N/A
Completed N=32
Compare the Q-Cup With Other Umbilical Cord Blood Collection Techniques
Pregnant
Source: ClinicalTrials.gov NCT03144180 ↗
Enrolled (actual)
32
Serious AEs
—
Results posted
Jan 2020
Primary outcomePrimary: Mean Blood Collection Time — 49; 44 Seconds
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Blood Collection Time |
49; 44 | — |
| SECONDARY Determining Umbilical Cord Collection Cleanliness With the Q-cup as Compared to the Standard Blood Collection Method |
7; 10; 7; 1 | 0.0295 sig |
| SECONDARY Fill Capacity of Umbilical Cord Blood Using the Qcup Compared to Standard of Care |
11; 10; 3; 1 | 0.403 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03144180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.