跳至主要内容
临床试验/CTRI/2024/07/069796
CTRI/2024/07/069796尚未招募不适用

Implementation Research to develop an optimized model of comprehensive intervention package and delivery strategies to reduce stillbirth

ICMR3 个研究点 分布在 1 个国家目标入组 7,000 人开始时间: 2024年7月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
ICMR
入组人数
7,000
试验地点
3
主要终点
Proportion of pregnant women covered by the package of interventions

研究概览

简要总结

Despite progress in maternal and child health, India contributes the maximum number of stillbirths globally (0.34 million stillbirths annually). Additionally, there is a lack of robust data on stillbirths’ burden, timing, and causes. Interventions are scattered across multiple national guidelines with the absence of a comprehensive package and effective delivery strategies. This implementation research aims to integrate effective antepartum and intrapartum care interventions and develop a comprehensive intervention package to reduce stillbirth. The primary outcome is reduction in stillbirth as well as development of a scalable sustainable model. The creation of innovative delivery strategies will utilize an exploratory sequential mixed-methods approach. The study will be conducted in three phases:  Phase 1: Formative research, baseline survey, and development of the initial Model or Model 1 of intervention delivery strategies. Phase 2: Develop a comprehensive package of interventions and effective delivery strategies through an iterative process of model optimization. Phase 3: Implementation and evaluation of the optimized model for intervention coverage and process indicators that are likely to have an impact on stillbirth reduction.

Project  Coordinator :

 Dr. Reema Mukherjee

Scientist E

Division of RCN,

ICMR,

Ansari Nagar

Delhi

研究设计

研究类型
Observational

入排标准

年龄范围
15.00 Year(s) 至 49.00 Year(s)(—)
性别
All

入选标准

  • All women in the reproductive age group and pregnant women, again specified that this is an IR study hence the study will also in its formative research interview family members, health care workers, etc.

排除标准

  • 未提供

结局指标

主要结局

Proportion of pregnant women covered by the package of interventions

时间窗: Baseline (0-3 months) and Endline (30-36 months)

次要结局

  • Stillbirth rate(Baseline (0-3 months) & Endline (30-36 months). The sites will be assessing if the package of interventions resulted in a reduction of the SBR in the study sites, hence this will be assessed at baseline & then at endline)

研究者

发起方
ICMR
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Reema Mukherjee

Indian Council of Medical Research

研究点 (3)

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