DeFranco E A, O'Brien J M, Adair C D, Lewis D F, Hall D R, Fusey S, Soma-Pillay P, Porter K, How H, Schakis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy G W
Department of Obstetrics and Gynecology and Center for Preterm Birth Research, Washington University School of Medicine, St. Louis, Missouri, USA.
Ultrasound Obstet Gynecol. 2007 Oct;30(5):697-705. doi: 10.1002/uog.5159.
To investigate the efficacy of vaginal progesterone to prevent early preterm birth in women with sonographic evidence of a short cervical length in the midtrimester.
This was a planned, but modified, secondary analysis of our multinational, multicenter, randomized, placebo-controlled trial, in which women were randomized between 18 + 0 and 22 + 6 weeks of gestation to receive daily treatment with 90 mg of vaginal progesterone gel or placebo. Cervical length was measured with transvaginal ultrasound at enrollment and at 28 weeks of gestation. Treatment continued until either delivery, 37 weeks of gestation or development of preterm rupture of membranes. Maternal and neonatal outcomes were evaluated for the subset of all randomized women with cervical length < 28 mm at enrollment. The primary outcome was preterm birth at </= 32 weeks.
A cervical length < 28 mm was identified in 46 randomized women: 19 of 313 who received progesterone and 27 of 307 who received the placebo. Baseline characteristics of the two groups were similar. In women with a cervical length < 28 mm, the rate of preterm birth at </= 32 weeks was significantly lower for those receiving progesterone than it was for those receiving the placebo (0% vs. 29.6%, P = 0.014). With progesterone, there were fewer admissions into the neonatal intensive care unit (NICU; 15.8% vs. 51.9%, P = 0.016) and shorter NICU stays (1.1 vs. 16.5 days, P = 0.013). There was also a trend toward a decreased rate of neonatal respiratory distress syndrome (5.3% vs. 29.6%, P = 0.060).
Vaginal progesterone may reduce the rate of early preterm birth and improve neonatal outcome in women with a short sonographic cervical length.
探讨阴道用黄体酮对孕中期超声检查显示宫颈长度短的女性预防早期早产的疗效。
这是对我们的多国、多中心、随机、安慰剂对照试验进行的一项计划但经过修改的二次分析，该试验中女性在妊娠18 + 0至22 + 6周之间被随机分组，接受每日90毫克阴道用黄体酮凝胶或安慰剂治疗。在入组时和妊娠28周时经阴道超声测量宫颈长度。治疗持续至分娩、妊娠37周或胎膜早破发生。对入组时宫颈长度<28 mm的所有随机分组女性的子集评估母婴结局。主要结局是孕周≤32周时的早产。
46名随机分组女性的宫颈长度<28 mm：接受黄体酮治疗的313名中有19名，接受安慰剂治疗的307名中有27名。两组的基线特征相似。宫颈长度<28 mm的女性中，接受黄体酮治疗者孕周≤32周时的早产率显著低于接受安慰剂治疗者（0%对29.6%，P = 0.014）。使用黄体酮时，新生儿重症监护病房（NICU）收治人数较少（15.8%对51.9%，P = 0.016）且NICU住院时间较短（1.1天对16.5天，P = 0.013）。新生儿呼吸窘迫综合征发生率也有降低趋势（5.3%对29.6%，P = 0.060）。
阴道用黄体酮可能降低超声检查显示宫颈长度短的女性的早期早产率并改善新生儿结局。
