An observational study in Anesthesia, sponsored by Stanford University. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2016-11-28.
Sponsored by Stanford University · Observational
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.
All obstetric patients presenting for elective induction of labor or elective Cesarean delivery will be informed about the study prior to and on admission to the labor and delivery unit. Admission blood sampling will take place by venepuncture for the following analysis:TEG, PT, PTT, INR, Hct, Platelet count.The results of oxytocin influence on thromboelastogram parameters will be compared to a control. The control is an aliquot of parturient blood with no added oxytocin. Thromboelastography will be used to assess coagulation changes between control samples and blood samples with added oxytocin. The results will not be used to influence clinical management of any case.
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healthy pregnant patients awaiting elective induction of labor or cesarean delivery.
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.
For each patient, 1 solution with citrated whole blood (control) and 3 solutions with citrated whole blood and exogenous oxytocin were prepared in separate vials using micropipettes as follows: Citrated whole blood 1mL + 23μU oxytocin: final exogenous oxytocin concentration=22.5 μU/mL Citrated whole blood 1mL + 31μU oxytocin: final exogenous oxytocin concentration=30.1μU/mL Citrated whole blood 1mL + 34μU oxytocin: final exogenous oxytocin concentration=32.9μU/mL After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
Drug: Final exogenous oxytocin concentration=22.5 μU/mL · Drug: Final exogenous oxytocin concentration=30.1μU/mL · Drug: Final exogenous oxytocin concentration=32.9μU/mL
Citrated whole blood 1mL + 23μU oxytocin. After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
Also known as: TEG
Citrated whole blood 1mL + 31μU oxytocin. After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
Also known as: TEG
Citrated whole blood 1mL + 34μU oxytocin. After mixing by inversion 8-10 times, 360μL kaolin-activated blood of each study solution was pipetted into a plastic cup in a prewarmed Thromboelastograph® (37°C). Each sample was recalcified in a plastic cup with 10μL of CaCl2 6.45%, and TEG® analysis was commenced within 1 minute of reconstituted sample preparation.
Also known as: TEG
r Time
thromboelastographic indices - reaction time (normal range, 5-10 min)
Time frame: 6 months
k Time
thromboelastographic indices - clot formation time (normal range, 1-3 min)
Time frame: 6 months
Alpha Angle
thromboelastographic - alpha angle = clot formation rate (normal range, 53 degress to 72 degrees)
Time frame: 6 months
MA
thromboelastographic indices - maximum amplitude (normal range, 50-70 mm)
Time frame: 6 months
MRTG
thromboelastographic indices - maximum rate of thrombus generation (normal range, 5-17 mm/min)
Time frame: 6 months
Tmax
thromboelastographic indices - time to initiation of clot formation plus time to achieve maximum rate of clot strength development (normal range, 6-12 min)
Time frame: 6 months
TTG
thromboelastographic indices - total thrombus generation (normal range, 584-796 mm)
Time frame: 6 months
| Milestone | All Participants |
|---|---|
| Started | 25 |
| Oxytocin infusion 1: 22.5 μu/ml | 25 |
| Oxytocin infusion 2: 30.1μu/ml | 25 |
| Oxytocin infusion 3: 32.9μu/ml | 25 |
| Oxytocin: 0 μu/ml | 25 |
| Completed | 25 |
| Not completed | 0 |
thromboelastographic indices - reaction time (normal range, 5-10 min)
| minutes | All Participants |
|---|---|
| Exogenous Oxytocin 22.5 | 5.6 ± 1.4 |
| Exogenous Oxytocin 30.1 | 4.2 ± 1.3 |
| Exogenous Oxytocin 32.9 | 3.9 ± 1.3 |
| Exogenous oxytocin 0 | 6 ± 1.5 |
thromboelastographic indices - clot formation time (normal range, 1-3 min)
| minutes | All Participants |
|---|---|
| Exogenous Oxytocin 22.5 | 1.6 ± 0.4 |
| Exogenous Oxytocin 30.1 | 1.5 ± 0.7 |
| Exogenous Oxytocin 32.9 | 1.4 ± 0.4 |
| Exogenous Oxytocin 0 | 1.7 ± 0.4 |
thromboelastographic - alpha angle = clot formation rate (normal range, 53 degress to 72 degrees)
| degrees | All Participants |
|---|---|
| Exogenous Oxytocin 22.5 | 67.4 ± 4.2 |
| Exogenous Oxytocin 30.1 | 67.7 ± 3.7 |
| Exogenous Oxytocin 32.9 | 69.4 ± 4.2 |
| Exogeneous oxytocin 0 | 66.2 ± 4.4 |
thromboelastographic indices - maximum amplitude (normal range, 50-70 mm)
| mm | All Participants |
|---|---|
| Exogenous Oxytocin 22.5 | 69.8 ± 4.3 |
| Exogenous Oxytocin 30.1 | 67.2 ± 3.7 |
| Exogenous Oxytocin 32.9 | 69.0 ± 4.2 |
| Exogeneous Oxytocin 0 | 67.2 ± 3.9 |
thromboelastographic indices - maximum rate of thrombus generation (normal range, 5-17 mm/min)
| mm/min | All Participants |
|---|---|
| Exogenous Oxytocin 22.5 | 13.5 ± 2.7 |
| Exogenous Oxytocin 30.1 | 14.9 ± 3.7 |
| Exogenous Oxytocin 32.9 | 14.3 ± 2.8 |
| Exogeneous Oxytocin 0 | 12.8 ± 2.5 |
thromboelastographic indices - time to initiation of clot formation plus time to achieve maximum rate of clot strength development (normal range, 6-12 min)
| minutes | All Participants |
|---|---|
| Exogenous Oxytocin 22.5 | 6.9 ± 1.6 |
| Exogenous Oxytocin 30.1 | 5.4 ± 1.9 |
| Exogenous Oxytocin 32.9 | 5.0 ± 1.5 |
| Exogeneous Oxytocin 0 | 7.5 ± 1.7 |
thromboelastographic indices - total thrombus generation (normal range, 584-796 mm)
| mm | All Participants |
|---|---|
| Exogenous Oxytocin 22.5 | 845.9 ± 53.9 |
| Exogenous Oxytocin 30.1 | 820 ± 45.9 |
| Exogenous Oxytocin 32.9 | 839.7 ± 51.8 |
| Exogeneous Oxytocin 0 | 819.4 ± 48.9 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 22.5 μU/mL Exogenous Oxytocin | — | 0/25 (0%) | 0/25 (0%) |
| 30.1 μU/mL Exogenous Oxytocin | — | 0/25 (0%) | 0/25 (0%) |
| 32.9 μU/mL Exogenous Oxytocin | — | 0/25 (0%) | 0/25 (0%) |
| 0 μU/mL Exogenous Oxytocin | — | 0/25 (0%) | 0/25 (0%) |
All blood samples for this study were taken from a total cohort of 25 patients
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 25 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 25 |
| Male | 0 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| United States | 25 |
Plan to share: No
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