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Sudies in simpler tubocclusion methods.

This report reviews animal and human studies undertaken to develop simpler, safer, and more acceptable methods of female sterilization. Animal studies revealed inadequate prevention of pregnancy by tubocclusive methods from within the uterus, and the laparoscopic route was chosen. A series of clips were evaluated, and a clip was designed which would have a spring load, be wide enough to cause true tissue necrosis, have a firm grip on the tube to prevent dislodgement, and have a smooth external surface. Extensive human trials of the clip and applicator have resulted in over 1,000 patients with clips applied by 27 physicians in 10 centers throughout the world. Six pregnancies appear to have been due so far to application onto structures other than the isthmic portion of the tube. Complications due to the clip itself appear to be minimal, and the feasibility of performing this operation under local anesthesia in a hospital facility other than the operating room is currently under evaluation.

Ambulatory Care↗

Clinical study of a progesterone-releasing intrauterine contraceptive device.

A double-blind clinical study was performed to determine whether the release of progesterone from an intrauterine contraceptive device (IUD) had any effect on IUD event rates. A total of 101 women received intrauterine contraceptive devices containing progesterone, resulting in the accumulation of 877 women-months experience; 100 women received IUD's without steroid, resulting in the accumulation of 780 women-months. The only significant difference was a higher incidence of pregnancy in those patients using devices which did not contain progesterone.

Adult↗

Factors affecting intrauterine contraceptive device performance. I. Endometrial cavity length.

The relationship of endometrial cavity length to intrauterine contraceptive device (IUD) performance was evaluated in 319 patients wearing three types of devices. The rate of events, defined as pregnancy, expulsion, or medical removal, increased significantly when the length of the IUD was equal to, exceeded, or was shorter by two or more centimeters than the length of the endometrial cavity. Total uterine length was found to be a less accurate prognostic indicator of IUD performance than endometrial cavity length alone.

Adult↗

Incidence of infections associated with the intrauterine contraceptive device in an isolated community.

In an attempt to estimate more precisely the frequency of infections associated with the intrauterine contraceptive device (IUD), all gynecologic morbidity resulting from infection and occurring during a two-year period in an isolated community was reviewed. Ten septic abortions occurred, and all but one were associated with IUD use. In 26 gynecologic inpatients (41 per cent of all admissions for acute pelvic inflammatory disease), pelvic infection was associated with IUD use. In contradistinction to the septic abortion data, implicating only the Dalkon Shield, the gynecologic infections were associated with various types of devices.

Abortion, Septic↗

A new procedure for the statistical evaluation of intrauterine contraception.

An improved statistical method for assessing the efficacy of intrauterine contraception is presented. This method, called the log-rank method, is based on a daily life table, which yields the best estimates of the cumulative net termination probabilities. It provides a sensitive chi-square test statistic to detect differences among these probabilities for two or more contraceptive devices. When three or more devices are compared, the chi-square statistic may be partitioned into additive components representing comparisons among groups of devices. The log-rank method also permits adjusting for differences among subgroups by controlling for factors such as parity or age. Although calculations may be performed on a desk calculator, a FORTRAN-IV computer program is made available to interested researchers.

Computers↗

Comparison of three different models of the copper T intrauterine contraceptive device.

A random sequential comparative study of three models of the Copper T intrauterine contraceptive device (IUD) was undertaken in 1,792 women. For 7 months, the TCu 300 and TCu 220C were randomly inserted, and then the TCu 380A and 220C were randomly inserted for the next 12 months. The log-risk method of life-table analysis of event rates was performed at the end of each of the first 3 years of use of each device. The TCu 380A had the lowest pregnancy rate during each year of use, although the difference was not significant. At the end of each of the first 2 years, the TCu 300 was removed significantly less than the TCu 220C and TCu 380A for bleeding and pain. At the end of three years, the rates of removal for bleeding and pain for the TCu 380A and TCu 300 were similar and lower than that for the TCu 220C, but the overall difference was not significant. There were no differences among the devices for any other relevant use-related reasons. The TCu 380A was removed for other medical reasons significantly more frequently than the other devices at the end of 2 and 3 years. Adjusting for parity did not alter the results. The findings of this study suggest that the copper sleeves along the horizontal arms together with copper wire on the vertical arm in the TCu 380A model provide greater protection against intrauterine pregnancy, whereas the copper sleeves along the vertical arm as in the TCu 220C caused increased removals for bleeding and pain. The TCu 380A should be studied in a larger number of patients for a longer period of time to determine its clinical effectiveness. It may become the IUD of choice for all women irrespective of parity.

Female↗

A collaborative study of the progesterone intrauterine device (Progestasert). The World Health Organization Task Force on Methods for the Regulation of Implantation.

A randomised double blind study of a plain T-shaped IUD and an active T-shaped IUD releasing 65 micrograms/day of progesterone, has been completed in four centres. A study of 1320 progesterone-releasing IUD's in parous women for 9660 women months of use significant to 18 months, gave a pregnancy rate of 1.0 +/- 0.4, expulsion of 4.7 +/- 0.6 and removals for pain and bleeding of 6.0 +/- 0.7. A detailed analysis of the menstrual bleeding patterns in these patients gave details of the number and length of bleeding and spotting episodes, count of bleeding days, and count of spotting episodes and days for four one-hundred-day reference periods. While the plain IUD contributed a significant number of intermenstrual spotting and bleeding days, the progesterone-releasing IUD contributed more spotting days.

Adult↗

Timing of the IUD insertion.

The relationship between the time in the menstrual cycle when a TCu-200 or Cu-7-200 is inserted and subsequent IUD-related events was evaluated. For women who had either TCus or Cu-7s inserted, the pregnancy, expulsion and medical removal rates were similar for insertions performed at any time of the menstrual cycle.

Aging↗

Polyurethane contraceptive vaginal sponge: product modifications resulting from user experience.

A preliminary study of a new contraceptive vaginal sponge containing the spermicide nonoxynol -9 (N-9), was undertaken to assess acceptability of the method among a group of sexually active volunteers in Mexico City. Numerous modifications of the product and its packaging resulted from user experience and feedback to the physicians and bioengineers conducting the study. Although determining efficacy of the sponge was not an objective, it quickly became clear that spermicide is a crucial component of the intravaginal sponge contraceptive system; a high incidence of pregnancies led us to increase the spermicide level from 10% to 20%, then to the current 30% of dry sponge weight, or about 1.0 gram per sponge. (It should be noted that the high pregnancy rates were consistent with our experience using other vaginal contraceptive methods in the same clinic population). This initial evaluation of the contraceptive sponge has resulted in significant modification which should increase its acceptability to a small but important group of contracepting women. The sponge is currently being evaluated by the International Fertility Research Program (IFRP) in multicentered comparative clinical trials to determine use-effectiveness and acceptability in various cultures.

Clinical Trials as Topic↗