Validating a New Method to Assess Estimated Blood Loss in the Obstetric Population
Completed · Not applicable
Conditions studied: Pregnancy Complications
In brief
Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and the primary cause of nearly one quarter of all maternal deaths globally. Estimates of blood loss at delivery are notoriously inaccurate, with under-estimation more common than over-estimation. Traditionally, the surgeon performing the cesarean section would estimate the blood loss by visually assessing the blood collected in the surgical drape and counting the number of lap sponges used thru out the procedure. The investigators would like to study and validate an FDA approved device called the gauss Triton device used to estimate blood loss during scheduled cesarean sections.
Key facts
- Study ID
- NCT03404375
- Run by
- The University of Texas Medical Branch, Galveston
- People needed
- 242
- Starts
- 2018-03-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2021-02-25
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Pregnant women between the ages of 18-50
- Scheduled cesarean delivery
You may not qualify if…
- Incarcerated patients
- Patient unwilling or unable to provide consent
- Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians)
- Placenta previa or other known placental anomalies
- Enrolled in another trial that may affect outcome.
Where it is running
- University of Texas Medical Branch — Galveston, Texas, United States
Full record on ClinicalTrials.gov
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