Pregnancy Clinical Trial
Official title:
Non-Invasive, Highly Specific Detection of Oxytocin in Biological Fluids
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.
Oxytocin, a neuropeptide hormone, plays an important role in the dynamic function of the
brain and a variety of complex social behaviors including affiliation, sexual behavior,
social recognition, and aggression. Oxytocin is best known for its role to facilitate the
birth process through induction of uterine smooth muscle contractions. Oxytocin is primarily
used to induce labor, and contract the uterus after delivery. Oxytocin is considered the
first line uterotonic to prevent and treat uterine atony and manage postpartum hemorrhage.
Currently, there is no instrument that is capable of point-of-care oxytocin detection. A
practical research tool to monitor peripheral levels of both endogenous and exogenous
oxytocin is therefore needed to better understanding the pharmacokinetics and
pharmacodynamics of oxytocin in the mother, fetus and newborn. A better understanding of
drug concentration and effect may lead to optimal dosing and better management of induction
of labor and/or uterine atony after delivery.
With increased research on the importance of oxytocin monitoring, a bedside oxytocin monitor
is envisioned that would allow healthcare professionals to improve our
pharmacokinetic/dynamic understanding of oxytocin and to monitor and adjust the dose of
oxytocin administered during childbirth. Currently, there is no instrument that is capable
of point-of-care oxytocin detection.
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