The Use of Thromboelastometry (ROTEM) to Evaluate the Changes in Coagulation With Two Different Doses of Oxytocin Following Cesarean Delivery

Study Overview
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Brief Summary
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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.

Official Title
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The Use of Thromboelastometry (ROTEM) to Evaluate the Changes in Coagulation With Two Different Doses of Oxytocin Following Cesarean Delivery

Conditions
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Coagulation Changes With Oxytocin

Intervention / Treatment
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* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose oxytocin infusion<br>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 | Drug: Oxytocin<br> <br> |
| Active Comparator: High dose oxytocin infusion<br>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 | Drug: Oxytocin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coagulation as assessed by ROTEM |  | 30 minutes after oxytocin infusion started | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |