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缩宫素单次推注与缩宫素单次推注加输注用于控制择期剖宫产术出血的效果比较:双盲、安慰剂对照、随机临床试验。

Oxytocin bolus versus oxytocin bolus and infusion for control of blood loss at elective caesarean section: double blind, placebo controlled, randomised trial.

机构信息

Academic Department of Obstetrics and Gynaecology, Trinity College Dublin, Coombe Women and Infants University Hospital, Dublin 8, Ireland.

出版信息

BMJ. 2011 Aug 1;343:d4661. doi: 10.1136/bmj.d4661.

Abstract

OBJECTIVES

To determine the effects of adding an oxytocin infusion to bolus oxytocin on blood loss at elective caesarean section.

DESIGN

Double blind, placebo controlled, randomised trial, conducted from February 2008 to June 2010.

SETTING

Five maternity hospitals in the Republic of Ireland.

PARTICIPANTS

2069 women booked for elective caesarean section at term with a singleton pregnancy. We excluded women with placenta praevia, thrombocytopenia, coagulopathies, previous major obstetric haemorrhage (>1000 mL), or known fibroids; women receiving anticoagulant treatment; those who did not understand English; and those who were younger than 18 years.

INTERVENTION

Intervention group: intravenous slow 5 IU oxytocin bolus over 1 minute and additional 40 IU oxytocin infusion in 500 mL of 0.9% saline solution over 4 hours (bolus and infusion). Placebo group: 5 IU oxytocin bolus over 1 minute and 500 mL of 0.9% saline solution over 4 hours (placebo infusion) (bolus only). Main outcomes Major obstetric haemorrhage (blood loss >1000 mL) and need for an additional uterotonic agent.

RESULTS

We found no difference in the occurrence of major obstetric haemorrhage between the groups (bolus and infusion 15.7% (158/1007) v bolus only 16.0% (159/994), adjusted odds ratio 0.98, 95% confidence intervals 0.77 to 1.25, P=0.86). The need for an additional uterotonic agent in the bolus and infusion group was lower than that in the bolus only group (12.2% (126/1033) v 18.4% (189/1025), 0.61, 0.48 to 0.78, P<0.001). Women were less likely to have a major obstetric haemorrhage in the bolus and infusion group than in the bolus only group if the obstetrician was junior rather than senior (0.57, 0.35 to 0.92, P=0.02).

CONCLUSION

The addition of an oxytocin infusion after caesarean delivery reduces the need for additional uterotonic agents but does not affect the overall occurrence of major obstetric haemorrhage. Trial Registration Current Controlled Trials ISRCTN17813715.

摘要

目的

比较缩宫素点滴与单次推注在择期剖宫产术中对出血量的影响。

设计

双盲、安慰剂对照、随机临床试验,于 2008 年 2 月至 2010 年 6 月进行。

地点

爱尔兰共和国的 5 家产科医院。

对象

2069 名年龄在 18 岁以上、妊娠 37 周以上、单胎妊娠、拟行择期剖宫产的孕妇。排除前置胎盘、血小板减少症、凝血障碍、既往严重产科出血(>1000ml)、已知肌瘤、正在接受抗凝治疗、无法理解英语的孕妇。

干预

缩宫素组:静脉缓慢推注 5IU 缩宫素 1 分钟,再以 40IU 缩宫素加入 500ml0.9%生理盐水,4 小时内持续点滴(推注+点滴);安慰剂组:静脉推注 5IU 缩宫素 1 分钟,再以 500ml0.9%生理盐水持续点滴 4 小时(仅推注)。主要结局:主要产科出血(出血量>1000ml)和需要额外使用宫缩剂。

结果

两组间主要产科出血的发生率无差异(推注+点滴组 15.7%(158/1007)比仅推注组 16.0%(159/994),调整后的比值比为 0.98,95%可信区间为 0.77 至 1.25,P=0.86)。与仅推注组相比,推注+点滴组需要额外使用宫缩剂的比例较低(12.2%(126/1033)比 18.4%(189/1025),0.61,0.48 至 0.78,P<0.001)。如果麻醉师级别较低(而非较高),则推注+点滴组的产妇发生主要产科出血的可能性低于仅推注组(0.57,0.35 至 0.92,P=0.02)。

结论

剖宫产术后给予缩宫素点滴可减少对额外宫缩剂的需求,但不影响主要产科出血的总体发生率。

试验注册

当前对照试验 ISRCTN80777026。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/056c/4788089/6928da69e2a5/shes853523.f1_default.jpg

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