Pregnancy Clinical Trial
Official title:
Non-Invasive, Highly Specific Detection of Oxytocin in Biological Fluids
Verified date | May 2017 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will aid in the development of a research instrument for rapid and highly
sensitive detection of perinatal salivary oxytocin, by non-invasive means. There will be two
study cohorts: Induction of labor cohort (20) and Cesarean delivery cohort (5) for a total
of 25 participants.The standard clinical protocols for administering oxytocin to human
subjects at Lucile Packard Children's Hospital will be followed. Oxytocin will be prescribed
and dosed as per standard of care with no change due to study enrollment. The study will
only involve sampling of saliva and blood.
The general hypothesis to be tested is that 1) the sensor will accurately report the levels
of oxytocin in saliva samples as compared with standard reference methods and 2) the sensor
yields rapid (<20 minutes) oxytocin results with minimal discomfort to subjects. Overall,
this will allow to optimize the administration of oxytocin, and for a better understanding
of the blood concentration and effects of oxytocin on mother and child.
Status | Completed |
Enrollment | 28 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Generally healthy, pregnant woman (37-41 weeks) - Scheduled for induction of labor (not already in active labor) or cesarean section - Ages 18-45 years old - ASA physical status 1 or 2 - Singleton pregnancy - Able and willing to sign consent Exclusion Criteria: - Women with any significant medical or obstetric condition (such as gestational hypertension, diabetes,coagulopathy, and renal impairment) - Morbid obesity (BMI greater than/equal to 40) - In active labor upon arrival to L&D |
Country | Name | City | State |
---|---|---|---|
United States | Lucile Packard Children's Hospital | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | Aptagen, LLC, Fraunhofer Center for Manufacturing Innovation, Giner, Inc, Rose Biotech, LLC |
United States,
Butwick AJ, Coleman L, Cohen SE, Riley ET, Carvalho B. Minimum effective bolus dose of oxytocin during elective Caesarean delivery. Br J Anaesth. 2010 Mar;104(3):338-43. doi: 10.1093/bja/aeq004. — View Citation
Dyer RA, Butwick AJ, Carvalho B. Oxytocin for labour and caesarean delivery: implications for the anaesthesiologist. Curr Opin Anaesthesiol. 2011 Jun;24(3):255-61. doi: 10.1097/ACO.0b013e328345331c. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantification of salivary oxytocin assay levels | Test novel aptamer-based electrochemical assay for the detection and quantification of salivary oxytocin | 15 minutes after dose change | |
Secondary | Quantification of blood oxytocin levels | Standard of care detection protocol for oxytocin blood levels to compare sensitivity and specificity of aptamer-based electrochemical assay | 15 minutes after dose change |
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