Pharmacokinetics of Oxytocin at Cesarean Delivery

NCT03898882 | Completed FDA Device

• 1 other identifier: 201810134
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to obtain data to inform the design of a population pharmacokinetic study of oxytocin after administration at CD as per standard institutional practice.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (2)

• Arterial [OXT]

  Concentration of oxytocin in arterial samples

  Scheduled samples during the first 30 minutes after oxytocin administration

• Venous [OXT]

  Concentration of oxytocin in venous samples

  Scheduled samples during the first 30 minutes after oxytocin administration

Secondary Outcomes (5)

• Arterial [OXTase]

  Scheduled samples during the first 30 minutes after oxytocin administration

• Uterine tone

  Scheduled measurements during the first 30 minutes after oxytocin administration

• Hypotension

  Measured intraoperatively

• Nausea & Vomiting

  Recorded intraoperatively

• EBL

  Estimated at the end of surgery

Study Arms (2)

BMI 20 - 29.9 kg/m2

Drug: oxytocin; Device: Shore durometer

BMI > 30 kg/m2

Drug: oxytocin; Device: Shore durometer

Interventions

oxytocin DRUG

PK measurements of oxytocin

BMI 20 - 29.9 kg/m2; BMI > 30 kg/m2

Shore durometer DEVICE

The investigators will take serial readings from a digital durometer at the uterine fundus at 3, 6, 9 and 12 minutes following OXT administration to provide data that will inform an estimate of the timing of peak effect. Shore durometers measure the hardness of materials on a scale of 0-100 Shore Units (SU). Preliminary (unpublished) data provided a range of 10-56 SU after oxytocin administration at cesarean delivery. Durometer readings were also shown to correlate positively with the obstetrician's manual assessment of uterine contractility, which is traditionally used to determine the success or failure of uterotonic therapy.

BMI 20 - 29.9 kg/m2; BMI > 30 kg/m2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Participants must be scheduled for cesarean delivery of their baby
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women scheduled for cesarean delivery of their babies at term

You may qualify if:

• Term singleton pregnancy
• Age 18-45 years of age
• ASA classification 2 or 3
• Scheduled cesarean delivery under neuraxial anaesthesia

You may not qualify if:

• Need for general anaesthesia
• Absence of consent
• Inability to communicate in English or other barrier to providing informed consent

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

• Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.

  PMID: 25103301 BACKGROUND

• Attilakos G, Psaroudakis D, Ash J, Buchanan R, Winter C, Donald F, Hunt LP, Draycott T. Carbetocin versus oxytocin for the prevention of postpartum haemorrhage following caesarean section: the results of a double-blind randomised trial. BJOG. 2010 Jul;117(8):929-36. doi: 10.1111/j.1471-0528.2010.02585.x. Epub 2010 May 19.

  PMID: 20482535 BACKGROUND

• Chiou WL. The phenomenon and rationale of marked dependence of drug concentration on blood sampling site. Implications in pharmacokinetics, pharmacodynamics, toxicology and therapeutics (Part II). Clin Pharmacokinet. 1989 Oct;17(4):275-90. doi: 10.2165/00003088-198917040-00005. No abstract available.

  PMID: 2686884 BACKGROUND

• Chiou WL. The phenomenon and rationale of marked dependence of drug concentration on blood sampling site. Implications in pharmacokinetics, pharmacodynamics, toxicology and therapeutics (Part I). Clin Pharmacokinet. 1989 Sep;17(3):175-99. doi: 10.2165/00003088-198917030-00004.

  PMID: 2680213 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

• David T Monks, MBChB

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 2, 2019
• Study Start: May 24, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)