A study to evaluate and compare the expulsion and continuation rates of post placental insertion of Cu 375 and CuT 380A in Indian women at a premier hospital in New Delhi, India

Abstract

Background: The Study was planned to evaluate and compare the expulsion and continuation rates of post placental insertion of Cu 375 and CuT380A in Indian women at Safdarjung Hospital New Delhi, after approval was obtained from Institutional Ethical committee.Methods: Study group consisted of 300 women, divided into two groups: Group A and Group B. The data was analysed by using ‘student “t” test/ non-parametric ‘Wilcoxon Mann Whitney’ for quantitative variables to evaluate the safety, efficacy and acceptability.Results: Mean age was 24.99 years (range: 19-35years), All women were married (off which 64% literate) and Mean parity in group A was 1.97 and 2.06 in group B. Mean pain score during intrauterine contraceptive device (IUCD) insertion on visual analogue scale was 2.93 in group A and 3 in group B and was not statistically different. 84% women completed 12 months follow up in group A and 83.33% women in group B. Strings were visible in 74% women in group A and in 34% women in group B at 1 month of IUCD insertion. Visibility of strings increased in successive follow up visits and was visible in >80% of women at the end of one year in the both groups. String visibility after intra-Caesarean insertion was delayed. Fifty one percent (n=77) subjects in group A and 54% (n=81) in group B experienced amenorrhea up to six months. Menorrhagia was reported in 7.33% in group A and women 8.66% in group B at the end of 1 year of follow up. Pain was complained by 26 out of 150 (17.3%) women in group A as compared to 36 out of 150 (24%) women in group B after 1 month of insertion. There was no case of PID in group A whereas there were 3 cases of PID in group B. There was no perforation/trauma and pregnancy in either group.Conclusions: Overall expulsion rate was 13% and removal rate was 5% in our study. Continuation rate was 83.3% in Cu 375 and 80.6% in CuT380A at 12 months. There was no significant difference between the IUCDs regarding the safety, efficacy and complications such as expulsion, bleeding etc.

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

“…The overall discontinuation rate following expulsions in the present study (5.0%) was less than the previously reported rate (13.0%) . The expulsion rate of 3.4% with TCu380Ag was also less than the 4.9% and 5.6% rates recorded for Nova‐T200 and Nova‐T380, respectively.…”

“…The present study demonstrated that the 1‐year continuation rate for postpartum insertions (82.2%) was greater than that for interval (78.1%) and MTP (71.3%) insertions in both groups. Previous studies reported a higher 6‐month continuation rate for postpartum insertions (88.2%) versus interval insertions (81.8%) . Postpartum insertions are therefore acceptable despite the expulsion rate (6.0%).…”

Comparison between two types of copper bearing intrauterine device Cu375 and Cu380Ag regarding bleeding pattern: Randomized controlled trial

“…Menorrhagia was reported by 7.33% (n=11) subjects in group "A" and 8.66% (n=13) subjects in group "B" at the end of 1 year follow up. This difference was not statistically significant (P>0.05) [12] .…”

“…Mean age of the study population was 24.99 ± 4.2 years. The study showed that in group "A" 12% (n=18) women and in group "B" 14% (n=21) subjects complained of post insertion bleeding/spotting per vaginum at 1 month of IUCD insertion [12] . Menorrhagia was reported by 7.33% (n=11) subjects in group "A" and 8.66% (n=13) subjects in group "B" at the end of 1 year follow up.…”

“…In Kumar et al [12] study where 300 women were included in the study and were divided into two groups.…”