Clinical trial NCT03144180: Compare the Q-Cup With Other Umbilical Cord Blood Collection Techniques
Official title: Compare the Q-Cup With Other Umbilical Cord Blood Collection Techniques: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnant
Keywords: pregnant
third trimester
umbilical cord blood collection
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Although we tested device feasibility and we should have fewer than 10 participants, we did want to run a two-sided, two-sample t-test with 80% power and an alpha of 0.05, and a common standard deviation of 14 seconds. In order to achieve this, we needed to recruit 30 subjects in total, 15 in the control and 15 in the study group.
Primary purpose: OTHER

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Blood Collection Time
timeFrame: 12 weeks
Secondary outcomes:
measure: Determining Umbilical Cord Collection Cleanliness With the Q-cup as Compared to the Standard Blood Collection Method
timeFrame: At Delivery which could be between 1 to 12 weeks after Baseline.
measure: Fill Capacity of Umbilical Cord Blood Using the Qcup Compared to Standard of Care
timeFrame: 12 weeks
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center El Paso
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center, El Paso
name: Michael Schaffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perry J, Jagger J. Collecting umbilical cord blood. Nursing. 2004 Oct;34(10):20. doi: 10.1097/00152193-200410000-00016. No abstract available.
citation: Eder JM, Cutter GR. A new device for collecting cord blood. Obstet Gynecol. 1995 Nov;86(5):850-2. doi: 10.1016/0029-7844(95)00274-U.