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  • Title: Performances of copper T 380A and multiload copper 375/250 intrauterine contraceptive devices in a comparative clinical trial.
    Author: Arowojolu AO, Otolorin EO, Ladipo OA.
    Journal: Afr J Med Med Sci; 1995 Mar; 24(1):59-65. PubMed ID: 7495202.
    Abstract:
    An evaluation of the performances of copper T 380A (TCU 380A) and multiload copper 375/250 (MLCU 375/250) intrauterine contraceptive devices (IUCDS) was carried out at University College Hospital, Ibadan, Nigeria (UCH) in a clinical comparative trial. The IUCDS showed similar low vent rates at one year of continuous use. The difference in cumulative net probabilities for termination due to pelvic inflammatory disease was weakly significant at the sixth month of follow up with MLCU 250 having the highest rate. (TCU 380A-0%; MLCU 375-0%; MLCU 250-3.1%; X2 = 6.0; P < 0.05). This significant difference disappeared by the twelfth month of continuous use. Likewise, the difference in cumulative net probabilities for overall termination was significant at six months and insignificant at twelve months of follow up. The continuation rate after one year were 86%, 92% and 87% respectively for TCU 380A, MLCU 375 and MLCU 250. These rates were higher than 80% and 51% quoted for the previously available Lippes loop in the same environment [1,2]. It was therefore concluded that the three IUCDS are comparable in performances in the first year of use and could be used at our family planning clinic or any other clinic in a similar setting. Between April 1988 and June 1991, health workers in Nigeria followed 300 women aged 20-40 who had had a copper releasing IUD inserted during menstruation at the family planning clinic of the University College Hospital in Ibadan. The double blind clinical trial compared the effectiveness and side effects of three copper releasing IUDs: Copper T380A, Multiload 375, and Multiload 250. 75.7% had used no contraception before admission to the study. Pelvic inflammatory disease (PID) occurred more often in the MLCU 250 group than the other two groups. Only two women were hospitalized for PID. These two women used the TCU 380A or MLCU 250. Many IUD users experienced abdominal pain during menstruation and TCU 380A users had the highest rate (27% vs. 21-24%). Heavy bleeding during menstruation was more common in TCU 380A and MLCU 375 users (5% and 4%, respectively, vs. 2%). Pelvic pain/cramps were present in 1-3% of women, but did not contribute to removal. The only case of uterine perforation was in a user of the TCU 380A. None of the MLCU 375 users experienced IUD expulsion, while two TCU 380A users experienced total expulsion and two and one MLCU 250 users experienced total and partial expulsion, respectively. PID was related to IUD removal at 6 months (3.1% vs. 0; p 0.05). The pregnancy rate at 6 months was 1.1% for the TCU 380A group and 0 for the other groups. At 12 months, it was 1.1% for the TCU 380A group and the MLCU 375 group and 0 for MLCU 250. The net 6-month IUD cumulative termination rate was highest in the TCU 380A group (11.1% vs. 3-7%; p 0.05). These differences were no longer significant at 12 months. The net 6- and 12-month IUD continuation rate was 97% and 92% for MLCU 375 compared to 88.9% for TCU 380A and 93% for MLCU 250 and 85.8% for TCU 380A and 87% for MLCU 250, respectively. These findings suggest that these three IUD devices could be used in the hospital's family planning clinic.
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