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临床试验/NCT02412293
NCT02412293已完成不适用

Community-based Perinatal and Newborn Care in Gilgit District, Northern Areas, Pakistan: an AKU-AKHSP Collaboration

Aga Khan University2 个研究点 分布在 1 个国家目标入组 3,200 人开始时间: 2001年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,200
试验地点
2
主要终点
Reduction in perinatal and neonatal mortality

研究概览

简要总结

There is limited evidence from community-based interventions to guide the development of effective maternal, perinatal and newborn care practices and services in developing countries. Investigators planned to evaluate the impact of a low-cost package of community-based interventions implemented through government sector lady health workers (LHWs) and community health workers (CHWs) of a NGO namely Aga Khan Health Services on perinatal and neonatal outcomes in a sub-population of the remote mountainous district of Gilgit, Northern Pakistan.

A community-based package for use by LHWs and CHWs geared towards prevention and promotion of maternal and newborn health practices and services will be developed based on formative research in the study district. The package will include promotion of antenatal care, adequate nutrition, skilled delivery and healthy newborn care practices at household level. The health workers will be trained in recognition of danger sign that warrant referral to health care service. LHWs and CHWs will delivered the package via community awareness sessions and two one-to-one counselling sessions to pregnant women during third trimester and five newborn assessment visits in the neonatal period. In addition to this, community mobilization activities included formation of CHCs and creation of support for the uptake of the interventions. Control areas will continue to receive the routine standard health services of governmental and non-governmental organizations in the area. The intervention areas will receive the intervention package in addition to the routine standard health services. Outcome measures will include changes in maternal and newborn-care practices and perinatal and neonatal mortality rates between the intervention and control areas.

详细描述

The World Health Organization estimates that globally over 9 million infants die annually before birth or in the first few weeks of life, and that the majority of these deaths occur in the neonatal period. The bulk of these deaths result from pregnancy or delivery associated complications, premature births, intrauterine growth retardation and infectious diseases.

There are over seven million perinatal deaths annually globally mostly in developing countries. Almost 4 million newborns suffer moderate to severe birth asphyxia, with at least 800,000 dying and probably a higher number developing sequel such as epilepsy, mental retardation, cerebral palsy and learning disabilities. A recent community based study in Zimbabwe, which audited perinatal mortality showed the commonest single cause was perinatal asphyxia and an avoidable factor was detected in 76% of cases. In another population based study in Bangladesh, which showed a perinatal mortality rate of 75 per 1000 births (37 stillbirths, 38 first week deaths), the major causes of early neonatal death were attributed to a small size at birth (54%), birth asphyxia (26%), and tetanus (8%). In Bangalore, South India a prospective hospital based study of 4572 births showed a perinatal mortality of 43/1000. Using the Wiggles worth's classification , 24% were considered due to birth asphyxia, even after exclusion of the premature group. Similarly a recent evaluation of a large hospital-based birth cohort for perinatal deaths in Karachi according to the Wiggles worth's criteria, indicated that almost 30% of all deaths were related to acute asphyxia.

Hypotheses

  1. A concerted and coordinated community-based program of training first level primary care workers i.e. TBAs, LHWs, lady health visitors and rural health center physicians in the prevention, early recognition and management of common perinatal / neonatal problems will result in a significant reduction in perinatal and neonatal mortality in the Northern areas of Pakistan.
  2. A coordinated program of community education and awareness in the importance of perinatal care, prevention and recognition of neonatal problems will lead to improved neonatal health, better recognition of neonatal problems and care-seeking behavior.
  3. The strengthening of secondary care perinatal and newborn care and reproductive health services will lead to improved referral patterns for perinatal / neonatal problems with better outcome.
  4. Increasing the community awareness of neonatal problems and training of first level primary care workers will result in better domiciliary management of neonatal problems.

Phase 1: Formative Research The objectives of this first phase of the study are as follows

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pregnant women & participants who agree to participate in the study

排除标准

  • Pregnant women & participants who disagree to participate in the study

结局指标

主要结局

Reduction in perinatal and neonatal mortality

时间窗: 3 years

Baseline \& Endline Surveys

次要结局

  • Improvements in delaying first bath after birth(3 Years)
  • Improvements in colostrum administration(3 Years)
  • Improvements in antenatal care practices(3 Years)
  • Improvements in cord application practices(3 Years)
  • Improvements in initiation of breastfeeding practices within 1 hour after birth(3 Years)

研究者

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

Dr Zulfiqar Ahmed Bhutta

Professor

Aga Khan University

研究点 (2)

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