Pregnant
Conditions
Keywords
pregnant, third trimester, umbilical cord blood collection
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.
Interventions
DEVICEQ-cup
This technology is a different way of collecting umbilical cord blood.
Sponsors
Texas Tech University Health Sciences Center, El Paso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Blood Collection Time | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determining Umbilical Cord Collection Cleanliness With the Q-cup as Compared to the Standard Blood Collection Method | At Delivery which could be between 1 to 12 weeks after Baseline. | 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. |
| Fill Capacity of Umbilical Cord Blood Using the Qcup Compared to Standard of Care | 12 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at an academic medical center between July 2017 and August 2017. The first participant was enrolled on July 19, 2017 and the last participant was enrolled on August 24, 2017.
Pre-assignment details
Of the 32 enrolled participants, 16 were randomized to the study arm.
Participants by arm
| Arm | Count |
|---|---|
| Control The Q-cup will not be used to collect umbilical cord blood. | 16 |
| Study Group The Q-cup will be used to collect umbilical cord blood.
Q-cup: This technology is a different way of collecting umbilical cord blood. | 16 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Provider forgot to fill out forms | 1 | 3 |
| Overall Study | Provider forgot to use the Q-cup | 0 | 1 |
| Overall Study | Scrub tech removed tube cap | 0 | 1 |
| Overall Study | STAT Delivery | 1 | 1 |
Baseline characteristics
| Characteristic | Control | Study Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 16 Participants | 32 Participants |
| Delivery Type Cesarean Section | 0 Participants | 2 Participants | 2 Participants |
| Delivery Type Missing | 2 Participants | 5 Participants | 7 Participants |
| Delivery Type Vaginal Delivery | 14 Participants | 9 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants | 16 Participants | 32 Participants |
| Participants Delivery Provider Delivered by Faculty | 10 Participants | 6 Participants | 16 Participants |
| Participants Delivery Provider Delivered by Resident | 2 Participants | 4 Participants | 6 Participants |
| Participants Delivery Provider Delivered by Unknown | 4 Participants | 6 Participants | 10 Participants |
| Region of Enrollment United States | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 12 weeks
Population: All participants were assigned to the standard of care or the q-cup. The delivery providers collected this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care (Control) | Mean Blood Collection Time | 49 Seconds | Standard Deviation 47 |
| Q Cup (Study) | Mean Blood Collection Time | 44 Seconds | Standard Deviation 25 |
95% CI: [15.459, 82.571]
Secondary
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.
Time frame: At Delivery which could be between 1 to 12 weeks after Baseline.
Population: All participants randomized to Standard of Care or Qcup. Delivery Providers filled out the survey in regards to the collection method.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care (Control) | Determining Umbilical Cord Collection Cleanliness With the Q-cup as Compared to the Standard Blood Collection Method | Excellent/ Good | 7 Participants |
| Standard of Care (Control) | Determining Umbilical Cord Collection Cleanliness With the Q-cup as Compared to the Standard Blood Collection Method | Fair/ Poor | 7 Participants |
| Q Cup (Study) | Determining Umbilical Cord Collection Cleanliness With the Q-cup as Compared to the Standard Blood Collection Method | Fair/ Poor | 1 Participants |
| Q Cup (Study) | Determining Umbilical Cord Collection Cleanliness With the Q-cup as Compared to the Standard Blood Collection Method | Excellent/ Good | 10 Participants |
p-value: 0.0295Chi-squared
Secondary
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.
Time frame: 12 weeks
Population: All participants randomized to Standard of Care or Qcup. Delivery Providers filled out the survey in regards to the fill capacity.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care (Control) | Fill Capacity of Umbilical Cord Blood Using the Qcup Compared to Standard of Care | Tube Filled to Capacity | 11 Participants |
| Standard of Care (Control) | Fill Capacity of Umbilical Cord Blood Using the Qcup Compared to Standard of Care | Tube Not Filled to Capacity | 3 Participants |
| Q Cup (Study) | Fill Capacity of Umbilical Cord Blood Using the Qcup Compared to Standard of Care | Tube Filled to Capacity | 10 Participants |
| Q Cup (Study) | Fill Capacity of Umbilical Cord Blood Using the Qcup Compared to Standard of Care | Tube Not Filled to Capacity | 1 Participants |
p-value: 0.403Chi-squared