Pregnant Clinical Trial
— qcupOfficial title:
Compare the Q-Cup With Other Umbilical Cord Blood Collection Techniques: A Feasibility Study
NCT number | NCT03144180 |
Other study ID # | E17020 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 19, 2017 |
Est. completion date | November 28, 2017 |
Verified date | December 2019 |
Source | Texas Tech University Health Sciences Center, El Paso |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 32 |
Est. completion date | November 28, 2017 |
Est. primary completion date | September 14, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Texas Tech University Health Sciences Center El Paso | El Paso | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University Health Sciences Center, El Paso |
United States,
Eder JM, Cutter GR. A new device for collecting cord blood. Obstet Gynecol. 1995 Nov;86(5):850-2. — View Citation
Perry J, Jagger J. Collecting umbilical cord blood. Nursing. 2004 Oct;34(10):20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 12 weeks | |
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. | At Delivery which could be between 1 to 12 weeks after Baseline. | |
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. | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04786314 -
The Effect of Hot and Cold Water Application on Pregnant Women With Restless Leg Syndrome
|
N/A | |
Completed |
NCT02527005 -
A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients
|
Phase 1 | |
Completed |
NCT02189356 -
Gulhane Military Medical Academy Ethical Committee Exercise Program for Pregnant Women With Low Back and Pelvic Pain
|
N/A | |
Recruiting |
NCT04417283 -
Project HOPE 1000: Health Outcomes Pregnancy Exposures
|
||
Completed |
NCT03105492 -
Pregnant Women s Views About the Ethics of Prenatal Whole Genome Sequencing
|
||
Not yet recruiting |
NCT06239753 -
The Impact of Dynamic Neuromuscular Stabilization on Pregnancy
|
N/A | |
Completed |
NCT03680235 -
Informational Intervention in Increasing Lactation Practices by African American Women
|
N/A | |
Completed |
NCT05725746 -
Feasibility of Remote Data Collection With a Point of Care Device to Measure HbA1c
|
||
Active, not recruiting |
NCT03664648 -
DV2-HBV-27: Observational Pregnancy Registry
|
||
Completed |
NCT05715476 -
The Effect of Different Altitude Levels on Spinal Anesthesia in Cesarean Section Surgery
|
N/A | |
Completed |
NCT05578729 -
The Effect of Different Masks Used by Pregnant Women on Vital Signs and Non Stress Test During The COVID-19
|
N/A | |
Withdrawn |
NCT01307839 -
Lidocaine Patch for Relief of Pain During Epidural Placement in Laboring Patients
|
N/A | |
Completed |
NCT03383653 -
Safety Profile Following Td Vaccination in Indonesian Pregnant Woman
|
N/A | |
Recruiting |
NCT03688087 -
Study of Programm Interest 'Bouge' to Improve the Daily Physical Activity at the Pregnant Women.
|
N/A | |
Active, not recruiting |
NCT03079258 -
Physical Activity and Vascular Health During Pregnancy
|
N/A |