels), 49.4 +/- 2.4, 196 +/- 21; d-norgestrel, 21.6 +/- 1.4. Clinical studies with these devices indicate that the women usually ovulate (with the exception of the high-dose norethindrone-releasing devices) while sperm penetration of the cervix was inhibited by all four fromulations, most consistently by the norgestrel-releasing devices.

Contraceptive Devices↗

Ultrasonographically guided intrauterine contraceptive device removal before chorionic villus sampling.

OBJECTIVE: Management of a retained intrauterine contraceptive device with no visible string during early pregnancy presents a dilemma. Because these devices are frequently used by multiparous women, it is not unusual that many women with retained devices are also of advanced maternal age. We describe our experience with ultrasonographically guided first-trimester retrieval of an intrauterine contraceptive device in conjunction with chorionic villus sampling. STUDY DESIGN: Patients with a first-trimester pregnancy and a retained intrauterine contraceptive device where no string was visible were offered ultrasonographically guided retrieval of the device. If the patient had genetic risks and desired prenatal diagnosis, chorionic villus sampling was offered at the same office visit. RESULTS: Six patients underwent intrauterine contraceptive device retrieval, under continuous ultrasonographic guidance, by use of an intrauterine contraceptive device hook. All patients had a posterior or fundal device. One patient had two in situ: a Lippes Loop (Ortho Pharmaceutical Corp., Raritan, N.J.) removed by its string and a Cu-7 (G.D. Searle & Co., Chicago) removed under ultrasonographic guidance. The remaining five patients had a Cu-7. Four of six patients had chorionic villus sampling performed immediately after the intrauterine contraceptive device removal and one patient had chorionic villus sampling 3 weeks later. There were two losses in our series: one after a lengthy procedure and one before documented viability. All infants were structurally normal and born at term. CONCLUSION: First-trimester ultrasonographically guided retrieval of a retained intrauterine contraceptive device may be safely performed in conjunction with chorionic villus sampling.

Adult↗