CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Oxytocindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03140709
NCT03140709N/ACompleted

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

Stanford University·observational·Posted May 4, 2017·Updated May 4, 2017

In Brief

An observational study evaluating Oxytocin for Oxytocin and Pregnancy. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsOxytocin, Pregnancy
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 4, 2017
Enrollment StartMay 1, 2016
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.2 years ago

Interventions

Oxytocindrug

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