Abstract

PIP: A randomized prospective trail was conducted to assess the comparative complication rates of the 7Cu200 and 2 newer copper bearing IUDs -- the TCu220C and the MLCu250 -- in Singapore. Recruitment for this 2-year trail began in 1976. These results represent the Singapore component of a 3-center (Singapore, Medan, Kuala Lumpur) trial, conducted in conjunction with the International Development Research Center in Ottawa, Canada. The 600 patients recruited between April 1976 and November 1978 were allocated randomly to 1 of the 3 IUDs using a series of presealed envelopes. All volunteers were healthy and ranged in age from 19-35 years. They were of proven fertility and exposed to the risk of pregnancy. There were no significant differences in the age, parity, race, or immediate past contraceptive use in the 3 groups. Insertions were performed at least 8 weeks postpartum (or 4 weeks postabortion) by 1 of 20 different physicians. Followup appointments were scheduled for 6 weeks and 3, 6, 12, and 24 months. Data was recorded for all unscheduled visits, and when necessary, letters, telephone calls, and home visits were used to trace defaulters. 98 (49%) 7C8200 users completed the study compared with the 116 (58%) for both the TCu220C and the MLCu250 users. 4% of the patients were lost to followup, and 1% were withdrawn by the investigators. There were significant differences in the pregnancy rates between the 3 devices. Pregnancy was more common with the 7Cu200 than with the TCu220C and MLCu250. Expulsion was significantly less frequent with the MLCu250 when compared with the 7Cu200 and the TCu220C. There were significant differences in both use-related and total termination rates between the 3 IUDs, but no one IUD was significantly better than either of the other 2 devices.