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世界卫生组织安全分娩清单对印度尼西亚亚齐省母婴保健质量和分娩结局的影响:一项整群随机临床试验。

Effects of the World Health Organization Safe Childbirth Checklist on Quality of Care and Birth Outcomes in Aceh, Indonesia: A Cluster-Randomized Clinical Trial.

机构信息

Department of Economics, University of Göttingen, Göttingen, Germany.

German Development Institute, Bonn, Germany.

出版信息

JAMA Netw Open. 2021 Dec 1;4(12):e2137168. doi: 10.1001/jamanetworkopen.2021.37168.

Abstract

IMPORTANCE

To address major causes of perinatal and maternal mortality, the World Health Organization developed the Safe Childbirth Checklist (SCC), which to our knowledge has been rigorously evaluated only in combination with high-intensity coaching.

OBJECTIVE

To evaluate the effect of the SCC with medium-intensity coaching on health care workers' performance of essential birth practices.

DESIGN, SETTING, AND PARTICIPANTS: This cluster randomized clinical trial without blinding included 32 hospitals and community health centers in the province of Aceh, Indonesia (a medium-resource setting) that met the criterion of providing at least basic emergency obstetric and newborn care. Baseline data were collected from August to October 2016, and outcomes were measured from March to April 2017. Data were analyzed from January 2020 to October 2021.

INTERVENTIONS

After applying an optimization method, facilities were randomly assigned to the treatment or control group (16 facilities each). The SCC with 11 coaching visits was implemented during a 6-month period.

MAIN OUTCOMES AND MEASURES

For the primary outcome, clinical observers documented whether 36 essential birth practices were applied at treatment and control facilities at 1 or more of 4 pause points during the birthing process (admission to the hospital, just before pushing or cesarean delivery, soon after birth, and before hospital discharge). Probability models for binary outcome measures were estimated using ordinary least-squares regressions, complemented by Firth logit and complier average causal effect estimations.

RESULTS

Among the 32 facilities that participated in the trial, a significant increase of up to 41 percentage points was observed in the application of 5 of 36 essential birth practices in the 16 treatment facilities compared with the 16 control facilities, including communication of danger signs at admission (treatment: 136 of 155 births [88%]; control: 79 of 107 births [74%]), measurement of neonatal temperature (treatment: 9 of 31 births [29%]; control: 1 of 20 births [5%]), newborn feeding checks (treatment: 22 of 34 births [65%]; control: 5 of 21 births [24%]), and the rate of communication of danger signs to mothers and birth companions verbally (treatment: 30 of 36 births [83%]; control: 14 of 22 births [64%]) and in a written format (treatment: 3 of 24 births [13%]; control: 0 of 16 births [0%]).

CONCLUSIONS AND RELEVANCE

In this cluster randomized clinical trial, health facilities that implemented the SCC with medium-intensity coaching had an increased rate of application for 5 of 36 essential birth practices compared with the control facilities. Medium-intensity coaching may not be sufficient to increase uptake of the SCC to a satisfying extent, but it may be worthwhile to assess a redesigned coaching approach prompting long-term behavioral change and, therefore, effectiveness.

TRIAL REGISTRATION

isrctn.org Identifier: ISRCTN11041580.

摘要

重要性

为了解决围产期和孕产妇死亡的主要原因,世界卫生组织制定了安全分娩清单(SCC),据我们所知,该清单仅在与高强度辅导相结合的情况下得到了严格评估。

目的

评估中等强度辅导的 SCC 对卫生保健工作者实施基本分娩实践的效果。

设计、地点和参与者:这项无盲目的群组随机临床试验包括印度尼西亚亚齐省的 32 家医院和社区卫生中心(资源中等的环境),这些医院符合提供至少基本紧急产科和新生儿护理的标准。基线数据于 2016 年 8 月至 10 月收集,结果于 2017 年 3 月至 4 月测量。数据分析于 2020 年 1 月至 2021 年 10 月进行。

干预措施

在应用优化方法后,设施被随机分配到治疗组或对照组(每组 16 个设施)。在 6 个月的时间里实施了包含 11 次辅导访问的 SCC。

主要结果和测量

对于主要结局,临床观察员在分娩过程中的 4 个停顿点中的 1 个或多个记录了 36 项基本分娩实践在治疗和对照设施中的应用情况(入院、即将推挤或剖腹产、出生后不久和出院前)。使用普通最小二乘回归估计二项结局措施的概率模型,并补充使用 Firth 对数和遵医行为平均因果效应估计。

结果

在参与试验的 32 家设施中,与 16 家对照设施相比,治疗组中 36 项基本分娩实践中的 5 项的应用率显著提高,高达 41 个百分点,包括入院时的危险信号沟通(治疗:155 例分娩中的 136 例[88%];对照:107 例分娩中的 79 例[74%])、新生儿体温测量(治疗:31 例分娩中的 9 例[29%];对照:20 例分娩中的 1 例[5%])、新生儿喂养检查(治疗:34 例分娩中的 22 例[65%];对照:21 例分娩中的 5 例[24%]),以及口头向母亲和分娩伙伴传达危险信号的比率(治疗:36 例分娩中的 30 例[83%];对照:22 例分娩中的 14 例[64%])和书面格式(治疗:24 例分娩中的 3 例[13%];对照:16 例分娩中的 0 例[0%])。

结论和相关性

在这项群组随机临床试验中,实施中等强度辅导的 SCC 的卫生设施与对照组相比,基本分娩实践的应用率提高了 5 项。中等强度的辅导可能不足以将 SCC 的采用率提高到令人满意的程度,但评估一种新的辅导方法以促使长期的行为改变,从而提高效果,可能是值得的。

试验注册

isrctn.org 标识符:ISRCTN11041580。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/619e/8642783/b9ce209da264/jamanetwopen-e2137168-g001.jpg

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