Departments of Obstetrics and Gynecology, West China Second University Hospital of Sichuan University, Chengdu, Southwest Hospital of Third Military Medical University, Chongqing, Shanghai First Maternity and Infant Hospital of Tongji University, Shanghai, and Women's Hospital School of Medicine of Zhejiang University, Hangzhou, China.
Obstet Gynecol. 2013 Aug;122(2 Pt 1):290-295. doi: 10.1097/AOG.0b013e3182999085.
To evaluate whether sustained transabdominal uterine massage can reduce blood loss after vaginal delivery.
In this multicenter randomized controlled trial, eligible women who had delivered vaginally were randomly assigned to receive 10 units oxytocin intramuscularly immediately after delivery of the shoulder plus 30 minutes of sustained transabdominal uterine massage after delivery of the placenta or to 10 units oxytocin intramuscularly alone. The primary outcome was blood loss of 400 mL or more in the 2 hours after delivery of the neonate. Secondary outcomes included blood loss of 1,000 mL or more, blood loss in the 2 hours after delivery, use of therapeutic uterotonics or other hemostatic procedures, hemoglobin of lower than 80 g/L before discharge, and need for blood transfusion. Analysis was by intent to treat. With a one-sided α of 0.05 and a power of 0.8, a sample size of 1,061 women per group was calculated to detect a 3% absolute decrease in the primary outcome.
Of 2,340 eligible women, 1,170 were randomized to oxytocin plus uterine massage and 1,170 to the oxytocin-only group. Baseline characteristics were similar in both groups. The incidence of blood loss of 400 mL or more in the 2 hours after delivery was not significantly different between the two groups (143/1,170 [12.2%] compared with 144/1,170 [12.3%]; relative risk 0.99, 95% confidence interval 0.88-1.13) according to intent-to-treat analysis with a power of more than 0.8. No significant differences were found in the secondary outcomes.
In patients delivered vaginally, transabdominal uterine massage after delivery of the placenta in addition to oxytocin does not reduce blood loss when compared with administration of oxytocin alone.
Chinese Clinical Trial Registry, www.chictr.org, ChiCTR-TRC-11001763.
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评估持续性经腹子宫按摩能否减少阴道分娩后的出血量。
在这项多中心随机对照试验中，符合条件的阴道分娩产妇被随机分配接受分娩肩后立即肌内注射 10 单位缩宫素加胎盘娩出后 30 分钟持续经腹子宫按摩，或单独肌内注射 10 单位缩宫素。主要结局是新生儿出生后 2 小时出血量超过 400ml。次要结局包括出血量超过 1000ml、分娩后 2 小时出血量、使用治疗性宫缩剂或其他止血措施、出院前血红蛋白低于 80g/L 和需要输血。分析采用意向治疗。单侧 α 值为 0.05，把握度为 0.8，计算每组需要 1170 名女性，以检测主要结局的绝对减少 3%。
在 2340 名符合条件的女性中，1170 名被随机分配至缩宫素加子宫按摩组，1170 名被随机分配至缩宫素组。两组的基线特征相似。根据意向治疗分析，两组新生儿出生后 2 小时出血量超过 400ml 的发生率无显著差异（143/1170[12.2%]与 144/1170[12.3%]；相对风险 0.99，95%置信区间 0.88-1.13），把握度超过 0.8。次要结局也无显著差异。
在阴道分娩产妇中，与单独使用缩宫素相比，胎盘娩出后进行经腹子宫按摩并不能减少出血量。
中国临床试验注册中心，www.chictr.org，ChiCTR-TRC-11001763。
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