BleedingNCT01514591
Thromboelastography in Non-elective Cesarean Delivery
An observational study of Bleeding, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study is to assess the coagulation changes that occur in laboring patients undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bleeding
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult
Study population: Obstetrical laboring patients who are undergoing non-elective Cesarean delivery with an 'epidural top up' for surgical anesthesia.
Who may be able to join
- Obstetric in-patients
- Laboring patients with Epidurals for Labor Analgesia going for non-elective Cesarean
- Patients of all ethnic backgrounds will be included
- Singleton pregnancy
- ASA 1 or 2
Who cannot join
- Patients with underlying coagulation disorders.
- Patients with thrombocytopenia (platelet count <100).
- Patients with pregnancy-induced hypertension, pre-eclampsia.
- Patients requiring the following medications prior to surgery: NSAIDS, aspirin, anticoagulants.
- Patients requiring elective Cesarean delivery.
- 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
Lucile Packard Children's Hospital
Stanford, California, 94305
About this study
Official title: Thromboelastography to Assess Hemostatic Changes in Laboring Patients Undergoing Non-elective (Intrapartum) Cesarean Delivery
The purpose of the study is to assess the coagulation changes that occur in laboring patients undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). We will compare coagulation data to assess potential coagulation changes associated with hemoglobin changes before and after surgery, and related to estimated blood loss.
Read the detailed description
The purpose of the study is to assess the coagulation changes that occur in laboring patients undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). TEG is a point- of-care device which measures the viscoelastic properties of clot formation. This device can provide rapid and detailed information about coagulation changes in the perioperative period. We will compare coagulation data collected from the study to assess potential coagulation changes associated with Hemoglobin changes before and after surgery, and related to estimated blood loss.
- Conditions
- Bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-elective Cesarean Delivery | We will only enroll patients undergoing non-elective CS with an 'epidural top-up' for surgical anesthesia. By definition, our study will only apply to laboring women with working labor epidurals (which were provided for labor analgesia). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated blood loss; Coagulation data (Thromboelastography, Laboratory)
This study will allow us to collect more information about the hemostatic effects that occur during non-elective Cesarean delivery. This information will add to current knowledge base (which we have published) about coagulation changes in the peripartum period in patients undergoing non-elective Cesarean section.
Measured: pre and post cesarean delivery, an expected average of 75 minutes
Secondary outcomes (1)
Hematologic indices
Hematologic indices will include: Hemoglobin concentration and platelet count.
Measured: Pre and post cesarean delivery, an expected average of 75 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startAug 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BleedingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 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
- Alex Butwick, MBBS, FRCA, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514591
- Sponsor's protocol ID
- SU-08162011-8270
- Other IDs
- IRB 22205
- Status last verified
- Jun 2013
- First submitted
- 11 Jan 2012
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Butwick A, Ting V, Ralls LA, Harter S, Riley E. The association between thromboelastographic parameters and total estimated blood loss in patients undergoing elective cesarean delivery. Anesth Analg. 2011 May;112(5):1041-7. doi: 10.1213/ANE.0b013e318210fc64. Epub 2011 Apr 7.
PubMed 21474664
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboelastography to Assess Hemostatic Changes in Laboring Patients Undergoing Non-elective (Intrapartum) Cesarean Delivery
- ClinicalTrials.gov ID
- NCT01514591
- Acronym / sponsor ID
- SU-08162011-8270
- Conditions
- Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the coagulation changes that occur in laboring patients undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). We will compare coagulation data to assess potential coagulation changes associated with hemoglobin changes before and after surgery, and related to estimated blood loss.
Detailed description
The purpose of the study is to assess the coagulation changes that occur in laboring patients undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). TEG is a point- of-care device which measures the viscoelastic properties of clot formation. This device can provide rapid and detailed information about coagulation changes in the perioperative period. We will compare coagulation data collected from the study to assess potential coagulation changes associated with Hemoglobin changes before and after surgery, and related to estimated blood loss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-elective Cesarean Delivery | – | –We will only enroll patients undergoing non-elective CS with an 'epidural top-up' for surgical anesthesia. By definition, our study will only apply to laboring women with working labor epidurals (which were provided for labor analgesia). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Obstetrical laboring patients who are undergoing non-elective Cesarean delivery with an 'epidural top up' for surgical anesthesia.
Key inclusion criteria (5 listed)
- Obstetric in-patients
- Laboring patients with Epidurals for Labor Analgesia going for non-elective Cesarean
- Patients of all ethnic backgrounds will be included
- Singleton pregnancy
- ASA 1 or 2
Key exclusion criteria (7 listed)
- Patients with underlying coagulation disorders.
- Patients with thrombocytopenia (platelet count <100).
- Patients with pregnancy-induced hypertension, pre-eclampsia.
- Patients requiring the following medications prior to surgery: NSAIDS, aspirin, anticoagulants.
- Patients requiring elective 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.
Primary outcome
Estimated blood loss; Coagulation data (Thromboelastography, Laboratory)
Time frame: pre and post cesarean delivery, an expected average of 75 minutes
This study will allow us to collect more information about the hemostatic effects that occur during non-elective Cesarean delivery. This information will add to current knowledge base (which we have published) about coagulation changes in the peripartum period in patients undergoing non-elective Cesarean section.
1 secondary outcome
Hematologic indices
Time frame: Pre and post cesarean delivery, an expected average of 75 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
- Background: PubMed 21474664Butwick A, Ting V, Ralls LA, Harter S, Riley E. The association between thromboelastographic parameters and total estimated blood loss in patients undergoing elective cesarean delivery. Anesth Analg. 2011 May;112(5):1041-7. doi: 10.1213/ANE.0b013e318210fc64. Epub 2011 Apr 7.
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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.
Alex Butwick, MBBS, FRCA 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 Bleeding, 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?
The sponsor lists 5 inclusion and 7 exclusion criteria. 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 21 Jun 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Estimated blood loss; Coagulation data (Thromboelastography, Laboratory) (time frame: pre and post cesarean delivery, an expected average of 75 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01514591, which also lists 1 linked publication.
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 21 Jun 2013.