Evaluation of the CRADLE vital sign alert device in the management of hypertension and shock in pregnancy in low-resource settings to reduce maternal mortality and morbidity: a stepped wedge randomised controlled trial
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30784635 results 2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/30925157 secondary analysis 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30999963 results (added 27/08/2019) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/33882864/ secondary analysis (added 23/04/2021) 2020 Abstract results in https://doi.org/10.1186/s13012-020-01062-3 P24 (added 10/03/2023) 2018 Other publications in http://dx.doi.org/10.1136/bmjinnov-2017-000235 Development and evaluation of a novel Vital Signs Alert device for use in pregnancy in low-resource settings (added 10/03/2023) 2018 Other publications in https://doi.org/10.1186/s12884-018-1737-x Feasibility study results (added 10/03/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. All pregnant/postpartum women living in Trial Area catchment areas* within the trial time frame
- •2. Women identified as pregnant or within the 6 weeks post-partum period, presenting for antenatal, intrapartum or postpartum care
- •*Catchment areas will be defined by local investigators, and include all possible outreach facilities that result in women being assessed and referred to a defined central facility/ies, prior to randomisation and remain constant throughout the study period.
排除标准
- •There will be no exclusion criteria, including age of women, as, from an ethical and logistical standpoint, all pregnant women (including those below the age of 16 years) should have access to blood pressure measurement during pregnancy. Data are to be collected at a cluster level rather than at an individual level.