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Failure in intrauterine contraception. Analysis of 137 cases of unfavourable outcome.

137 cases of unfavourable outcome in IUD insertion (i.e. early removal or expulsion because of complications) were investigated as regards age, parity, previous intrauterine contraception, previous induced abortion, type of device inserted, and type of complications observed. Moreover, this group was compared for each feature mentioned with a control group of 454 women who successfully concluded the prescribed period from the insertion. All the devices were inserted with a significantly higher rate of favourable outcome in pluriparous versus nulliparous patients; age probably didn't affect the outcome, but strongly conditioned the prevalence of particular complications such as PID and abnormal bleeding. Progesterone-loaded IUD didn't show a more favourable outcome than copper devices.

Adult↗

[Clinical effects in 1136 cases of Beijing silicon rubber IUD and its effect on the endometrium].

Beijing Silicon Rubber IUD was designed by Xuan Wu Hospital and Beijing Silicon Rubber Manufacturing Research Institute in 1980. Animal experiments of the silicon rubber were done, and toxic effect studied before clinical use. 1136 cases were reported at the end of 12 months by 6 hospitals in Beijing. The followup rate was 93.75%. Life table of 12 months showed the cumulative continuation rate of the IUD was 82.45%, pregnancy rate 4.5%, expulsion rate 8.49%, removal for medical cause 3.9%, and removal for personal reasons 0.64%. Among the side effects, menstrual irregularity was 5.03%, blood discharge 6.35%, dysmenorrhea 11.95%, backache 31.1%, and leucorrhea 18.12%. Menstrual blood loss was measured in 30 cases before and after 1, 2, 3 months of insertion. The mean blood loss before insertion was 51.96 ml (51.71 +or- 15.95), while 1 month after insertion it was 62.9 ml (70.59 +or- 26.81), 2 months after insertion 71 ml, and 3 months after insertion 75 ml. The morphological endometrial change as compared with that by induced stainless steel ring is not much heavier especially in regard to glandular and stromal changes. The endometrial cytologic count of white cells of the IUD group (34 cases) in comparison with that of the control group (36 cases) was about twice as much in number. As Moyer reported, the endometrial cell count of IUD cases was about 6-10 times that of control cases. The authors consider that the cellular reaction of this IUD is not much greater than that of other types of IUDs.

Birth Rate↗

An evaluation of IUD insertion by a non-clinical delivery system.

To evaluate the safety, effectiveness, side-effects, and continuation rate associated with non-clinical IUD insertion compared to IUD insertion in routine clinical facilities, a cohort comparative study was done on two groups of IUD users self-selected for either the non-clinical or clinical delivery system in Yogyakarta Special Area Province. During the months of January to March 1985, 454 non-clinical and 625 clinical acceptors were recruited into this study. However, only 414 non-clinical and 605 clinical acceptors fulfilled the inclusion criteria and were included in the analysis. Bleeding and pain were the most common side-effects reported by acceptors. The frequency of bleeding was higher in the non-clinical group than in the clinical group. However, the difference was a not statistically significant relative risk (RR) of 1.09 (0.8-1.4) to 1.2 (0.9-1.5). Severe menstrual blood loss mostly occurred in the first three months after insertion and then declined in the rest of the year in both groups. The frequency of pain was not clearly different between the two groups during the whole year, with RR 0.8 (0.5-1.3) to 1.3 (0.8-2.0). The actual number of pregnancies was very small and the difference was not statistically significant (p = 0.375). The 12-month expulsion rates were 7.22 per 100 IUD users for the non-clinical group and 7.00 for the clinical group. The difference was not statistically significant (p = 0.660). The cumulative probability of women who were still using IUDs at 12 months was 89.7% and 89.1% for the non-clinical and clinical groups, respectively. The non-clinical delivery system seemed to be responsive to an unmet demand for family planning among women with lower educational background compared with those in the clinical setting service. While the characteristics of a population obviously influence the contraceptive behavior, this study shows that the non-clinical delivery system family planning method provides a similarly efficacious and safe service to the usual clinical system.

Cohort Studies↗

Complications of the intrauterine device in nulliparous and parous women.

OBJECTIVES: The intrauterine device (IUD) is still related to pelvic inflammatory disease (PID), pregnancy, expulsion, perforation and menstrual problems, particularly in nulliparous women. We aimed to study the complications and symptoms of the intrauterine device in general practice, particularly in nulliparous women. METHODS: We used a retrospective cohort study in four general practices participating in the Nijmegen Continuous Morbidity Registration. Selected women had one or more IUDs inserted between 1981 and 2000. Data on complications, symptoms and removal of the IUD were obtained from the medical records. RESULTS: 461 women were included, 129 nulliparous and 332 parous women. Users of copper IUDs had a rate of PID of 3.5 per 1000 women-years, rates of (ectopic) pregnancy of 0.6 to 1.1% per year and rates of expulsion of 0 to 1.2% per year. Rates of expulsion for the levonorgestrel-releasing IUDs were 0 to 0.2% per year. Nulliparous women did not show more complications than parous women. Menstrual problems were frequent among users of copper and levonorgestrel-releasing IUDs. One third of the IUDs were removed within the first year after insertion. There was no significant excess of IUD removal among nulliparous women compared with parous women. Main reasons for removal were 'menstrual problems' and 'contraception no longer necessary'. CONCLUSION: Both copper and levonorgestrel-releasing IUDs are safe and highly effective contraceptives, which can adequately be inserted and monitored by general practitioners in nulliparous and parous women.

Adolescent↗

A comparative study of two techniques used in immediate postplacental insertion (IPPI) of the Copper T-380A IUD in Shanghai, People's Republic of China.

Chinese women in Shanghai who delivered vaginally and who chose to use an IUD for contraception received a Copper T-380A IUD inserted vaginally within 10 minutes after delivery of the placenta (i.e., immediate postplacental insertion, IPPI). Among them, 97.7% were primipara. The women were randomly divided into two groups: IUD inserted by hand and IUD via ring forceps. The follow-up rate of six months was 95.2%. Using Tietze's life table method and log rank test, the expulsion and other discontinuation rates were compared at three and six months postinsertion between these two different insertion techniques. Expulsions were the main reason for discontinuation. The six-month gross cumulative expulsion rates were 13.3 and 12.7 per 100 women in the hand-insertion group and ring forceps-insertion group, respectively. Discontinuation rates for medical removals (bleeding/pain) were 2.1 and 1.0 in these two groups, respectively. Neither of the differences was statistically significant (p > 0.05). No uterine perforation, infection or pregnancy occurred. The results suggest that these two different insertion techniques do not significantly affect discontinuation rates in vaginal IPPI using the TCu 380A, and the TCu 380A appears to be suitable for postpartum insertion in Chinese women. Other relevant issues, such as breastfeeding and IUD placement in uterine cavity, are also analyzed and discussed in this report.

Adult↗

Another look at the Dalkon Shield: meta-analysis underscores its problems.

Numerous non-comparative clinical trials of the Dalkon Shield appear to provide ample evidence that the Dalkon Shield was an effective IUD; they seem to yield little evidence that it was a dangerous device, nor markedly different from its contemporaries. Equating the performance of the Dalkon Shield IUD to that of the Lippes Loop or of Copper IUDs is erroneous, however, with respect to rates of pregnancy, expulsion, pelvic infection, septic abortion, death with the device in situ, and tubal infertility. Randomized studies show the Dalkon Shield had approximately double the pregnancy rates of the Lippes Loop D or Copper IUDs (P < .05) and a significantly lower expulsion rate. These differences coupled together with the distinguishing multifilament tail of the Dalkon Shield underlay the higher rates of pregnancy complications, including septic abortions with the device in situ and deaths, associated with the Shield. A five-fold increased risk of hospitalized pelvic infection among Dalkon Shield users found in the Women's Health Study resulted not from ascertainment bias, but was related to the fact that Dalkon Shield users had more severe hospitalized PID than did other hospitalized women with PID and IUD use. Following cessation of distribution and of use of the Dalkon Shield, and following the FDA's recommendation to remove IUDs in case of pregnancy, there have been no deaths reported among pregnant American women with an IUD in situ in a 15-year period. Neither the IUDs of today nor those in use during 1970-1974 are equitable to the Dalkon Shield [corrected].

Case-Control Studies↗

Long-term clinical experience with the Cu-7-IUD. Evaluation of a prospective study.

In a prospective Swedish three-center study, totally 1446 women wearing a Cu-7-IUD were carefully followed for a minimum 2 years. Smaller subgroups have been followed for 4 years (n=278) or for even longer periods up to 8 years (n=48) with the same Cu-7-IUD in situ. Data are given concerning continuation rate, efficiency, expulsion, removals, pain, bleeding and risk for pelvic inflammatory disease. Prolonged use of the Cu-7-IUD beyond 2 years up to 4 years seems to be associated with fewer side effects and a lower incidence of accidental pregnancies than during the first 2 years of use. The computerized data confirm our earlier impression that the Cu-7-IUD provides a substantial efficacy and is associated with a relatively low rate of adverse effects.

Adolescent↗

The lost IUD.

Ultrasonic B-scanning is a convenient method of confirming the presence of an IUD within the endometrial cavity. The acoustic properties of each device from normal uterine tissue are demonstrated according to the particular type of device used. These produce easily recognizable patterns. The value of ultrasonic scanning the the event of malposition, expulsion, perforation, and unplanned pregnancy with an IUD in situ are discussed. Ultrasonic scanning is a safe, noninvasive method of locating an IUD within the uterine cavity and thereby assessing correct placement. Difficulties encountered in localization of the IUD within the uterine cavity are also discussed. Methods of management of a misplaced IUD are further presented.

Contraception↗

Use of the intrauterine device by inner-city women.

OBJECTIVE: To examine the use, effectiveness, acceptability, and continuation rates of the copper T 380 A intrauterine device (IUD) among women attending an inner-city family planning clinic. DESIGN: A 1-year prospective cohort study. SETTING: The family planning clinic of Grady Memorial Hospital, which serves the inner-city indigent population of Fulton and Dekalb counties in metropolitan Atlanta, Ga. PARTICIPANTS: A total of 115 women with 1 or more live births who were in a mutually monogamous relationship for the previous year had the copper T 380 A IUD inserted between December 20, 1990, and June 28, 1991. MAIN OUTCOME MEASURES: Follow-up, consisting of history and a pelvic examination, was done 2, 6, and 12 months after IUD insertion to determine the status of the IUD and to detect any complications related to its use. At the end of the study, the continuation rates, reasons for removal, and complications related to IUD use were assessed. RESULTS: Thirty-seven women were unavailable for follow-up. Eight of those were seen in other clinics at Grady Memorial Hospital, but no mention was made of their IUD status. Fifty-six of the remaining 78 women were known to continue IUD use without any complications at the end of the 12 months. Among the 22 women known to have the IUD removed, 8 women cited no problems. Pelvic pain, menometrorrhagia, desire for permanent sterilization, and expulsion of the device were mentioned as reasons for other IUD removals. Pelvic inflammatory disease was not documented in any of the patients during the year of follow-up. CONCLUSION: With proper screening and counseling, the IUD may be used successfully in selected patients in inner-city family planning clinics.

Adolescent↗

Postpartum IUD contraception--a review of an international experience.

Postpartum insertion of intrauterine contraceptive devices (IUDs) performed while women are still in hospital has a number of advantages. Earlier reports, however, generally associated this procedure with high expulsion rates. Recent studies, on the other hand, have shown that if IUDs are inserted immediately (within 10 minutes) after placental delivery, it is safe and effective. In some experienced centers, fairly low expulsion rates are reported. In this paper the experiences with postplacental IUD insertions from international studies are reviewed, the lessons we have learned from these experiences summarized, and future research directions suggested.

Cross-Cultural Comparison↗

Factors affecting the clinical performance of Nova T and Copper T 200.

In a randomized comparative use-effectiveness study of the copper-releasing intrauterine devices (IUDs), Nova T and Copper T 200, an analysis was made of the differences in women between the participating countries and of the influence of various factors on pregnancy rate and rates of terminations. In a cohort of 1865 women the five-year gross cumulative pregnancy rates were 3.4 per 100 women for Nova T and 8.7 per 100 women for Copper T 200. The rate of unwanted pregnancy was significantly related to the type of IUD, the country, and the age of the women. Prognostic factors for expulsion or removal of the device were age, country, parity, previous use of IUD, previous vaginal delivery, and previous abortion. The differences among the results for the participating countries may reflect the effects of different policies in clinics.

Abortion, Induced↗

A cohort study of Norplant implant: side-effects and acceptance.

OBJECTIVES: Menstrual irregularity is the main cause of termination of Norplant use; a study of its safety and level of acceptance is needed. STUDY METHODS: A cohort study using medical records of Dr Kariadi Hospital, Semarang, Indonesia and interviews between Norplant and IUD users who had in 1993 been followed-up for 5 years. Expulsion rate, removal rate, level of acceptance and satisfaction were examined. RESULTS: From 170 Norplant and 168 IUD acceptors, the net cumulative pregnancy rates by month 36 of the Norplant and the IUD groups were 0.0% and 1.19%, respectively (p > 0.05). The net cumulative expulsion rates were 0.61% and 1.32% (p > 0.05). The net cumulative rates of removal for medical reasons were 2.37% and 1.97% (p > 0.05). The net cumulative removal rates for non-medical reasons were 1.80% and 10.38% (p < 0.001); the net cumulative continuation rates were 95.29% and 85.60% (p < 0.002). The net cumulative acceptance rates were 97.04% and 93.83% (p > 0.05). The Norplant users experienced less menstrual and inter-menstrual bleeding and more amenorrhea than the IUD group. The psychological satisfaction scores among the Norplant and IUD users were high (p > 0.05). The Norplant contraceptive is well accepted. CONCLUSIONS: The findings could be very useful for further steps in promoting Norplant as a contraceptive that is long-acting, with good efficacy, acceptance, and safety.

Adolescent↗

A comparison of the Lippes Loop and two copper-bearing intrauterine devices.

A review of published studies and studies conducted through the International Fertility Research Program on the Lippes Loop D, TCu and Cu-7 shows that none of the three devices evaluated is better with respect to continuation and all types of event rates. There is a trend toward lower expulsion rates for the copper-bearing IUDs, but other factors such as the cost of devices and the need for replacement must be considered in determining the merits of the devices for large-scale programs.

Evaluation Studies as Topic↗

Analysis of 100 cases of missing IUD strings.

In a study of 100 patients with missing IUD strings 69 women had their IUD in utero (4 were pregnant) and 17 had unnoticed expulsions (4 pregnancies); 9 devices were in the peritoneal cavity and one had perforated the cervix. Since the IUD was in the uterine cavity in the majority of these cases, most contraceptors whose IUD strings disappear can be managed in the office or clinic with relatively simple techniques to locate and remove the device.

Abortion, Spontaneous↗

Postpartum IUD insertions in Manila, Philippines.

In comparative IUD trials conducted in the Philippines, IUDs were inserted immediately postpartum (within ten minutes postplacenta). The first study was designed to compare the IPCS-52 mg (Intrauterine Progestasert Contraceptive System) IUD with the TCu200 when inserted either by hand or with an inserter. Follow-up continued for three years because the IPCS model was designed to release progesterone for this length of time. There was one suspected pregnancy for which the IUD was removed during the study period. The expulsion rates were higher in the IPCS groups than in the TCu groups (p less than or equal to 0.05) and they were higher in the hand insertion groups than in the inserter groups (p less than or equal to 0.05). The second study was a comparison of the Lippes Loop D and a Delta Loop, modified by the addition of three biodegradable suture projections (made of Ethicon #2 chromic material) on the upper arms of the device. The purpose of this modification was to lower the expulsion rates associated with postpartum insertions. The expulsion rates for these two devices were comparable. There were no difficulties during insertion in either study, and few complaints were reported at follow-up. These two studies demonstrated that immediate postpartum IUD insertion proved a safe, effective means of postpartum contraception.

Adult↗

Long-term contraception with the levonorgestrel 20 mcg/day (LNg 20) and the copper T 380Ag intrauterine devices: a five-year randomized study.

An intrauterine device, releasing approximately 20 micrograms/day of levonorgestrel (LNg 20), used by 1124 women, was studied in a randomized trial of five years duration in comparison with the Copper T, model TCu 380Agm in 1121 women. At five years, the gross cumulative pregnancy rate of 1.1 +/- 0.5 per 100 among users of the LNg 20 devices was not significantly different from the rate of 1.4 +/- 0.4 per 100 experienced by users of the Copper T 380Ag. The steroid-releasing IUD had significantly higher termination rates for expulsion and amenorrhea, a significantly lower termination rate for other menstrual problems and pain, and a lower continuation rate. The five-year continuation rate among women using the TCu 380Ag was 40.6 per 100 as compared with that of 33.0 per 100 among women randomized to the LNg 20 device (P less than .001). Terminations attributed to amenorrhea with the LNg device primarily account for differences in continuation. These two intrauterine devices are the most effective long-term, reversible IUDs yet reported in the literature. No other contraceptive methods have exhibited such low long-term pregnancy rates in randomized comparative trials.

Adolescent↗

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↗