Clinical outcomes of post-placental insertion of Copper T380A and Multiload 375 contraceptive devices during cesarean section: a randomized clinical trial

Abstract

BackgroundTo compare two types of intrauterine devices, namely Cu T380A IUD and Multiload 375 IUD, inserted immediately post-placental during cesarean section, with regard to expulsion rates and side effects.MethodsA randomized comparative clinical trial was carried out over 200 patients with 100 patients in each group. Transabdominal ultrasonography (US) was done on all patients before discharge to ensure the adequate position of the IUD in addition to casco speculum examination to assess the IUD threads, and then women were requested to attend a follow-up appointment at 6 weeks after delivery; gynecological examinations in addition to transvaginal sonography were done to measure the top-fundal distance that reflects the position of the IUD. The participants were instructed to report the pattern of bleeding during the puerperium, fever, or vaginal discharge.ResultsThe ultrasonographic assessment of IUD position before patient discharge (1st assessment) revealed that 18% of Cu T380A IUD users were displaced in comparison to 24% of Multiload 375 IUD, and such difference between both groups was not statistically significant (P = 0.3); furthermore, the ultrasonographic assessment of IUD position after 6 weeks (2nd assessment) revealed that 19% of Cu T380A IUD users were displaced in comparison to 30% of Multiload 375 IUD, and such difference between both groups was statistically significant (P = 0.047). In addition, none of the included patients in both groups suffered from fever after IUD insertion.ConclusionThe present study demonstrated that post-placental insertion of Multiload 375 IUCD results in significantly higher displacement compared to post-placental insertion of Cu T380A IUCD, as well as significantly more bleeding problems with Cu T380A IUCD as compared with Multiload 375 IUCD.Trial registrationThe study was registered prospectively on clinical trial.gov with trial registeration number NCT05624411 (Registered 22-October-2022, https://clinicaltrials.gov/study/NCT05624411).