International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2019
A 1-year comparison of TCu380Ag versus TCu380A intrauterine contraceptive devices in India.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Kriplani Alka, Sehgal Rohini, Konar Hiralal, Vivekanand Achanta, Vanamail Perumal, Purandare Chittaranjan N
Аннотация
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.
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.