An interventional study of blood loss estimation in Postpartum Hemorrhage, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-14.
Sponsored by Northwestern University · Not applicable, Interventional, and Health services research
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.
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.
445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
This study's enrollment of 106 is below the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: blood loss estimation
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.
Procedure: blood loss estimation
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.
Also known as: Estimated Blood Loss (EBL)
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.
Time frame: 1 hour
Number and Type of Care Providers Assigned to Study Arms.
Time frame: 1 hour
Level of Training
Time frame: 1 hour
Number of Years of Clinical Experience Providing Patient Care Requiring Blood Loss Estimation.
Time frame: 1 hour
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.
| Milestone | Calibrated Vaginal Delivery Drapes Viewed First | Noncalibrated Drapes Viewed First |
|---|---|---|
| Started | 53 | 53 |
| Completed | 53 | 53 |
| Not completed | 0 | 0 |
| Milestone | Calibrated Vaginal Delivery Drapes Viewed First | Noncalibrated Drapes Viewed First |
|---|---|---|
| Started | 53 | 53 |
| Completed | 53 | 53 |
| Not completed | 0 | 0 |
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.
| milliliters | Calibrated Vaginal Delivery Drapes Viewed First | Noncalibrated Drapes Viewed First |
|---|---|---|
| 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) |
| participants | Calibrated Vaginal Delivery Drapes Viewed First | Noncalibrated Drapes Viewed First |
|---|---|---|
| Anesthesia | 21 | 22 |
| Obstetrics | 20 | 22 |
| Nursing | 12 | 9 |
| participants | Calibrated Vaginal Delivery Drapes Viewed First | Noncalibrated Drapes Viewed First |
|---|---|---|
| Attending physician | 19 | 22 |
| Resident physician | 22 | 22 |
| Nurse | 12 | 9 |
| participants | Calibrated Vaginal Delivery Drapes Viewed First | Noncalibrated Drapes Viewed First |
|---|---|---|
| < 5 years | 30 | 29 |
| 5-10 years | 11 | 13 |
| > 10 years | 12 | 11 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Calibrated Vaginal Delivery Drapes Viewed First | — | 0/53 (0%) | 0/53 (0%) |
| Noncalibrated Drapes Viewed First | — | 0/53 (0%) | 0/53 (0%) |
| Age, Categorical(Participants) | Calibrated Vaginal Delivery Drapes Viewed First | Noncalibrated Drapes Viewed First | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 53 | 53 | 106 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Calibrated Vaginal Delivery Drapes Viewed First | Noncalibrated Drapes Viewed First | Total |
|---|---|---|---|
| Female | 34 | 32 | 66 |
| Male | 19 | 21 | 40 |
| Region of Enrollment(participants) | Calibrated Vaginal Delivery Drapes Viewed First | Noncalibrated Drapes Viewed First | Total |
|---|---|---|---|
| United States | 53 | 53 | 106 |
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Northwestern University