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

Objective: 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.

Study Design: 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.

Results: 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.

Conclusion: 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.

Implications: 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.