The Use of Thromboelastometry (ROTEM) to Evaluate the Changes in Coagulation With Two Different Doses of Oxytocin Following Cesarean Delivery

December 14, 2015 updated by: Duke University
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • English speaking
  • Age > or = 18 yrs
  • Non-laboring women
  • cesarean delivery under spinal anesthesia with pfannenstiel incision
  • ASA I-III

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low dose oxytocin infusion
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
Drug: Oxytocin
Active Comparator: High dose oxytocin infusion
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
Drug: Oxytocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
coagulation as assessed by ROTEM
Time Frame: 30 minutes after oxytocin infusion started
30 minutes after oxytocin infusion started

Secondary Outcome Measures

Outcome Measure
Time Frame
cardiac output changes with oxytocin
Time Frame: from start of surgery until 30 min after oxytocin infusion started
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
from start of surgery until 30 minutes after oxytocin started
estimated blood loss with different doses of oxytocin
Time Frame: upon completion of surgery
upon completion of surgery
changes in blood pressure with oxytocin
Time Frame: from start of surgery until 30 minutes after oxytocin started
from start of surgery until 30 minutes after oxytocin started

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Estimate)

December 16, 2015

Last Update Submitted That Met QC Criteria

December 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00051122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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