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Up-Down Oxytocin Infusion

Primary Purpose

Uterine Atony

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Oxytocin infusion

About this trial

This is an interventional prevention trial for Uterine Atony

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

IWK Health Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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 Outcome Measures

Secondary outcomes will include need for additional uterotonics, calculated intra-operative blood loss and presence of oxytocin related adverse effects.

Full Information

NCT ID

NCT00785395

First Posted

October 27, 2008

Last Updated

November 1, 2011

Sponsor

IWK Health Centre

1. Study Identification

Unique Protocol Identification Number

NCT00785395

Brief Title

Up-Down Oxytocin Infusion

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IWK Health Centre

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Atony

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare Provider

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Oxytocin infusion

Intervention Description

Up-down dosing determination

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Secondary outcomes will include need for additional uterotonics, calculated intra-operative blood loss and presence of oxytocin related adverse effects.

Time Frame

2 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald B George, MD FRCPC

Organizational Affiliation

IWK

Official's Role

Principal Investigator

Facility Information:

Facility Name

IWK Health Centre

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3K 6R8

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

20238255

Citation

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. doi: 10.1007/s12630-010-9297-1. Epub 2010 Mar 18.

Results Reference

derived

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