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非充气抗休克服用于产科出血的整群随机对照试验:津巴布韦组的亚组分析

A cluster randomized controlled trial of the non-pneumatic anti-shock garment for obstetric haemorrhage: sub-analysis of the Zimbabwean Arm.

作者信息

Magwali T L, Butrick E, Ayadi A E, Bergel E, Gibbons L, Huong N T, Merialdi M, Mambo V, Miller S

出版信息

Cent Afr J Med. 2015 May-Aug;61(5-8):27-32.

PMID:29144074
Abstract

OBJECTIVES

To determine whether earlier application of the Non-pneumatic Anti-Shock Garment (NASG) at clinic level compared to the referral hospital level reduces maternal morbidity and mortality and recovery time from shock due to severe Obstetric Haemorrhage (OH) and to determine the safety of the NASG when applied at clinic level.

DESIGN

A cluster Randomized Controlled Trial (RCT)

SETTING

Harare and Parirenyatwa Referral Hospitals (RH) in Harare and the twelve Harare City Council clinics that offer maternity care.

SUBJECTS

Women who had suffered severe OH at clinic level and were being transferred to a Referral Hospital (RH).

ITERVENTIONS

The clinics were randomized into two groups. In the early NASG group eligible women were given the standard management for OH and had the NASG applied at the clinic level before transport to RH. In the control group, eligible women were given the standard management for OH at the clinic level, transferred to the RH, and received the NASG at the RH. All women received equivalent OH/hypovolemic shock management at the RH.

MAIN OUTCOME MEASURES

The main outcome measures were maternal mortality and morbidity, blood loss, recovery from shock and the occurrence of side effects whilst in the NASG.

RESULTS

There were few maternal deaths and morbidities, and no statistically significant differences between the two groups were noted. Women in the early NASG group spent a statistically significant shorter time in the NASG at referral hospital level (OR 0.64, 95% CI 0.52 - 0.79, p < 0.001) and had a non-significant 40% faster recovery from shock (HR 1.39; 95% CI 0.98-1.97, p=0.07). There were no differences in reported side effects.

CONCLUSION

Earlier NASG application at the clinic level was associated with faster recovery from shock in women who had suffered severe OH and appears safe to use.

摘要

目的

确定与转诊医院层面相比,在诊所层面更早应用非充气抗休克服(NASG)是否能降低因严重产科出血(OH)导致的孕产妇发病率和死亡率以及休克恢复时间,并确定在诊所层面应用NASG的安全性。

设计

整群随机对照试验(RCT)

地点

哈拉雷的哈拉雷和帕里伦亚瓦转诊医院(RH)以及提供产科护理的12家哈拉雷市议会诊所

研究对象

在诊所层面发生严重OH并被转诊至转诊医院(RH)的女性

干预措施

诊所被随机分为两组。在早期NASG组,符合条件的女性接受OH的标准管理,并在转运至RH之前在诊所层面应用NASG。在对照组,符合条件的女性在诊所层面接受OH的标准管理,转诊至RH,并在RH接受NASG。所有女性在RH接受同等的OH/低血容量性休克管理。

主要结局指标

主要结局指标为孕产妇死亡率和发病率、失血量、休克恢复情况以及使用NASG期间的副作用发生情况。

结果

孕产妇死亡和发病情况较少,两组之间未发现统计学上的显著差异。早期NASG组的女性在转诊医院层面使用NASG的时间在统计学上显著更短(比值比0.64,95%置信区间0.52 - 0.79,p < 0.001),且从休克中恢复的速度快40%,但差异不显著(风险比1.39;95%置信区间0.98 - 1.97,p = 0.07)。报告的副作用没有差异。

结论

在诊所层面更早应用NASG与严重OH女性休克恢复更快相关,且使用起来似乎是安全的。

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