Implementing and Evaluating an Antenatal High-Risk Pregnancy Intervention Bundle in Rural Nepal
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Maternal Near Miss
研究概览
简要总结
The proposed study will assess and implement a comprehensive antenatal HRP screening and telehealth follow-up program in rural Nepal. The main questions it aims to answer are:
- To estimate the burden of HRPs using the existing Antenatal Risk-Score Checklist in rural Nepal
- Assess acceptability, feasibility, preliminary effectiveness, and implementation outcomes of the HRP bundle at the primary healthcare in Nepal
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •all pregnant women above who are receiving antenatal care at Melamchi Primary Health Care Center
排除标准
- •life-threatening maternal or fetal conditions requiring immediate tertiary-level care
- •unable to provide informed consent due to cognitive or language barriers
- •do not have access to a mobile phone for telehealth consultations.
研究组 & 干预措施
Standard of Care
Usual prenatal care, including on-site consultation and visits from health facility staff
High Risk Pregnancy (HRP) Bundle Intervention Arm
The intervention arm would include 1. identification of high-risk pregnancy 2. Teleconsultation with expert consultant 3. weekly call with patient navigator 4. training of health care provider for HRP care, and 5. visits in the weekly prenatal telehealth clinic
干预措施: High Risk Pregnancy Bundle (Other)
结局指标
主要结局
Maternal Near Miss
时间窗: up to 60 days postpartum
life-threatening complication during pregnancy, childbirth, or within 42 days postpartum, but survives with appropriate medical intervention (We will use WHO criteria)
次要结局
- Neonatal death(Up to 28 days after birth)
- Low Apgar Score at 5 Minutes(At 5 minutes after birth)
- Neonatal Intensive Care Unit Admission(Up to 30 days after birth)
- Need for Mechanical Ventilation(up to 30 days after birth)
- Neonatal Respiratory Distress Syndrome(Up to 30 days after birth)
- Neonatal Hypoglycemia(Up to 48 hours after birth)
- Low Birth Weight(At birth)
- Composite Adverse Neonatal Outcome(up to 30 days after birth)
- Antenatal Risk Screening Rate(Up to 24 months)
- Referral Rate(Up to 24 months)
- Telehealth Consultation Utilization Rate(Up to 24 months)