The Pharmacokinetics of Oxytocin in Pregnant Women Undergoing Cesarean Delivery - a Feasibility Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- oxytocin
- Conditions
- Postpartum Hemorrhage
- Sponsor
- Washington University School of Medicine
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Venous [OXT]
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
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.
Investigators
Eligibility 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
Arms & Interventions
BMI 20 - 29.9 kg/m2
Intervention: oxytocin
BMI 20 - 29.9 kg/m2
Intervention: Shore durometer
BMI > 30 kg/m2
Intervention: oxytocin
BMI > 30 kg/m2
Intervention: Shore durometer
Outcomes
Primary Outcomes
Venous [OXT]
Time Frame: Scheduled samples during the first 30 minutes after oxytocin administration
Concentration of oxytocin in venous samples
Arterial [OXT]
Time Frame: Scheduled samples during the first 30 minutes after oxytocin administration
Concentration of oxytocin in arterial samples
Secondary Outcomes
- Arterial [OXTase](Scheduled samples during the first 30 minutes after oxytocin administration)
- Hypotension(Measured intraoperatively)
- Uterine tone(Scheduled measurements during the first 30 minutes after oxytocin administration)
- EBL(Estimated at the end of surgery)
- Nausea & Vomiting(Recorded intraoperatively)