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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMI 20 - 29.9 kg/m2 |
| ||
| BMI > 30 kg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxytocin | Drug | PK measurements of oxytocin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial [OXTase] | Concentration of oxytocinase in arterial samples | Scheduled samples during the first 30 minutes after oxytocin administration |
| Uterine tone | Uterine tone measured using a Shore Durometer or assessed by obstetrician using numerical rating score (NRS, 0-10) |
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Inclusion Criteria:
Exclusion Criteria:
Participants must be scheduled for cesarean delivery of their baby
Pregnant women scheduled for cesarean delivery of their babies at term
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| Name | Affiliation | Role |
|---|---|---|
| David T Monks, MBChB | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25103301 | Background | 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. | |
| 20482535 | 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. |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| 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. |
|
| Scheduled measurements during the first 30 minutes after oxytocin administration |
| Hypotension | Incidence of systolic BP reduced by 20% from baseline | Measured intraoperatively |
| Nausea & Vomiting | Incidence of nausea and vomiting | Recorded intraoperatively |
| EBL | Estimated blood loss in milliliters | Estimated at the end of surgery |
| 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 II). Clin Pharmacokinet. 1989 Oct;17(4):275-90. doi: 10.2165/00003088-198917040-00005. No abstract available. |
| 2680213 | 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. |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |