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用于剖宫产术中即时放置的无框架固定式宫内节育器的现状

Current status of frameless anchored IUD for immediate intracesarean insertion.

作者信息

Wildemeersch Dirk, Goldstuck Norman D, Hasskamp Thomas

机构信息

Gynecological Outpatient Clinic and IUD Training Center, Ghent, Belgium, e-mail:

Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa.

出版信息

Dev Period Med. 2016 Jan-Mar;20(1):7-15.

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.

摘要

产后即时宫内节育器(IUD)置入值得高度关注,因为它能提供即时、及时且便捷的避孕效果,还能额外预防再次意外怀孕。虽然经阴道分娩的女性可从胎盘娩出后即时避孕中获益,但剖宫产女性显然也需要避孕,因为分娩间隔短于18个月会使她们面临子宫破裂的高风险。目前用于产后即时置入IUD的有框架IUD装置的主要缺点是,在阴道分娩和剖宫产术后即时置入时,其排出和移位率很高。当前研究表明,传统IUD置入存在一个10分钟的短暂窗口期,在此之后,即时及长期的排出率都会大幅提高。本文总结了为克服与传统T形装置相关的排出问题以及通过使用无框架锚定式装置所开展的当前研究。在20世纪70年代和80年代,人们试图通过改良现有装置来解决排出问题,比如添加可吸收缝线(Delta - T)或额外附件。这些尝试在临床上未获成功,因为添加到横臂上的肠线缝合线没有提供足够阻力来防止向下移位和排出。20世纪80年代在比利时研发出一种将铜IUD悬吊至子宫底部的锚定技术,自1985年以来一直是广泛持续临床研究的主题。最近,无框架铜释放锚定IUD(吉妮柔适)已针对胎盘娩出后置入进行了测试。最初,通过在锚定结下方添加一个可生物降解的锥体对锚进行了改良。临床研究证实了这种方法的可行性,表明在剖宫产术后以及阴道分娩后即时锚定IUD在技术上是可行的,排出发生率极低。然而,发现一些要求提前取出IUD的女性取出困难,原因是锥体分解时间缓慢。基于这些先前经验,发明并开发了一种在胎盘娩出后即时锚定无框架IUD的新方法,专门用于剖宫产术后即时使用。除了提供方便及时的避孕外,该预期用途使女性有足够时间从手术和分娩负担中恢复,同时确保未来有足够的避孕措施。预计它还将有额外益处,即允许更多女性进行后续阴道分娩。锚定 procedure是在直视下进行的。可在胎盘取出后立即进行,不受时间限制。它包括将无框架IUD的锚精确放置在子宫浆膜下方,然后用非常细的可吸收缝线将锚定结固定到位。早期研究已证实这种方法的适用性和易用性,目前正在进行更多临床试验。锚定技术简单、快速、安全且有效,12个月时无排出情况。该方法被认为是一项重大进展,因其简单且只需有限培训而适合广泛使用。

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