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Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia

2015年10月6日 更新者:Stine Lund, MD, PhD fellow、University of Copenhagen

Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia: A Cluster-randomised Controlled Trial

The purpose of this trial is to determine if the safe delivery smartphone application distributed to health workers in Ethiopia will decrease perinatal mortality and the incidence of postpartum haemorrhage. It is also the purpose to determine if the safe delivery smartphone application distributed to health workers in Ethiopia will increase health workers knowledge and skills in intra-partum management of active management of third stage labour 2) treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal resuscitation.

研究概览

详细说明

Abstract Hypothesis A safe delivery smartphone application distributed to health workers in Ethiopia will decrease perinatal mortality and the incidence of postpartum haemorrhage

A safe delivery smartphone application distributed to health workers in Ethiopia will increase health workers knowledge and skills in intra-partum management of active management of third stage labour 2) treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal resuscitation

Intervention A safe delivery smartphone application with animated videos to improve clinical management during delivery will be introduced in the intervention clusters

Design Cluster randomized controlled trial with health facilities as the unit of randomization

Area Nole Kaba, Haru, Homa, Genji and Gimbie districts in Ethiopia

Population Pregnant women and their newborns delivered in a randomized health facility. For secondary outcomes health workers at randomized health facilities.

Sample size 77 health facilities with minimum 2 health workers per facility and 30 deliveries per health worker

Duration Pregnant women will be enrolled at delivery and followed to 7 days postpartum

Outcomes Primary outcomes are perinatal mortality and postpartum haemorrhage. Secondary outcomes are health workers knowledge and skills

Study time Data collection expected from September 2013 to September 2014

研究类型

介入性

注册 (实际的)

3601

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • København V、丹麦、1658
        • University of Copenhagen

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

10年 至 45年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

• Women in active labor

Exclusion Criteria:

• None

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Safe Delivery Smartphone Application
The safe delivery smartphone application is designed to train midwives and other birth attendants in developing countries in management of normal and complicated deliveries. The safe delivery smartphone application will be introduced to health workers in the intervention clusters.
The safe delivery smartphone application is designed to train midwives and other birth attendants in developing countries in management of normal and complicated deliveries. The application is furthermore intended as a reference tool that could be used during clinical work for example for preparation before attending a birth, in a situation when a complication occurs, or for debriefing and self-evaluation after a complication. The application features four animated videos with clinical instructions of 3-8 minutes duration and written lists of essential obstetric drugs (indications, contraindications, dosage and administration and side effects) and essential equipment for a safe delivery.
无干预:Control
Health workers in the control clusters will not have access to the Safe Delivery App

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Perinatal mortality (stillbirth and early neonatal death)
大体时间:Participants will be followed from delivery until 7 days postpartum
Participants will be followed from delivery until 7 days postpartum
Postpartum haemorrhage
大体时间:Participants will be followed from delivery until two hours postpartum
Participants will be followed from delivery until two hours postpartum

次要结果测量

结果测量
大体时间
Health workers clinical performance in active management of third stage of labour, postpartum haemorrhage and manual removal of placenta
大体时间:0, 6 and 12 months
0, 6 and 12 months
Health workers clinical performance in management of neonatal resuscitation
大体时间:0, 6 and 12 months
0, 6 and 12 months
Health workers knowledge of management of active management of third stage of labour, manual removal of placenta and postpartum haemorrhage
大体时间:0, 6 and 12 months
0, 6 and 12 months
Health workers knowledge of management of neonatal resuscitation
大体时间:0, 6 and 12 months
0, 6 and 12 months

其他结果措施

结果测量
大体时间
Mortality stratified according to gestational age and birth weight
大体时间:Participants will be followed from delivery until 7 days postpartum
Participants will be followed from delivery until 7 days postpartum
Use of the Safe Delivery application (when, how much and by whom)
大体时间:Participants will be followed during the 12 months trial period
Participants will be followed during the 12 months trial period
Process indicators of services provided
大体时间:Participants will be followed from delivery until 7 days postpartum
Participants will be followed from delivery until 7 days postpartum

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年9月1日

初级完成 (实际的)

2014年12月1日

研究完成 (实际的)

2015年1月1日

研究注册日期

首次提交

2013年9月5日

首先提交符合 QC 标准的

2013年9月16日

首次发布 (估计)

2013年9月19日

研究记录更新

最后更新发布 (估计)

2015年10月8日

上次提交的符合 QC 标准的更新

2015年10月6日

最后验证

2015年10月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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