Non-Pneumatic Anti-Shock Garment for Obstetrical Hemorrhage: Zambia and Zimbabwe (NASG)
This trial will address the question of whether early application of the Non-pneumatic Anti-Shock Garment (NASG) at the Satellite Health Facility (SHF) level before transport to a Referral Hospital (RH) will decrease maternal mortality and morbidity. The available evidence indicates that the NASG substantially decreases blood loss, but there is no evidence that its application will reduce extreme adverse outcomes. It is also not known if possible side effects associated with NASG use might outweigh potential benefits. This study would rigorously test the effectiveness of the NASG using an experimental design with adequate power to detect statistically significant decreases in morbidity and mortality.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Non-Pneumatic Anti-Shock Garment for Obstetrical Hemorrhage: Zambia and Zimbabwe|
- Frequency of mortalities and frequency of severe morbidities combined as extreme adverse outcomes [ Time Frame: during hospital stay ] [ Designated as safety issue: No ]
- Mean amount of blood loss in mL , frequency of emergency hysterectomy, time to recovery from shock. [ Time Frame: during hospital stay ] [ Designated as safety issue: No ]Blood loss as measured by the blood collection drape at the RH or pad between SHF and RH.
|Study Start Date:||October 2007|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
No Intervention: Control
Clinics will collect data on patients experiencing shock due to obstetrical hemorrhage. In the control arm, half of the study clinics will not use the NASG but the NASG will be available at the referral hospital for patients transported there.
Clinics will collect data on patients experiencing shock due to obstetrical hemorrhage. In the intervention arm, half of the study clinics will use the NASG on patients before transporting to the referral hospital.
Device: non-pneumatic anti-shock garment
In the intervention arm, half of the study clinics will use the NASG when a patient meets the study criteria.
This study is a cluster randomized controlled trial to examine the effects of NASG application as a first-aid device at the SHFs before transfer to Referral Hospitals (RHs).
The first step will include 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. Next will be a period of baseline data collection at the RHs and SHFs, during which clinical and demographic data will be collected from women diagnosed with obstetric hemorrhage and shock. After this baseline data collection period, we will introduce the study intervention, initially at the RHs and then at SHFs.
The intervention will include: 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 are fully trained and have become proficient in NASG use, SHFs will be randomized into 19 intervention and 19 control facilities. Intervention SHFs will receive the NASG training described above, while control SHFs will receive a refresher training on the topics included in the baseline training.
The final step will be three years 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. A total of approximately 2,340 women from the SHFs will be included in the NASG-intervention data collection phase of the cluster randomized trial: 1,170 women in the intervention group and 1,170 women in the control group.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488462
|Kitwe Central Hospital|
|Kitwe, Copperbelt, Zambia|
|Ndola Central Hospital|
|Ndola, Copperbelt, Zambia|
|University Teaching Hospital (UTH)|
|Parienyatwa Group of Hospitals|
|Principal Investigator:||Suellen Miller, CNM, PhD||University of California, San Francisco|
|Study Director:||Elizabeth Butrick, MPH, MSW||University of California, San Francisco|
|Principal Investigator:||Thulani Magwali, OBGYN||University of Zimbabwe Hospital, Harare, Zimbabwe (UZ)|
|Principal Investigator:||Gricelia Mkumba, OBGYN||University Teaching Hospital, Lusaka Zambia (UTH)|