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Bacterial colonization of intrauterine devices (IUDs).

The bacterial colonizing of the intrauterine device (IUD) and its tail were studied in 152 IUDs obtained from 70 symptomless IUD wearers, 13 women with dysfunctional bleeding, 23 women with pelvic inflammatory disease, 31 women in whom the tail of an IUD was no longer visible and 17 women who were pregnant with an IUD in situ. The IUDs were either removed by the transcervical route or through a fundal incision in the uterus after hysterectomy. Most IUD were heavily contaminated by bacteria, especially Staphylococcus epidermidis, Enterococci and anaerobic Lactobacilli. The number of colonies was higher in women with dysfunctional bleeding and pelvic inflammatory disease than in others with a predominance of pathogenic bacteria, namely beta-hemolytic Streptococci, Staphylococcus aureus and Escherichia coli. Almost half of the IUDs without a tail protruding through the cervix were sterile. With pregnancy in the presence of an IUD, 71% of devices grew bacteria which were mainly anaerobic.

Bacteria↗

Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial.

A 20 micrograms/24 hours levonorgestrel-releasing intrauterine contraceptive device (LNG-IUD) has, in an open randomized multicenter study, been compared to the copper-releasing device Nova T during 5 years of use; 1821 women had the LNG-IUD and 937 women had the Nova T inserted. The 5-year cumulative gross pregnancy rate was 5.9% for Nova T and 0.5% for the LNG-IUD. The local effect of levonorgestrel in the uterine cavity causes reduction of menstrual blood loss and development of oligo-amenorrhea, and the termination rates because of heavy and/or prolonged menstrual flow were significantly (P < 0.001) lower among LNG-IUD users. However, the gross termination rate because of amenorrhea was 6.0 in this group. Hb increased during use of the LNG-IUD and decreased during Nova T use, and the difference between the devices was statistically significant. The incidence of pelvic inflammatory disease (PID) was low in LNG-IUD users regardless of age, whereas in the Nova T group, the PID rate was increased among the youngest women, which makes the difference between the devices significant (P < 0.01). The gross termination rate for reasons considered to be hormonal was 12.1 in the LNG-IUD group compared to 2.0 in the Nova T group (P < 0.001). The LNG-IUD is a long-acting reversible contraceptive method for 5 years with a pregnancy rate comparable to female sterilization. The incidence of PID is low even in young women. In addition, the positive health effects such as decreased menstrual blood loss and increased blood haemoglobin concentration make the LNG-IUD a favorable combination of hormonal and intrauterine contraception.

Adult↗

Clinical performance of the TCu 380A and Lippes Loop IUDs in three developing countries.

The clinical performance of the Copper T 380A (TCu 380A) and the Lippes Loop intrauterine devices (IUDs) were evaluated for 12 months in a group of 710 women who had one of the two IUDs inserted. Results are from a randomized clinical trial conducted at three collaborating research sites located in three developing countries. The gross cumulative life-table pregnancy rate of the TCu 380A IUD was found to be lower than that of the Lippes Loop IUD at 12 months (0.7 and 2.1 per women, respectively). Although this difference was not statistically significant (p = 0.25), it is similar to findings from other studies. The 12-month cumulative removal rate due to personal reasons was significantly different (1.4 and 0.0, respectively, p = 0.05). Statistically significant differences between the two study IUDs were not found with regard to IUD expulsion or IUD removal due to bleeding/pain, medical reasons, planned pregnancy or investigator's choice. A statistically significant difference (p = 0.03) was observed in the number of TCu 380A IUD users experiencing dysmenorrhea (26.1%) during the 12-month study period, compared to Lippes Loop IUD users (18.8%).

Adolescent↗

The use of vaginal ultrasound to identify copper T IUDs at high risk of expulsion.

A total of 235 women who had a TCu 380A IUD inserted had a vaginal ultrasound scan performed to identify if the IUDs were correctly placed in the uterine fundus. Women identified as having a misplaced IUD had it removed. The remaining women were compared to 201 women who had an IUD inserted and had no ultrasound evaluation, matched by age and parity. Women were followed-up for one year. Gross cumulative discontinuation rates and continuation rates were calculated by life table analysis. Comparison between groups was done by the Gehan test. The study group had 34 IUDs removed because they were misplaced according to the established criteria. The expulsion rate was significantly higher in the control group, also influencing the continuation rate which was lower in the same group. Of the 34 women who had their IUD removed because it was not correctly placed, only 22 requested and had another IUD inserted. The removal of IUD determined by an ultrasound to be incorrectly placed significantly decreased expulsion rates. However, many IUDs may have been removed unnecessarily, probably resulting in many women not returning to the clinic or deciding to use another contraceptive method.

Adult↗

Mechanism of action of IUDs: an ultrastructural view.

Endometrial samples from 64 women using different types of IUDs were used to study the ultrastructural changes of the human endometrium as influenced by nonmedicated and copper devices, using SEM and TEM in an attempt to explain the physiological mechanism of their actions. The absence of cytoplasmic macro-apocrine secretory granules with copper devices and their defective separation with nonmedicated IUDs support the theory that the IUD interferes with the carbohydrate metabolism and secretory function of the endometrial cells. It also indicates that IUDs may function through the interference with the blastocyst-endometrial interaction and blastocyst survival. The change in the intrauterine environment due to the absence of normal secretion may also affect sperm capacitation and/or the acrosomal reaction, with subsequent failure of fertilization. The absence of ciliated cells at the site of copper IUD contact zone and their defective ciliation away from it in the presence of normal steroid function may indicate an effect of the copper ions on the estrogen receptors. The asynchronous development of the endometrium and blastocyst mechanism of IUD function was not supported in this study. The occurrence of intermenstrual bleeding with IUDs is governed by 2 factors: 1) the pressure exerted by the IUD causing endothelial vascular injury and release of erythrocytes into endometrial stroma; and 2) the increased stromal hydrostatic pressure which acts as a force against the basal lamina and epithelial integrity. This was proven by the loss of normal microvillous pattern of the endometrial cells even away from the copper IUD, which support the rigidity of the cellular membranes.

Biology↗

IUD use and the risk of ectopic pregnancy: a meta-analysis of case-control studies.

Because of inconsistent findings among case-control studies on the relationship between IUD use and the risk of ectopic pregnancy, a meta-analysis of published literature was conducted. From 1977 through 1994, 19 publications regarding 16 studies of ectopic pregnancy and IUD use were found by MEDLINE and manual search. The odds ratio (ORs) of ectopic pregnancy with current and past IUD use in each study were pooled. A quality score system was developed to assess each study. Funnel plot was used to assess potential publication biases. For current IUD use, when cases were compared to pregnant controls, there was an increased risk of ectopic pregnancy (pooled OR: 10.63, 95% confidence interval (CI): 7.66-14.74); when cases were compared to non-pregnant controls, there was no risk of ectopic pregnancy (pooled OR: 1.06, 95% CI: 0.91-1.24). Past IUD use could mildly increase the risk of ectopic pregnancy (pooled OR: 1.40, 95% CI: 1.23-1.59). Selecting pregnant or non-pregnant women as controls, however, did not affect the OR estimates of past IUD use. Current IUD use does not increase the risk of the ectopic pregnancy. However, a pregnancy with an IUD in situ is more often an ectopic one than a pregnancy with no IUD. Past IUD use could mildly elevate the risk of ectopic pregnancy.

Adolescent↗

Inhibition of an IUD-induced precocious luteolysis by prostaglandin E1 (PGE1) in sheep.

Fifteen ewes were assigned as they came into estrus to one of three randomized treatment groups: 1. Sham IUD + Vehicle, 2. IUD + Vehicle or 3. IUD + PGE1 in vehicle. An IUD was inserted adjacent to the luteal-bearing ovary on day 3 postestrus. Prostaglandin E1 (500 micrograms) in vehicle (Na2CO3) or vehicle was given intrauterine through an indwelling uterine cannula every four hours from day 3 postestrus until ewes returned to estrus. Precocious estrus was induced in both the sham IUD and IUD groups receiving vehicle. Prostaglandin E1 prevented an IUD-induced premature luteolysis based on daily concentrations of progesterone in peripheral blood and the interestrous interval. It is concluded that an IUD-induced premature luteolysis is not necessarily via physical distention by the IUD. It is also concluded that chronic intrauterine infusions of PGE1 can prevent an IUD-induced premature luteolysis.

Alprostadil↗

Is users' knowledge about contraceptives adequate? A case study of Finnish IUD users.

Intrauterine contraceptive devices (IUDs) are popular: in Finland, in 1987, about 25% of women of childbearing age used them. We studied Finnish women's knowledge about contraindications for and side-effects of IUD use, with emphasis on current users. In December 1987-January 1988, a postal questionnaire was sent to a random sample of 1000 women of childbearing age, in Uusimaa province, which includes the capital, Helsinki. After three reminders, the response rate was 84%. We compared the answers of current and past users and nonusers of IUDs, and analyzed the associations between IUD use, education, age, and knowledge about side-effects. In contrast to the recommendations for use and information to be given to the contraceptive users, a substantial proportion of current IUD users assumed there are few limitations for IUD use. Some side-effects possibly leading to severe consequences were not considered to be connected with IUD use, not even by users. Although risk of infection was a quite well known fact, infertility was seldom associated with IUD use, and 22% of current IUD users did not associate ectopic pregnancy with IUDs. The results thus suggest that contraceptive counseling is not fully adequate and should receive more attention.

Adolescent↗

Survey of IUD replacing status in Sichuan, PR China.

To investigate the status of copper-bearing intrauterine device (IUD) replacing inert IUD in Sichuan Province, cluster random sampling method was adopted for the survey. Questionnaires were completed and IUD were inspected through ultrasound among 12,804 subjects of 15 counties, who were inserted an IUD from 1994 to 1998. The insertion rate of copper-bearing IUD was 42.1%, in a gradually increasing trend; it was lower in mountain areas than in plain and hilly areas and increased after induced abortion and previous IUD failure. Some factors, such as lower pregnancy rate, lower expulsion rate and easy removal, etc., contributed to copper-bearing IUD use. On the other hand, other factors like longer contraception period, lower side effects and lower cost contributed to inert IUD use. The results show that the adoption of copper-bearing IUD is increasing, but those factors influencing copper-bearing IUD replacement should not be neglected.

Adolescent↗

Risk factors for IUD failure: results of a large multicentre case-control study.

BACKGROUND: This study was conducted to identify the risk factors for intrauterine device (IUD) failure. METHODS: A retrospective case-control study was carried out between 1999 and 2002. Cases (women with an IUD and a confirmed pregnancy) and controls (women with an IUD and who were not pregnant) were recruited by gynaecologists. An anonymous questionnaire was filled in during the consultation, with specific items regarding any type of drugs used before the predicted fertile period for cases and within the cycle that ended in menses for controls. RESULTS: Two hundred and sixteen cases were compared with 657 controls. Age was associated with IUD failure, with a significantly lower failure risk in women>35 years. A significant relationship was observed between a history of IUD expulsion and IUD failure risk (age-adjusted odds ratio 3.31, 95% CI 1.40-7.81). No relationship was observed between the risk of IUD failure and gynaecological background (fibroma, polyps and miscarriage), nor with any type of medicine taken by the woman. CONCLUSION: This study is clearly reassuring, as we found that anti-inflammatory drugs and any other medicines taken by the woman were not implicated in IUD failure. Only a history of previous IUD expulsion was found to be a risk factor for failure, indicating that these women should have regular medical and echographical follow-up. Comparing the efficacy rate of various types of IUDs, we found a clear advantage for levonorgestrel-releasing devices.

Adolescent↗

Compelling reasons for recommending IUDs to any woman of reproductive age.

The intrauterine device (IUD) is a highly effective method of contraception that, as opposed to other countries around the world, is underutilized in the United States by women of all ages. Lingering concerns about the safety of IUDs are in large part responsible for their lack of adoption, but a systematic review published recently nullified some of the major safety concerns about IUD use. The author summarized the methodologically sound evidence regarding the risk of upper-genital-tract infection and infertility associated with IUD use and reported that a slightly increased risk of pelvic inflammatory disease (PID) exists only in the first month following IUD insertion; that the risk of PID in women with symptomless sexually transmitted diseases (STDs) having an IUD inserted is similar to the risk in women not having an IUD inserted; and that there appears to be no negative effect on fertility following IUD removal. In addition, Mirena provides noncontraceptive benefits, such as treatment for menorrhagia, dysmenorrhea, and anemia, and ParaGard may help protect against endometrial cancer. An IUD is also a safer alternative to sterilization for perimenopausal women seeking a long-term and also reversible method of contraception. While both IUDs are suitable for many women of all ages, there are differences in their mechanisms of action, physical characteristics, and clinical effects that make each more or less appropriate for certain women.

Endometrial Hyperplasia↗

Will progesterone save the IUD?

In 1971 we began studying pelvic inflammatory disease (PID) in IUD users by examining fallopian tube specimens obtained after elective female sterilization. We studied four groups: 175 nonhormonal-IUD users, 22 Progestasert users, 1,500 non-IUD users and 100 non-IUD users who had had IUDs in the past. We found histologically detectable salpingitis in 49% of the nonhormonal-IUD users, none of whom had symptoms of PID. Culture of 100 specimens from these nonhormonal-IUD specimens proved to be sterile. Viewing the inflammation as predisposing the tissues to bacterial infection would help explain the higher frequency of PID among IUD users than among nonusers. All the Progestasert users lacked histologically detectable salpingitis; the difference was statistically significant (p < 10(-6). This finding suggests that women using progesterone-releasing IUDs have a lower risk of developing PID than do users of other kinds of IUDs.

Adult↗

Levonorgestrel-releasing IUD as a method of contraception with therapeutic properties.

The levonorgestrel-releasing intrauterine device LNg IUD is a new contraceptive method that combines the advantages of both hormonal and intrauterine contraception. It gives users non-contraceptive health benefits and can also be used as an effective therapy for menorrhagia. The local release of LNg within the endometrial cavity results in strong suppression of endometrial growth as the endometrium becomes insensitive to ovarian estradiol. The endometrial suppression is the reason for a significant reduction of menstrual blood loss or amenorrhea, and for the disappearance of dysmenorrhea. The bleeding pattern during the use of the LNg IUD is characterized by reduction of the blood loss and in the number of bleeding days per cycle. During the first two to three months of use, however, irregular spotting is common. The removal of the device results in a quick return of menstrual bleeding and fertility. The failure rate of copper-releasing IUDs, as with other methods of fertility regulation, is higher in young women and decreases with age. The LNg IUD, on the other hand, has the same low pregnancy rate in every age group of the users. The LNg IUD also gives protection against ectopic pregnancy and pelvic inflammatory disease and, by reducing menstrual blood loss, increases the body iron stores. The LNg IUD can be used to effectively treat menorrhagia. This has been demonstrated in studies with quantitative determination of menstrual blood loss. During the first year of use, the LNg IUD reduced menstrual blood loss by 90% from pretreatment levels. Comparative clinical trials with the LNg IUD cover more than 10,000 women-years of follow-up during use over five to seven years. The Pearl pregnancy rate in studies has been 0.0-0.2 per 100 women-years. The overall ectopic Pearl pregnancy rate is 0.02 per 100 woman-years. The LNg IUD is marketed in Denmark, Finland, Norway, Sweden and in the United Kingdom.

Adolescent↗

Clinical outcomes of two early postpartum IUD insertion programs in Africa.

Postpartum IUD insertion programs are new to Africa and few have been carefully evaluated. Also, data on the clinical outcomes of postpartum IUD insertions using the Copper T 380A IUD are sparse. Therefore, we conducted a study to evaluate introductory postpartum IUD programs using the Copper T 380A IUD in Kenya and Mali. Postpartum IUD acceptors in Kenya (n = 224) and Mali (n = 110) were interviewed at baseline and at 1, 3, amd 6 months after delivery. We compared expulsion, medical removal, and discontinuation rates by insertion characteristics in each country. Six-month cumulative expulsion rates were lower for immediate insertions (those within 10 minutes of placental delivery) than for late insertions (generally between 10 minutes and 72 hours after placental delivery) in both Kenya (0.01 vs 0.05) and Mali (0.15 vs 0.27). Medical removals occurred in 1% and 7% of Kenyan and Malian acceptors, respectively, while pelvic infections were rare in both countries (< or = 2%). Differences in 6-month cumulative discontinuation rates between immediate and late insertions were not significant in either Kenya (0.05 vs 0.07) or in Mali (0.24 vs 0.32). This study suggests that postpartum IUD insertions can be performed safely with acceptable expulsion rates in African settings. Previous studies of other IUDs showed that expulsion rates are lower for immediate insertions compared with late postpartum insertions. This study suggests that these findings can be extended to the Copper T 380A IUD.

Adult↗

Role of retention in avoiding expulsion of IUDs--measuring devices for basic research.

320 medicated IUDs were removed from 292 women by means of the dynamometer. This instrument indicates the highest retention force (HRF) in newtons (N). Ages of the women ranged from 17-50 years. The IUDs were fitted in nulligravidae (56%), nulliparous with 1 or more abortions (13%), primiparous (18%), and multiparous (13%) women. The IUDs used were the ML Cu 250-standard, 7 Cu 200, T Cu 200-adapted, with a shortened transversal arm of 15-30 mm and T Cu 200 standard. With the low expulsion rate, the ML Cu 250-standard IUD needed 5.8-5.4N and the 7 Cu 200 3.8-2.6N. The adapted T Cu 200 IUD needed 2.6-1.6N, i.e., about 1N more thant the T Cu 200-standard with an HRF of 1.7-1.0N. As the dynamomoeter only indicated the highest retention force, a retentiograph was devised to demonstrate the different retention forces and phases of the various IUDs by characteristic curves. The possible connections between retention and expulsion of IUDs are discussed. The retention forces of the different IUDs compared are congruent with the published expulsion rates. The retentiograph showed new patterns to test IUDs before they demonstrate side effects in vitro.

Age Factors↗

Effectiveness of IUDs: a review.

Large, multicenter, randomized trials of IUDs conducted between 1970 and 1986 encompass more than 50,000 woman-years of experience in the two-year interval following device insertion. Taken singly and collectively, these trials demonstrate that IUD failure rates are strongly affected by the age of participants, notably by the proportion of women under age 25 admitted to the studies. Individual trials and overall comparisons indicate further that: 1. Non-medicated devices such as the Mahua steel ring and Lippes loop D have pregnancy rates above 2 per 100 woman-years. 2. The first approved copper IUDs, the Copper 7 and the TCu 200, do not markedly differ in pregnancy rates from standard plastic devices with rates significantly above 2 per 100 woman-years. 3. Five more recent, widely used copper IUDs have had failure rates significantly below 2 per 100 woman-years in multicenter trials. The point estimate of the failure rate was less than 1 pregnancy per 100 woman-years for three of these IUDs. One copper-bearing device had a failure rate significantly below 1 per 100 woman-years. 4. Devices releasing either 25 mcg/day of progesterone or 2 mcg/day of levonorgestrel have had significantly higher failure rates than the more effective copper-releasing IUDs; however, devices releasing 20 mcg/day of levonorgestrel appear at least as effective as the most effective copper IUDs. Long-term IUD failure rates derived from straight assignment as well as randomized trials indicate 4-year gross cumulative failure rates do not exceed 10 per 100 for any of the standard copper devices or the Lippes loop D. Point estimates of the four-year gross cumulative pregnancy rates have been below 5 per 100 users in studies of the TCu 220C, the Nova T, the TCu 380A, and the MLCu 375.

Adolescent↗

Immediate post-abortal insertion of the frameless GyneFix IUD: initial experience in China.

The promising results obtained with the frameless GyneFix IUD for interval insertion led to the belief that the technology could be useful for immediate post-abortal application to reduce the number of induced and repeat abortions. IUDs have many advantages and the method is acceptable and safe. However, side effects and expulsion of conventional IUDs remain a problem. In an attempt to minimise these problems, the frameless GyneFix IUD was developed. Clinical studies conducted over the past 14 years have shown that the principles on which the device is based are valid. An increasing bulk of clinical evidence shows that the design characteristics of the device (fixed, frameless and flexible) are responsible for the low expulsion, high effectiveness, and high tolerance and continuation rates.1 Experience with the frameless IUD in China since 1989 confirms the international experience with the device. The present communication is a second report from China with the GyneFix IUD. In the present study the GyneFix IUD is inserted immediately following termination of pregnancy of less than 10 weeks amenorrhea. It is concluded that immediate post-abortal insertion of the frameless IUD is easy and safe, and appears to be as reliable and as effective as when it is inserted at interval. The GyneFix IUD could, therefore, constitute an important new option in the prevention of abortion.

Abortion, Induced↗

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↗