Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?
Primary Purpose
Postpartum Hemorrhage, Uterine Atony
Status
Withdrawn
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Oxytocin
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Oxytocin, Intramyometrial
Eligibility Criteria
Inclusion Criteria:
- Healthy Parturients
- Elective cesarean Delivery
- Term (> 37 wks gestational age) as defined by ultrasound or last menstrual period
- Singleton fetus
- Vertex presentation
- Age > 18
- BMI < 40
- Height > 5'2" and < 5"8"
- Written informed consent
Exclusion Criteria:
- Placenta previa
- Multiple gestation
- Preeclampsia
- Gestational Diabetes or pre-existing diabetes
- Macrosomia (estimated fetal weight prior to delivery)
- Polyhydramnios
- Oligohydramnios
- Uterine fibroids
- More than 2 previous cesarean deliveries
- Suspected adherent placenta (acreta/increta/percreta)
- Planned general anesthesia
Sites / Locations
- Royal University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intramyometrial oxytocin
Intramyometrial Saline
Arm Description
Outcomes
Primary Outcome Measures
Uterine Tone
Secondary Outcome Measures
Estimated Blood Loss
Pre-operative to post-operative change in hematocrit
Need for additional unterotonics
Need for blood pressure support
Full Information
NCT ID
NCT01252342
First Posted
November 30, 2010
Last Updated
January 9, 2012
Sponsor
University of Saskatchewan
1. Study Identification
Unique Protocol Identification Number
NCT01252342
Brief Title
Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?
Official Title
Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Proposed doses were too large, bolus oxytocin may cause cases of arrythmias, and some even advocate slowing down the infusion rates that are currently used.
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Saskatchewan
4. Oversight
5. Study Description
Brief Summary
Oxytocin use has become routine practice in elective cesarean delivery to promote uterine contraction and reduce blood loss. However, there is a lack of consensus regarding the best dose of oxytocin and the most effective route of administration. Most dosage and delivery systems have been empirically derived.
It is currently our practice at the Royal University Hospital to start an oxytocin infusion (20U/L) once the baby has been delivered. Some anesthesiologists use bolus intravenous oxytocin and it is occasionally requested by the obstetrician. A few obstetricians also choose to inject bolus oxytocin directly into the uterus (intramyometrial).
The primary objectives of the study include:
Determine if our standard 'low dose' oxytocin infusion is adequate prophylaxis to prevent need for additional uterotonics, including additional oxytocin;
Determine if the addition of prophylactic intramyometrial oxytocin improves both the primary outcome (uterine tone) and secondary outcomes (estimated blood loss, preoperative to postoperative change in hematocrit, need for additional uterotonics, and need for blood pressure support); and
Act as a dose finding study to determine if the intramyometrial dose is sufficient to augment uterine contraction.
The working hypothesis is that the use of intramyometrial oxytocin will not improve primary or secondary outcomes compared to the current practice of an oxytocin infusion alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage, Uterine Atony
Keywords
Oxytocin, Intramyometrial
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intramyometrial oxytocin
Arm Type
Experimental
Arm Title
Intramyometrial Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
10 U intramyometrial oxytocin bolus immediately after cesarian delivery, and an infusion of 20 U/L of oxytocin at 500ml/hr.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
10U intramyometrial normal saline bolus immediately after cesarian delivery, and an infusion of 20U/L of oxytocin at 500ml/hr.
Primary Outcome Measure Information:
Title
Uterine Tone
Time Frame
The blinded obstetrician will assess uterine tone at 1,2,4,6, 8 and 10-minute intervals
Secondary Outcome Measure Information:
Title
Estimated Blood Loss
Time Frame
Immediately Post-operatively
Title
Pre-operative to post-operative change in hematocrit
Time Frame
24 hrs post-operative
Title
Need for additional unterotonics
Time Frame
Immediately post delivery
Title
Need for blood pressure support
Time Frame
Intra-operative period following administration of oxytocin
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Parturients
Elective cesarean Delivery
Term (> 37 wks gestational age) as defined by ultrasound or last menstrual period
Singleton fetus
Vertex presentation
Age > 18
BMI < 40
Height > 5'2" and < 5"8"
Written informed consent
Exclusion Criteria:
Placenta previa
Multiple gestation
Preeclampsia
Gestational Diabetes or pre-existing diabetes
Macrosomia (estimated fetal weight prior to delivery)
Polyhydramnios
Oligohydramnios
Uterine fibroids
More than 2 previous cesarean deliveries
Suspected adherent placenta (acreta/increta/percreta)
Planned general anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica K San Vicente, MD
Organizational Affiliation
University of Saskatchewan, Department of Anesthesia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David C Campbell, MD, FRCPC
Organizational Affiliation
University of Saskatchewan, Department of Anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
12. IPD Sharing Statement
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Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?
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