Clinical experience with a novel anchored, frameless copper-releasing contraceptive device for intra-caesarean insertion.

Objectives: The primary objective of the study was to determine the expulsion rate of the newly developed frameless GyneFix Caesarean Section (Gyn-CS (R)) device, specifically developed to minimise expulsion when inserted immediately after delivery of the placenta during caesarean section. Secondary objectives included evaluation of side effects, patient's satisfaction with the method and continuation of use. Methods: A prospective, non-randomised clinical trial was conducted at a single university hospital research centre in Istanbul, Turkey, with follow-up at 4-6 weeks and again at 3 months. The majority of participants (similar to 80%) were planned for elective caesarean delivery. Results: The study analysed 100 Gyn-CS devices inserted immediately after delivery of the placenta in a group of multiparous women undergoing planned or emergency caesarean section. One expulsion occurred early in the study, which was subsequently attributed to improper anchoring of the device. No serious adverse events (e.g. pelvic inflammatory disease or perforation) were reported. At the last follow-up visit, at approximately 90 d, 89 Gyn-CS devices were still in place (one participant was lost to follow-up). Conclusion: The study confirms that intra-caesarean implantation of the newly designed frameless Gyn-CS to the uterine fundus is a simple procedure that has no timing restraints, high patient acceptance and minimal risk of expulsion and displacement, while affording all the contraceptive benefits of a conventional copper-releasing intrauterine device. In addition, by preventing a shortened interpregnancy interval, the Gyn-CS can promote proper healing of the laparotomy wound. As insertion is easy, safe and quick, the Gyn-CS could significantly increase the use of immediate postplacental delivery intrauterine contraception, thus serving to reduce the number of unintended follow-on pregnancies.