Ellen Wiebe1, James Trussell2. 1. Willow Women's Clinic, Vancouver, BC, Canada V5Z 1H9. Electronic address: ellenwiebe@gmail.com. 2. Office of Population Research, Princeton University, Princeton, NJ 08544, USA; The University of Edinburgh, Edinburgh EH8 9YL, Scotland, United Kingdom.
Abstract
OBJECTIVE: To characterize method-related discontinuation rates and acceptability over 1 year of SCu380A use. STUDY DESIGN: Women enrolled into this prospective pilot study underwent SCu380A placement by a single clinician with follow-up at 6-8 weeks and at 3, 6, 9 and 12 months. Outcome measures included reasons for discontinuation and satisfaction. RESULTS: Fifty-one women had a 12-mm-diameter intrauterine ball (IUB; SCu380A) inserted by a single clinician (EW). Postinsertion ultrasonography showed all the devices to be correctly placed. By 8 weeks, there were 9 expulsions and 2 removals for symptoms. By 12 months, there were 14 expulsions (27%), 8 removals for symptoms (16%), 1 pregnancy and 7 lost to follow-up. Of the remaining 21 women, 15 said that they were satisfied. CONCLUSION: The high rate of expulsions and removals for symptoms in the first year indicates that this device, as presently designed, is unacceptable as an alternative to the currently available copper intrauterine devices. IMPLICATIONS: More research is needed before we know if it is the spherical design, the size of the device or some other factor that led to the high expulsion rate. There are currently three different IUBs (12, 15 and 18 mm) approved and being investigated.
OBJECTIVE: To characterize method-related discontinuation rates and acceptability over 1 year of SCu380A use. STUDY DESIGN:Women enrolled into this prospective pilot study underwent SCu380A placement by a single clinician with follow-up at 6-8 weeks and at 3, 6, 9 and 12 months. Outcome measures included reasons for discontinuation and satisfaction. RESULTS: Fifty-one women had a 12-mm-diameter intrauterine ball (IUB; SCu380A) inserted by a single clinician (EW). Postinsertion ultrasonography showed all the devices to be correctly placed. By 8 weeks, there were 9 expulsions and 2 removals for symptoms. By 12 months, there were 14 expulsions (27%), 8 removals for symptoms (16%), 1 pregnancy and 7 lost to follow-up. Of the remaining 21 women, 15 said that they were satisfied. CONCLUSION: The high rate of expulsions and removals for symptoms in the first year indicates that this device, as presently designed, is unacceptable as an alternative to the currently available copper intrauterine devices. IMPLICATIONS: More research is needed before we know if it is the spherical design, the size of the device or some other factor that led to the high expulsion rate. There are currently three different IUBs (12, 15 and 18 mm) approved and being investigated.