Does change in the shape of intrauterine contraceptive device Cu 375 and Cu T 380A affect the expulsion after post-partum insertion – a prospective randomized control trial: The European Journal of Contraception & Reproductive Health Care: Vol 0, No 0
Abstract
Purpose
The aim of the study was to detect the difference in the expulsion rates of two types of Copper containing intrauterine contraceptive devices (IUCDs): Cu 375 & CuT 380 A, within or at 6 weeks after insertion.
Method
This is a randomized control trial. A total of 396 pregnant women were recruited. Ultrasonography was performed to locate the position of the IUCD at the time of discharge and at six-week follow-up and the expulsion rate was calculated.
Results
Of the 396 participants, 22 PPIUCDs were completely eradicated at 6 weeks (modified intention-to-treat analysis [ITA]), 10 (5.3%) and 12 (6.7%) in the Cu 375 and CuT 380 A groups respectively. The expulsion rate was 6.02%. However, this difference was not statistically significant. When ultrasonologically assessed partial expulsions were also taken into account, the total expulsion rate in both groups (14.3% and 14.1% respectively) was also not significantly different. The expulsion rate was higher in the vaginal delivery group (10.7%) than in the caesarean section (3.6%) group (p= 0.007) and early postpartum insertion 12.3% than the immediate post-placental insertion group, 3.7% (p= 0.002).
Conclusions
The study concluded that the modified shape of Cu 375 effectively played no role in lowering the expulsion rate. Placement of the IUCD in or near the uterine fundus immediately after delivery of the placenta (post-placental) decreases the expulsion rate, thereby increasing contraceptive efficacy.
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SHORT CONDENSATION
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The modified shape of Cu 375 effectively plays no role in lowering the expulsion rate. Placement of the IUCD in or near the uterine fundus immediately after delivery of the placenta (post-placental) decreases the expulsion rate, thereby increasing contraceptive efficacy.
Disclosure statement
No potential conflicts of interest are reported by the author(s).
Author contributions
NC and CS searched the literature and conceived the study. SS, PS, MG, and MJ were involved in protocol development, obtaining ethical approval, patient recruitment and data analysis. MKG was involved in the statistical analysis. NC and CS wrote the first draft of the manuscript. All authors reviewed and edited the manuscript and approved the final version of the manuscript
Data availability statement
Datasets generated during and/or analyzed in the present study are available from the corresponding author upon reasonable request.
Code availability
SPSS software version 23 was used. Coding Key can be obtained from the corresponding author if required
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