Postpartum HemorrhageNCT00462839
Accuracy of Blood Loss Estimation After Vaginal Delivery
A study testing blood loss estimation in people with Postpartum Hemorrhage, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- blood loss estimation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Apr 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any anesthesia or obstetric attending or resident may participate provided that they have rotated through obstetrics/obstetric anesthesia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Accuracy of Blood Loss Estimation After Simulated Vaginal Delivery
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.
Read the 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.
- Conditions
- Postpartum Hemorrhage
- Being tested
- blood loss estimation
- Keywords
- Estimated Blood Loss, Obstetrics, postpartum hemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood loss estimationProcedure or surgery
Also called Estimated Blood Loss (EBL)
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.
| Study group | Role | What they receive |
|---|---|---|
| Calibrated drapes viewed first | Experimental | 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. Receives: Procedure: blood loss estimation |
| Non-calibrated drapes viewed first | Active comparator | 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. Receives: Procedure: blood loss estimation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (3)
Number and Type of Care Providers Assigned to Study Arms.
Measured: 1 hour
Level of Training
Measured: 1 hour
Number of Years of Clinical Experience Providing Patient Care Requiring Blood Loss Estimation.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startJul 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Wong, Northwestern University
- Investigators
- Cynthia A Wong, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462839
- Sponsor's protocol ID
- 0524-029
- Status last verified
- Mar 2014
- First submitted
- 17 Apr 2007
- Last updated
- 14 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
C. Beckman. Obstetrics and Gynecology. Post Partum Hemorrhage, Chapter 12. 3rd edition. Lippincott Williams & Wilkins 1998; 154-161.
Cunningham FG, Leveno KL, Bloom SL, et al. Williams Obstetrics, 22th ed, New York: McGraw-Hill, 2005.
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.
PubMed 16626718Prasertcharoensuk 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.
PubMed 11044547
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Blood Loss Estimation After Simulated Vaginal Delivery
- ClinicalTrials.gov ID
- NCT00462839
- Acronym / sponsor ID
- 0524-029
- Conditions
- Postpartum Hemorrhage
- Keywords
- Estimated Blood Loss, Obstetrics, postpartum hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 19 Apr 2007 (estimated)
- Results
- Posted 9 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calibrated drapes viewed first | Experimental | Procedure: blood loss estimationCaregivers 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. |
| Non-calibrated drapes viewed first | Active comparator | Procedure: blood loss estimationStandard 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any anesthesia or obstetric attending or resident may participate provided that they have rotated through obstetrics/obstetric anesthesia.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood loss estimationAlso: Estimated Blood Loss (EBL)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. | Procedure or surgery | Calibrated drapes viewed first, Non-calibrated drapes viewed first |
Primary outcome
Difference in Actual Blood Volume and Estimated Blood Volume in Milliliters.
Time frame: 1 hour
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.
3 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundC. Beckman. Obstetrics and Gynecology. Post Partum Hemorrhage, Chapter 12. 3rd edition. Lippincott Williams & Wilkins 1998; 154-161.
- BackgroundCunningham FG, Leveno KL, Bloom SL, et al. Williams Obstetrics, 22th ed, New York: McGraw-Hill, 2005.
- Background: PubMed 16626718Patel 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.
- Background: PubMed 11044547Prasertcharoensuk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia A Wong, M.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood loss estimation in people with Postpartum Hemorrhage, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Actual Blood Volume and Estimated Blood Volume in Milliliters. (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00462839, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.