Direct vs. standard method of insertion of an intrauterine contraceptive device: insertion pain and outcomes at 6 months

Abstract

Objectives: The direct method is a procedure designed to cause less pain during insertion of an intrauterine contraceptive device (IUCD). It was first reported in 2005 and differs from the standard method of insertion recommended by IUCD manufacturers. In France, the direct method is well known and used by experienced practitioners, but it has never been evaluated against the standard method of insertion. The aim of the study was therefore to compare the direct method with the standard method in terms of pain experienced during insertion and the side effects and satisfaction rates over 6 months.

Methods: A prospective observational study was conducted in France between June and December 2016 to compare the direct and standard methods of IUCD insertion.

Results: The study included 535 women: 281 in the direct method group (DM group) and 254 in the standard method group (SM group). Women in the DM group reported less pain. This difference was assessed by multilevel multivariate analysis (−8.3 mm, 95% confidence interval (CI) −14.3, −2.3). There was no difference in the occurrence of infection (1.4% vs. 2.8%; p = .366) and 6-month continuation rates (89.4% vs. 89.2%; p = .936). Satisfaction rates at 6 months were higher in the DM group (93.6% vs. 87.4%; p = .019).

Conclusions: The results of the study suggest that the direct method of IUCD insertion is associated with less pain and does not increase the risk of adverse effects. Widespread adoption of the direct method could improve women’s comfort and lead to a higher uptake of the IUCD as a form of contraception.

摘要

目的：直接法是一种在植入宫内节育器（IUCD）时减少疼痛的方法。它于2005年首次报道, 与IUCD制造商推荐的标准植入方法不同。在法国, 直接法为经验丰富的从业人员所熟知并使用, 但从未与植入的标准法进行对比评估。因此, 本研究的目的是比较直接法和标准法在植入过程中所经历的疼痛, 以及使用超过6个月的副作用和满意率。

方法：2016年6月至12月在法国进行了一项前瞻性观察研究, 比较IUCD植入的直接方法和标准方法。

结果：本研究纳入535例女性：直接法组281例（DM组）, 标准法组254例（SM组）。DM组女性的结果显示疼痛更少。采用多水平因素分析评价差异（-8.3mm, 95% 置信区间 (CI) -14.3, -2.3）。感染率(1.4% vs. 2.8%; p=.366)和6个月的延续率 (89.4% vs. 89.2%; p=.936)无显著性差异。DM组6个月的满意率较高 (93.6% vs. 87.4%; p=.019)。

结论：本研究的结果表明, 直接植入IUCD的方法疼痛较轻, 不会增加不良反应风险的风险。广泛采用直接避孕法可以改善女性的舒适度, 并导致IUCD作为避孕手段的使用率提高。

Keywords:

• Direct method
• insertion
• intrauterine contraceptive device
• IUD
• pain
• standard method

Disclosure statement

The authors report no conflict of interest.