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At least 19 recordsLinked to original sources

Assessment of menstrual blood loss in Brazilian users of the frameless copper-releasing IUD with copper surface area of 330 mm2 and the frameless levonorgestrel-releasing intrauterine system.

OBJECTIVE: This study was conducted to evaluate the effect of two types of IUDs on the amount of menstrual blood loss (MBL): the frameless copper-releasing intrauterine device (IUD) with copper surface area of 330 mm2 (GyneFix; Contrel Research, Ghent, Belgium) and the frameless levonorgestrel (LNG)-releasing intrauterine system (IUS) releasing 14 microg per day (FibroPlant-LNG; Contrel Research). Heavy and abnormal MBL is the main reason for discontinuation of intrauterine devices. METHODS: In 20 Brazilian women using GyneFix 330 and 32 using FibroPlant-LNG, respectively, MBL was measured by the quantitative alkaline hematin technique. In addition, ferritin levels were measured in GyneFix 330 and FibroPlant-LNG users. RESULTS: MBL with GyneFix 330, measured over a 24-month period, increased but was less when compared with TCu380A. Ferritin levels with GyneFix 330 were not affected in contrast with TCu380A. In FibroPlant-LNG users, mean MBL decreased by about 90% and ferritin levels increased significantly. CONCLUSIONS: The authors confirm earlier reports that, especially for women with low body iron stores and heavy menstrual bleeding, there is an order of preference for IUD use to minimize MBL. The choice should first be a progestin-releasing IUS, then a copper IUD, which has the least effect on menstrual bleeding, such as the frameless GyneFix IUD.

Brazil↗

Assessment of menstrual blood loss in Belgian users of the frameless copper-releasing IUD with copper surface area of 200 mm2 and users of a copper-levonorgestrel-releasing intrauterine system.

OBJECTIVE: This study was conducted to evaluate the effect of a miniaturized frameless copper IUD (GyneFix 200 small) and a copper-levonorgestrel (GynePlant) intrauterine system (IUS) on the amount of menstrual blood loss (MBL). METHODS: In 60 Belgian women using GyneFix 200 and 21 using GynePlant, MBL was assessed with the visual assessment technique. RESULTS: MBL scores in GyneFix 200 users did not change from baseline during the mean observation period of 31 months. In GynePlant users, mean MBL scores decreased by at least 50% in all but one user. CONCLUSION: The impact of copper IUDs on MBL can be minimized by reducing the surface area of the foreign body. Reduction of MBL, without causing amenorrhea, can be obtained by adding levonorgestrel.

Adolescent↗

Duration of use of copper releasing IUDs and the incidence of copper wire breakage.

The incidence of copper wire breakage for IUDs (Multiloads) using 0.3 and 0.4 mm diameter copper wire was evaluated by examining 969 devices that had been removed for various reasons. The IUDs were examined by light microscopy to determine the integrity of the copper wire. As expected, the incidence of breakage increased with increasing duration of IUD use. The cumulative breakage rate (life table) was significantly lower (p less than 0.05) for the Multiload 375 that used 0.4 mm diameter wire, compared to the Multiload 250 that used 0.3 mm diameter wire. The cumulative rates were 5.4 per 100 IUDs after 3 years for the Multiload 250, and 3.8 per 100 IUDs after 5 years for the Multiload 375. In only 1 (0.1%) of the 969 Multiloads examined, the breakage of the copper wire was sufficiently extensive to adversely affect the user's risk of pregnancy.

Equipment Failure↗

A comparative study of the clinical performance of two copper-releasing IUDs, Nova-T & Copper-T-200 in Lagos, Nigeria.

A non-randomised study was performed to compare the use-effectiveness of the Copper-T-200 and Nova-T intrauterine devices. It was found that generally, results compared favourably with other world-wide studies. No accidental pregnancies were experienced and no significant difference was found between the expulsion rate of the Nova-T (5.0) and that of the Copper-T-200 (6.5) and the removal rates for bleeding and pain, which were 1.5 and 3.8, respectively. The continuation rate for the Nova-T was 91.3 compared with 88.2 for the Copper-T. The total experience was based on 815 woman-months of use.

Adult↗

An evaluation of the levonorgestrel-releasing IUD: its advantages and disadvantages when compared to the copper-releasing IUDs.

The levonorgestrel-releasing IUD (LNG-IUD-20), providing a daily dose of 20 ug, has recently been approved for marketing in Finland. The IUD's high efficacy in preventing accidental pregnancy and other numerous positive features make it a promising contraceptive device for worldwide use, just like the currently available T-shaped copper-releasing (TCu) IUDs. This paper reviews published reports comparing the LNG-IUD-20 and the currently used TCu IUDs. The merits and disadvantages of the steroid-releasing IUD are evaluated in terms of its performance and other special features relative to the TCu IUDs. Also, a number of future studies with medical and programmatic importance are proposed. A broader understanding about these two IUD families will facilitate their use in a complementary way for family planning programs.

Drug Evaluation↗

Randomized comparison of clinical performance of two copper-releasing IUDs, Nova-T and Copper-T-200, in Denmark, Finland and Sweden.

A randomized study was conducted simultaneously in three countries to compare the clinical performance of two new IUDs, the Nova-T and Copper-T-200. Forty-four persons, midwives, general practitioners, residents and specialists in obstetrics and gynecology inserted 907 Nova-Ts and 936 Copper-Ts. The pregnancy rate of Nova-T (0.7 at one year) was significantly lower than that of Copper-T (2.2 at one year). No significant differences were observed in other termination rates. The continuation rates were 72.6 for Nova-T and 71.3 for Copper-T-200. The total experience was based on 18,035 woman months of use, with a lost to follow-up of less than 7 per cent for both IUDs.

Adult↗

Comparative clinical performances of 4 copper-releasing IUDs.

Clinical performances of the Copper 7, Gyne T 200, MLcu 250 and Tcu 200 were compared on 203 patients in this random study conducted over a period of 18 months. Insertion-linked events, tolerance (markers were bleeding or spotting, IUD-linked pain and partner discomfort) and causes for removal (spontaneous expulsion, pregnancies and pelvic infection) were considered. Randomization was performed at the beginning, using prescriptions that came from a randomized pool. Validity of the randomization method was checked against four criteria: number of models inserted per IUD type, prevalence of IUD type per age group, per previous gravidities and per previous means of contraception. No major difference in clinical performance among the four IUD types appeared upon analysis of the resulting data.

Adult↗

Puerperal insertion of a copper-releasing and a levonorgestrel-releasing intrauterine contraceptive device.

A copper-releasing IUD and levonorgestrel-releasing IUDs releasing 30 micrograms and 10 micrograms levonorgestrel per day were inserted six weeks after delivery in 110 volunteers. During the treatment, events and patterns of bleeding were recorded and plasma levonorgestrel concentrations were measured. The number of events in one year of follow-up was very low, four removals out of 40 in the copper-releasing IUD group and five removals out of 70 in the levonorgestrel-releasing IUD group. Bleeding and spotting was significantly more common after insertion of a levonorgestrel-releasing IUD than a copper-releasing IUD, but it was scanty and well-tolerated. After three months, levonorgestrel-releasing IUD patients had less bleeding and spotting than the copper-releasing IUD patients. No pregnancies occurred during the study period. There were two uterine perforations with a uterine sound at the insertion. In the 30-micrograms per day levonorgestrel-releasing IUD group, initially high plasma levonorgestrel concentrations reached a plateau four weeks after the insertion. In the 10-micrograms per day levonorgestrel-releasing IUD group, the plasma concentrations of levonorgestrel stabilized after the initial two weeks.

Adult↗

Five years' experience with levonorgestrel-releasing IUDs.

Two levonorgestrel-releasing IUDs and a copper-releasing IUD of the same shape were studied in a randomized comparative study over five years. The levonorgestrel-releasing IUDs released 20 micrograms or 30 micrograms per day. The Pearl index during the 10,600 woman-months of LNG-IUD use was 0.11. The control device releasing copper had a Pearl index of 1.6. The amount and duration of menstrual bleeding was greatly reduced, leading to a high incidence of oligo- or amenorrhea. The continuation rate in this pioneer trial was 53 per 100 users for the levonorgestrel-releasing IUD (LNG-IUDs) and 50 per 100 users for the copper-releasing IUD (Nova T). The removal rates for reasons other than amenorrhea were not significantly different. Discontinuation because of amenorrhea occurred during the first two years, the cumulative termination rate for this reason was 11.6 per 100 users at five years. The LNG-IUDs removed for investigation after five years of use revealed that the devices contained about 40 percent of the original load. The effective lifespan of the device has been demonstrated by this study to be five years; the residual steroid gives an additional safety period of two more years. The LNG-IUD is a highly effective reversible contraceptive method, which strongly reduced the amount and duration of bleeding. During the first two months there is scanty but frequent spotting which, like the high incidence of oligo- and/or amenorrhea, requires counselling of health personnel and women using LNG-IUDs.

Adult↗

Prolonged intrauterine contraception: a seven-year randomized study of the levonorgestrel 20 mcg/day (LNg 20) and the Copper T380 Ag IUDS.

A levonorgestrel-releasing IUD and the Copper T 380Ag IUD were in randomized comparison for seven years in five clinics. In two other clinics the randomized study was truncated at five years, but use of the Copper T continued. No pregnancies occurred to users of either device in years 6 and 7. Cumulative pregnancy rates were 1.1 per 100 at seven years for the steroid-releasing and 1.4 per 100 for the copper-releasing IUDs. Cumulative rates of PID did not differ between devices. Infection rates appeared to be lowest during the sixth and seventh years of the study. Termination attributable to amenorrhea was the principal contributor to differences in cumulative continuation rates between devices. At the five clinics that carried the comparative study to seven years, cumulative continuation rates were 24.9 per 100 for LNg20 IUD users and 29.4 per 100 for TCu 380Ag users. Women who used either method for periods of five to seven years experienced, on average, marked to mild increases in hemoglobin as compared with levels at admission. The Copper T380 family and the LNg20 IUDs represent the most effective reversible contraceptive methods yet studied in long-term randomized trials.

Adolescent↗

Intrauterine contraception with Nova-T and copper-T-200 during three years.

A randomized comparative trial on the clinical performance of two copper-releasing IUDs (Nova-T and Copper-T-200) was performed simultaneously in Denmark, Finland and Sweden. After three years the cumulative pregnancy rate was 1.9 for Nova-T and 5.0 for Copper-T. This difference in efficacy was statistically significant (p less than 0.001). Copper-T had a lower expulsion rate (p less than 0.05) in the total series but not in postmenstrual insertions. Differences between the two devices in other termination rates were not statistically significant. Analysis according to age and parity demonstrated that the pregnancy rate of Nova-T was lower than that of Copper-T in every age and parity group. The pregnancy rate of Nova-T was not effected by age or parity whereas the pregnancy rate and the expulsion rate of Copper-T decreased with increasing age and parity. The removal rate because of infection decreased markedly after the first year of use for both devices. The cumulative rate of removals for infection during the three years of use was not significantly correlated to age and there was no correlation to parity. The continuation rates increased with age and parity. The continuation rates of nulli- and primiparous women were almost identical with both devices and lower than continuation rates of women with 2 or three or more children. Only 11% of the women were lost to follow-up during 36 months. Nova-T had superior effectiveness in preventing undesired pregnancies when compared with Copper-T. The performance of Nova-T is less affected by age and parity then the performance of Copper-T. The silver core in copper wire gives a prolongation of the life-span for Nova-T. For these reasons, Nova-T appears to meet the requirements for an ideal IUD.

Adult↗

Early chorionic activity in women bearing inert IUD, copper IUD and levonorgestrel-releasing IUD.

Early chorionic activity was assessed in the premenstrual days by means of serum HCG beta-fraction. As control, a group of women with no contraceptive use was studied; early chorionic activity was detected in 31.8% of the cycles. In the group bearing an inert IUD the incidence was 20%, which did not differ from the control; while in the medicated IUD groups (Cu-IUD and LNG-IUD) the incidences were 4.8% and nil, respectively. Both medicated IUD groups showed a significant difference when compared with the control, as well as the inert IUD groups. The meaning of these findings, pointing out differences in the main mechanism of action between inert and medicated IUDs, is discussed.

Adult↗

Detailed analysis of menstrual bleeding patterns after postmenstrual and postabortal insertion of a copper IUD or a levonorgestrel-releasing intrauterine system.

Detailed information on the menstrual bleeding patterns in users of copper-releasing intrauterine devices (IUDs) and levonorgestrel-releasing intrauterine systems (IUSs) is lacking. Even less is known about the menstrual bleeding patterns associated with postabortal insertion of IUDs. We postulated that the scarcity of IUD studies including detailed analysis of bleeding could be a result of the lack of an easy-to-use computer program designed for this purpose. We therefore developed a set of graphical user interface (Windows) programs for entering, editing, and analyzing menstrual diary data. With these programs, we reanalyzed the menstrual diaries of the subjects of one of the hospital clinics that participated in a previous multicenter study comparing copper IUDs and LNg IUSs. The group included patients who had the IUD inserted postabortally. Copper IUD users had patterns of bleeding that were stable over time, and clearly more bleeding than LNg IUS users, many of whom had either infrequent bleeding, bleeding completely replaced by regularly occurring spotting, or amenorrhea. Postabortal insertion of LNg IUSs was associated with slightly better patterns of bleeding than postmenstrual insertion. Detailed statistics on bleeding help clinicians in counseling patients regarding these methods. The statistics permit assumptions to be made about the probabilities of specific menstrual disturbances and their changes over time.

Abortion, Induced↗

Two-year rates for Nova T and Copper T in a comparative study.

A random assignment comparative study between Nova T and Copper T 200 after two years of use revealed that the Nova T resulted in a significantly lower pregnancy rate than the Copper T. The study was performed simultaneously in Denmark, Sweden and Finland. The pregnancy rate in Nova T users was lower than in Copper T users in every country and in every age and parity group. There was no clinic effect in the pregnancy rate of Nova T users. The other termination rates of these two devices were not significantly different. The first segment continuation rates at two years of postmenstrual insertions were 64.7 for Nova T and 65.5 for Copper T 200. It seems that Nova T is an improved copper-releasing IUD.

Actuarial Analysis↗

Mineral deposits formation in bioactive IUD's.

Mineral organic deposits have been observed in inert IUDs. The authors studied the presence of these deposits in bioactive IUDs. Inert, progesterone, and copper-releasing IUDs were removed at 12,24, and 36 months postinsertion. When the devices were cut between their vertical (body) and horizontal (arms) branches, both parts were processed independently. After laxly bound organic material was eliminated, the devices were extracted at 60 degrees Celsius for 90 minutes with 3N HC1, and finally all undissolved material was dissolved in 1N NaOH. In each fraction, protein and inorganic ions were measured. Mineral organic deposits were formed in all types of IUDs. The deposits increased with time in utero in a characteristic device-dependent pattern. The deposits were essentially made of proteins, sodium, and calcium ions and were higher on the inert Lippes Loop D (7.0 +or- 2.4 mg proteins; 2.8 +or- 0.85 mg calcium, and 0.138 +or- 0.048 mg sodium/device); less in the copper IUD (5.7 +or- 1.36 mg proteins, 0.89 +or- 0.12 mg calcium, and 0.180 +or- 0.046 mg sodium/device at 24 months); and even less in the progesterone-releasing IUDs (1.6 +or- 1.3 mg protein, 0.235 +or- 0.028 mg calcium, and 0.262 +or- 0.063 mg sodium/device).

Calcium↗

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↗

Attitudes of Israeli gynecologists towards the levonorgestrel-releasing intrauterine system: a questionnaire survey.

OBJECTIVES: The aim of the study was to examine the current attitudes and practices of gynecologists regarding the use of the levonorgestrel-releasing intrauterine system (LNG-IUS, Mirena, Schering AG, Germany) as a contraceptive device and for the treatment of menorrhagia in the premenopausal period. In addition, physician knowledge of patient satisfaction with the device was evaluated. METHODS: A written, self-administered questionnaire was given to 300 gynecologists actively employed in gynecological departments and outpatient clinics in urban centers in Israel. The items covered the indications for which the LNG-IUS was prescribed, the estimated rate of use of the LNG-IUS compared to copper intrauterine devices (IUDs), patient satisfaction with the LNG-IUS and previous knowledge about it, and demographic characteristics of the population using IUDs. All forms were completed on an anonymous basis. RESULTS: The questionnaire was returned, properly completed, by 298 physicians, yielding a response rate of 99.3%. Almost one-half of the physicians (n = 147, 49.3%) used the LNG-IUS only as a contraceptive device, 17.4% only as treatment for menorrhagia, and 33.2% for both indications. The vast majority of gynecologists (82.2%) reported a patient satisfaction rate of 70% or more. Among the gynecologists using the LNG-IUS as treatment for menorrhagia, the estimated overall patient satisfaction rate was more than 50%. Although most physicians expressed greater patient satisfaction with the LNG-IUS than with copper-releasing IUDs (p < 0.004), the majority of gynecologists still used the copper-releasing IUDs more frequently. Most considered the LNG-IUS as an appropriate method for endometrial protection in postmenopausal women using estrogen replacement therapy. CONCLUSIONS: Physicians should be made aware of the beneficial health effects of the LNG-IUS, particularly in premenopausal women with menorrhagia and for endometrial protection during hormone replacement.

Adult↗