Comparison of expulsions following intracesarean placement of an innovative frameless copper-releasing IUD (Gyn-CS®) versus the TCu380A: A randomized trial

• Published in: Contraception (Stoneham) 2018-08, Vol.98 (2), p.135-140
• Main Authors: Unal, Ceren, Eser, Ahmet, Tozkir, Elif, Wildemeersch, D.
• Format: Article
• Language: English
• Subjects: Anchoring technology; Cesarean section; Frameless IUD; IUD expulsion; Postpartum IUD; TCu380A
• ISSN: 0010-7824; 1879-0518
• DOI: 10.1016/j.contraception.2018.03.034

The intent of this study (primary outcome measure) is to assess the expulsion rate of a newly developed copper releasing frameless intrauterine IUD GyneFix® Cesarean Section (Gyn-CS®) at 3 months' follow-up, compared to the TCu-380A IUD, inserted immediately postplacental expulsion following cesarean section delivery. This is a randomized trial from one hospital research center in Istanbul, Turkey. Eligible pregnant women, the majority undergoing elective cesarean delivery (n=106), and the remaining emergency cesarean section cases (n=34), received intracesarean insertion of Gyn-CS or TCu380A insertion. Follow-up ended with a 3 month-visit. The Zeynep Kamil University Hospital Ethics Committee approved this study. The study explores the retention of 140 insertions, 70 Gyn-CS and 70 TCu380A. There were two follow-up visits after discharge from hospital at 6 weeks and 3 months. A single Gyn-CS expulsion occurred after approximately 6 weeks likely a consequence of improper anchoring. Expulsion was more common in the TCu380 A IUD group (11.4% vs 1.4%, p=.039). There were 4 removals for medical reasons in the Gyn-CS patients and 4 in the TCu380A patients, respectively, with 4 non-medical removals occurred, 2 in each group. No serious adverse events (e.g., PID, perforation) were reported. At the study conclusion of 3 months, 61 Gyn-CS (88%) and 54 TCu380A (79%) IUDs remain in place. This immediate postplacental study in cesarean section patients suggests that the anchoring technique employed resulted in the excellent retention of Gyn-CS. Insertion was easy, safe and quick requiring minimal physician training. The possibility of direct visualization of the anchor by ultrasound at insertion and follow-up allows the surgeon to verify the position of the IUD serving to enhance provider and patient confidence and assurance. The frameless anchored intrauterine IUD is effective in minimizing displacement and expulsion. The results of this study suggest that the Gyn-CS IUD is appropriate for wider intracesarean use.