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Accuracy of Blood Loss Estimation After Vaginal Delivery

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
blood loss estimation
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Postpartum Hemorrhage focused on measuring Estimated Blood Loss, Obstetrics, postpartum hemorrhage

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Any anesthesia or obstetric attending or resident may participate provided that they have rotated through obstetrics/obstetric anesthesia.

Exclusion Criteria:

  • Any provider that does not complete all of the stations will be excluded from analysis. Any participant who chooses to withdraw from the study will also be excluded from the analysis.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Calibrated drapes viewed first

Non-calibrated drapes viewed first

Arm Description

Caregivers were shown calibrated drape demonstrating level of blood and asked to estimate amount of blood in collection bag. These same individuals were then crossed over and shown non-calibrated drapes and asked to estimate the amount of blood they contained.

Standard vaginal delivery drape (non-calibrated) was shown to caregiver who was asked to estimate amount of blood. These same individuals were then crossed over and shown calibrated delivery drapes and asked to estimate the amount of blood they contained.

Outcomes

Primary Outcome Measures

Difference in Actual Blood Volume and Estimated Blood Volume in Milliliters.
Two types of drapes were used: drapes with and without volume calibrations. Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. The participants were asked to estimate the volume contained in the bag and the difference in milliliters between the estimate and actual volume was calculated.

Secondary Outcome Measures

Number and Type of Care Providers Assigned to Study Arms.
Level of Training
Number of Years of Clinical Experience Providing Patient Care Requiring Blood Loss Estimation.

Full Information

First Posted
April 17, 2007
Last Updated
March 17, 2014
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT00462839
Brief Title
Accuracy of Blood Loss Estimation After Vaginal Delivery
Official Title
The Accuracy of Blood Loss Estimation After Simulated Vaginal Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Post-partum hemorrhage (PPH) is defined as blood loss greater than 500 mL after vaginal delivery. Delayed diagnosis of PPH is a major cause of maternal morbidity and mortality. Obstetricians estimate blood loss at delivery by visual estimation of blood collected in the obstetric drapes. Blood is often mixed with urine and surgical sponges. The urine, blood, and sponges collect in a cone shaped plastic bag that is suspended from the perineum during delivery. Visual estimation of blood loss is insensitive in diagnosing PPH. In one study visual assessment of blood loss underestimated postpartum blood loss by 33% to 50% compared to an objective measurement of blood loss using photospectrometry. Other studies have shown that the magnitude of underestimation increases as the amount of blood loss is increased. A limitation of previous studies is that there is no "gold standard" for blood loss determination in the third stage of labor. Care providers (obstetricians, anesthesiologists, and labor & delivery nurses) need to be able to accurately estimate blood loss in order to better care for mothers and prevent morbidity and mortality. It is unknown whether provider type or experience (obstetric and anesthesiology resident, fellow, attending physicians, and nurses) influences the accuracy of blood loss estimation, or whether blood loss estimation can be improved by providing graduated markings on the vaginal delivery drape.
Detailed Description
Packed red blood cells discarded by the blood bank will be mixed with normal saline to simulate whole blood with a hematocrit of 33%. A total of eight isolated study stations will be set up (study participants will only be able to visualize the vaginal delivery drape for one station at a time). The simulated blood will be mixed with urine and sponges and be placed in suspended blood collection drapes which are used during vaginal deliveries at Northwestern Memorial Hospital. Two types of drapes will be used: drapes without calibrated markings and drapes with calibrated markings. Calibrated volume markings will begin at 500 mL at 500 mL intervals to 2500 mL. Study participants will be randomized to one of two groups. Randomization will occur in blocks depending on provider type. Group 1 will view the unmarked vaginal collection drapes first and Group 2 will view the collection drapes with the calibrated markings first. Both groups will analyze the initial four study stations in random order. At the completion of the four study stations, the group which evaluated the drapes without markings will cross over to view the stations with calibrated markings and the group that views uncalibrated drapes will then view the calibrated drapes. Each study participant will view a station and write his/her estimation of blood loss on a data card. Study participants will NOT be allowed to change answers once they have been recorded. Demographic data on study participants will include provider type, level of training/years of practice, and gender.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Estimated Blood Loss, Obstetrics, postpartum hemorrhage

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calibrated drapes viewed first
Arm Type
Experimental
Arm Description
Caregivers were shown calibrated drape demonstrating level of blood and asked to estimate amount of blood in collection bag. These same individuals were then crossed over and shown non-calibrated drapes and asked to estimate the amount of blood they contained.
Arm Title
Non-calibrated drapes viewed first
Arm Type
Active Comparator
Arm Description
Standard vaginal delivery drape (non-calibrated) was shown to caregiver who was asked to estimate amount of blood. These same individuals were then crossed over and shown calibrated delivery drapes and asked to estimate the amount of blood they contained.
Intervention Type
Procedure
Intervention Name(s)
blood loss estimation
Other Intervention Name(s)
Estimated Blood Loss (EBL)
Intervention Description
Participants were randomized in blocks, by provider type to view either the four calibrated stations or the four non-calibrated stations. The order of the volumes within each set of stations was randomized. Participants received a data card for each station on which they wrote the volume estimated. After each station, the data card was collected. Alterations to the estimations were not allowed once the answers were recorded. Subjects were then crossed over to the other group and asked to estimate the blood volumes in the non-calibrated drapes if they had first viewed the calibrated drape or the calibrated drape if they had viewed the non-calibrated drape. The order of viewing the four volumes was again randomized. The volumes were the same at the corresponding station for the calibrated and non-calibrated stations so the impact of the calibration markings on accuracy could be determined.
Primary Outcome Measure Information:
Title
Difference in Actual Blood Volume and Estimated Blood Volume in Milliliters.
Description
Two types of drapes were used: drapes with and without volume calibrations. Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. The participants were asked to estimate the volume contained in the bag and the difference in milliliters between the estimate and actual volume was calculated.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Number and Type of Care Providers Assigned to Study Arms.
Time Frame
1 hour
Title
Level of Training
Time Frame
1 hour
Title
Number of Years of Clinical Experience Providing Patient Care Requiring Blood Loss Estimation.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Any anesthesia or obstetric attending or resident may participate provided that they have rotated through obstetrics/obstetric anesthesia. Exclusion Criteria: Any provider that does not complete all of the stations will be excluded from analysis. Any participant who chooses to withdraw from the study will also be excluded from the analysis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia A Wong, M.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
Citation
C. Beckman. Obstetrics and Gynecology. Post Partum Hemorrhage, Chapter 12. 3rd edition. Lippincott Williams & Wilkins 1998; 154-161.
Results Reference
background
Citation
Cunningham FG, Leveno KL, Bloom SL, et al. Williams Obstetrics, 22th ed, New York: McGraw-Hill, 2005.
Results Reference
background
PubMed Identifier
16626718
Citation
Patel A, Goudar SS, Geller SE, Kodkany BS, Edlavitch SA, Wagh K, Patted SS, Naik VA, Moss N, Derman RJ. Drape estimation vs. visual assessment for estimating postpartum hemorrhage. Int J Gynaecol Obstet. 2006 Jun;93(3):220-4. doi: 10.1016/j.ijgo.2006.02.014. Epub 2006 Apr 12. Erratum In: Int J Gynaecol Obstet. 2006 Dec;95(3):312.
Results Reference
background
PubMed Identifier
11044547
Citation
Prasertcharoensuk W, Swadpanich U, Lumbiganon P. Accuracy of the blood loss estimation in the third stage of labor. Int J Gynaecol Obstet. 2000 Oct;71(1):69-70. doi: 10.1016/s0020-7292(00)00294-0. No abstract available.
Results Reference
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Accuracy of Blood Loss Estimation After Vaginal Delivery

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