Reeves Matthew F, Katz Bob H, Canela Juan M, Hathaway Mark J, Tal Michael G
Johns Hopkins School of Public Health, Baltimore, MD, USA; Stanford University School of Medicine, Stanford, CA, USA.
ContraMed, Campbell, CA, USA.
Contraception. 2017 Jun;95(6):544-548. doi: 10.1016/j.contraception.2017.04.002. Epub 2017 May 8.
We sought to compare VeraCept (VC175), a novel nitinol intrauterine contraceptive (IUC) with 175 square-mm of copper surface area, to a copper T380S IUC.
We enrolled parous women into a randomized subject-blinded comparison of VC175 and a copper T380S in a 2:1 fashion at a single clinic. The primary outcomes were total adverse events and continuation at 12 months. We also examined pain on insertion, ease of placement, expulsion, tolerability and pregnancy. Subjective ratings were on a 5-point Likert scale (0, no pain to 5, worst pain). We followed subjects through 24-month follow-up.
We enrolled 300 women with 199 randomized to VC175 and 101 to the T380S. Insertion was successful in 198 subjects for VC175 and 100 for the T380S. Mean age was 25 years (range 18, 41), and median parity was 2 (range 1, 8), with 39% having only had Cesarean deliveries. No subjects developed clinical infection or reported serious adverse events. In the VC175 and T380S groups, mean pain at insertion was 1.4 and 2.4, respectively (p<.01). At the 12-month primary endpoint for VC175 and T380S, respectively, continuation was 84% and 68% (p<.002) with expulsions in 5.0% and 12.0% (p<.05) and removal for pain/bleeding in 3.5% and 17.0% (p<.01). At the 24-month visit for VC175 and T380S, respectively, continuation was 77% and 62% (p<.02 by log-rank). One ectopic pregnancy was identified at the 12-month follow-up in a VC175 user. No other pregnancies were diagnosed. With 297.3 and 132.4 woman-years, pregnancy rates were 0.3 and 0.0 per 100 woman-years for VC175 and T380S, respectively.
VC175 resulted in less pain at insertion, fewer expulsions and higher total continuation than the T380S, with similar contraceptive efficacy.
VC175 is a promising new intrauterine copper contraceptive on a nitinol frame that warrants further clinical trials.
我们试图将一种新型的镍钛诺宫内节育器（IUC）VeraCept（VC175，铜表面积为175平方毫米）与铜T380S宫内节育器进行比较。
我们在一家诊所按2:1的比例将经产妇随机纳入VC175和铜T380S的受试者盲法比较研究。主要结局为12个月时的总不良事件和持续使用情况。我们还检查了放置时的疼痛、放置的难易程度、脱落、耐受性和妊娠情况。主观评分采用5分李克特量表（0分表示无疼痛，5分表示最剧烈疼痛）。我们对受试者进行了24个月的随访。
我们招募了300名女性，其中199名随机分配至VC175组，101名分配至T380S组。VC175组198名受试者放置成功，T380S组100名受试者放置成功。平均年龄为25岁（范围18至41岁），中位产次为2次（范围1至8次），39%的女性仅行剖宫产。没有受试者发生临床感染或报告严重不良事件。在VC175组和T380S组中，放置时的平均疼痛评分分别为1.4分和2.4分（p<0.01）。在12个月的主要终点时，VC175组和T380S组的持续使用率分别为84%和68%（p<0.002），脱落率分别为5.0%和12.0%（p<0.05），因疼痛/出血取出率分别为3.5%和17.0%（p<0.01）。在24个月随访时，VC175组和T380S组的持续使用率分别为77%和62%（对数秩检验p<0.02）。在12个月随访时，一名VC175使用者被诊断为异位妊娠。未诊断出其他妊娠。VC175组和T380S组的妇女年数分别为297.3和132.4，妊娠率分别为每100妇女年0.3例和0例。
与T380S相比，VC175放置时疼痛较轻，脱落较少，总持续使用率较高，避孕效果相似。
VC175是一种有前景的新型镍钛诺框架含铜宫内节育器，值得进一步进行临床试验。
