Compare the Q-Cup With Other Umbilical Cord Blood Collection Techniques: A Feasibility Study
Phase: NA
Conditions: Pregnant
Sponsor: Texas Tech University Health Sciences Center, El Paso

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Official Title:  Compare the Q-Cup With Other Umbilical Cord Blood Collection 
Techniques 
NCT number: NCT03144180 
Document Date: August 25, 2017 
 
 

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Study Title:  Compare Q-Cup with other umbilical blood collection techniques for umbilical cord blood 
collection and transfer to laboratory tubes: A Feasibility Study 
Principal Investigator: Sireesha Reddy, M.D., M.S. 
Co- Investigator: Michael Schaffer, M.D. and Zuber D. Mulla, MSPH, PhD  
I. Abstract:  
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.  We propose to use our Q-Cup technology for 
collecting cord blood. Our 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). 
II. Background  
Approximately 4 million babies were born in the United States in 2015.1 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. 2 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. 2-5 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. 6-
8The Needlestick Safety and Prevetion Act was signed into law on November 6, 2000 in which employees 
were required to implement safer medical devices. 5l Many patents have been obtained for umbilical 
cord blood collection devices3,7,9, however, there has not been a standardized method of collecting and 

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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.  
III. Objective  
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 we 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. Our 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. 
IV. Hypothesis 
We hypothesize the Q-Cup will be a more effective transfer method than current practices utilized for 
umbilical cord blood collection.  
IV. Study Design and Procedures 
a. Setting. University Medical Center at El Paso Labor and Delivery unit.  
 
b. Target Population. This study will consent OB patients to use the Q-cup, however, the actual 
feasibility project and evaluation of the Q-cup will be conducted by healthcare providers.  
a. Providers (Certified Nurse Midwives, Residents, Medical Doctors) employed at the 
Texas Tech University Health Sciences Center El Paso 
Blood transfer method: Blood will be collected as a standard of care from the 
expelled umbilical cord.  
b. Patients delivering at University Medical Center 
Patients with established care at Texas Tech University Health Sciences Center El 
Paso and who will be delivering their baby at University Medical Center will be 
recruited to participate in this study.  Their expelled umbilical cord blood will be 
used to test the Q-cup device.  Inclusion criteria will include: women over 18 years 
of age, in their third trimester of pregnancy and receiving their prenatal care with a 
TTUHSC El Paso provider.  
 
c. Procedure:  
a. Providers:  
i. Delivery providers will be added to the research protocol. The research 
personnel will introduce and train the use of the blood collection methods 

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to the delivery providers; Providers will be trained on the Q-cup collection 
and review the standard collection currently used (drain umbilical cord 
blood into the vial). This project will not have an impact on direct patient 
care. At the time of delivery, the Q-cup will be provided to the provider in a 
sterilized bag. The bag is opened and the vacuum tube with needle is 
inserted into the barrel of the Q-cup.  
ii. The expelled umbilical cord is usually clamped after delivery. 
iii. The clamp is then opened and the blood specimen is drained into the blood 
vial or will be drained into the Q-cup.  
1. If the Q cup is involved, then an additional step will be to use 
vacuum pressure to push the blood specimen into the vacuum 
collection tube.  
iv. The tube is rinsed in saline and sent to the lab for standard of care.  
v. The provider will fill out a data sheet to assess safety, ease of use, and 
length of procedure. The provider will also fill out a survey to assess their 
satisfaction and other questions on blood collection techniques comparing 
the standard method, passive flow to the Q-cup technique.   
b. Patients 
i. Patients will be recruited at the TTUHSC EP OBGYN Clinic. The clinical 
personnel will introduce the study to the potential participant. If the 
participant would like to hear more information, research personnel will be 
called to explain in more detail, assess eligibility, and describe the consent 
process.  
ii. If the patient would like to participate in the study and meets eligibility, she 
will be asked to sign a consent form and will be randomly placed into the 
control or study (Q-cup) group. Participant will be given a laminated card to 
pack in her hospital bag directing her to take this card with her to the 
hospital when she goes into labor. 
1. The card will indicate to hospital staff that she is participating in the 
study.   
2. The participant will give the card to her assigned nurse who will 
inform the providers on duty about the participant.  
3. The card will indicate if the participant is in the control or study (Q-
cup) group.  
iii. Eligibility states the participant must be pregnant in their third trimester 
since the actual feasibility of the Q-cup will take place when the baby is 
delivered and cord blood is collected. Due to this, all participants in the 
study are expected to be admitted to the hospital. When participants are 
admitted to the hospital to deliver their baby, this will not be considered an 
unanticipated event.  
 

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iv. At the time of delivery, umbilical cord blood will be collected and sent out to 
the lab for standard testing.  
1. If the participant is in the control group, umbilical cord blood will be 
collected per the hospital standard.  
2. If the participant is in the study group, umbilical cord blood will be 
collected with the Q-cup.  
v. This research study will not collect any of the participant’s specimens for 
research purposes.  
V. Data analysis: Anticipating the average lengths of cord blood collection with the standard method is 
15 seconds and 30 seconds with the Q-cup, we will need 30 subjects total. 15 in the Q-cup arm of the 
study and 15 in the comparison group (for a two-sided two-sample t-test with 80% power, an alpha of 
0.05, and a common standard deviation of 14 seconds). Data will be entered into REDCap by research 
personnel and will be analyzed using SAS 9.3.  Data will be coded appropriately for missing information 
as 999, and “not applicable” sections as 88. Additionally, frequencies and tabulations will be created 
from the collected data. 
 
VII. References 
1. 
Martin J, Hamilton B, Osterman M. Births in the United States, 2015. 2016; 
http://www.cdc.gov/nchs/data/databriefs/db258.pdf. 
2. 
Cord blood testing: MedlinePlus Medical Encyclopedia. 2016. 
3. 
Perry J, Jagger J. Collecting umbilical cord blood. Nursing. Oct 2004;34(10):20. 
4. 
Safety and Health Topics | Bloodborne Pathogens and Needlestick Prevention - Hazard 
Recognition. 2016; https://www.osha.gov/SLTC/bloodbornepathogens/recognition.html. 
5. 
Frequently Asked Questions - Needlesticks. 2016; 
https://www.osha.gov/needlesticks/needlefaq.html. 
6. 
Eder JM, Cutter GR. A new device for collecting cord blood. Obstet Gynecol. Nov 1995;86(5):850-
852. 
7. 
Haswell JN, Haswell JN. Umbilical cord blood collection. 2001-1-30 2001. 
8. 
Perry J, Jagger J. Collecting umbilical cord blood. Nursing2016. 2004;34(10):20. 
9. 
Hessel SR, Young HT, Katz M, Utah Medical Products I. Umbilical cord clamping, cutting, and 
blood collecting device and method. 1995-5-16 1995.