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临床试验/NCT05640063
NCT05640063已完成不适用

Evaluation of the Impact of Enhanced Delivery and Newborn Kits as Compared to Standard Delivery Kits in the Flood Affected Districts of Sindh Pakistan A Cluster Randomized Trial

Aga Khan University2 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2023年3月1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
2,400
试验地点
2
主要终点
Perinatal mortality rate

研究概览

简要总结

The evidence is required to assess the effectiveness of enhanced delivery and newborn kits as compared to standard delivery kits in the flood affected districts that can increase the utilization of services and reduce the delays that are responsible for poor maternal and newborn health through Lady Health Worker (LHW) program.

详细描述

Addressing birth-related deaths is especially important since they frequently result from problems during childbirth, creating emergency situations with a limited window of opportunity for intervention (1).Globally, 2.4 million newborns die each year with one million of these neonatal deaths in the first week of life and 1.2 million stillborn neonates are caused by maternal health complications, indicating a significant intervention gap exists throughout pregnancy, childbirth, and the early postpartum period, when mothers and babies are most at risk (2). The major cause of maternal mortality is obstetric hemorrhage, puerperal sepsis, and hypertensive disorders in pregnancy. Anemia and malaria are the commonest indirect cause of maternal morbidity and mortality (3). Among newborn deaths sepsis is the leading cause followed by birth asphyxia and low birth weight. These complications compounded by unhygienic delivery practices such as lack of cord care, with no proper handwashing and improper waste disposal at home and at facility (4).

Though, there are many variables that contribute to maternal and neonatal fatalities, one of the most efficient ways to address this issue is to quickly provide mothers and newborns with effective preventive measures or treatment, frequently at home or at first level healthcare platform (5; 6).

Recent rains and floods also have damaged not only the health care facilities but access to these facilities is a challenge (10). In times of crisis, the capacity of health facilities, including skilled birth attendants and emergency obstetric care is often unavailable, which increases women's vulnerability. Complications that occur during pregnancy or childbirth are a leading cause of death and illness among women and young girls in the affected areas. According to the United Nations Population Fund, more than 650,000 pregnant women in flood affected areas require urgent maternal health services, with at least 73,000 women expected to give birth. (11).Hypothesis We hypothesize that provision of the Enhanced delivery and newborn kits will reduce the Perinatal mortality as compared to standard delivery kits Operational Definition of Perinatal Mortality "Perinatal mortality is an important outcome indicator for newborn care and directly mirrors the quality of prenatal, intra partum and newborn care" (18).

The specific objectives of this study are

Primary Objective:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Pregnant women in the project sites living in the area till expected date of their delivery.

排除标准

  • The individuals who would not consent to participate in the study voluntarily.

结局指标

主要结局

Perinatal mortality rate

时间窗: 12 months

"Perinatal mortality is an important outcome indicator for newborn care and directly mirrors the quality of prenatal, intra partum and newborn care"

次要结局

  • Cause specific neonatal mortality(12 months)
  • Cause specific maternal mortality(12 months)
  • Maternal morbidity(12 months)

研究者

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

Dr Zulfiqar Ahmed Bhutta

Distinguish University Professor

Aga Khan University

研究点 (2)

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