Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462839
Status:
COMPLETED
Last Update Posted:
2014-04-14
First Post:
2007-04-17
Brief Title:
Accuracy of Blood Loss Estimation After Vaginal Delivery
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
The Accuracy of Blood Loss Estimation After Simulated Vaginal Delivery
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hisher 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 trainingyears of practice and gender
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 hisher 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 trainingyears of practice and gender
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None