Current status of frameless anchored IUD for immediate intracesarean insertion

Abstract

Immediate postpartum intrauterine device (IUD) insertion deserves great attention as it can provide immediate, timely and convenient contraception plus the added benefit of preventing repeat unintended pregnancies. Although women post vaginal delivery can benefit from immediate post-placenta contraception, women undergoing Cesarean section clearly need contraception, as an inter-delivery interval shorter than 18 months places them at a high risk for uterine rupture. The main drawback of currently available framed IUD devices for immediate postpartum insertion of an IUD is their high expulsion and displacement rates when inserted immediately postpartum after both vaginal and Cesarean delivery. Current research suggests that a brief window of opportunity exists of 10 minutes for insertion of conventional IUDs after which time expulsion rates both immediately and over time are greatly enhanced. This paper summarizes the current research conducted to overcome the expulsion problems associated with conventional T-shaped devices as well as through the use of an anchored frameless device. In the 1970s and 1980s, attempts were made to solve the expulsion problem by modifying existing devices, such as adding absorbable sutures (Delta-T) or additional appendages. These attempts proved to be clinically unsuccessful as the catgut suture added to the transverse arms did not provide sufficient resistance to prevent downward displacement and expulsion. An anchoring technique to suspend a copper IUD to the fundus of the uterus was developed in Belgium in the 1980s and has been the subject of extensive ongoing clinical research since 1985. Recently the frameless copper releasing anchor IUD, GyneFix, has been tested for postplacental insertion. Initially, the anchor was modified by the inclusion of a biodegradable cone which was added below the anchoring knot. Clinical studies confirmed the adequacy of this approach suggesting that it was technically possible to anchor an IUD immediately following Cesarean section as well as after vaginal delivery with minimal incidence of expulsion. However, it was found that removal of the IUD was difficult in a number of women who requested early removal, due to the slow disintegration time of the cone. Based on these prior experiences, a new approach for anchoring of a frameless IUD immediately after delivery of the placenta was invented and developed specifically for use immediately post-Cesarean delivery. Beyond providing convenient and timely contraception the intended use allows a woman adequate time to recover from both the surgery and the burden of childbirth, while ensuring adequate future contraception. It is anticipated that it will also have an added benefit of allowing a greater number of women to have follow-on vaginal deliveries. The anchoring procedure is conducted under direct vision. It can be performed immediately after placental removal without the burden of timing restraints. It consists of the precise placement of the anchor of the frameless IUD immediately below the serosa of the uterus, followed by fixing the anchoring knot in place with a very thin absorbable suture. Early stage studies have confirmed the suitability and ease of use of this approach with additional clinical trials currently being conducted. The anchoring technique is easy, quick, safe and effective with no expulsions at 12 months. The method is considered a major advance, suitable for general use due to its simplicity requiring limited training.

Keywords: Cesarean section; copper IUD; expulsion; frameless IUD; postpartum IUD.