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

Purpose

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.

Condition	Intervention
Thrombelastography Anesthesia	Procedure: thromboelastography

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	In-vitro Study to Assess the Coagulation Effects of Exogenous Oxytocin Using Thromboelastography.

Resource links provided by NLM:

Drug Information available for: Oxytocin

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Effect of oxytocin on coagulation as assessed by thromboelastography [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Venous blood

Enrollment:	25
Study Start Date:	October 2008
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

healthy pregnant patients awaiting elective induction of labor or cesarean delivery.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788255

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Alexander J Butwick

Stanford University

More Information

No publications provided

Responsible Party:	Alex James Butwick, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT00788255 History of Changes
Other Study ID Numbers:	SU-10242008-1327
Study First Received:	November 6, 2008
Last Updated:	November 5, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Oxytocin
Oxytocics
Reproductive Control Agents

Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013