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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Oxytocin
• Intervention / Treatment: Drug: Oxytocin

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.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Lucile Packard Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Induced vaginal delivery; Saliva samples will be obtained both during induction and infusion, every 15 minutes after each change in dose. An estimated total of 5 saliva samples will be collected from each patient. Therefore, the last collection point (sample 5) will be during the oxytocin infusion after the 4th dose change. In addition, 2 blood samples will be collected from 5 patients - one baseline sample and another sample at same time as last saliva sample.	Drug: Oxytocin; 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 Names: Pitocin
Cesarian delivery; A total of 3 saliva samples will be collected from each patient - one at baseline preoperative, one intrapartum at least 15 min after starting the standard 250 ml/h oxytocin infusion, and one postpartum in post-anesthesia care unit (PACU) at least 15 min after starting the standard 125 ml/h oxytocin infusion. Therefore, the last collection point (sample 3) will be during the oxytocin infusion in PACU. In addition, 1 blood sample will be collected from each patient in this cohort - at same time as last saliva sample.	Drug: Oxytocin; 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 Names: Pitocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Giner, Inc; Aptagen, LLC; Fraunhofer Center for Manufacturing Innovation; Rose Biotech, LLC
• Investigators: Principal Investigator: Brendan Carvalho, MBBCh MDCH, Stanford University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: May 15, 2016
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Oxytocin; Labor; Salivary; Induction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 36843

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No