孕激素对早产风险妇女宫颈缩短的影响：一项多中心、随机、双盲、安慰剂对照试验的二次分析。
Effect of progesterone on cervical shortening in women at risk for preterm birth: secondary analysis from a multinational, randomized, double-blind, placebo-controlled trial.
机构信息
Perinatal Diagnostic Center, Central Baptist Hospital, Lexington, KY 40503, USA.
出版信息
Ultrasound Obstet Gynecol. 2009 Dec;34(6):653-9. doi: 10.1002/uog.7338.
OBJECTIVES
To determine whether progesterone supplementation alters cervical shortening in women at increased risk for preterm birth.
METHODS
We performed a planned secondary analysis from a large, multinational preterm birth prevention trial of daily intravaginal progesterone gel, 90 mg, compared with placebo in women with a history of spontaneous preterm birth or premature cervical shortening. Transvaginal cervical length measurements were obtained in all randomized patients at baseline (18 + 0 to 22 + 6 weeks' gestation) and at 28 weeks' gestation. For this secondary analysis, the difference in cervical length between these time points was compared for the study population with a history of spontaneous preterm birth and for a population with premature cervical shortening (< or = 30 mm) at randomization. Differences between groups in cervical length for the 28-week examination were analyzed using ANCOVA, including adjustment for relevant clinical parameters and maternal characteristics.
RESULTS
Data were analyzed from 547 randomized patients with a history of preterm birth. The progesterone-treated patients had significantly less cervical shortening than the placebo group (difference 1.6 (95% CI, 0.3-3.0) mm; P = 0.02, ANCOVA). In the population of 104 subjects with premature cervical shortening at randomization, the cervical length also differed significantly on multivariable analysis, with the treatment group preserving more cervical length than the placebo group (difference 3.3 (95% CI, 0.3-6.2) mm; P = 0.03, ANCOVA), with adjustment for differences in cervical length at screening. A significant difference was also observed between groups for categorical outcomes including the frequency of cervical length progression to < or = 25 mm and a > or = 50% reduction in cervical length from baseline in this subpopulation.
CONCLUSIONS
Intravaginal progesterone enhances preservation of cervical length in women at high risk for preterm birth.
目的
确定孕激素补充是否会改变有早产风险的妇女的宫颈缩短。
方法
我们对一项大型国际早产预防试验进行了计划中的二次分析，该试验比较了每天阴道内应用 90 毫克普罗gesterone 凝胶与安慰剂在有自发性早产或宫颈过早缩短史的妇女中的效果。所有随机患者在基线（妊娠 18+0 至 22+6 周）和 28 周妊娠时进行经阴道宫颈长度测量。对于这项二次分析，比较了有自发性早产史的研究人群和随机时宫颈缩短（≤30 毫米）的人群在这两个时间点之间的宫颈长度差异。使用 ANCOVA 分析 28 周检查时的宫颈长度组间差异，包括对相关临床参数和母亲特征的调整。
结果
对 547 名有早产史的随机患者进行了数据分析。与安慰剂组相比，孕激素治疗组的宫颈缩短明显减少（差异 1.6（95%CI，0.3-3.0）毫米；P=0.02，ANCOVA）。在随机时宫颈缩短的 104 名受试者人群中，多变量分析也显示宫颈长度差异显著，治疗组比安慰剂组保留更多的宫颈长度（差异 3.3（95%CI，0.3-6.2）毫米；P=0.03，ANCOVA），同时调整了筛查时的宫颈长度差异。在该亚组中，还观察到组间分类结局的差异，包括宫颈长度进展至≤25 毫米的频率和宫颈长度从基线减少≥50%的频率。
结论
阴道内孕激素可增强有早产风险的妇女的宫颈长度保留。
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