高剂量催产素与阴道分娩后出血：一项随机对照试验。
Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial.
机构信息
Center for Women's Reproductive Health and Maternal-Fetal Medicine Division, Department of Obstetrics and Gynecology, University Hospital, University of Alabama at Birmingham, Birmingham, Alabama, USA.
出版信息
Obstet Gynecol. 2012 Feb;119(2 Pt 1):293-300. doi: 10.1097/AOG.0b013e318242da74.
OBJECTIVE
Higher-dose oxytocin is more effective than lower-dose regimens to prevent postpartum hemorrhage after cesarean delivery. We compared two higher-dose regimens (80 units and 40 units) to our routine regimen (10 units) among women who delivered vaginally.
METHODS
In a double-masked randomized trial, oxytocin (80 units, 40 units, or 10 units) was administered in 500 mL over 1 hour after placental delivery. The primary outcome was a composite of any treatment of uterine atony or hemorrhage. Prespecified secondary outcomes included outcomes in the primary composite and a decline of 6% or more in hematocrit. A sample size of 600 per group (N=1,800) was planned to compare each of the 80-unit and 40-unit groups to the 10-unit group. At planned interim review (n=1,201), enrollment in the 40-unit group was stopped for futility and enrollment continued in the other groups.
RESULTS
Of 2,869 women, 1,798 were randomized as follows: 658 to 80 units; 481 to 40 units; and 659 to 10 units. Most characteristics were similar across groups. The risk of the primary outcome in the 80-unit group (6%; relative risk [RR] 0.93, 95% confidence interval [CI] 0.62-1.40) or the 40-unit group (6%; RR 0.94, 95% CI 0.61-1.47) was not different compared with the 10-unit group (7%). Treatment with additional oxytocin after the first hour was less frequent with 80 units compared with 10 units (RR 0.41, 95% CI 0.19-0.88), as was a 6% or more decline in hematocrit (RR 0.83, 95% CI 0.69-0.99); both outcomes declined with increasing oxytocin dose. Outcomes were similar between the 40-unit and 10-unit groups.
CONCLUSION
Compared with 10 units, 80 units or 40 units of prophylactic oxytocin did not reduce overall postpartum hemorrhage treatment when administered in 500 mL over 1 hour for vaginal delivery. Eighty units decreased the need for additional oxytocin and the risk of a decline in hematocrit of 6% or more.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00790062.
LEVEL OF EVIDENCE
I.
目的
与低剂量方案相比，高剂量催产素更能有效预防剖宫产产后出血。我们比较了两种高剂量方案（80 单位和 40 单位）与我们常规方案（10 单位）在阴道分娩产妇中的效果。
方法
在一项双盲随机试验中，在胎盘娩出后 1 小时内，将催产素（80 单位、40 单位或 10 单位）输注于 500ml 液体中。主要结局为任何子宫收缩乏力或出血的综合治疗。预设的次要结局包括主要复合结局和血细胞比容下降 6%或更多。每个组（n=1,800）计划入组 600 例，以比较 80 单位和 40 单位组与 10 单位组的差异。在计划的中期审查（n=1,201）时，由于无效性而停止了 40 单位组的入组，而其他组继续入组。
结果
在 2869 名妇女中，1798 名被随机分配如下：658 名至 80 单位；481 名至 40 单位；659 名至 10 单位。大多数特征在各组之间相似。80 单位组（6%；相对风险 [RR] 0.93，95%置信区间 [CI] 0.62-1.40）或 40 单位组（6%；RR 0.94，95% CI 0.61-1.47）的主要结局风险与 10 单位组（7%）无差异。与 10 单位组相比，80 单位组在第一个小时后接受额外催产素治疗的频率较低（RR 0.41，95% CI 0.19-0.88），血细胞比容下降 6%或更多的发生率也较低（RR 0.83，95% CI 0.69-0.99）；随着催产素剂量的增加，这两个结局都有所下降。40 单位组和 10 单位组的结局相似。
结论
与 10 单位相比，在阴道分娩时，在 1 小时内输注 500ml 时，80 单位或 40 单位预防性催产素并未减少总体产后出血治疗。80 单位减少了对额外催产素的需求和血细胞比容下降 6%或更多的风险。
临床试验注册
ClinicalTrials.gov，www.clinicaltrials.gov，NCT00790062。
证据水平
I。
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