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At least 73 records · Page 4Linked to original sources
PubMed1979

Treatment of rhesus monkeys (Macaca mulatta) with intrauterine devices loaded with levonorgestrel.

The effects of levonorgestrel-loaded plastic intrauterine devices on endometrial morphology were investigated in 15 rhesus monkeys for 14 weeks. The devices were designed to release 25 microgram of the hormone per day and were inserted in the uterus by hysterotomy. Control animals were sham operated or received inert placebo devices. With the levonorgestrel-releasing devices, widespread changes in endometrial morphology were seen. These changes included atrophy of the endometrial mucosal and glandular epithelium and decidualization of the endometrial stroma. With the inert placebo control devices, only minor changes in endometrial morphology were observed.

Animals↗
PubMed1982

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↗
PubMed1982

Randomized clinical study of the T-Cu 380A and the Lippes loop C, in Campinas, Brazil.

The copper IUD model T-Cu 380A has shown the best performance when compared with other copper and inert IUDs in studies carried out in the U.S.A., but it had not been tried out in developing countries yet. T-Cu 380A and Lippes loop C were inserted at random in 328 healthy parous women, in Campinas, SP, Brasil. Forty-five percent of the T-Cu 380A insertions and 40% of the Lippes loop insertions were performed by trained midwives. No pregnancies occurred in 1419 woman-months of use of T-Cu 380A, against 5 pregnancies in 1454 woman-months of use of Lippes loop. The difference was significant at the 5% level. No other significant differences were found. The continuation rate after one year of use was 82.5 for the T-Cu 380A and 75.1 for the Lippes loop. These results suggest that the performance of the T-Cu 380A in developing countries could be similar to the one observed in the United States, provided that the users are carefully selected and that an adequate insertion technique is followed.

Adolescent↗
PubMed1984

Intrauterine contraception with copper and with levonorgestrel: a randomized study of the TCu 380Ag and levonorgestrel 20 mcg/day devices.

First year results of a randomized study of 1509 users of the Copper T380Ag with a silver core or of an IUD releasing 20 mcg day of levonorgestrel are reported. The cumulative gross pregnancy rate for each device was 0.3 per 100 at one year, with more than 490 women having one year of use with each device. The levonorgestrel-releasing device was associated with significantly fewer bleeding days and significantly increased hemoglobin levels when compared with pre-admission values or the one year values observed among users of the TCu380Ag. Terminations attributable to amenorrhea were significantly more frequent among users of the levonorgestrel-releasing device. The TCu 380Ag was associated with increased frequency and severity of dysmenorrhea compared with pre-admission levels or with the steroid-releasing device. Hemoglobin levels were somewhat reduced among users of the TCu 380Ag device. Terminations attributable to pain were, however, not significantly different by device. Continuation rates at the end of the first year were not significantly different by device.

Adolescent↗
PubMed1987

Effective contraception with the levonorgestrel-releasing intrauterine device: 12-month report of a European multicenter study.

The use-effectiveness of an intrauterine contraceptive device releasing 20 mcg of levonorgestrel daily (Lng-IUD), and of a Nova T copper-releasing IUD, were studied in a randomized, comparative multicenter trial. The Lng-IUD was inserted in 1821, and the Nova T in 937 women. The 12-month net pregnancy rate with the Lng-IUD (0.1 per hundred women) was significantly lower than that with the Nova T (0.9 per hundred). Removal rates for menstrual problems and/or pain were similar for the two methods (net rates 7.5 and 8.7, respectively). The 12-month continuation rates were 82.2 for the Nova T and 79.7 for the Lng-IUD. The reduction of the bleeding led to oligomenorrhea and amenorrhea in users of the Lng-IUD; the removal rate for these reasons was 1.4. The removal rate for hormonal side effects with the Lng-IUD was 2.4. Blood hemoglobin concentrations increased among users of the Lng-IUD and decreased among users of the Nova T. The results show that the Lng-IUD was a highly effective contraceptive method which reduced menstrual bleeding. It is a promising alternative for women desiring a highly effective method for long-term use.

Adult↗
PubMed1987

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↗
PubMed1992

The FlexiGard 330 ICC, an ultrasound evaluation.

The FlexiGard 330 intrauterine copper contraceptive (ICC) was studied by ultrasound in 405 patients immediately following insertion and at each follow-up visit, for up to 5 years. The present study confirms the validity of the anchoring concept for the suspension of bioactive substances in the uterine cavity. The major conclusion from the study is that the anchor is non-migrating even when observed over a long period of time. Ultrasound examination is the method of choice to evaluate proper insertion technique as well as proper positioning of the device at follow-up.

Evaluation Studies as Topic↗
PubMed1993

The TCu-380A (AG), MLCu375, and Nova-T IUDs and the IUD daily releasing 20 micrograms levonorgestrel--four pillars of IUD contraception for the nineties and beyond?

With recent studies repeatedly showing results clearing the IUDs from their formerly suspected role in causing pelvic inflammatory disease (PID), very likely IUD use will further increase worldwide. While most previous IUDs have been withdrawn from the US market during the 1980s, newer and more effective IUDs have subsequently been developed; and some, marketed. Four of these devices will probably become the pillars for future IUD contraception worldwide. This review evaluates the relative performance and safety of these four devices. Consistent findings have proven the Copper-T 380A (Ag) and the Multiload-375 (MLCu375) IUDs to be safe with high and long-lasting efficacy. The Nova-T IUD showed favorable results in some studies, but showed deteriorated efficacy after three years of use in others; more studies are needed. Studies show that the IUD that daily releases 20 micrograms levonorgestrel (LNG-20) is associated with the highest efficacy in preventing accidental pregnancy among the four devices, but it has a uniquely high medical removal rate because of amenorrhea. This steroid-releasing device could be a high-performance IUD if this type of medical removal can be reduced through patient counseling devised according to local cultural background.

Evaluation Studies as Topic↗
PubMed1994

Effect of prophylactic antibiotics on morbidity associated with IUD insertion: results of a pilot randomized controlled trial. IUD Study Group.

The efficacy of administering an antibiotic prior to IUD insertion to reduce the risk of introducing an upper genital tract infection during the procedure has not yet been established. Two double-blind randomized studies conducted in Africa comparing a 200 mg prophylactic dose of doxycycline with a placebo did not conclusively identify a reduced risk of post-insertion pelvic inflammatory disease (PID). A clinical trial of comparable design is currently under way in the US. This multi-site trial will evaluate whether use of an antibiotic prior to insertion reduces the risk of IUD removal for all medical reasons, including upper genital tract infection, within the first three months after insertion. This paper reports on the pilot phase of this study, which was designed to test the protocols and data collection instruments in advance of the full-scale clinical trial. A total of 447 prospective IUD (TCu-380A) users were randomly assigned to receive either a 200 mg dose of doxycycline or a placebo one hour before IUD insertion. 3.6% (8/219) of participants who received the antibiotic had the device removed for medical reasons (infection, bleeding, cramping, etc.) within three months post-insertion compared to 4.5% (10/223) of participants who received the placebo. This reduction in the removal rate was not statistically significant given the limited size of the pilot study (RR = 0.81; 95% CI 0.28-2.29). Only two subjects, one from each treatment group, met the diagnostic criteria for acute PID. The overall three-month retention rate was 91.8% for the antibiotic group and 89.7% for the placebo group.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1981

Postpartum contraception.

Recently-delivered women who wish to avoid pregnancy should initiate contraception before ovulation. Since the return of ovulation is not predictable, regardless of the woman's lactation status and duration of postpartum amenorrhea, contraception should be initiated as soon as is reasonable after delivery. The choice of contraceptive method will depend on several factors, including: the woman's lactation status, the preference of the woman and her partner, and the health status of the newborns. For women who do not wish to have additional children, tubal sterilization through a minilaparotomy incision is the procedure of choice. For other women who are not lactating, all methods, with the exception of the use of cervical caps and diaphragms, may be initiated immediately after delivery. However, preference should be given to IUD use by lactating and non-lactating woman, especially for women who may not return for any additional postpartum care.

Contraception↗
PubMed1987

A comparison between Nova T and Copper T 200 Ag in Hungary.

In a comparative use-effectiveness study, 855 Nova T and 883 TCu 200 Ag devices were inserted in a randomised sequence. By the end of the first year the gross rate of unplanned pregnancy was 1.1 per 100 users of Nova T and 2.1 per 100 users of TCu. After 2 years the pregnancy rates for Nova T and TCu were 3.1 and 4.8 per 100 users, respectively. Although there was no statistically significant difference between the rates for the two devices, they suggest a higher contraceptive efficacy for Nova T.

Clinical Trials as Topic↗
PubMed1987

The use effectiveness of the Copper T-200 in Matlab, Bangladesh.

Using a unique record keeping system, the use effectiveness of the Copper T-200 is examined in rural Bangladesh. In Matlab the Copper T-200 is a highly effective contraceptive modality. The adopters are typically low to medium parity women under 30 years of age. The most important cause of termination among women in the study was voluntary removal of the device. The complaint most often reported was bleeding followed by pain and weakness. The Matlab experience suggests that sustained motivation and regular resupply are the two key components of this highly successful family planning program.

Adult↗