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临床试验/NCT01994304
NCT01994304已完成不适用

Assessment and Evaluation of the Safe Childbirth Checklist --Phase II Rajasthan, India

Public Health Foundation of India1 个研究点 分布在 1 个国家目标入组 200,000 人开始时间: 2012年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200,000
试验地点
1
主要终点
Perinatal mortality

研究概览

简要总结

PHFI independently evaluated the effectiveness of the Safe Childbirth Checklist program in preventing stillbirths and early neonatal deaths. Evaluation used a quasi-experimental design with data collection from 34 facilities across six intervention districts and four control districts. The study with a sample of 137,000 births has 88% power to detect 15% reduction in intrapartum mortality. Data on this was collected over a period of 17 months (November 2013 to April 2015).

详细描述

The Safe Childbirth Checklist (SCC), a tool that provides reminders and is a job aid to health care providers is a new maternal and newborn care intervention that is being implemented by the Government of Rajasthan with technical support from Jhpeigo. SCC is thus expected to improve the quality of delivery care practices and was implemented in Community Health Centres (CHCs) and District Hospitals (DHs) across seven districts in Rajasthan over a two-year time period (2013 to 2015). PHFI independently evaluated the effectiveness and cost-effectiveness of the SCC in preventing intrapartum (stillbirths and very early neonatal deaths within 3-days after births). Data on 137,000 births was collected over a period of 17 months (November 2013 to April 2015) from 34 facilities with sick newborn care centres (SNC).

Facility records were main source of outcome data. Labor room provided data on stillbirths whereas information on very early neonatal deaths came from SNCs. All Data collection and management was done through software specifically developed for this purpose.

For a better understanding on how maternal and neonatal complications are diagnosed and managed at the facility, in-depth interviews were conducted with the service providers (specialists, physicians, labor room staff nurses, and pharmacists) from the District hospitals and CHCs. In addition, interviews focused on understanding the use, acceptability and feasibility of the SCC among various types of providers.

Cost of this intervention was estimated from a program perspective, and cost effectiveness in terms of cost per perinatal death prevented was calculated.

Preliminary analysis has found that SCC is significantly associated with a 11% reduction in intrapartum deaths.

研究设计

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

入排标准

年龄范围
15 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • All women who deliver at the District Hospitals (DHs), Sub-District Hospitals (SDHs) and Community Health Centres (CHCs)

排除标准

  • 未提供

研究组 & 干预措施

Safe Childbirth Checklist

Active Comparator

The selected districts for SCC intervention include Alwar, Jalore, Sirohi, Sikar, Dausa, and Churu

干预措施: SCC (Behavioral)

No safe childbirth checklist

No Intervention

The selected control districts include Bharatpur, Pali, Jhunjhunu, and Nagaur

结局指标

主要结局

Perinatal mortality

时间窗: 18 months (Nov-2013 to May-2015)

This evaluation will independently estimate the effectiveness of the Safe Childbirth Checklist in reduce perinatal mortality by 15% in the intervention areas

次要结局

  • Morbidity rates for infants and mothers(18 months (Nov-2013 to May-2015))

研究者

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

Dr. Beena Varghese

Sr. Health Economist and Additional Professor

Public Health Foundation of India

研究点 (1)

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