Accuracy of Blood Loss Estimation After Vaginal Delivery - Full Text View

Sponsored by:	Northwestern University
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00462839

Purpose

Post-partum hemorrhage (PPH) is defined as blood loss greater than 500 mL after vaginal delivery (1). Delayed diagnosis of PPH is a major cause of maternal morbidity and mortality (2). 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 (3). Other studies have shown that the magnitude of underestimation increases as the amount of blood loss is increased (4). 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, anesthesiologist, 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, and 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.

Condition	Intervention
Hemorrhage Obstetrics	Procedure: blood loss estimation

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Accuracy of Blood Loss Estimation After Vaginal Delivery

Further study details as provided by Northwestern University:

Primary Outcome Measures:

How accurate are anesthesia and obstetric care providers at estimating true blood loss after vaginal delivery? 2. Do graduated markings on the vaginal delivery drape improve the accuracy of estimated blood loss? [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

All care providers will underestimate simulated blood loss after vaginal delivery. 2) Graduated markings on the vaginal delivery drape will improve the accuracy of estimated blood loss. [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	132
Study Start Date:	July 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Detailed Description:

Packed red blood cells discarded by the Blood Bank will be mixed with normal saline to simulate 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 (see Table) 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 one will view the unmarked vaginal collection drapes first and the Group 2 will view the collection drapes with the calibrated markings first. Both groups will analyze the 4 study stations in random order. At the completion of the 4 study stations, the group which analyzed the drapes without markings will cross over to view the stations with calibrated markings and vice versa.

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.

The study stations will be set up in for an 8-12 hour period in an empty Labor and Delivery Room (LDR) at PWH at a time that is convenient for the Labor and Delivery Unit and the investigators. At the end of the study, the blood mixtures will be disposed of in accordance with safe handling of biohazardous material.

Demographic data on study participants will include provider type, level of training/years of practice, and gender.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Any anesthesia or obstetric attending or resident

Criteria

Inclusion Criteria:

Any anesthesia or obstetric attending or resident may participate provided that they have rotated on 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462839

Locations

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:

Cynthia A Wong, M.D.

Northwestern University

More Information

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. Epub 2006 Apr 12. Erratum in: Int J Gynaecol Obstet. 2006 Dec;95(3):312.

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. No abstract available.

Responsible Party:	Northwestern University ( Cynthia A. Wong, M.D. )
Study ID Numbers:	0524-029
Study First Received:	April 17, 2007
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00462839
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

Estimated Blood Loss
Obstetrics
Post partum Hemorrhage

Study placed in the following topic categories:

Postpartum Hemorrhage
Hemorrhage

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009