Trial Outcomes & Findings for Compare the Q-Cup With Other Umbilical Cord Blood Collection Techniques (NCT NCT03144180)

Last Updated: 2020-01-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

12 weeks

Results posted on

2020-01-09

Participant Flow

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.

Of the 32 enrolled participants, 16 were randomized to the study arm.

Participant milestones

Participant milestones
Measure	Control The standard of care methods of umbilical cord collection was used. These include: 1) milking the blood from the umbilical cord into an open specimen tube 2) holding the umbilical cord over a basin and letting blood drip into it, then drawing up the blood into a needless syringe 3) Holding the umbilical cord over a specimen tube and letting the blood drip into it 4) using a conventional needle and syringe to draw blood directly from the cord.	Study Group Umbilical cord blood was collected using the Q-cup device.
Overall Study STARTED	16	16
Overall Study COMPLETED	14	10
Overall Study NOT COMPLETED	2	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Control The standard of care methods of umbilical cord collection was used. These include: 1) milking the blood from the umbilical cord into an open specimen tube 2) holding the umbilical cord over a basin and letting blood drip into it, then drawing up the blood into a needless syringe 3) Holding the umbilical cord over a specimen tube and letting the blood drip into it 4) using a conventional needle and syringe to draw blood directly from the cord.	Study Group Umbilical cord blood was collected using the Q-cup device.
Overall Study STAT Delivery	1	1
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

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=16 Participants The Q-cup will not be used to collect umbilical cord blood.	Study Group n=16 Participants The Q-cup will be used to collect umbilical cord blood. Q-cup: This technology is a different way of collecting umbilical cord blood.	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants
Participants Delivery Provider Delivered by Faculty	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Participants Delivery Provider Delivered by Resident	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Participants Delivery Provider Delivered by Unknown	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Delivery Type Vaginal Delivery	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Delivery Type Cesarean Section	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Delivery Type Missing	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: All participants were assigned to the standard of care or the q-cup. The delivery providers collected this outcome.

Outcome measures

Outcome measures
Measure	Standard of Care (Control) n=14 Participants A timer was used to measure how long (in seconds) it took for the collection tube to fill up with umbilical cord blood using the standard methods.	Q Cup (Study) n=10 Participants A timer was used to measure how long (in seconds) it took for the collection tube to fill up with umbilical cord blood using the Q-cup device.
Mean Blood Collection Time	49 Seconds Standard Deviation 47	44 Seconds Standard Deviation 25

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Standard of Care (Control) n=14 Participants A timer was used to measure how long (in seconds) it took for the collection tube to fill up with umbilical cord blood using the standard methods.	Q Cup (Study) n=11 Participants A timer was used to measure how long (in seconds) it took for the collection tube to fill up with umbilical cord blood using the Q-cup device.
Determining Umbilical Cord Collection Cleanliness With the Q-cup as Compared to the Standard Blood Collection Method Excellent/ Good	7 Participants	10 Participants
Determining Umbilical Cord Collection Cleanliness With the Q-cup as Compared to the Standard Blood Collection Method Fair/ Poor	7 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: All participants randomized to Standard of Care or Qcup. Delivery Providers filled out the survey in regards to the fill capacity.

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.

Outcome measures

Outcome measures
Measure	Standard of Care (Control) n=14 Participants A timer was used to measure how long (in seconds) it took for the collection tube to fill up with umbilical cord blood using the standard methods.	Q Cup (Study) n=11 Participants A timer was used to measure how long (in seconds) it took for the collection tube to fill up with umbilical cord blood using the Q-cup device.
Fill Capacity of Umbilical Cord Blood Using the Qcup Compared to Standard of Care Tube Filled to Capacity	11 Participants	10 Participants
Fill Capacity of Umbilical Cord Blood Using the Qcup Compared to Standard of Care Tube Not Filled to Capacity	3 Participants	1 Participants

Adverse Events

Standard of Care (Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Qcup (Study)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Associate Director of Ob/Gyn Research

Texas Tech University Health Sciences Center at El Paso

Phone: 9152155103

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place