Excellent BRASSS-V Drape™ Versus Indirect Measurement Protocol for Measurement of Postpartum Blood Loss
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

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).
    

Detailed description: 
      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. However, visual
      estimation of postpartum hemorrhage often leads to underestimation of blood loss and
      subsequent delays in the seeking or provision of appropriate treatment. 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).

      We propose a randomized prospective study to compare the measurement of blood loss during the
      third stage of labor with two different methods: the modified WHO blood measurement protocol
      and the Excellent BRASSS-V Drape™. Upon admission in the labor ward, study staff will
      approach all delivering women about participation in the study and seek informed consent.
      Blood loss will be measured for all consenting women with vaginal deliveries.

      Women who agree to participate will be randomized to one of two blood collection techniques:
      a modified version of the WHO blood measurement protocol or the Excellent BRASSS-V Drape™.
      Blood loss will be measured from immediately after delivery and cord clamping for a period of
      at least one hour or until active bleeding stops. The blood loss will then be quantified by
      the study staff and recorded on the study form. Women will receive the facility's standard
      care for the management of the third stage of labor and, if applicable, treatment of PPH.

      Measures of postpartum hemoglobin levels will be taken at admission for delivery and
      twenty-four hours post-delivery for a randomly selected sub-set of study participants.
      Besides the measurement of blood loss and the regular measurement of hemoglobin for a
      sub-sample of participants, there will be no change to the hospital's standard procedures for
      labor and delivery.
    

Intervention name(s): Excellent BRASSS-V Drape™.; Indirect weight assesment of blood loss
Intervention type(s): Device; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: postpartum blood loss measurement; BRASSS-V drape