N/A
N=25
In-vitro Study to Assess the Coagulation Effects of Exogenous Oxytocin Using Thromboelastography.
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT00788255 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: r Time — 5.6; 4.2; 3.9; 6 minutes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Final exogenous oxytocin concentration=22.5 μU/mL (Drug); Final exogenous oxytocin concentration=30.1μU/mL (Drug); Final exogenous oxytocin concentration=32.9μU/mL (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY r Time |
5.6; 4.2; 3.9; 6 | — |
| PRIMARY k Time |
1.6; 1.5; 1.4; 1.7 | — |
| PRIMARY Alpha Angle |
67.4; 67.7; 69.4; 66.2 | — |
| PRIMARY MA |
69.8; 67.2; 69.0; 67.2 | — |
| PRIMARY MRTG |
13.5; 14.9; 14.3; 12.8 | — |
| PRIMARY Tmax |
6.9; 5.4; 5.0; 7.5 | — |
| PRIMARY TTG |
845.9; 820; 839.7; 819.4 | — |
Summary
Oxytocin is normally administered following delivery in pregnant patients to reduce postpartum bleeding by increasing uterine tone. It is unclear whether the use of intravenous oxytocin alters coagulation in pregnant patients. The purpose of the in-vitro study is to assess the coagulation changes of oxytocin in blood samples from pregnant patients using thromboelastrography (TEG). TEG is a point-of-care device which measures the viscoelastic properties of clot formation, and can provide rapid and detailed information about coagulation changes. We aim to collect blood samples from pregnant patients to assess the in-vitro effects of synthetic oxytocin on coagulation using TEG.
Eligibility Criteria
Inclusion Criteria:All obstetric patients with singleton pregnancies admitted to the labor and delivery unit at Lucile Packard Childrens Hospital awaiting elective induction of labor or elective Cesarean delivery. We will select 25 healthy ASA 1 patients with singleton pregnancies who are scheduled for uncomplicated elective induction of labor. Gestational age equal to or greater than 37 weeks.
Exclusion Criteria:Patients with underlying coagulation disorders. Patients with thrombocytopenia. Patients with pregnancy-induced hypertension, pre-eclampsia. Patients admitted for non-elective cesarean section. Patients in active labor. Patients requiring the following medications prior to surgery: NSAIDS, aspirin, anticoagulants.
Patients with significant obstetric or medical disease. No patients <18 years of age will be recruited.
Data sourced from ClinicalTrials.gov (NCT00788255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.