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.
Keywords
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References
- Complications of the intrauterine device in nulliparous and parous women.Eur J Gen Pract. 2004; 10: 82-87
- Effects of age, parity, and device type on complications and discontinuation of intrauterine devices.Obstet Gynecol. 2014; 123: 585-592
- Intrauterine devices and intrauterine systems.Hum Reprod Update. 2008; 14: 197-208
- The IUB, a newly invented IUD: a brief report.Contraception. 2014; 89: 139-141
Article info
Publication history
Published online: December 08, 2015
Accepted:
December 4,
2015
Received in revised form:
November 26,
2015
Received:
September 24,
2015
Footnotes
☆Support: This work was supported by a Eunice Kennedy Shriver National Institute of Child Health and Human Development/National Institutes of Health grant for Infrastructure for Population Research at Princeton University, Grant R24HD047879 (JT). The SCu380A devices were supplied by Ocon Medical Ltd.
☆☆Competing Interests: None declared.
Identification
Copyright
© 2016 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
