Clinical trial NCT03140709: Non-Invasive, Highly Specific Detection of Oxytocin in Biological Fluids
Official title: Non-Invasive, Highly Specific Detection of Oxytocin in Biological Fluids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxytocin
Pregnancy
Keywords: Salivary
Oxytocin
Induction
Labor
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Giner, Inc
name: Aptagen, LLC
name: Fraunhofer Center for Manufacturing Innovation
name: Rose Biotech, LLC
First posted: 2017-05-04
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 generally healthy, pregnant adult women of all ethnicities, between the ages of 18 and 45, admitted for scheduled induction of labor or Cesarean section

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quantification of salivary oxytocin assay levels
timeFrame: 15 minutes after dose change
Secondary outcomes:
measure: Quantification of blood oxytocin levels
timeFrame: 15 minutes after dose change
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Brendan Carvalho, MBBCh MDCH
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.