The CLIP (Community Level Interventions for Pre-Eclampsia)Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81,200
- 试验地点
- 1
- 主要终点
- The primary outcome will be combined maternal and or perinatal outcome (either maternal, fetal or neonatal death or severe morbidity for the mother or baby)
研究概览
简要总结
Pre-eclampsia remains a leading cause of maternal and perinatal mortality and morbidity. Globally 76000 maternal deaths occurs annually in addition 500000 fetal and newborn lives or lost annually due to the perinatal consequences of pre-eclampsia. Over 99 percent of theses deaths occur in low and middle income countries primarily in south Asia and sub Saharan Africa. In general, previous research has focused on institutional level interventions with MgSO4 and treatment of severe pregnancy hypertension, However if we limit ourselves to studying in patients, facility level, intervention with fully assessed treatment options, many women will die or be irreversibly affected by pre-eclapmsia prior to arriving at the in-patient facility. Maternal lives lost from pre-eclampsia and eclampsia as a result of delay in triage, transport and treatment. CLIP study is oriented to overcome these by Community Engagement, Community Health Care Provider training in home based maternity assessment, Diagnosis and triage by miniPIERS and CLIP PIERS on Move mobile applications (ASHA), Lowering severe hypertension by giving - oral methyldopa 750mg and or IM MgSO4 10g loading dose (only one dose is given and then refer to higher level of health care facility) and facility enhancement for management of pre-eclampsia and eclampsia.
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 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •All pregnant women permanent residents in selected clusters of Belgaum and Bagalkot district of Karnataka.
排除标准
- 未提供
结局指标
主要结局
The primary outcome will be combined maternal and or perinatal outcome (either maternal, fetal or neonatal death or severe morbidity for the mother or baby)
时间窗: During Antenatal, Delivery and Postnatal 42 day followup
次要结局
- Impact of the CLIP intervention on the delays around triage and transport.(During Antenatal, Delivery and Postnatal 42 day followup)
