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.

Screening and management of preinvasive lesions of the cervix: Good clinical practice recommendations from the Federation of Obstetrics and Gynaecologic Societies of India (FOGSI).

In India, there are marked variations in resources for cervical cancer screening. For the first time, resource-stratified screening guidelines have been developed that will be suitable for low middle-income countries with similar diversities. The current article describes the process and outcomes of these resource stratified guidelines for screening and treatment of preinvasive lesions of cervix. Evidence from literature was collated and various guidelines were reviewed by an expert panel. Based on the level of evidence, guidelines were developed for screening by human papillomavirus (HPV) testing, cytology and visual inspection after application of acetic acid (VIA), and management of screen positive lesions in different resource settings. Expert opinion was used for certain country-specific situations. The healthcare system was stratified into two resource settings - good or limited. The mode of screening and treatment for each was described. HPV testing is the preferred method for cervical cancer screening. VIA by trained providers is especially suitable for low resource settings until an affordable HPV test becomes available. Healthcare providers can choose the most appropriate screening and treatment modality. A single visit approach is encouraged and treatment may be offered based on colposcopy diagnosis ('see and treat') or even on the basis of HPV test or VIA results ('screen and treat'), if compliance cannot be ensured. The Federation of Obsterician and Gynaecologists of India Good Clinical Practice Recommendations (FOGSI) GCPR are appropriately designed for countries with varied resource situations to ensure an acceptable cervical cancer prevention strategy.