Obstetrix Medical Group, Mednax Inc., Sunrise, FL, USA.
Am J Obstet Gynecol. 2011 Mar;204(3):221.e1-8. doi: 10.1016/j.ajog.2010.12.042.
We sought to determine whether prophylactic treatment with 17-alpha-hydroxyprogesterone caproate (17Pc) in twin pregnancy will reduce neonatal morbidity (primary outcome) by prolonging pregnancy (secondary outcome).
This was a double-blind, randomized clinical trial. Mothers carrying dichorionic-diamniotic twins were randomly assigned (in a 2:1 ratio) to weekly injections of 250 mg of 17Pc or placebo, starting at 16-24 weeks and continued until 34 weeks.
In all, 160 women were randomized to 17Pc and 80 to placebo. Composite neonatal morbidity occurred with similar frequency in the 17Pc and placebo groups (14% vs 12%, respectively, P = .62). Mean gestational age at delivery was not affected by 17Pc (35.3 vs 35.9 weeks, P = .10), but a 3-day difference in median gestational age favored placebo (P = .02). There were no perinatal deaths with 17Pc and 3 with placebo.
In twin pregnancy, prophylactic treatment with 17Pc did not prolong gestation or reduce neonatal morbidity.
我们旨在确定在双胎妊娠中预防性应用 17α-羟孕酮己酸酯(17Pc)是否会通过延长妊娠(次要结局)来降低新生儿发病率(主要结局)。
这是一项双盲、随机临床试验。携带双绒毛膜-双羊膜双胞胎的母亲被随机分配(2:1 比例)接受每周 250mg 17Pc 或安慰剂注射,起始时间为 16-24 周,并持续至 34 周。
共有 160 名女性被随机分配至 17Pc 组,80 名女性被随机分配至安慰剂组。17Pc 组和安慰剂组的复合新生儿发病率相似(分别为 14%和 12%,P=.62)。17Pc 组的平均分娩孕周不受影响(分别为 35.3 周和 35.9 周,P=.10),但中位数的 3 天差异有利于安慰剂组(P=.02)。17Pc 组无围产期死亡,安慰剂组有 3 例。
在双胎妊娠中,预防性应用 17Pc 不能延长孕周或降低新生儿发病率。