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  • Title: The comparative trial of TCu 380A IUD and progesterone-releasing vaginal ring used by lactating women.
    Author: Chen JH, Wu SC, Shao WQ, Zou MH, Hu J, Cong L, Miao L, Wang C, Dong J, Gao J, Xiao BL.
    Journal: Contraception; 1998 Jun; 57(6):371-9. PubMed ID: 9693396.
    Abstract:
    The objective of this paper was to compare the efficacy, acceptability, safety, and bleeding pattern of TCu 380A intrauterine device (IUD) and progesterone-releasing vaginal ring used by breastfeeding women. The study population included 97 breastfeeding women using IUD and 100 women using vaginal ring. Of the IUD users, no insertion failure, perforation, or accidental pregnancy occurred in 12 months. There was one IUD expulsion. There were no discontinuations of IUD due to medical reasons other than expulsion. The total discontinuation rate was 2.3%. In the ring group, no accidental pregnancy occurred. The major reasons for discontinuation were ring use-related problems and vaginal problems. The total discontinuation rate was 65.4% within 1 year. The frequency of any one complaint among the ring users was higher than that among the IUD users. There were no differences in the proportion of women having no sexual activity and in the weight of their babies between the two groups. Compared with the IUD users, the median number of bleeding/spotting (B/S) episodes and B/S days of the vaginal ring users were fewer; consequently, the mean length of B/S-free interval was longer in all four reference periods; the mean length of B/S episode and segment were the same; the occurrence of amenorrhea was more frequent; in contrast, the proportions of normal bleeding patterns were fewer. The frequencies of prolonged bleeding, frequent bleeding, and infrequent bleeding patterns did not differ between the two groups. The percentage of irregular bleeding was fewer only in the first two reference periods. It is concluded that the TCu 380A IUD and progesterone-releasing vaginal ring used by breastfeeding women are safe and effective. The higher discontinuation rate of the ring users was mainly because of use-related problems. Breastfeeding women with TCu 380A IUD had better tolerance and acceptability. The TCu 380A IUD does not, but the progesterone-releasing vaginal ring does, suppress the recovery of ovarian function. However, once return of menstruation occurred, there were no differences in bleeding patterns between the two contraceptive methods. The efficacy, acceptability, and bleeding patterns associated with use of the Copper T 380A IUD and the progesterone-releasing vaginal ring during lactation were compared in a 12-month study conducted in Beijing City, China. Enrolled were 97 breast-feeding IUD users and 100 lactating vaginal ring acceptors. The devices were inserted 29-64 days postpartum. In the IUD group, there was one expulsion during the study period, but no cases of perforation, pelvic inflammatory disease, or pregnancy. The two IUD discontinuations (2.3/100 woman-years) were attributable to user rather than medical-related reasons. There were no accidental pregnancies in the ring group either. However, there were 50 medical-related and four user-related discontinuations among ring users, for a 12-month discontinuation rate of 65.4/100 woman-years. Three women discontinued ring use due to menstrual problems, 10 requested removal for vaginal problems such as increased discharge and vaginitis, seven experienced frequent ring expulsion, 12 left the device out for more than 48 hours, and 13 found the ring unpleasant to use. Significantly more ring than IUD users had at least one complaint at the 1-, 3-, and 6-month post-insertion visits. Menstruation diaries revealed bleeding/spotting immediately post-insertion in both groups, followed by a variable period of amenorrhea until resumption of menses. The median number of bleeding/spotting episodes and the occurrence of amenorrhea were more frequent in the vaginal ring group. Once menstruation resumed, there were no differences in bleeding patterns between the two contraceptive methods. The results indicated progesterone suppresses the recovery of ovulation in breast-feeding women but does not interrupt the regulation of menstruation.
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