Compare the Q-Cup With Other Umbilical Cord Blood Collection Techniques (qcup)

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).

Study Overview

• Status: Completed
• Conditions: Pregnant
• Intervention / Treatment: Device: Q-cup

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79912
      • Texas Tech University Health Sciences Center El Paso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The Q-cup will not be used to collect umbilical cord blood.
Active Comparator: Study Group; The Q-cup will be used to collect umbilical cord blood.	Device: Q-cup; This technology is a different way of collecting umbilical cord blood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Blood Collection Time	Anticipating the average lengths of cord blood collection with the standard method is 15 seconds and 30 seconds with the Q-cup, we needed 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). 30 participants were recruited into the study, however, the delivery providers were in charge of collecting this outcome.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determining Umbilical Cord Collection Cleanliness With the Q-cup as Compared to the Standard Blood Collection Method	Participants' delivery providers were asked to self-administer a survey in which they were to assess blood collection for cleanliness. Possible choices were excellent/ good or fair/poor. Some delivery providers did not fill out the surveys and therefore, data was missing.	At Delivery which could be between 1 to 12 weeks after Baseline.
Fill Capacity of Umbilical Cord Blood Using the Qcup Compared to Standard of Care	Participant delivery providers were asked to self-administer a survey in which they were to assess the fill capacity of the lab tubes using the Qcup or the standard method. Possible choices were filled to capacity and not filled to capacity. Some delivery providers did not fill out the surveys and therefore, data was missing.	12 weeks

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center, El Paso
• Investigators: Principal Investigator: Michael Schaffer, MD, Texas Tech University Health Sciences Center, El Paso

Publications and helpful links

General Publications

• Perry J, Jagger J. Collecting umbilical cord blood. Nursing. 2004 Oct;34(10):20. doi: 10.1097/00152193-200410000-00016. No abstract available.
• 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.

Helpful Links

• cord blood

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2017
• Primary Completion (Actual): September 14, 2017
• Study Completion (Actual): November 28, 2017

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: pregnant; umbilical cord blood collection; third trimester
• Other Study ID Numbers: E17020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes