Trial · Observational

CompletedPhase not statedResults postedRegistry data

In-vitro Study to Assess the Coagulation Effects of Exogenous Oxytocin Using Thromboelastography.

NCTNCT00788255Other idSU-10242008-1327

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Overview

Status: Completed
Phase: Phase not stated
Enrollment: 25 participants (actual)
Sponsor: Stanford University · Other
Design: Not stated
Countries: 1 country
United States
Start: Oct 2008
Primary completion: Jun 2009
Completion: Jun 2009
First posted: 10 Nov 2008 (estimated)
Last update posted: 28 Nov 2016 (estimated)
Conditions: Anesthesia

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200820092010

Ph –
In-vitro Study to Assess the Coagulation Effects of Exogenous Oxytocin Using Thromboelastography.
NCT00788255
Oct 2008 to Jun 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Final exogenous oxytocin concentration=22.5 μU/mLDrug
Final exogenous oxytocin concentration=30.1μU/mLDrug
Final exogenous oxytocin concentration=32.9μU/mLDrug

Arms1

Other
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.

Primary outcomes7

Outcomes the sponsor listed as primary.

r Time
Time frame · 6 months
Registry description
thromboelastographic indices - reaction time (normal range, 5-10 min)
k Time
Time frame · 6 months
Registry description
thromboelastographic indices - clot formation time (normal range, 1-3 min)
Alpha Angle
Time frame · 6 months
Registry description
thromboelastographic - alpha angle = clot formation rate (normal range, 53 degress to 72 degrees)
MA
Time frame · 6 months
Registry description
thromboelastographic indices - maximum amplitude (normal range, 50-70 mm)
MRTG
Time frame · 6 months
Registry description
thromboelastographic indices - maximum rate of thrombus generation (normal range, 5-17 mm/min)
Tmax
Time frame · 6 months
Registry description
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
Registry description
thromboelastographic indices - total thrombus generation (normal range, 584-796 mm)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 6 months

r Time

Group	Value (minutes)	Spread
All Participants	5.6	1.4

Primary outcomeMean· 6 months

k Time

Group	Value (minutes)	Spread
All Participants	1.6	0.4

Primary outcomeMean· 6 months

Alpha Angle

Group	Value (degrees)	Spread
All Participants	67.4	4.2

Primary outcomeMean· 6 months

MA

Group	Value (mm)	Spread
All Participants	69.8	4.3

Primary outcomeMean· 6 months

MRTG

Group	Value (mm/min)	Spread
All Participants	13.5	2.7

Primary outcomeMean· 6 months

Tmax

Group	Value (minutes)	Spread
All Participants	6.9	1.6

Primary outcomeMean· 6 months

TTG

Group	Value (mm)	Spread
All Participants	845.9	53.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
22.5 μU/mL Exogenous Oxytocinthromboelastography: TEG was performed on kaolin-activated citrated blood samples	–	0 / 25	0 / 25
30.1 μU/mL Exogenous Oxytocinthromboelastography: TEG was performed on kaolin-activated citrated blood samples	–	0 / 25	0 / 25
32.9 μU/mL Exogenous Oxytocinthromboelastography: TEG was performed on kaolin-activated citrated blood samples	–	0 / 25	0 / 25
0 μU/mL Exogenous OxytocinThromboelastography on native blood sample.	–	0 / 25	0 / 25

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 40 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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