Coagulation Changes With OxytocinNCT02063568
The Use of Thromboelastometry (ROTEM) to Evaluate the Changes in Coagulation With Two Different Doses of Oxytocin Following Cesarean Delivery
A study testing Oxytocin in people with Coagulation Changes With Oxytocin, run by Duke University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Coagulation Changes With Oxytocin
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2015
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- Age > or = 18 yrs
- Non-laboring women
- cesarean delivery under spinal anesthesia with pfannenstiel incision
- ASA I-III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27705
About this study
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.
- Conditions
- Coagulation Changes With Oxytocin
- Being tested
- Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
| Study group | Role | What they receive |
|---|---|---|
| Low dose oxytocin infusion | Active comparator | oxytocin will be administered as an intravenous infusion at a rate of 0.33 units/min starting after fetal delivery upon umbilical cord clamping and continuing for a total of 30 minutes Receives: Drug: Oxytocin |
| High dose oxytocin infusion | Active comparator | oxytocin will be administered as an intravenous infusion at a rate of 1.33 units/min starting after fetal delivery upon umbilical cord clamping and continuing for a total of 30 minutes Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
coagulation as assessed by ROTEM
Measured: 30 minutes after oxytocin infusion started
Secondary outcomes (4)
cardiac output changes with oxytocin
Measured: from start of surgery until 30 min after oxytocin infusion started
incidence of nausea and vomiting with oxytocin
Measured: from start of surgery until 30 minutes after oxytocin started
estimated blood loss with different doses of oxytocin
Measured: upon completion of surgery
changes in blood pressure with oxytocin
Measured: from start of surgery until 30 minutes after oxytocin started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coagulation Changes With OxytocinStudies of the same condition, open and under way.
- More trials run by Duke 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063568
- Sponsor's protocol ID
- Pro00051122
- Status last verified
- Oct 2015
- First submitted
- 12 Feb 2014
- Last updated
- 16 Dec 2015
- Results posted
- No
Publications
Solomon C, Collis RE, Collins PW. Haemostatic monitoring during postpartum haemorrhage and implications for management. Br J Anaesth. 2012 Dec;109(6):851-63. doi: 10.1093/bja/aes361. Epub 2012 Oct 16.
PubMed 23075633George RB, McKeen D, Chaplin AC, McLeod L. Up-down determination of the ED(90) of oxytocin infusions for the prevention of postpartum uterine atony in parturients undergoing Cesarean delivery. Can J Anaesth. 2010 Jun;57(6):578-82. doi: 10.1007/s12630-010-9297-1. Epub 2010 Mar 18.
PubMed 20238255Balki M, Erik-Soussi M, Kingdom J, Carvalho JC. Oxytocin pretreatment attenuates oxytocin-induced contractions in human myometrium in vitro. Anesthesiology. 2013 Sep;119(3):552-61. doi: 10.1097/ALN.0b013e318297d347.
PubMed 23676375Tita AT, Szychowski JM, Rouse DJ, Bean CM, Chapman V, Nothern A, Figueroa D, Quinn R, Andrews WW, Hauth JC. Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):293-300. doi: 10.1097/AOG.0b013e318242da74.
PubMed 22227638Butwick A, Harter S. An in vitro investigation of the coagulation effects of exogenous oxytocin using thromboelastography in healthy parturients. Anesth Analg. 2011 Aug;113(2):323-6. doi: 10.1213/ANE.0b013e3182222a82. Epub 2011 Jun 3.
PubMed 21642611Neuenschwander S, Pliska V. Effects of neurohypophyseal hormone analogues on blood clotting factor VIII and fibrinolytic activity in sheep. Eur J Pharmacol. 1997 Apr 4;323(2-3):205-13. doi: 10.1016/s0014-2999(97)00036-8.
PubMed 9128840
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Thromboelastometry (ROTEM) to Evaluate the Changes in Coagulation With Two Different Doses of Oxytocin Following Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02063568
- Acronym / sponsor ID
- Pro00051122
- Conditions
- Coagulation Changes With Oxytocin
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Feb 2014 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose oxytocin infusion | Active comparator | Drug: Oxytocinoxytocin will be administered as an intravenous infusion at a rate of 0.33 units/min starting after fetal delivery upon umbilical cord clamping and continuing for a total of 30 minutes |
| High dose oxytocin infusion | Active comparator | Drug: Oxytocinoxytocin will be administered as an intravenous infusion at a rate of 1.33 units/min starting after fetal delivery upon umbilical cord clamping and continuing for a total of 30 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English speaking
- Age > or = 18 yrs
- Non-laboring women
- cesarean delivery under spinal anesthesia with pfannenstiel incision
- ASA I-III
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Oxytocin | Drug | High dose oxytocin infusion, Low dose oxytocin infusion |
Primary outcome
coagulation as assessed by ROTEM
Time frame: 30 minutes after oxytocin infusion started
4 secondary outcomes
cardiac output changes with oxytocin
Time frame: from start of surgery until 30 min after oxytocin infusion started
incidence of nausea and vomiting with oxytocin
Time frame: from start of surgery until 30 minutes after oxytocin started
estimated blood loss with different doses of oxytocin
Time frame: upon completion of surgery
changes in blood pressure with oxytocin
Time frame: from start of surgery until 30 minutes after oxytocin started
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
- Background: PubMed 23075633Solomon C, Collis RE, Collins PW. Haemostatic monitoring during postpartum haemorrhage and implications for management. Br J Anaesth. 2012 Dec;109(6):851-63. doi: 10.1093/bja/aes361. Epub 2012 Oct 16.
- Background: PubMed 20238255George RB, McKeen D, Chaplin AC, McLeod L. Up-down determination of the ED(90) of oxytocin infusions for the prevention of postpartum uterine atony in parturients undergoing Cesarean delivery. Can J Anaesth. 2010 Jun;57(6):578-82. doi: 10.1007/s12630-010-9297-1. Epub 2010 Mar 18.
- Background: PubMed 23676375Balki M, Erik-Soussi M, Kingdom J, Carvalho JC. Oxytocin pretreatment attenuates oxytocin-induced contractions in human myometrium in vitro. Anesthesiology. 2013 Sep;119(3):552-61. doi: 10.1097/ALN.0b013e318297d347.
- Background: PubMed 22227638Tita AT, Szychowski JM, Rouse DJ, Bean CM, Chapman V, Nothern A, Figueroa D, Quinn R, Andrews WW, Hauth JC. Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):293-300. doi: 10.1097/AOG.0b013e318242da74.
- Background: PubMed 21642611Butwick A, Harter S. An in vitro investigation of the coagulation effects of exogenous oxytocin using thromboelastography in healthy parturients. Anesth Analg. 2011 Aug;113(2):323-6. doi: 10.1213/ANE.0b013e3182222a82. Epub 2011 Jun 3.
- Background: PubMed 9128840Neuenschwander S, Pliska V. Effects of neurohypophyseal hormone analogues on blood clotting factor VIII and fibrinolytic activity in sheep. Eur J Pharmacol. 1997 Apr 4;323(2-3):205-13. doi: 10.1016/s0014-2999(97)00036-8.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Coagulation Changes With Oxytocin, run by Duke 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 6 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: withdrawn, as of the sponsor's last update on 16 Dec 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
coagulation as assessed by ROTEM (time frame: 30 minutes after oxytocin infusion started). 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 NCT02063568, which also lists 6 linked publications.
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 16 Dec 2015.