Up-Down Oxytocin Infusion

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ronald George, IWK Health Centre

ClinicalTrials.gov Identifier:

NCT00785395

First received: October 27, 2008

Last updated: November 1, 2011

Last verified: November 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

October 27, 2008

Last Updated Date

November 1, 2011

Start Date ^ICMJE

June 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary outcome measure is the response of effective uterine contraction as either satisfactory or unsatisfactory as determined by the obstetrician blinded to the oxytocin infusion dose. [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00785395 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Secondary outcomes will include need for additional uterotonics, calculated intra-operative blood loss and presence of oxytocin related adverse effects. [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Up-Down Oxytocin Infusion

Official Title ^ICMJE

Up-down Determination of the ED90 of Oxytocin Infusions for the Prevention of Postpartum Uterine Atony in Parturients Undergoing Cesarean Delivery

Brief Summary

This study is designed to determine the minimum effective dose (ED90) of infusions of oxytocin for the prevention of uterine atony / postpartum hemorrhage and the need for additional uterotonics, in low risk parturients presenting for an elective CD.

The primary outcome measure is the response of effective uterine contraction as either satisfactory or unsatisfactory as determined by the obstetrician blinded to the oxytocin infusion dose. Secondary outcomes will include need for additional uterotonics, calculated intra-operative blood loss and presence of oxytocin related adverse effects.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention

Condition ^ICMJE

Uterine Atony

Intervention ^ICMJE

Drug: Oxytocin infusion

Up-down dosing determination

Study Arm (s)

Experimental: A

Intervention: Drug: Oxytocin infusion

Publications *

George 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. Epub 2010 Mar 18.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Non-emergent cesarean delivery with planned spinal anesthesia (i.e. elective planned cesarean delivery for malposition, patient choice, cervical pelvic disproportion, previous cesarean delivery and other diagnosis that require a predetermined cesarean delivery)
American Society of Anesthesia physical status class I & II (ASA I - Healthy, ASA II - mild and controlled systemic disease, eg. controlled essential hypertension)
Age ≥ 18 years
Term gestational age (≥ 37 weeks)
English-speaking

Exclusion Criteria:

Morbid Obesity (Body Mass Index ≥ 45 kg/m2) (Morbidly obese parturients require a dose of local anesthetic less than the standardized dose in this study and the blood pressure cuff occasionally needs to be replaced by an intraarterial catheter due to limitations in size)
Laboring women
Urgent or emergency cesarean delivery
Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP) > 160mmHg, diastolic blood pressure (DBP) > 110mmHg and/or requiring antihypertensive treatment or associated with significant proteinuria
Severe maternal cardiac disease
Subjects predisposed to uterine atony and postpartum hemorrhage (i.e. placenta previa, multiple gestation, macrosomia, polyhydramnios, uterine abnormalities, or bleeding diathesis, > 2 previous CD)
Fetal anomalies /Intrauterine Fetal Demise
Failed spinal anesthesia
Patient enrollment in another study involving a study medication within 30 days of CD
Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00785395

Other Study ID Numbers ^ICMJE

IWK-4329-2008

Has Data Monitoring Committee

Yes

Responsible Party

Ronald George, IWK Health Centre

Study Sponsor ^ICMJE

IWK Health Centre

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ronald B George, MD FRCPC

IWK

Information Provided By

IWK Health Centre

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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