AnesthesiaNCT00788255
In-vitro Study to Assess the Coagulation Effects of Exogenous Oxytocin Using Thromboelastography.
An observational study of Anesthesia, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- Final exogenous oxytocin concentration=22.5 μU/mL, Final exogenous oxytocin concentration=30.1μU/mL and Final exogenous oxytocin concentration=32.9μU/mL
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jun 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
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.
Read the detailed description
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.
- Conditions
- Anesthesia
- Being tested
- Final exogenous oxytocin concentration=22.5 μU/mL, Final exogenous oxytocin concentration=30.1μU/mL, Final exogenous oxytocin concentration=32.9μU/mL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Final exogenous oxytocin concentration=22.5 μU/mLDrug
Also called TEG
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.
Final exogenous oxytocin concentration=30.1μU/mLDrug
Also called 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.
Final exogenous oxytocin concentration=32.9μU/mLDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| All participants | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
r Time
thromboelastographic indices - reaction time (normal range, 5-10 min)
Measured: 6 months
k Time
thromboelastographic indices - clot formation time (normal range, 1-3 min)
Measured: 6 months
Alpha Angle
thromboelastographic - alpha angle = clot formation rate (normal range, 53 degress to 72 degrees)
Measured: 6 months
MA
thromboelastographic indices - maximum amplitude (normal range, 50-70 mm)
Measured: 6 months
MRTG
thromboelastographic indices - maximum rate of thrombus generation (normal range, 5-17 mm/min)
Measured: 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)
Measured: 6 months
TTG
thromboelastographic indices - total thrombus generation (normal range, 584-796 mm)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex James Butwick, Stanford University
- Investigators
- Alexander J Butwick, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788255
- Sponsor's protocol ID
- SU-10242008-1327
- Status last verified
- Oct 2016
- First submitted
- 6 Nov 2008
- Last updated
- 28 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-vitro Study to Assess the Coagulation Effects of Exogenous Oxytocin Using Thromboelastography.
- ClinicalTrials.gov ID
- NCT00788255
- Acronym / sponsor ID
- SU-10242008-1327
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 10 Nov 2008 (estimated)
- Results
- Posted 18 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Drug: Final exogenous oxytocin concentration=22.5 μU/mL, Drug: Final exogenous oxytocin concentration=30.1μU/mL, Drug: Final exogenous oxytocin concentration=32.9μU/mLFor 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- healthy pregnant patients awaiting elective induction of labor or cesarean delivery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Final exogenous oxytocin concentration=22.5 μU/mLAlso: TEGCitrated 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. | Drug | All participants |
| Final exogenous oxytocin concentration=30.1μU/mLAlso: TEGCitrated 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. | Drug | All participants |
| Final exogenous oxytocin concentration=32.9μU/mLAlso: TEGCitrated 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. | Drug | All participants |
Primary outcome
r Time
Time frame: 6 months
thromboelastographic indices - reaction time (normal range, 5-10 min)
k Time
Time frame: 6 months
thromboelastographic indices - clot formation time (normal range, 1-3 min)
Alpha Angle
Time frame: 6 months
thromboelastographic - alpha angle = clot formation rate (normal range, 53 degress to 72 degrees)
MA
Time frame: 6 months
thromboelastographic indices - maximum amplitude (normal range, 50-70 mm)
MRTG
Time frame: 6 months
thromboelastographic indices - maximum rate of thrombus generation (normal range, 5-17 mm/min)
Tmax
Time frame: 6 months
thromboelastographic indices - time to initiation of clot formation plus time to achieve maximum rate of clot strength development (normal range, 6-12 min)
TTG
Time frame: 6 months
thromboelastographic indices - total thrombus generation (normal range, 584-796 mm)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander J Butwick principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
r Time (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.