阴道用孕酮降低超声检查宫颈短的孕妇早产率：一项多中心、随机、双盲、安慰剂对照试验。
Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial.
机构信息
Perinatology Research Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development/National Institutes of Health/Department of Health and Human Services, Bethesda, MD, USA.
出版信息
Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31. doi: 10.1002/uog.9017. Epub 2011 Jun 15.
OBJECTIVES
Women with a sonographic short cervix in the mid-trimester are at increased risk for preterm delivery. This study was undertaken to determine the efficacy and safety of using micronized vaginal progesterone gel to reduce the risk of preterm birth and associated neonatal complications in women with a sonographic short cervix.
METHODS
This was a multicenter, randomized, double-blind, placebo-controlled trial that enrolled asymptomatic women with a singleton pregnancy and a sonographic short cervix (10-20 mm) at 19 + 0 to 23 + 6 weeks of gestation. Women were allocated randomly to receive vaginal progesterone gel or placebo daily starting from 20 to 23 + 6 weeks until 36 + 6 weeks, rupture of membranes or delivery, whichever occurred first. Randomization sequence was stratified by center and history of a previous preterm birth. The primary endpoint was preterm birth before 33 weeks of gestation. Analysis was by intention to treat.
RESULTS
Of 465 women randomized, seven were lost to follow-up and 458 (vaginal progesterone gel, n=235; placebo, n=223) were included in the analysis. Women allocated to receive vaginal progesterone had a lower rate of preterm birth before 33 weeks than did those allocated to placebo (8.9% (n=21) vs 16.1% (n=36); relative risk (RR), 0.55; 95% CI, 0.33-0.92; P=0.02). The effect remained significant after adjustment for covariables (adjusted RR, 0.52; 95% CI, 0.31-0.91; P=0.02). Vaginal progesterone was also associated with a significant reduction in the rate of preterm birth before 28 weeks (5.1% vs 10.3%; RR, 0.50; 95% CI, 0.25-0.97; P=0.04) and 35 weeks (14.5% vs 23.3%; RR, 0.62; 95% CI, 0.42-0.92; P=0.02), respiratory distress syndrome (3.0% vs 7.6%; RR, 0.39; 95% CI, 0.17-0.92; P=0.03), any neonatal morbidity or mortality event (7.7% vs 13.5%; RR, 0.57; 95% CI, 0.33-0.99; P=0.04) and birth weight < 1500 g (6.4% (15/234) vs 13.6% (30/220); RR, 0.47; 95% CI, 0.26-0.85; P=0.01). There were no differences in the incidence of treatment-related adverse events between the groups.
CONCLUSIONS
The administration of vaginal progesterone gel to women with a sonographic short cervix in the mid-trimester is associated with a 45% reduction in the rate of preterm birth before 33 weeks of gestation and with improved neonatal outcome.
目的
在中期妊娠时超声检查显示宫颈短的女性早产风险增加。本研究旨在确定使用米索前列醇阴道凝胶降低超声检查显示宫颈短的女性早产风险和相关新生儿并发症的效果和安全性。
方法
这是一项多中心、随机、双盲、安慰剂对照试验，纳入了 19+0 至 23+6 周妊娠、超声检查显示宫颈短（10-20mm）且无症状的单胎妊娠女性。从 20 周到 23+6 周开始，女性随机分配接受阴道孕酮凝胶或安慰剂治疗，直至胎膜破裂或分娩，以先发生者为准。随机序列按中心和既往早产史分层。主要终点是 33 周前早产。分析采用意向治疗。
结果
在 465 名随机分配的女性中，有 7 名失访，458 名（阴道孕酮凝胶组，n=235；安慰剂组，n=223）纳入分析。与安慰剂组相比，接受阴道孕酮治疗的女性 33 周前早产的发生率较低（8.9%（n=21）vs 16.1%（n=36）；相对风险（RR），0.55；95%置信区间，0.33-0.92；P=0.02）。调整协变量后，效果仍然显著（调整 RR，0.52；95%置信区间，0.31-0.91；P=0.02）。阴道孕酮也与 28 周前早产率（5.1% vs 10.3%；RR，0.50；95%置信区间，0.25-0.97；P=0.04）和 35 周前早产率（14.5% vs 23.3%；RR，0.62；95%置信区间，0.42-0.92；P=0.02）、呼吸窘迫综合征（3.0% vs 7.6%；RR，0.39；95%置信区间，0.17-0.92；P=0.03）、任何新生儿发病率或死亡率事件（7.7% vs 13.5%；RR，0.57；95%置信区间，0.33-0.99；P=0.04）和出生体重<1500g（6.4%（15/234）vs 13.6%（30/220）；RR，0.47；95%置信区间，0.26-0.85；P=0.01）的发生率降低有关。两组间治疗相关不良事件的发生率无差异。
结论
在中期妊娠时超声检查显示宫颈短的女性中使用米索前列醇阴道凝胶与 33 周前早产率降低 45%有关，并改善新生儿结局。
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