N/A
N=242
Validating a New Method to Assess Estimated Blood Loss in the Obstetric Population
Pregnancy Complications
Bottom Line
View on ClinicalTrials.gov: NCT03404375 ↗Enrolled (actual)
242
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Clinical Estimated Blood Loss (EBL) Between Cases and Controls Using Clinical Estimate Versus Device Assessment — 800; 800 milliLiters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gauss Triton system (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Estimated Blood Loss (EBL) Between Cases and Controls Using Clinical Estimate Versus Device Assessment |
800; 800 | — |
| PRIMARY Triton Device Estimated Blood Loss (EBL) Between Cases and Controls Using Clinical Estimate Versus Device Assessment |
474; 331 | — |
| SECONDARY Transfusion Requirements |
0; 1 | — |
| SECONDARY Number of Participants With Post-partum Hemorrhage |
8; 11 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Pregnant women between the ages of 18-50
- Scheduled cesarean delivery
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03404375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.