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Pharmacokinetics of Oxytocin at Cesarean Delivery (Peacocks)

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ClinicalTrials.gov Identifier: NCT03898882
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment
Postpartum Hemorrhage Drug: oxytocin Device: Shore durometer

Detailed Description:
In this pilot study the investigators will compare plasma oxytocin concentrations measured in arterial and venous blood, after oxytocin administration at cesarean delivery, in order to assess the validity of venous samples. They will also measure oxytocinase to explore how levels vary around the time of delivery of the placenta and to assess the effect that this may have on the metabolism of oxytocin.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Pharmacokinetics of Oxytocin in Pregnant Women Undergoing Cesarean Delivery - a Feasibility Pilot Study
Actual Study Start Date : May 24, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Group/Cohort Intervention/treatment
BMI 20 - 29.9 kg/m2 Drug: oxytocin
PK measurements of oxytocin

Device: Shore durometer
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 Preliminary (unpublished) data provided a range of 10-56 SU after oxytocin administration at cesarean delivery.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 > 30 kg/m2 Drug: oxytocin
PK measurements of oxytocin

Device: Shore durometer
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.




Primary Outcome Measures :
  1. Arterial [OXT] [ Time Frame: Scheduled samples during the first 30 minutes after oxytocin administration ]
    Concentration of oxytocin in arterial samples

  2. Venous [OXT] [ Time Frame: Scheduled samples during the first 30 minutes after oxytocin administration ]
    Concentration of oxytocin in venous samples


Secondary Outcome Measures :
  1. Arterial [OXTase] [ Time Frame: Scheduled samples during the first 30 minutes after oxytocin administration ]
    Concentration of oxytocinase in arterial samples

  2. Uterine tone [ Time Frame: Scheduled measurements during the first 30 minutes after oxytocin administration ]
    Uterine tone measured using a Shore Durometer or assessed by obstetrician using numerical rating score (NRS, 0-10)

  3. Hypotension [ Time Frame: Measured intraoperatively ]
    Incidence of systolic BP reduced by 20% from baseline

  4. Nausea & Vomiting [ Time Frame: Recorded intraoperatively ]
    Incidence of nausea and vomiting

  5. EBL [ Time Frame: Estimated at the end of surgery ]
    Estimated blood loss in milliliters



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must be scheduled for cesarean delivery of their baby
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women scheduled for cesarean delivery of their babies at term
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age or ASA classification outside of inclusion criteria
  • Need for general anaesthesia
  • Absence of consent
  • Inability to communicate in English or other barrier to providing informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898882


Contacts
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Contact: David T Monks, MBChB +1 314 273 2633 dmonks@wustl.edu
Contact: Arvind Palanisamy, MBBS +1 314 362 2628

Locations
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United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kristi Kraus, RN    314-273-7921    kristinkraus@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: David T Monks, MBChB Washington University School of Medicine

Publications:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03898882     History of Changes
Other Study ID Numbers: 201810134
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs