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

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03140709
Study type	Observational
Source	Stanford University
Contact
Status	Completed
Phase	N/A
Start date	May 2016
Completion date	July 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03442582` - Afluria Pregnancy Registry
Terminated	`NCT02161861` - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study	N/A
Not yet recruiting	`NCT05934318` - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)	N/A
Enrolling by invitation	`NCT05415371` - Persistent Poverty Counties Pregnant Women With Medicaid	N/A
Completed	`NCT04548102` - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman	N/A
Completed	`NCT03218956` - Protein Requirement During Lactation	N/A
Completed	`NCT02191605` - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy	N/A
Completed	`NCT02223637` - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Recruiting	`NCT06049953` - Maternal And Infant Antipsychotic Study
Active, not recruiting	`NCT02577536` - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting	`NCT06336434` - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy	Phase 1/Phase 2
Not yet recruiting	`NCT05412238` - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months	N/A
Not yet recruiting	`NCT04786587` - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting	`NCT05028387` - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed	`NCT02783170` - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women	Phase 4
Completed	`NCT02683005` - Study of Hepatitis C Treatment During Pregnancy	Phase 1
Recruiting	`NCT02619188` - Nutritional Markers in Normal and Hyperemesis Pregnancies	N/A
Recruiting	`NCT02564250` - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women	N/A
Recruiting	`NCT02507180` - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Completed	`NCT02408315` - Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.