Non-Invasive, Highly Specific Detection of Oxytocin in Biological Fluids
Condition: Oxytocin; Pregnancy
Study type: Observational

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.
    

Intervention name(s): Oxytocin
Intervention type(s): Drug
Intervention description(s): Induction-Vaginal Delivery: Begin at 1mU/min IV infusion and increase by 2mU/30min q30min to a max of 30mU/min. Postpartum infusion adjusted to 2U/hr.
Cesarian Delivery: 1U bolus via IV at delivery, followed by 7.5U/hr up to 30U/hour max depending on uterine tone. Postpartum infusion adjusted to 2U/hr
Other intervention name(s): Pitocin
Intervention MeSH terms: Oxytocin
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
      
Biospecimen description: 
      Saliva and blood samples will be obtained from study participants to monitor oxytocin levels.
      Observational study. Standard of care management. Oxytocin assays during normal clinical
      care.
    
Keywords: Salivary; Oxytocin; Induction; Labor