Department of Woman, Child & Adolescent, University Hospitals (HUG) Genève, Switzerland.
Department of Women, Mother & Child, University Hospital (CHUV) Lausanne, Switzerland.
Contraception. 2023 Jul;123:110004. doi: 10.1016/j.contraception.2023.110004. Epub 2023 Mar 11.
To compare patient-reported pain, bleeding, and device safety between intrauterine contraceptive device (IUD) insertion procedures employing a suction cervical stabilizer or single-tooth tenaculum.
This was a randomized, prospective, single-blinded study conducted at two centers, enrolling women aged 18 years or older, eligible for IUD insertion. The primary end point measure was patient-reported pain, measured on a 100-mm Visual Analogue Scale. Safety was assessed on the amount of bleeding, adverse events, and serious adverse events.
One hundred women were randomized, 48 to the investigational device and 52 to control. There were no statistically significant differences between the groups in factors potentially associated with pain on IUD insertion. IUD insertion was successful in 94% of all subjects. Subjects in the investigational device group reported pain scores ≥14 points lower than in the control group at cervix grasping (14.9 vs 31.3; p < 0.001) and traction (17.0 vs 35.9; p < 0.001), and smaller differences in pain scores at the IUD insertion (31.5 vs 44.9; p = 0.021) and cervix-release (20.6 vs 30.9; p = 0.049) steps. Nulliparous women experienced the greatest pain differences to control. Mean blood loss was 0.336 (range 0.022-2.189) grams in the investigational device group and 1.336 (range 0.201-11.936) grams in the control group, respectively (p = 0.03 for the comparison). One adverse event (bruising and minor bleeding) in the investigational device group was considered causally related to the study device.
The suction cervical stabilizer had a reassuring safety profile and its use was associated with significant reductions in pain during the IUD insertion procedure compared with standard single-tooth tenaculum use, particularly among nulliparous women.
Pain can be an important barrier to greater use of IUD devices among prescribers and users, particularly nulliparous women. The suction cervical stabilizer may provide an appealing alternative to currently available tenacula, filling an important unmet need.
比较使用宫腔吸引宫颈稳定器与单齿牙槽挺进行宫内节育器（IUD）放置术时患者报告的疼痛、出血和装置安全性。
这是一项在两个中心进行的随机、前瞻性、单盲研究，纳入年龄在 18 岁及以上、适合 IUD 放置的女性。主要终点测量指标为患者报告的疼痛，采用 100mm 视觉模拟量表测量。安全性评估包括出血、不良事件和严重不良事件的发生情况。
共有 100 名女性被随机分配至研究组（宫腔吸引宫颈稳定器）和对照组（单齿牙槽挺），每组 48 名。两组中与 IUD 放置相关的潜在疼痛因素无统计学差异。所有受试者中，94%的 IUD 放置成功。研究组患者在宫颈钳夹时报告的疼痛评分比对照组低 14 分以上（14.9 比 31.3；p<0.001），在牵引时低 17 分以上（17.0 比 35.9；p<0.001），在 IUD 放置时低 31.5 分以上（31.5 比 44.9；p=0.021），在宫颈释放时低 20.6 分以上（20.6 比 30.9；p=0.049）。初产妇的疼痛差异最大。研究组平均出血量为 0.336 克（范围 0.022-2.189 克），对照组为 1.336 克（范围 0.201-11.936 克），两组比较差异有统计学意义（p=0.03）。研究组发生 1 例不良事件（瘀斑和少量出血），认为与研究装置有关。
宫腔吸引宫颈稳定器具有可靠的安全性，与标准单齿牙槽挺相比，其使用与 IUD 放置过程中疼痛的显著减轻相关，尤其是在初产妇中。
疼痛可能是阻碍医生和使用者更多使用 IUD 装置的一个重要因素，尤其是初产妇。宫腔吸引宫颈稳定器可能为目前可用的牙槽挺提供一种有吸引力的替代方案，满足了重要的未满足需求。
