Coagulation Changes With Oxytocin Clinical Trial
Official title:
The Use of Thromboelastometry (ROTEM) to Evaluate the Changes in Coagulation With Two Different Doses of Oxytocin Following Cesarean Delivery
| Verified date | October 2015 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke University Hospital | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University |
United States,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | coagulation as assessed by ROTEM | 30 minutes after oxytocin infusion started | No | |
| Secondary | cardiac output changes with oxytocin | from start of surgery until 30 min after oxytocin infusion started | No | |
| Secondary | incidence of nausea and vomiting with oxytocin | from start of surgery until 30 minutes after oxytocin started | No | |
| Secondary | estimated blood loss with different doses of oxytocin | upon completion of surgery | No | |
| Secondary | changes in blood pressure with oxytocin | from start of surgery until 30 minutes after oxytocin started | No |