Comparison between two methods of the immediate post-placental insertion of copper intrauterine device in vaginal birth-a protocol for a randomized clinical trial

Background: Ensuring effective and long-term contraception in the immediate postpartum period is an effective strategy for reducing unplanned pregnancies. In the meantime, the intrauterine device (IUD) is an excellent option. The aim of our study was to evaluate the best way to insert post-placental IUDs in the immediate postpartum period. Discomfort during insertion, expulsion rate, uterine perforation rate, and proper positioning 40-60 days postpartum will be analyzed. Methods: Randomized, controlled, open clinical trial. The study group will be composed of women between 18 and 43 years old who are admitted for vaginal birth at the Women's Hospital of the State University of Campinas and who wish to use the IUD as a contraceptive method. The sample will be randomized into two insertion groups: manual and forceps. To calculate the sample size, the method of comparing the proportion between 2 groups was used, setting the level of significance alpha at 5% (alpha=0.05) and the power of the sample at 80% (beta=0.20). Based on the results, it was estimated that a sample of n=186 women (n=93 with manual insertion and n=93 with forceps) would be representative for comparison of expulsion between the 2 groups. All participants will undergo a postpartum consultation 40-60 days after birth with transvaginal ultrasound to assess the proper placement of the IUD. Discussion: Insertion of an IUD in the immediate postpartum period has been considered a good option to increase coverage and access to contraception, and its benefit outweighs the inconvenience of a higher expulsion rate.

Automated summary

This study aims to evaluate the best way to insert post-placental IUDs in the immediate postpartum period, analyzing discomfort during insertion, expulsion rate, uterine perforation rate, and proper positioning 40-60 days postpartum. The study will be a randomized, controlled, open clinical trial, with a sample size of 186 women.