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Trial · Interventional

WithdrawnNot applicableRegistry data

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

NCTNCT02063568 (opens ClinicalTrials.gov in a new tab)Other idPro00051122
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Not applicable
Enrollment
0 participants (actual)
Sponsor
Duke University · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Jan 2015
Primary completion
Dec 2015
Completion
Dec 2015
First posted
14 Feb 2014 (estimated)
Last update posted
16 Dec 2015 (estimated)
Conditions
Coagulation Changes With Oxytocin

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016
  1. N/A

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

    NCT02063568

    Jan 2015 to Dec 2015

    Withdrawn

Registry summary

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

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.

Interventions

  • OxytocinDrug

Arms2

  • 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

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. coagulation as assessed by ROTEM

    Time frame · 30 minutes after oxytocin infusion started

Secondary outcomes(4)

  1. cardiac output changes with oxytocin

    Time frame · from start of surgery until 30 min after oxytocin infusion started

  2. incidence of nausea and vomiting with oxytocin

    Time frame · from start of surgery until 30 minutes after oxytocin started

  3. estimated blood loss with different doses of oxytocin

    Time frame · upon completion of surgery

  4. changes in blood pressure with oxytocin

    Time frame · from start of surgery until 30 minutes after oxytocin started

Posted results

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

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

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

Studies5

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Observational study · 1997

3 results

Effects of neurohypophyseal hormone analogues on blood clotting factor VIII and fibrinolytic activity in sheep.

Neuenschwander et al. 1997European journal of pharmacologycited by 4

PMID 9128840DOI 10.1016/s0014-2999(97)00036-8PUB-09128840

Full text at the publisher3 results
Publisher pageSee results (3)

More studies

4 studies on this page

Indexing hint: In vitro study · 2013

Oxytocin pretreatment attenuates oxytocin-induced contractions in human myometrium in vitro.

Balki et al. 2013Anesthesiologycited by 54

PMID 23676375DOI 10.1097/aln.0b013e318297d347PUB-23676375

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2012

Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial.

Tita et al. 2012Obstetrics and gynecologycited by 34

PMID 22227638PMC3282278DOI 10.1097/aog.0b013e318242da74PUB-22227638

Rights unknown
Source link

Indexing hint: In vitro study · 2011

An in vitro investigation of the coagulation effects of exogenous oxytocin using thromboelastography in healthy parturients.

Butwick et al. 2011Anesthesia and analgesiacited by 10

PMID 21642611DOI 10.1213/ane.0b013e3182222a82PUB-21642611

Rights unknown
Source link

Indexing hint: Randomized controlled trial · 2010

Up-down determination of the ED(90) of oxytocin infusions for the prevention of postpartum uterine atony in parturients undergoing Cesarean delivery.

George et al. 2010Canadian journal of anaesthesia = Journal canadien d'anesthesiecited by 61

PMID 20238255DOI 10.1007/s12630-010-9297-1PUB-20238255

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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