Compare the Q-Cup With Other Umbilical Cord Blood Collection Techniques
Condition: Pregnant
Study type: Interventional

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.
    

Intervention name(s): Q-cup
Intervention type(s): Device
Intervention description(s): This technology is a different way of collecting umbilical cord blood.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Other
Keywords: pregnant; third trimester; umbilical cord blood collection