Sponsors:
US National Institutes of Child Health and Human Development
The Bill & Melinda Gates Foundation
Protocol Summary:
This study was a cluster randomized controlled trial to examine the effects of NASG application as a first-aid device at satellite health facilities (SHFs) before transfer to Referral Hospitals (RHs). The first step included start-up activities and formative data collection, including facility staff training in data collection, how to collect blood in the closed-end blood collection drape, and in an evidence-based standardized clinical protocol for obstetric hemorrhage prevention and hemorrhage and shock management. The next was a period of baseline data collection at the RHs and SHFs, during which clinical and demographic data was collected from women diagnosed with obstetric hemorrhage and shock. After the baseline data collection period, the study intervention was introduced initially at the RHs and then at SHFs. The intervention included: review of study protocol differences between baseline and the NASG-intervention phases, provision of the NASG, detailed training on the use of NASG for health care providers and staff, as well as on-site support and supervision for use of the NASG. After the RH providers were fully trained and had become proficient in NASG use, SHFs were randomized into 19 intervention and 19 control facilities. Intervention SHFs received the NASG training described above, while control SHFs received a refresher training on the topics included in the baseline training. The final step was a three year period of NASG-intervention data collection at the RHs and the SHFs on women diagnosed with obstetric hemorrhage and shock on the same outcomes collected in the baseline period.
Years: 2007 – 2012
Investigators:
Thungali Magwalie, MBChB, MSc
Suellen Miller, PhD
Locations: City of Harare Polyclinics and Parirenyatwa and Harare Central Hospitals
Non-Network
Completed Study
Publication:
Miller S, Eergel EF, El Ayadi AM, Gibbons L, Butrick EA, et al. (2013) Non-pneumatic anti-shock garment (NASG), a first-aid device to decrease maternal mortality from obstetric hemorrhage: a cluster randomized trial. PloS One; 8(10): e76477.
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