Coagulation Changes With Oxytocin
Conditions
Brief summary
The purpose of this study is to evaluate the differences in blood clotting seen in healthy patients given two different doses of oxytocin following cesarean delivery. The secondary objectives are to evaluate changes in blood pressure, rates of nausea and vomiting, and differences in blood loss with the two separate doses of oxytocin.
Interventions
DRUGOxytocin
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English speaking * Age \> or = 18 yrs * Non-laboring women * cesarean delivery under spinal anesthesia with pfannenstiel incision * ASA I-III
Exclusion criteria
* Height \<5'0 * Allergy to phenylephrine * Severe cardiac disease in pregnancy with marked functional limitations * Women receiving NSAIDS, aspirin or other anticoagulants * Subject enrollment in another study involving a study medication within 30 days of cesarean delivery * Other physical or psychiatric condition which may impair the ability to cooperate with study data collection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| coagulation as assessed by ROTEM | 30 minutes after oxytocin infusion started |
Secondary
| Measure | Time frame |
|---|---|
| cardiac output changes with oxytocin | from start of surgery until 30 min after oxytocin infusion started |
| incidence of nausea and vomiting with oxytocin | from start of surgery until 30 minutes after oxytocin started |
| estimated blood loss with different doses of oxytocin | upon completion of surgery |
| changes in blood pressure with oxytocin | from start of surgery until 30 minutes after oxytocin started |
Countries
United States
Outcome results
None listed