A 5-year comparative study of efficacy and acceptability of three different sizes of TCu380Ag and TCu380A intrauterine devices.

BACKGROUND: The intrauterine contraceptive device TCu380Ag when compared with TCu380A at 1 year of use had better acceptability and continuation rates. OBJECTIVES: To study the continuation rate, efficacy, and acceptability of TCu380Ag in three sizes versus TCu380A at 5 years of use. METHODS: A total of 600 women opting for intrauterine contraceptive devices were randomized equally into two groups. Group 1 received the TCu380Ag device (Normal, Maxi, and Mini for uterocervical length 7-8.5 cm, 8-9 cm, and 6-7.5 cm, respectively) and Group 2 received the TCu380A device. Follow-up was performed at 5 years to assess efficacy, acceptability, and continuation. Frequency data comparisons was performed across categories using χ2 /Fisher exact test. RESULTS: At 5 years of use, Kaplan-Meier survival analysis showed that TCu380Ag compared with TCu380A had a higher continuation rate (45% vs. 35%, P = 0.010) with 100% efficacy each. TCu380Ag had fewer side effects, including heavy menstrual bleeding (16.6% vs. 34.1%, P < 0.001), abdomen pain (12.1% vs. 23.0%, P = 0.001), and expulsions (4.4% vs. 8.7%, P < 0.050), and fewer discontinuations attributable to contraceptive side effects (42.7% vs. 56.9%, P = 0.012). The mini TCu380Ag had the highest continuation rates and least menstrual irregularity (P < 0.050). CONCLUSIONS: The TCu380Ag device in three sizes is an alternative to TCu380A for women desiring 5 years of contraception with equal efficacy, better continuation, and acceptability. The mini size is preferred for women with a uterocervical length of 6 to 7.5 cm.

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

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.

Postnatal quality of life, depressive symptoms, and social support among women in southern India.

Evaluation of postnatal quality of life (QOL) has remained a poorly researched area in India. The present cross-sectional study assessed postnatal QOL, using the Mother Generated Index (MGI) and its associated risk factors, and was conducted during January-March 2013 among 274 mothers, 6-8 weeks postnatally. A semi-structured questionnaire was used to evaluate sociodemographic and obstetric characteristics and social support. Depressive symptoms were assessed by the Patient Health Questionnaire (PHQ-9) and QOL using the MGI. The vast majority (90.1 percent) of respondents in our study had a primary MGI score <5, those with significantly higher prevalence of physical problems and psychological distress. A total of 39.8 percent of respondents were screened as having other (not major) depressive symptoms and 4.7 percent as having major depressive symptoms. Multiple regression analysis revealed that age (ß = 0.033, p = .018) and socioeconomic status (ß = 0.156, p < .001) were significantly positively associated with QOL, while increased depressive symptom scores (ß = -0.075, p < .001) were significantly negatively associated with QOL. A wide spectrum of QOL aspects were reported, including physical, emotional, social, and economic concerns by the mothers. Prevention, evaluation, and treatment of postnatal depressive symptoms and impaired QOL are warranted, taking into account the role of various biopsychosocial risk factors and specific concerns raised by the mothers.