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At least 163 records · Page 9Linked to original sources
PubMed1992

Was the Dalkon Shield a safe and effective intrauterine device? The conflict between case-control and clinical trial study findings.

OBJECTIVE: To compare the findings of the case-control and cohort studies used to indict the Dalkon Shield (A.H. Robins Company, Inc., Richmond, VA) with the findings of the Dalkon Shield clinical trials. DATA IDENTIFICATION: All published reports on the Dalkon Shield were identified through MEDLARS system (United States National Library of Medicine) searches and by cross checking all references in these reports. The same approach was used to identify all case-control and cohort studies of the purported relationship between intrauterine devices (IUDs) and pelvic inflammatory disease (PID). STUDY SELECTION: Only studies of interval patients that included 50 or more women and 6 or more months of follow up that computed standard IUD event rates (rates of pregnancy and expulsion and removal for pain and bleeding) were selected for this study. All case-control and cohort studies identified were included except two case-control studies that included women with sterile chronic salpingitis. RESULTS: The 16 case-control and 2 cohort studies found or suggested that the Dalkon Shield increased the risk of PID. The 71 clinical trials of the Dalkon Shield show that when this device is inserted by an experienced clinician it is a safe and effective contraceptive method, comparable with other IUDs used at the time. There was no evidence of an increased risk of PID found in these clinical trials. CONCLUSIONS: This study offers convincing evidence that the indictment of the Dalkon Shield was a mistake. Additionally, this study shows that physician skill and experience is far more important to successful IUD insertion than previously recognized, a finding with considerable implications for IUD study designs and for marketing strategies.

Case-Control Studies↗
PubMed1998

[Intra-vesical translocation of an intrauterine device, report of a case].

The intra-uterine device TCu 380 (IUD) has a great acceptance among the group of women that take the fertility control in not definitive form and it is being accepted by more women. In spite of the simple technique to insert the IUD, the people in charge of the planning family program in the first level attention section of the centers of health, have not enough knowledge for its insertion. We reported the case of a 21 year old woman that applied the IUD immediately after her baby's birth and she had sudden expulsion the following week. She went to the first level attention section where they inserted the IUD again and four months later she began to have urinary symptoms and abdominal pain, she went for a check, but could not find the filaments of the IUD. The x-ray of her abdomen showed an inverted IUD, they tried to take it off, but without any success. She was sent to the General Hospital where made an ultrasound that showed the IUD in the urinary bladder. A transurethral endoscopy was made and also an ultrasonographic dragging without gerring it. That is why decided to take it off by abdominal and urinary bladder surgery. The IUD was inserted transurethral which the diameter of the applier is thin and lets it go free in thorough the urethra, besides that during the operation did not find any harm in the uterus or the bladder that could make suspect the perforation in order to make the IUD reach the urinary bladder. The above mention demonstrate the ignorance of the technique and the anatomic place for the insertion of the IUD. That is the reason why it is necessary a more detailed preparation it the whole personnel assigned to the family planning programs.

Adult↗
PubMed1991

Clinical experience with the GYNE-T 380 postpartum intrauterine device.

OBJECTIVE: The insertion of conventional intrauterine devices (IUDs) during the 1st 10 days after delivery is associated with a high rate of expulsions. DESIGN: The GYNE-T 380 (Ortho Pharmaceutical [Canada] Ltd., Toronto, Ontario, Canada) IUD was modified by the addition of a loose loop of knotted biodegradable no. 2 catgut to the top of the IUD (GYNE-T 380 postpartum IUD). After delivery, a special inserter was used to imbed the knotted portion of the loop into the myometrium of the uterine fundus. PATIENTS, PARTICIPANTS: This modified IUD was evaluated in a phase II trial involving 190 women at four clinical sites. MAIN OUTCOME MEASURES: There were no pregnancies during the 1st year of the study. The continuation rate was 74 per 100 women and a life table expulsion rate of 9.6 and 13.3 per 100 women was observed at 6 and 12 months, respectively. RESULTS: Complications associated with the insertion and the use of this IUD were minimal. Large scale trials evaluating this IUD are in progress.

Equipment Design↗
PubMed1998

Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices. IUD Study Group.

BACKGROUND: The value of antibiotic prophylaxis before insertion of an intrauterine device (IUD) remains uncertain. We undertook a triple-masked, randomised, placebo-controlled trial to find out whether such prophylaxis reduces the rate of IUD removal within 90 days. METHODS: 11 clinic sites in southern California enrolled women who requested IUD insertion and were at low risk of sexually transmitted infection according to self-reported medical history. We randomly assigned 1985 participants either 500 mg azithromycin or placebo capsules of identical appearance taken about 1 h before insertion of a Copper T 380A IUD. 118 women did not have an IUD inserted. We followed up 1833 of the remaining 1867 (98%) participants for at least 90 days after insertion. FINDINGS: The rate of IUD removal for any reason other than partial expulsion was 3.8% (35/918) in the antibiotic group and 3.4% (31/915) in the placebo group (relative risk 1.1 [95% CI 0.7-1.8]). The two treatment groups sought medical attention with equal frequency (mean 38 visits per 100 women). During the 90 days after IUD insertion, only one woman from each assignment group had salpingitis, as defined by established criteria. INTERPRETATION: Prophylaxis with azithromycin did not affect the likelihood that a woman would retain her IUD at 90 days or the frequency of postinsertion medical attention. In appropriately screened women, the risk of upper-genital-tract infection is negligible after IUD insertion, with or without the administration of prophylactic antibiotics.

Adult↗
PubMed2004

Intrauterine fragmentation of Gyne T380: an uncommon complication.

A case of intrauterine fragmentation of a Gyne T380 intrauterine device (IUD) is described that was detected during removal of the device. Pelvic ultrasound failed to detect the fragment. Subsequently the woman reported spontaneous expulsion of the device. A description of this uncommon complication of IUD use, diagnosis, management and the need for awareness of the possibility of spontaneous expulsion of the fragment are discussed.

Adult↗
PubMed1975

A fluid-filled intrauterine device: initial clinical trials.

Initial clinical trials of a saline-filled IUD were conducted with 697 women (397 nulliparas and 307 multiparas) experiencing 6,672 woman-months of use. The cumulative rates for multiparas were: pregnancy 1.5, expulsion 10.5, medical removal 10.9, continuation 68. For nulliparous women the rates were: pregnancy 4.3, expulsion 19.4, medical removal 14.3, continuation 58. Efforts are being made to modify the geometry and content of this IUD to decrease the expulsion rate and removals for bleeding.

Adolescent↗
PubMed1996

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↗
PubMed1992

The multiload IUD--a U.S. researcher's evaluation of a European device.

This evaluative review focused on the performance and safety of the Dutch-made Multiload copper IUD, primarily the Multiload-375 (MLCu-375) model which has a longer life expectancy (5 or more years) than the Multiload-250 (MLCu-250) model, usually cited for a life expectancy for three years. This copper-medicated IUD differs from the copper-T IUDs in shape and insertion technique. The review shows that (a) the MLCu-375 IUD seems to be slightly less effective in preventing pregnancies than TCu-380A IUD. Its efficacy is comparable to that of the Nova-T by two to three years of use; (b) the MLCu-250 IUD is similarly effective to TCu-200 but may be slightly less effective than TCu-220C; (c) no consistent differences were detectable in expulsion rates or in removal rates for bleeding/pain between the Multiload IUDs and comparative Copper-T IUDs; (d) the Multiload IUDs may perform better in nulliparous women than the T-shaped devices; (e) no or a very low incidence of uterine perforation is associated with insertions of the Multiload IUD; (f) ectopic pregnancy risks are similarly low in Multiload IUD users as in Copper-T-380A users; and (g) pelvic inflammatory disease (PID) risks are similarly low in Multiload IUD users as in users of T-shaped copper IUDs.

Evaluation Studies as Topic↗
PubMed1984

Postpartum insertion of modified intrauterine devices.

The immediate postpartum insertion of standard intrauterine devices (IUDs) and those specially modified for postpartum use was evaluated in a multicenter clinical trial. The immediate postpartum insertion of IUDs was not associated with any increased risk of perforation or infection, although expulsion rates were higher than with interval insertions. The expulsion rate varied widely between centers using similar devices, suggesting that training in insertion is essential. Postpartum IUD insertions can be a practical contraceptive option for patients and providers of medical services.

Adult↗
PubMed2003

Follow-up of users of intrauterine device with and without bacterial vaginosis and other cervicovaginal infections.

This study aimed to assess the prevalence of bacterial vaginosis (BV) and other cervicovaginal infections, as well as the incidence of complications among new users of IUD, 1 and 6 months after its insertion, in the City of Campinas, Brazil. A total of 223 women who had a TCu-380A IUD inserted from May through November 2001, were included in the study. After the IUD insertion all women were scheduled to two additional visits: after 1 month and after 6 months, when they were interviewed and a pelvic examination was performed, along with a collection of specimens from the vagina and the endocervix for laboratory testing. The Nugent's criterion was used for the BV diagnosis. They were also evaluated with regard to presence of complications possibly related to IUD insertion and use, i.e., abnormal bleeding, dysmenorrhea, expulsion and pelvic inflammatory disease. The prevalence of cervicovaginal infections was 29.1%, BV being the most frequent (19.7%). Dysmenorrhea was more frequent among women with BV than among women without BV (p = 0.03). A trend of abnormal bleeding being more frequent among women with BV was also found. In conclusion, BV after 1 month of IUD insertion was not associated with IUD complications, with the exception of dysmenorrhea.

Adolescent↗
PubMed1998

Managing clinical complexities of long-term contraception.

The 3 methods of long-term contraception (LTC) approved for use in the US are intrauterine devices (IUDs), levonorgestrel subdermal implants, and sustained-release medroxyprogesterone acetate injections. Women who use reversible LTC are likely to receive care from clinicians who did not prescribe the method of contraception originally. Fortunately, most concerns arising from the use of reversible LTC can be managed by clinicians regardless of their specialty. Problems associated with an IUD can include a missing string, partial expulsion of the device, change in menstrual pattern, vaginal discharge, or infection. Headaches, weight gain, dermatologic problems, changes in hair growth, and irregularities in menses are among the problems that clinicians may confront while caring for a woman who has had subdermal hormone implants or has been taking depot injections. Besides the problems caused by or complicating specific methods of LTC, a woman may seek clinical care for a variety of general concerns. These include a desire to terminate LTC in order to become pregnant, and physical changes that are suspected to indicate pregnancy or contraceptive failure. In addition, general health conditions such as concurrent medications, hypertension, and endocrine disorders may need special consideration in a woman using LTC. There are few medical indications for discontinuing or changing LTC, even when intercurrent illnesses arise.

Female↗
PubMed1993

Evaluation of the clinical performance of a levonorgestrel-releasing IUD, up to seven years of use, in Campinas, Brazil.

The clinical performance of a levonorgestrel IUD, releasing 20 mcg/day, used by 293 women at the Family Planning Clinic of the State University of Campinas, was evaluated up to the end of the seventh year of use. No pregnancies occurred in 899 women-years of observation. The cumulative removal rate for amenorrhea or severe hypomenorrhea was 15.7 per 100 women at seven years. The expulsion rate was within ranges observed with copper IUDs in the same clinic. The continuation rate was 49.5% at three years and 23.7 at seven years. The cumulative loss to follow-up rate was 13.7% at seven years. The effectiveness, good continuation rate, and reduction of the amount of blood loss make this device appropriate to be offered to Brazilian women, as an additional contraceptive option.

Adult↗
PubMed1987

Comparison of two copper IUDs: the MLCu375 and the Nova-T.

A comparative randomized trial was carried out on two intrauterine contraceptive devices: the Nova-T and the MLCu375. The IUDs were used by 1116 and 1237 women respectively, over a period of 2 years. The reasons for IUD removal were analyzed after one and two years using the life-table method. Statistically significant differences were found in the rates for pregnancy, expulsion and removal for bleeding and/or pain favoring the MLCu375 IUD.

Adolescent↗
PubMed1986

The postcoital IUD as an effective continuing contraceptive method.

A two-year controlled clinical study of the effectiveness of postcoital IUD as a continuing contraceptive method in 98 women requesting a postcoital contraception is presented. The control group was selected from women requesting an IUD as contraceptive choice. The rates of accidental pregnancy, expulsion and removal for medical reasons did not differ between the two groups. Removal for personal reasons was the only termination event that showed a significant difference at one year. Moreover, the removal for personal reasons of interceptive IUD users mainly occurred in the early months after insertion. Postcoital IUD has proved to be an effective continuing contraceptive method. Special attention and sympathetic counseling should be given to postcoital IUD users before insertion and during the three months following insertion.

Adolescent↗
PubMed1980

Experience with the copper 7 intrauterine device in an adolescent population.

A retrospective study was conducted of 120 consecutive patients who received a Cu-7 IUD at the Cincinnati Adolescent Clinic during a four-year period from July, 1974, through June, 1978. Follow-up was obtained in 116 (97%) of the initial patient population. Mean age at initial Cu-7 insertion was 16.8 years; 81% of the patients were nulliparous. An experience of 149.7 women years was accumulated; the pregnancy rate at the conclusion of the study was 2.0/100 women years. Continuation rate was 83% at six months, 70% at 12 months, 49% at 24 months, and 39% at 36 months. Patient expulsion rate was 18% overall, with a total of 17 expulsion events/100 woman years. Subjective satisfaction with the IUD as a contraceptive method was expressed by 72% of these patients. The Cu-7 has proven to be a safe, effective, well-tolerated contraceptive method in the adolescent female.

Adolescent↗
PubMed1990

Do retroverted uteri adversely affect insertions and performance of IUDs?

A large international multi-center IUD data set (N = 5520) coordinated by Family Health International was analysed to determine if the uterine position of a woman (anteverted, mid-positioned or retroverted) affects the ease of IUD insertion and if knowledge of uterine position would diminish insertion-related problems and improve IUD performance. Findings showed that insertion-related events were rare irrespective of uterine position. Women with retroverted uteri were not associated with higher termination rates for accidental pregnancy, expulsion or removal for bleeding and/or pain after 12 months of IUD use, as compared to the other two uterine position groups. All insertions in this data set were performed by experienced obstetricians/gynecologists, and our findings suggest that women with retroverted uteri should be equally good candidates for IUD contraception.

Adult↗
PubMed1979

[Clinical experience with the copper T-200 intrauterine device].

It is reported on experiences with 138 Cooper-T-200 IUDs, resulting in 1868 months of use. Both the Pearl-Index with 1,3 and the expulsion rate with 1,44% are no significant lower, than in a compared DANA-Super-IUD collective. In both groups the rate of all events like pains, spottings and hypermenorrhea is almost identically. Hypermeorrhea is of significant frequenter occur in the Copper-T-IUDs.

Adult↗