Compare the Q-Cup With Other Umbilical Cord Blood Collection Techniques
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/28/2018 |
| Start Date: | January 3, 2017 |
| End Date: | November 28, 2017 |
Compare the Q-Cup With Other Umbilical Cord Blood Collection Techniques: A Feasibility Study
Currently there is no standardized method of collecting and transferring umbilical cord blood
to laboratory vacuum tubes. Current methods are messy and may require needles to draw the
blood presenting risk of blood exposure and percutaneous injury to obstetrical personnel. A
safer, more efficient method of collecting cord blood is needed. The investigators propose to
use the Q-Cup technology for collecting cord blood. The Q-Cup device is a two-piece injection
molded blood collection and transfer device that enables safe and easy collection of blood
from the newborn's umbilical cord and readily transfers the blood into a laboratory vacuum
tube. The device consists of a collection cup with a wide opening to easily collect blood
from the umbilical cord and a guide tube with a recessed needle which is attached to the
collection cup. The operator is enabled to fill the required vacuum containing tubes in a
clean, quick, efficient and safe manner by simply inserting the vacuum tube into the guide
tube of the Q-Cup. As a result, there is less risk of blood exposure and percutaneous injury
and blood is collected more efficiently. This device allows the practitioner to collect and
transfer umbilical cord blood: without the need for removing the stopper from the vacuum tube
(reducing mess and contamination) and without the need for a syringe and exposed needle
(reducing injury and infection).
to laboratory vacuum tubes. Current methods are messy and may require needles to draw the
blood presenting risk of blood exposure and percutaneous injury to obstetrical personnel. A
safer, more efficient method of collecting cord blood is needed. The investigators propose to
use the Q-Cup technology for collecting cord blood. The Q-Cup device is a two-piece injection
molded blood collection and transfer device that enables safe and easy collection of blood
from the newborn's umbilical cord and readily transfers the blood into a laboratory vacuum
tube. The device consists of a collection cup with a wide opening to easily collect blood
from the umbilical cord and a guide tube with a recessed needle which is attached to the
collection cup. The operator is enabled to fill the required vacuum containing tubes in a
clean, quick, efficient and safe manner by simply inserting the vacuum tube into the guide
tube of the Q-Cup. As a result, there is less risk of blood exposure and percutaneous injury
and blood is collected more efficiently. This device allows the practitioner to collect and
transfer umbilical cord blood: without the need for removing the stopper from the vacuum tube
(reducing mess and contamination) and without the need for a syringe and exposed needle
(reducing injury and infection).
Approximately 4 million babies were born in the United States in 2015. Umbilical cord blood
(UBC) collection is a routine hospital procedure done to evaluate a newborn's health after
the birth of the fetus. UBC is tested to measure bilirubin levels, blood gases, blood sugar
levels, blood types, complete blood counts, and platelet counts. UBC is collected by either
draining the blood into the collection vial, milking the umbilical cord of blood, or
extracting the blood by injecting a needle with a syringe. The Center for Disease Control
(CDC) estimates 5.6 million workers in the health care industry are at risk of occupational
exposure to bloodborne pathogens. Occupational exposure during umbilical cord blood
collection may occur due to the great deal of blood and amniotic fluid present at the time of
delivery. This fluid causes the physician to have a slippery grasp on the umbilical cord and
vials for collection. These methods pose a risk of exposing Labor and Delivery staff to blood
borne diseases. The drainage and milking method can lead to an increased amount of spilled
blood while the extraction method may lead to accidental needle sticks. Exposure to
bloodborne pathogens may be amplified when the umbilical cord is engorged with blood and as
the needle is inserted in the cord, splatter may occur. The Needlestick Safety and Prevention
Act was signed into law on November 6, 2000 in which employees were required to implement
safer medical devices. Many patents have been obtained for umbilical cord blood collection
devices however, there has not been a standardized method of collecting and transferring
umbilical cord blood to the laboratory vacuum tubes. The goal of this project is to prove the
feasibility of using the Q-Cup, a patent pending disposable, two-piece blood collection and
transfer device for safely and efficiently collecting umbilical cord blood and transferring
it into laboratory vacuum tubes.
The overall objective of this project is to prove the feasibility of using a two-piece
umbilical blood collection and transfer device for safely and effectively collecting
umbilical cord blood and transferring the blood into a laboratory vacuum tube. Also, the
investigators will assess provider satisfaction, safety, ease of use, length of procedure
comparing passive flow into blood tubes and the Q-cup technology. The Q-Cup technology can
take part in the effort to reduce occupation exposures including percutaneous exposures
during labor and delivery in general and by studying specifically the heretofore neglected
category of umbilical cord blood collection and transfer. Efforts in this area will help
focus attention on this previously ignored domain and help establish a standard of care and
safety during this frequent procedure.
The investigators hypothesize the Q-Cup will be a more effective transfer method than current
practices utilized for umbilical cord blood collection.
(UBC) collection is a routine hospital procedure done to evaluate a newborn's health after
the birth of the fetus. UBC is tested to measure bilirubin levels, blood gases, blood sugar
levels, blood types, complete blood counts, and platelet counts. UBC is collected by either
draining the blood into the collection vial, milking the umbilical cord of blood, or
extracting the blood by injecting a needle with a syringe. The Center for Disease Control
(CDC) estimates 5.6 million workers in the health care industry are at risk of occupational
exposure to bloodborne pathogens. Occupational exposure during umbilical cord blood
collection may occur due to the great deal of blood and amniotic fluid present at the time of
delivery. This fluid causes the physician to have a slippery grasp on the umbilical cord and
vials for collection. These methods pose a risk of exposing Labor and Delivery staff to blood
borne diseases. The drainage and milking method can lead to an increased amount of spilled
blood while the extraction method may lead to accidental needle sticks. Exposure to
bloodborne pathogens may be amplified when the umbilical cord is engorged with blood and as
the needle is inserted in the cord, splatter may occur. The Needlestick Safety and Prevention
Act was signed into law on November 6, 2000 in which employees were required to implement
safer medical devices. Many patents have been obtained for umbilical cord blood collection
devices however, there has not been a standardized method of collecting and transferring
umbilical cord blood to the laboratory vacuum tubes. The goal of this project is to prove the
feasibility of using the Q-Cup, a patent pending disposable, two-piece blood collection and
transfer device for safely and efficiently collecting umbilical cord blood and transferring
it into laboratory vacuum tubes.
The overall objective of this project is to prove the feasibility of using a two-piece
umbilical blood collection and transfer device for safely and effectively collecting
umbilical cord blood and transferring the blood into a laboratory vacuum tube. Also, the
investigators will assess provider satisfaction, safety, ease of use, length of procedure
comparing passive flow into blood tubes and the Q-cup technology. The Q-Cup technology can
take part in the effort to reduce occupation exposures including percutaneous exposures
during labor and delivery in general and by studying specifically the heretofore neglected
category of umbilical cord blood collection and transfer. Efforts in this area will help
focus attention on this previously ignored domain and help establish a standard of care and
safety during this frequent procedure.
The investigators hypothesize the Q-Cup will be a more effective transfer method than current
practices utilized for umbilical cord blood collection.
Inclusion Criteria:
- Obstetric patients must be age 18 or older
- Obstetric patients must be receiving prenatal care at Texas Tech University Health
Sciences Center El Paso Department of Ob-Gyn
- Obstetric patients must be in their third trimester
- Obstetric patients must be delivering at University Medical Center
Exclusion Criteria:
- children will not be included
- patients in active labor
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