A 1‐year comparison of TCu380Ag versus TCu380A intrauterine contraceptive devices in India

• Published in: International journal of gynecology and obstetrics Vol. 145; no. 3; pp. 268 - 277
• Main Authors: Kriplani, Alka, Sehgal, Rohini, Konar, Hiralal, Vivekanand, Achanta, Vanamail, Perumal, Purandare, Chittaranjan N.
• Format: Journal Article
• Language: English
• Published: United States 01.06.2019
• Subjects: Acceptability; Continuation rate; Efficacy; Intrauterine contraceptive device; TCu380A; TCu380Ag; Intrauterine contraceptive device; Efficacy; TCu380A; Acceptability; Continuation rate; TCu380Ag
• ISSN: 0020-7292; 1879-3479
• DOI: 10.1002/ijgo.12809

Objective To compare TCu380Ag and TCu380A intrauterine contraceptive devices after 1 year of use. Methods A prospective randomized controlled trial was conducted among healthy married women aged 20–35 years who attended the family planning clinics of three tertiary centers in India between August 1, 2015, to March 31, 2018. The TCu380Ag group (n=300) received one of three sizes of this device depending on uterocervical length: maxi (8.0–9.0 cm), normal (7.0–8.5 cm), or mini (6.0–7.5 cm). The remaining 300 participants received TCu380A. Follow‐up was conducted at 3‐monthly intervals to assess continuation rate, acceptability, efficacy, adverse effects, and complications. Results The TCu380Ag group had a higher continuation rate than the TCu380A group at 1 year (84.0% vs 75.8%; P=0.01), with an efficacy of 99.6% versus 100.0% (P>0.05). Overall estimated continuation rates were 94.5% (95% confidence interval [CI] 91.7%–96.4%) and 88.4% (95% CI 83.2%–91.5%), respectively (P=0.026). Use of TCu380Ag was associated with fewer adverse effects (heavy menstrual bleeding, abdominal pain, or expulsion) when compared with TCu380A (P>0.05 for all comparisons). Discontinuation rates owing to adverse effects were 6.59% for TCu380Ag versus 13.26% for TCu380A (P=0.01). Conclusions Varying sizes of TCu380Ag could provide an alternative to TCu380A. After 1 year of use, TCu380Ag was associated with higher acceptance and continuation rates, reduced adverse effects, and similar efficacy when compared with TCu380A.