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

NCT03140709 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2017-05-04

No results posted yet for this study

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.

Conditions

  • Oxytocin
  • Pregnancy

Interventions

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

Sponsors & Collaborators

  • Giner, Inc

    collaborator OTHER

  • Aptagen, LLC

    collaborator UNKNOWN

  • Fraunhofer Center for Manufacturing Innovation

    collaborator UNKNOWN

  • Rose Biotech, LLC

    collaborator UNKNOWN

  • Stanford University

    lead OTHER

Principal Investigators

  • Brendan Carvalho, MBBCh MDCH · Stanford University

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03140709 on ClinicalTrials.gov