Non-Invasive, Highly Specific Detection of Oxytocin in Biological Fluids

Completed

• Conditions: Pregnancy; Oxytocin
• Interventions: Drug: Oxytocin

• Registration Number: NCT03140709
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-15
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-02
• Last Update Submitted: 2017-05-02
• Study First Posted: 2017-05-04
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Induced vaginal delivery	Oxytocin	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.
Cesarian delivery	Oxytocin	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.

Primary Outcome Measures

Name	Time	Method
Quantification of salivary oxytocin assay levels	15 minutes after dose change	Test novel aptamer-based electrochemical assay for the detection and quantification of salivary oxytocin

Secondary Outcome Measures

Name	Time	Method
Quantification of blood oxytocin levels	15 minutes after dose change	Standard of care detection protocol for oxytocin blood levels to compare sensitivity and specificity of aptamer-based electrochemical assay

Trial Locations

Locations (1)

Lucile Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States