Excellent BRASSS-V Drape™ Versus Indirect Measurement Protocol for Measurement of Postpartum Blood Loss

NCT01885845 | Completed

• 1 other identifier: 2.4.7
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

postpartum blood loss measurement; BRASSS-V drape

Outcome Measures

Primary Outcomes (1)

• Mean blood loss

  after delivery to when active bleeding has stopped or at least one hour

Study Arms (2)

BRASSS-V drape

EXPERIMENTAL

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.

Device: Excellent BRASSS-V Drape™.

Indirect weight method

EXPERIMENTAL

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.

Other: Indirect weight assesment of blood loss

Interventions

Excellent BRASSS-V Drape™. DEVICE

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.

BRASSS-V drape

Indirect weight assesment of blood loss OTHER

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.

Indirect weight method

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Vaginal birth

Sponsors & Collaborators

• Gynuity Health Projects: lead

Study Sites (1)

KEM Hospital

Pune, India

Location

Related Publications (1)

• Ambardekar S, Shochet T, Bracken H, Coyaji K, Winikoff B. Calibrated delivery drape versus indirect gravimetric technique for the measurement of blood loss after delivery: a randomized trial. BMC Pregnancy Childbirth. 2014 Aug 15;14:276. doi: 10.1186/1471-2393-14-276.

  PMID: 25128176 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hillary Bracken, PhD

  Gynuity Health Projects

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 25, 2013
• Study Start: November 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

IN (1)