Non-Pneumatic Anti-Shock Garment for Obstetrical Hemorrhage: Zambia and Zimbabwe (NASG)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00488462|
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : January 21, 2015
|Condition or disease||Intervention/treatment|
|Hypovolemic Shock Hemorrhage||Device: non-pneumatic anti-shock garment|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||887 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-Pneumatic Anti-Shock Garment for Obstetrical Hemorrhage: Zambia and Zimbabwe|
|Study Start Date :||October 2007|
|Primary Completion Date :||May 2012|
|Study Completion Date :||May 2012|
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.
- Frequency of mortalities and frequency of severe morbidities combined as extreme adverse outcomes [ Time Frame: during hospital stay ]
- Mean amount of blood loss in mL , frequency of emergency hysterectomy, time to recovery from shock. [ Time Frame: during hospital stay ]Blood loss as measured by the blood collection drape at the RH or pad between SHF and RH.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)|