A comparative clinical trial of the TCu 380A, lippes loop D and multiload Cu 375 IUDs in Indonesia

Sastrawinata, S.; Farr, Gaston; Prihadi, Siti Moetmainnah; Hutapea, H; Anwar, Mochamad; Wahyudi, Imam; Sunjoto,; Kemara, Ketut Putera; Champion, Cheryle B.; Robbins, Mark

doi:10.1016/0010-7824(91)90114-u

Cited by 40 publications

(8 citation statements)

References 3 publications

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“…The absolute rates of perforation, expulsion, upper genital tract infection, contraceptive failure and method discontinuation were all low. These rates are comparable to those reported for interval IUCD insertion with modern copper devices [18][19][20][21][22][23] . Overall, devices with copper had lower pregnancy rates than those without copper, and devices with a 'T' shape had lower expulsion rates compared with other shapes.…”

Section: Discussionsupporting

confidence: 83%

Insertion of an intrauterine contraceptive device after induced or spontaneous abortion: a review of the evidence

Stanwood

Grimes

Schulz

2001

British Journal of Obstetrics and Gynaecology

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Objective Assess the safety and efficacy of intrauterine contraceptive device (IUCD) insertion immediately after induced or spontaneous abortion. Design Systematic search for randomised trials that had at least one treatment arm that involved IUCD insertion immediately after an induced or spontaneous miscarriage using Medline, Popline, EMBASE, and review articles supplemented by correspondence with investigators. Population Women of any age or gravidity who had an IUCD inserted immediately after evacuation for spontaneous or induced abortion. Methods Articles were abstracted and the raw data from tables were analysed with RevMan 3.1 software. We focused on Tietze-Potter gross life table probabilities with denominators of person-time of exposure. Main outcome measures Rates of perforation, expulsion, pelvic inflammatory disease, contraceptive failure, and method continuation. Results Complication rates for immediate post-abortal IUCD insertion were low. Perforation was rare with a rate of approximately one per 1000 insertions. One year gross cumulative expulsion rates ranged from 1.8% to 12.6%, pregnancy rates from 0.6% to 2.1%, and continuation rates from 54% to 90%. The net discontinuation rate due to pelvic inflammatory disease was low, ranging from 0.0 to 0.8 per 100 women at one year. Increasing gestational age at insertion was associated with increased expulsion rates. Conclusions Post-abortal IUCD insertion is safe and effective. The risks of perforation, expulsion, pelvic inflammatory disease and contraceptive failure were low and similar to those reported for interval insertion. Second trimester gestational age is associated with an increased risk of expulsion. Immediate insertion may have a higher expulsion rate than delayed insertion. However, these risks may be outweighed by the benefit of immediate contraception.

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Section: Discussionsupporting

confidence: 83%

Insertion of an intrauterine contraceptive device after induced or spontaneous abortion: a review of the evidence

Stanwood

Grimes

Schulz

2001

British Journal of Obstetrics and Gynaecology

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“…If a partially expelled IUD is noted on physical examination, it should be removed and replaced as long as there are no signs of pregnancy or infection. The only factors that have been consistently associated with a higher rate of expulsion are age younger than 20 years and nulliparity 5,44,47…”

Section: Safetymentioning

confidence: 99%

Long-term safety, efficacy, and patient acceptability of the intrauterine Copper T-380A contraceptive device

Kaneshiro

Aeby²

2010

IJWH

109

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The intrauterine device (IUD), primarily in the form of the copper IUD, is used by more than 150 million women around the world, making it the most widely used reversible method of contraception. With a remarkably low failure rate of less than 1 per 100 women in the first year of use, the Copper T-380A is in the top tier of contraceptives in terms of efficacy. Risks of utilization include perforation and an increased risk of infection in the first 20 days following insertion. Overall, the number of adverse events is low, making the Copper T-380A a very safe contraceptive method. The most common reasons for the discontinuation of this method are menstrual bleeding and dysmenorrhea. However, cumulative discontinuation rates of Copper T-380A are lower than that have been reported for other methods, indicating that the Copper T-380A is highly acceptable to women. After 5 years, approximately 50% of all women, who have a Copper T-380A inserted, will continue to use this highly effective contraceptive method.

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“…The literature search yielded 3572 citations, of which 233 were screened for further judgment by reading full texts. Seventeen (3–9, 15–27) of the 233 articles met inclusion criteria and provided direct comparison data of TCu380A and MLCu375. After excluding one duplicate (20), we finally included 16 trials ( 1 ) for analysis.…”

Section: Resultsmentioning

confidence: 99%

“…Of the 16 included trials, four reported computer‐generated random sequences (3–8, 19), six adopted sealed opaque envelops to ensure concealed allocation (3–7, 16, 19, 25, 27), three performed single‐blinding for participants (8, 16, 25) and one conducted double‐blinding for both outcome evaluator and participants (19). The baseline information of three were not comparable (3, 15, 16) (Table 1). No obvious evidence of publication bias was suggested from creation of the funnel plots (Fig.…”

Section: Resultsmentioning

confidence: 99%

“…The former was originally approved by the U.S. FDA in 1984, and the latter invented by the Dutch in 1974. Several multi‐center randomized controlled trials (RCTs) have been performed to compare the effectiveness and safety of TCu380A and MLCu375 (3–9). Of these trials, the multi‐center trial (19 centers) initiated in 1989 by the WHO IUD research group was the most famous (4–7), and the results revealed that in the third year of follow up, the pregnancy rate, continuation rate, and expulsion rate for TCu380A and MLCu375 were 1.6% and 2.9%, 77.9% and 77.7%, and 5.2% and 6.4%, respectively.…”

Section: Introductionmentioning

confidence: 99%

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Comparative safety and effectiveness of TCu380A versus MLCu375: a systematic review of randomized trials

Wen

Liu

et al. 2009

J Evidence Based Medicine

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Objective To compare the relative effectiveness and side effects of two intrauterine devices (IUDs), TCu380A and Multiload Cu375 (MLCu375). Methods We searched PubMed, EMBASE, the Cochrane Library, POPLINE, SCO-PUS, and the Chinese Biomedical Literature Database in all languages, along with reference lists of retrieved papers. Randomized controlled trials comparing TCu380A with MLCu375 were included. The outcomes examined were pregnancy, continuation, removal, expulsion, infection, pain, abnormal menstruation, uterine perforation, and other adverse events. Two reviewers independently extracted the data. Data from the trials were combined to calculate relative risks (RRs) along with 95% confidence intervals (CIs). Results Sixteen trials were included, involving 15236 participants. Generally the methodological quality was poor. Compared to MLCu375, TCu380A was associated with less pregnancy and expulsion at five years with (RR: 0.49, 95% CI: 0.33 to 0.72; RR: 0.63, 95% CI: 0.45 to 0.89; respectively), as well as more removals for bleeding and/or pain at three years and pelvic infection disease over the whole study period (RR: 1.83, 95% CI: 1.28 to 2.62; RR: 1.47, 95% CI: 1.03 to 2.11; respectively). There were no statistical differences at all time intervals to 5 years in continuation rates or rates of uterine perforation. Conclusions While there was some variability between study results, we found evidence that TCu380A is more effective than MLCu375, with a similar side-effect profile.

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A comparative clinical trial of the TCu 380A, lippes loop D and multiload Cu 375 IUDs in Indonesia

Cited by 40 publications

References 3 publications

Insertion of an intrauterine contraceptive device after induced or spontaneous abortion: a review of the evidence

Insertion of an intrauterine contraceptive device after induced or spontaneous abortion: a review of the evidence

Long-term safety, efficacy, and patient acceptability of the intrauterine Copper T-380A contraceptive device

Comparative safety and effectiveness of TCu380A versus MLCu375: a systematic review of randomized trials

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