Pediatrics, Hospital Trinidad, University of Buenos Aires, Buenos Aires, Argentina.
Fundasamin, Buenos Aires, Argentina.
Arch Dis Child Fetal Neonatal Ed. 2020 Jan;105(1):14-17. doi: 10.1136/archdischild-2018-316649. Epub 2019 May 9.
To assess whether oxytocin administered before clamping the umbilical cord modifies the volume of placental transfusion.
Randomised controlled trial.
Mothers of term infants born vigorous by vaginal delivery with informed consent provided in early labour were randomly assigned to oxytocin (10 IU) given intravenously within 15 s of birth (group 1) or after clamping the umbilical cord 3 min after delivery (group 2). Soon after birth, all infants were weighed using a 1 g precision scale and subsequently placed on the mother's abdomen or chest. At 3 min, in both groups, the cord was clamped and cut, and the weight was again obtained. The primary outcome (volume of placental transfusion) was estimated by the difference in weights.
144 patients were included. There were no differences in the primary outcome: infants in group 1 (n=70) gained a mean weight of 85.9 g (SD 48.3), and in group 2 (n=74) 86.7 g (SD 49.6) (p=0.92). No differences were found in secondary outcomes, including newborns' haematocrit and bilirubin concentrations and severe maternal postpartum haemorrhage. On the advice of the Data and Safety Monitoring Committee, the trial was stopped due to futility at 25% of the planned sample size.
When umbilical cord clamping is delayed for 3 min, term newborn infants born vigorous receive a clinically significant placental transfusion which is not modified by the administration of intravenous oxytocin immediately after birth.
NCT02618499.
评估在脐带夹闭前给予催产素是否会改变胎盘输血量。
随机对照试验。
分娩时阴道分娩的足月、活力好的产妇,在早期分娩时获得知情同意,随机分配在出生后 15 秒内静脉内给予催产素(10IU)(第 1 组)或在分娩后 3 分钟夹闭脐带后(第 2 组)。出生后不久,所有婴儿均使用 1g 精密秤称重,随后放在母亲的腹部或胸部。在第 3 分钟,两组均夹闭和剪断脐带,并再次称重。通过重量差来估计主要结局(胎盘输血量)。
纳入了 144 例患者。主要结局无差异:第 1 组(n=70)婴儿平均增重 85.9g(SD 48.3),第 2 组(n=74)婴儿平均增重 86.7g(SD 49.6)(p=0.92)。次要结局也无差异,包括新生儿的血细胞比容和胆红素浓度以及严重的产后出血。根据数据和安全监测委员会的建议,在计划样本量的 25%时,由于无效而停止了试验。
当脐带夹闭延迟 3 分钟时,活力好的足月新生儿接受了临床显著的胎盘输血,而出生后立即静脉内给予催产素不会改变这一输血。
NCT02618499。