“Enhancing Intrapartum Care through Wireless Fetal Monitoring: Assessing Acceptability, feasibility, and Clinical Impact in Selected Health Facilities of Biharâ€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 9,720
- 试验地点
- 1
- 主要终点
- Feasibility of using such devices in healthcare settings of Bihar.
研究概览
简要总结
:Enhancing Intrapartum Care through Wireless Fetal Monitoring: Assessing Acceptability, feasibility, and Clinical Impact in
Selected Health Facilities of Bihar
Objective 1: To assess the clinical utility of wireless fetal monitoring (WFM) devices by comparing the proportion of abnormal fetal heart rate (FHR)tracings captured to the actual incidence of fetal asphyxia in babies requiring emergency delivery, resuscitation, or NICU care. Objective 2: To evaluate the feasibility, usability, and learnability of wireless fetal monitoring devices when utilized by frontline healthcare workers during intrapartum care. Objective 3: To explore the perceptions and experiences of laboring women towards the use of wireless fetal monitoring device.
Study design - Prospective observational study Study site- 3 centers-Arwal District Hospital, FRU Phulwarisharif, SDH Danapur Population- 9720 antenatal women Intervention (if any)- Intrapartum wireless electronic fetal monitoring Comparison Group (if any) - No Outcome Measures -This objective aims to determine the effectiveness of WFM in early detection of fetal distress and its potential impact on improving perinatal outcomes Sample size estimation (if required)-9720 antenatal women Statistical analysis- descriptive analysis Ethical issues- All data analysis will be conducted in compliance with ethical guidelines to ensure participant confidentiality and privacy.
Feasibility of using such devices in healthcare settings of Bihar will be better and whether the healthcare workers are able to use it for the benefit of labouring women. The qualitative part of the study is to assess the perceptions and experiences of laboring women towards the use of wireless fetal monitoring devices will be available analyzed thematically using qualitative content analysis The most important outcome will be on the detection of fetal distress in time to get intervention and improved stillbirth rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Consenting singleton pregnant women in labour (first stage) 18-40 years.
排除标准
- •Multiple pregnancy 2) Malpresentations 3) Previously scarred uterus (cesarean section, myomectomy) 4) Pregnant Women requiring referral for other high-risk conditions like eclampsia,sepsis, severe anemia, heart disease.
结局指标
主要结局
Feasibility of using such devices in healthcare settings of Bihar.
时间窗: 6 months, 12 months and 18 months
The qualitative part: to assess the perceptions and experiences of laboring women towards the use of wireless fetal monitoring devices will be available analyzed thematically using qualitative content analysis.
时间窗: 6 months, 12 months and 18 months
The most important outcome will be on the detection of fetal distress in time to get
时间窗: 6 months, 12 months and 18 months
intervention and improved stillbirth rates.
时间窗: 6 months, 12 months and 18 months
次要结局
- Assess the clinical utility of wireless fetal monitoring devices by comparing the proportion of abnormal fetal heart rate tracings captured to actual incidence of fetal asphyxia in babies requiring emergency delivery, resuscitation or neonatal care(6 months, 12 months, 18 months)