Excellent BRASSS-V Drape™ Versus Indirect Measurement Protocol for Measurement of Postpartum Blood Loss
NCT01885845 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900
Last updated 2013-06-25
Summary
Postpartum hemorrhage is one of the most common causes of maternal mortality and serious maternal morbidity, especially in the developing world. In India, hemorrhage is a major cause of maternal mortality: A study by the Register General in 1993 showed that 23 percent of all maternal deaths in rural areas were caused by hemorrhage (Sibley, 2005).
The measurement of postpartum blood loss and identification of postpartum hemorrhage are important measures in efforts to prevent and treat postpartum hemorrhage. In recent years, researchers have employed several different methods to measure blood loss in hospital and community-based birth settings. Although research has demonstrated that these laboratory measures are more accurate then visual estimation techniques, no studies have explicitly documented the systematic differences (if any) among different collection modalities. Moreover, only a few of these studies have correlated measured blood loss with changes in hemoglobin levels experienced between the antepartum and postpartum period. The aim of this study is to compare variations in the measurement of blood loss obtained using two popular measurement methods: the Excellent BRASSS-V Drape™ and a modified version of the blood collection method developed by the World Health Organization (WHO).
Conditions
- Postpartum Hemorrhage
Interventions
- DEVICE
-
Excellent BRASSS-V Drape™.
Immediately after delivery and cord clamping, blood measurement will begin. The calibrated delivery drape should be placed under the buttocks of the woman and tied around the woman's waist with the funnel portion hanging down between her legs. Blood loss will be measured for at least one hour or, if bleeding continues after one hour, until active bleeding has stopped.
- OTHER
-
Indirect weight assesment of blood loss
Just after delivery and cord clamping, a sheet with plastic backing will be placed under the buttocks of the woman. A basin will be placed directly under her on a small shelf on the delivery table. Blood loss will be measured for at least one hour or, if bleeding continues after one hour, until active bleeding has stopped. After bleeding has stopped, all gauze pieces and mops will be counted and then placed in the collection basin. The basin will be placed on the scale and weighed. The weight of the blood will be assessed by subtracting the weight of the basin, gauzes and mops from the total weight of the soaked materials assuming that one gram is equivalent to 1 ml.
Sponsors & Collaborators
-
Gynuity Health Projects
lead OTHER
Principal Investigators
-
Hillary Bracken, PhD · Gynuity Health Projects
Study Design
- Allocation
- RANDOMIZED
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2005-11-30
- Primary Completion
- 2007-09-30
- Completion
- 2007-09-30
Countries
- India
Study Locations
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