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临床试验/NCT01653626
NCT01653626Unknown不适用

A Matched Pair Cluster-randomized Implementation Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala

Hospital San Juan de Dios Guatemala1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2012年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
1
试验地点
1
主要终点
increase the proportion of institutional deliveries in intervention vs. control clusters

研究概览

简要总结

A matched pair cluster-randomized trial of this intervention package will be conducted in four rural and indigenous districts (Huehuetenango, Quiche, Alta Verapaz and San Marcos) of the Republic of Guatemala, using the health clinic as the unit of randomization. No external intervention is planned for control facilities, although enhanced monitoring, surveillance and data collection will occur throughout the study in all facilities in the four districts.

The package includes 3 interventions: 1) To train health care professionals in emergency obstetric and perinatal care using an innovative high-fidelity, low-tech, in situ, multidisciplinary simulation training curriculum (PRONTO); 2) To design and implement a social marketing strategy that promotes institution-based delivery; and 3) To integrate the role of obstetric nurse and professional midwife in intervention communities to act as liaisons between traditional birth attendants (TBA) and public health units. A fourth, cross-cutting component involves ongoing analysis, monitoring, surveillance and evaluation to strengthen information systems and monitor perinatal outcomes throughout the two years of the study.

详细描述

Overall goal

To evaluate the impact of a package of three interventions aiming to increase institution-based delivery and improve emergency obstetric and neonatal care on perinatal mortality, in the four districts with the highest maternal mortality ratios in Guatemala.

Specific objectives

  • Measure the impact of this intervention package on perinatal mortality rates.
  • Measure the impact of this intervention package on the proportion of institution-based delivery among study facilities.
  • Evaluate the processes and success of implementing this combined package of interventions by analyzing process indicators related to the intervention element designed to improve emergency obstetric and neonatal care (PRONTO: emergency obstetric and perinatal training program).

Primary outcome of interest:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •rural women
  • •indigenous
  • •Facilities at rural area
  • •Clinic attending vaginal deliveries

排除标准

  • •Facilities considered too close geographically to risk contamination of intervention to control facilities
  • •Clinics visits by pregnant women who present to intervention or control clinics for reasons other that an obstetric event
  • •Clinic or hospital visits by women who present to intervention or control clinics in the post partum period

研究组 & 干预措施

package

Experimental

干预措施: package of 3 interventions (Other)

结局指标

主要结局

increase the proportion of institutional deliveries in intervention vs. control clusters

时间窗: Up to 15 months

次要结局

  • Decrease perinatal death rate in intervention vs. control clinics(Up to 15 months)

研究者

发起方
Hospital San Juan de Dios Guatemala
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Edgar Kestler

Director

World Health Organization

研究点 (1)

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