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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03140709
• Other study ID #: 36843
• Status: Completed
• Phase: N/A
• First received: May 15, 2016
• Last updated: May 2, 2017
• Start date: May 2016
• Est. completion date: July 2016

Study information

• Verified date: May 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Oxytocin
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital	Palo Alto	California

Sponsors (5)

Lead Sponsor	Collaborator
Stanford University	Aptagen, LLC, Fraunhofer Center for Manufacturing Innovation, Giner, Inc, Rose Biotech, LLC

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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