The Use of Thromboelastometry (ROTEM) to Evaluate the Changes in Coagulation With Two Different Doses of Oxytocin Following Cesarean Delivery
- Registration Number
- NCT02063568
- Lead Sponsor
- Duke University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low dose oxytocin infusion Oxytocin oxytocin will be administered as an intravenous infusion at a rate of 0.33 units/min starting after fetal delivery upon umbilical cord clamping and continuing for a total of 30 minutes High dose oxytocin infusion Oxytocin oxytocin will be administered as an intravenous infusion at a rate of 1.33 units/min starting after fetal delivery upon umbilical cord clamping and continuing for a total of 30 minutes
- Primary Outcome Measures
Name Time Method coagulation as assessed by ROTEM 30 minutes after oxytocin infusion started
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Duke University Hospital
🇺🇸Durham, North Carolina, United States