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Trial record 2 of 14370 for:    Hemorrhage AND blood loss

Accuracy of Blood Loss Estimation After Vaginal Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00462839
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : December 9, 2011
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
Cynthia Wong, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Health Services Research
Condition Postpartum Hemorrhage
Intervention Procedure: blood loss estimation
Enrollment 106
Recruitment Details The study was conducted on two separate dates at Prentice Women's Hospital. Eight stations were set up in 8-12 hour periods in an empty labor and delivery room. Participants were randomized in blocks by provider type. The order of the volumes was randomized. Subjects were not informed that the volumes in the two groups were the same.
Pre-assignment Details  
Arm/Group Title Calibrated Vaginal Delivery Drapes Viewed First Noncalibrated Drapes Viewed First
Hide Arm/Group Description Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated. No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
Period Title: Viewed First
Started 53 53
Completed 53 53
Not Completed 0 0
Period Title: Viewed Second
Started 53 53
Completed 53 53
Not Completed 0 0
Arm/Group Title Calibrated Vaginal Delivery Drapes Viewed First Noncalibrated Drapes Viewed First Total
Hide Arm/Group Description Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated. No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated. Total of all reporting groups
Overall Number of Baseline Participants 53 53 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 53 participants 106 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
53
 100.0%
53
 100.0%
106
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 53 participants 106 participants
Female
34
  64.2%
32
  60.4%
66
  62.3%
Male
19
  35.8%
21
  39.6%
40
  37.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 53 participants 53 participants 106 participants
53 53 106
1.Primary Outcome
Title Difference in Actual Blood Volume and Estimated Blood Volume in Milliliters.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
per protocal
Arm/Group Title Calibrated Vaginal Delivery Drapes Viewed First Noncalibrated Drapes Viewed First
Hide Arm/Group Description:
Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
Overall Number of Participants Analyzed 53 53
Mean (95% Confidence Interval)
Unit of Measure: milliliters
300 ml
-20.8
(-56.8 to 15.1)
-41.7
(-77.7 to -5.7)
500 ml
-53.5
(-100.6 to -6.4)
-96.0
(-143.0 to -48.8)
1000 ml
-32.8
(-150.3 to 84.6)
-145.3
(-262.8 to -27.8)
2000 ml
-178
(-328.0 to -28.4)
-829.8
(-980.0 to -680.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calibrated Vaginal Delivery Drapes Viewed First, Noncalibrated Drapes Viewed First
Comments Repeated measures ANOVA comparing all levels of blood estimation (P=0.0002). Post-hoc comparisons using Bonferroni corrects t-tests.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments Post-hoc comparison of 500ml, 1000ml and 2000ml volumes were greater in the non-calibrated drape first group. Post-hoc comparisons made using Bonferroni correct t-test for 8 comparisons.
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Number and Type of Care Providers Assigned to Study Arms.
Hide Description [Not Specified]
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title Calibrated Vaginal Delivery Drapes Viewed First Noncalibrated Drapes Viewed First
Hide Arm/Group Description:
Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
Overall Number of Participants Analyzed 53 53
Measure Type: Number
Unit of Measure: participants
Anesthesia 21 22
Obstetrics 20 22
Nursing 12 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calibrated Vaginal Delivery Drapes Viewed First, Noncalibrated Drapes Viewed First
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
3.Secondary Outcome
Title Level of Training
Hide Description [Not Specified]
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calibrated Vaginal Delivery Drapes Viewed First Noncalibrated Drapes Viewed First
Hide Arm/Group Description:
Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
Overall Number of Participants Analyzed 53 53
Measure Type: Number
Unit of Measure: participants
Attending physician 19 22
Resident physician 22 22
Nurse 12 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calibrated Vaginal Delivery Drapes Viewed First, Noncalibrated Drapes Viewed First
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
4.Secondary Outcome
Title Number of Years of Clinical Experience Providing Patient Care Requiring Blood Loss Estimation.
Hide Description [Not Specified]
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calibrated Vaginal Delivery Drapes Viewed First Noncalibrated Drapes Viewed First
Hide Arm/Group Description:
Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
Overall Number of Participants Analyzed 53 53
Measure Type: Number
Unit of Measure: participants
< 5 years 30 29
5-10 years 11 13
> 10 years 12 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calibrated Vaginal Delivery Drapes Viewed First, Noncalibrated Drapes Viewed First
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Calibrated Vaginal Delivery Drapes Viewed First Noncalibrated Drapes Viewed First
Hide Arm/Group Description Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated. No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
All-Cause Mortality
Calibrated Vaginal Delivery Drapes Viewed First Noncalibrated Drapes Viewed First
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Calibrated Vaginal Delivery Drapes Viewed First Noncalibrated Drapes Viewed First
Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/53 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Calibrated Vaginal Delivery Drapes Viewed First Noncalibrated Drapes Viewed First
Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/53 (0.00%) 
A limitation to our study is that we asked participants to estimate blood loss based on inspection of the conical drape only. We did not ask them to estimate blood loss in hidden places. In addition, this was not an actual delivery but a simulation.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Robert J. McCarthy
Organization: Northwestern University Feinberg School of Medicine
Phone: (312)926-9015
Responsible Party: Cynthia Wong, Northwestern University
ClinicalTrials.gov Identifier: NCT00462839     History of Changes
Other Study ID Numbers: 0524-029
First Submitted: April 17, 2007
First Posted: April 19, 2007
Results First Submitted: June 22, 2011
Results First Posted: December 9, 2011
Last Update Posted: April 14, 2014