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

NCT03140709 | Completed

• 1 other identifier: 36843
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxytocin; Pregnancy

Keywords

Salivary; Oxytocin; Induction; Labor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quantification of blood oxytocin levels

  15 minutes after dose change

Study Arms (2)

Induced vaginal delivery

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.

Drug: Oxytocin

Cesarian delivery

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.

Drug: Oxytocin

Interventions

Oxytocin DRUG

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

Also known as: Pitocin

Cesarian delivery; Induced vaginal delivery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

25 generally healthy, pregnant adult women of all ethnicities, between the ages of 18 and 45, admitted for scheduled induction of labor or Cesarean section

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Giner, Inc: collaborator
• Aptagen, LLC: collaborator
• Fraunhofer Center for Manufacturing Innovation: collaborator
• Rose Biotech, LLC: collaborator

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94305, United States

Location

Related Publications (2)

• 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.

  PMID: 21415725 BACKGROUND

• 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.

  PMID: 20150347 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and blood samples will be obtained from study participants to monitor oxytocin levels. Observational study. Standard of care management. Oxytocin assays during normal clinical care.

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Brendan Carvalho, MBBCh MDCH

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Obstetric Anesthesia Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine

Study Record Dates

• First Submitted: May 15, 2016
• First Posted: May 4, 2017
• Study Start: May 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)