Non-Invasive, Highly Specific Detection of Oxytocin in Biological Fluids
Completed
Conditions studied: Oxytocin, Pregnancy
In brief
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.
Key facts
- Study ID
- NCT03140709
- Run by
- Stanford University
- People needed
- 28
- Starts
- 2016-05-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2017-05-04
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Lucile Packard Children's Hospital — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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