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

Abstract

Objectives: The primary objective of the study was to determine the expulsion rate of the newly developed frameless GyneFix Caesarean Section (Gyn-CS^®) 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 (∼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.

摘要

目的：本研究的主要目的是确定为减少脱落率而开发的无框GyneFix Caesarean Section (Gyn-CS®)装置的脱落率。次要目的是对副作用、患者满意度和持续使用情况进行评估。

方法：在土耳其伊斯坦布尔的一所大学附属医院的研究中心进行了一项前瞻性非随机临床试验, 随访时间为4-6周, 二次随访时间为3个月。绝大多数(约80%)入组的受试者为择期剖宫产女性。

结果：本研究主要对计划或紧急剖宫产的100名经产妇胎盘取出后置入的Gyn-CS装置进行后续随访观察。研究早期出现一例装置脱落, 后来证明是锚定装置固定不良导致的。无严重不良事件(如盆腔炎或穿孔)报告。最后一次随访时, 约第90 d, 89个Gyn-CS装置仍在原位(一名受试者在随访过程中脱落)。

结论：本研究证实新设计的无框宫底置入Gyn-CS术是一个简单的手术, 置入没有时间限制, 病人的接受率高, 且脱落率及移位率低, 该装置同时具备传统含铜宫内节育器的优点。此外, 通过延长怀孕的间隔时间, Gyn-CS可以适当促进剖腹手术伤口的愈合。由于置入简单、安全、快捷, Gyn-CS可以显著增加胎盘取出后宫内避孕装置的普及, 从而减少后续意外怀孕的概率。

Keywords:

• Anchoring technology
• caesarean section
• frameless IUD
• IUD expulsion
• postpartum IUD insertion

Acknowledgements

The authors are grateful to R. Colman and S. De Buyser (Biostatistics Unit, Department of Public Health, Ghent University, Ghent, Belgium) for carrying out the statistical analyses in this study. Contrel Research provided the Gyn-CS devices free of charge.

Disclosure statement

A. E., C. U. and B. A. report no conflicts of interest associated with this manuscript. D. W. is the developer of the frameless GyneFix IUD system. He has also been involved in the development and optimisation of new, innovative drug delivery systems for use in the uterus, such as the Gyn-CS.