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临床试验/NCT03656237
NCT03656237已完成不适用

The Impact of Case-based Focused Low-dose High-frequency hands-on Training of Facility Health Care Providers and Community Health Workers on Maternal and Newborn Health in Mali, a Cluster Randomized Trial.

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2019年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
79
试验地点
1
主要终点
Perinatal Mortality

研究概览

简要总结

This 3-arm cluster randomized trial (C-RCT) has the following objectives:

Primary Aim

To evaluate the effectiveness of an on-site case-based focused low-dose high-frequency training strategy in a primary health care facility labour room, during the provision of care to mothers and newborns, through childbirth and within seven days post-partum for the healthcare providers and the community health workers linked to the health facility in decreasing perinatal mortality.

Secondary Aims

To determine if introduction of an on-site case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting reduces:

  • Perinatal morbidity incidence
  • Post-partum Hemorrhage

To determine if introduction of an on-site case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting increases ENC practices:

  • Early initiation and exclusive breast feeding
  • Thermal protection (prevention of hypothermia)
  • Clean cord care
  • Delayed bathing
  • Resuscitation-Initiation of breathing

To determine if introduction of a case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting for CHWs decreases:

  • Delayed Identification of danger signs during pregnancy, labour and perinatal period
  • Delayed referral of complicated cases during pregnancy, labour and perinatal period

To determine the cost effectiveness of a case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting

详细描述

Hypothesis The investigators hypothesize that on-site case-based focused low-dose high-frequency hands on training of maternal and neonatal health care providers and community health workers will have an impact on reducing perinatal mortality rate (PMR) in comparison to Maternal Newborn and Child Health (MNCH) refresher training in a classroom setting.

Primary Aim To evaluate the effectiveness of an on-site case-based focused low-dose high-frequency training strategy in a primary health care facility labour room, during the provision of care to mothers and newborns, through childbirth and within seven days post-partum for the healthcare providers and the community health workers linked to the health facility in decreasing perinatal mortality.

Secondary Aims

To determine if introduction of an on-site case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting reduces:

  • Perinatal morbidity incidence
  • Post-partum Hemorrhage

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All CSComs providing basic obstetric care with at least one health care provider trained in AMTSL, ENC and PNC with data collection/ utilization in Koulikoro, Kolokani, Banamba and Dioïla study clusters.
  • All community health workers reporting to an included CSCom.
  • All CSCom deliveries (both mother and newborn) in study clusters and live home births referred to a facility within the perinatal period.
  • Mother intending to maintain residence in study area for first week of newborn's life.

排除标准

  • CSComs not providing basic obstetric care or not having trained maternal and neonatal health care providers in AMTSL, ENC and PNC and not collecting/utilizing data.
  • CHW's will be excluded if linked to an in-eligible CSCom or if they have not been trained in the standard MoH CHW training curriculum.
  • Failure to provide consent to enroll in study (intervention or control clusters).

结局指标

主要结局

Perinatal Mortality

时间窗: First 7 days of life

Deaths occurring within 7 days of birth and fetal deaths (stillbirth) per 1000 CSCOM births

次要结局

  • Resuscitation-Initiation of breathing(Immediately at birth)
  • Severe Infection(First 7 days of life)
  • Exclusive breastfeeding(First 7 days of life)
  • Thermal protection (dried and wrapped)(Immediately at birth)
  • Newborn weighed(First 24 hours of life)
  • Moderate to severe hypothermia - referral(First 7 days of life)
  • Severe infection - referral(First 7 days of life)
  • Thermal protection (Kangaroo mother care)(Immediately at birth)
  • Delayed first bath(First 24 hours of life)
  • Early initiation of breastfeeding(An hour after birth)
  • Clean cord care(First 7 days of life)
  • Neonatal hypothermia(First 7 days of life)
  • Perinatal bleeding(First 7 days of life)
  • Obstructed labor - referral(During delivery)
  • Low birth weight - referral(First 7 days of life)
  • Moderate to severe umbilical cord infection - referral(First 7 days of life)
  • Umbilical cord infection(First 7 days of life)
  • Post-partum hemorrhage - referral(Immediately after delivery)
  • Postpartum hemorrhage(Immediately after delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Diego Bassani

Director, International Program Evaluation Unit (IPE), Center for Global Child Health

The Hospital for Sick Children

研究点 (1)

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