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

NCT03144180 | Completed Results FDA Device

• 1 other identifier: E17020
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Pregnant

Keywords

pregnant; third trimester; umbilical cord blood collection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

• Fill Capacity of Umbilical Cord Blood Using the Qcup Compared to Standard of Care

  12 weeks

Study Arms (2)

Control

NO INTERVENTION

The Q-cup will not be used to collect umbilical cord blood.

Study Group

ACTIVE COMPARATOR

The Q-cup will be used to collect umbilical cord blood.

Device: Q-cup

Interventions

Q-cup DEVICE

This technology is a different way of collecting umbilical cord blood.

Study Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• children will not be included
• patients in active labor

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

Texas Tech University Health Sciences Center El Paso

El Paso, Texas, 79912, United States

Location

Related Publications (2)

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

  PMID: 15489606 BACKGROUND

• 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.

  PMID: 7566863 BACKGROUND

Related Links

• cord blood

Limitations and Caveats

Recruiting patients at the clinic, not at hospital; The patient forgot to tell the triage team they were on the study; At times the Participants' delivery providers forgot to fill out the surveys.

Results Point of Contact

• Title: Associate Director of Ob/Gyn Research
• Organization: Texas Tech University Health Sciences Center at El Paso

christina.bracamontes@ttuhsc.edu

9152155103

Study Officials

• Michael Schaffer, MD

  Texas Tech University Health Sciences Center, El Paso

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 8, 2017
• Study Start: July 19, 2017
• Primary Completion: September 14, 2017
• Study Completion: November 28, 2017
• Last Updated: January 9, 2020
• Results First Posted: January 9, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)