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Does the Rapid Intravenous Administration of Oxytocin After Delivery of the Baby Decrease the Bleeding During Cesarean Section in Women at Risk of Bleeding During Cesarean Section?

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oxytocin
Saline solution
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Oxytocin, bolus, postpartum hemorrhage

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Aged 19 years or over Having a cesarean section Have one or more of the following a larger than average uterus, because of a large baby twins, triplets, etc a large volume of fluid around the baby have received oxytocin to help stimulate labor for eight or more hours before cesarean section have infection inside the uterus that is treated with antibiotics bleeding after giving prior birth the placenta is in a position where it is more likely to bleed have had five or more pregnancies before current one Exclusion Criteria: Significant medical problem such that an oxytocin bolus might not be safe Active bleeding and their blood pressure or pulse rate are not normal Blood does not clot normally Aged less than 19 years Does not understand English

Sites / Locations

  • BC Women's Hospital, Department of Anesthesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

In the other group, the women will receive a small injection of oxytocin directly into the vein via their intravenous (bolus) after their baby is born.

In one group, women will receive a small injection of saline (salt water) directly into the vein via their intravenous (bolus) after their baby is born.

Outcomes

Primary Outcome Measures

Need for additional oxytocics in women at high risk of hemorrhage

Secondary Outcome Measures

Secondary outcomes include uterine tone and side effects.

Full Information

First Posted
November 21, 2005
Last Updated
March 14, 2014
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00257803
Brief Title
Does the Rapid Intravenous Administration of Oxytocin After Delivery of the Baby Decrease the Bleeding During Cesarean Section in Women at Risk of Bleeding During Cesarean Section?
Official Title
A Randomized Double-blind Comparison of a 5 Unit Intravenous Oxytocin Bolus Versus Placebo as a Strategy to Prevent Uterine Atony at Cesarean Section in Women Who Are at Increased Risk of Post-Partum Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Oxytocin is normally given either rapidly into the vein (bolus) or put into an intravenous bag and administered more slowly, after delivery of the baby by cesarean section. Both of these methods are commonly used. To date there has been little research to demonstrate that one method of giving oxytocin is better than another in women who are more likely to bleed after delivery. The purpose of the study is to see whether a small bolus of oxytocin makes the uterus contract better to reduce bleeding and decreases the need to give additional oxytocin or more powerful drugs in women who are at risk for bleeding after delivery of their baby by cesarean section.
Detailed Description
Oxytocin is normally given either rapidly into the vein (bolus) or put into an intravenous bag and administered more slowly, after delivery of the baby by cesarean section. Both of these methods are commonly used. To date there has been little research to demonstrate that one method of giving oxytocin is better than another in women who are more likely to bleed after delivery. The purpose of the study is to see whether a small bolus of oxytocin makes the uterus contract better to reduce bleeding and decreases the need to give additional oxytocin or more powerful drugs in women who are at risk for bleeding after delivery of their baby by cesarean section. Women who participate will be randomized (like a toss of a coin) to one of two groups. Neither the woman nor the anesthesiologist nor the obstetrician will know which group they are in. In one group, the women will receive a small injection of saline (salt water) directly into the vein via their intravenous (bolus) after their baby is born. In the other group, the women will receive a small injection of oxytocin directly into the vein via their intravenous (bolus) after their baby is born. Both groups will have the standard amount of oxytocin given slowly (over a 30 minute period) into the intravenous in their arm (infusion). The amount of oxytocin that is put into the intravenous bag is a normal amount that would be given during cesarean section in any woman not involved in the study and it will be started after the initial injection has been given. The only difference between the two groups is that one group will have an extra dose of oxytocin given directly into the vein via the intravenous while the other will have a saline solution given directly into the vein via the intravenous. Information that will be obtained during the study will include any decrease in blood pressure or increase in heart rate at the time the saline or oxytocin is given directly into the vein. The obstetrician will be asked to indicate how well the uterus is contracting and they can ask the anesthesiologist to give more oxytocin or a more powerful drug if, in their opinion, the uterus is not contracting well. This is the normal way that this is done. If the woman should feel dizzy (possibly secondary to low blood pressure) their anesthesiologist will treat them the same way as they would if this happened to any woman who is not part of the study. In other words, the anesthesiologist and obstetrician will treat the woman the way they normally would whether the woman was part of the study or not.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Oxytocin, bolus, postpartum hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
In the other group, the women will receive a small injection of oxytocin directly into the vein via their intravenous (bolus) after their baby is born.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
In one group, women will receive a small injection of saline (salt water) directly into the vein via their intravenous (bolus) after their baby is born.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
See detailed description
Intervention Type
Drug
Intervention Name(s)
Saline solution
Intervention Description
See detailed description
Primary Outcome Measure Information:
Title
Need for additional oxytocics in women at high risk of hemorrhage
Time Frame
within the first hour after delivery
Secondary Outcome Measure Information:
Title
Secondary outcomes include uterine tone and side effects.
Time Frame
within 10 minutes of delivery and time from giving the bolus until placenta delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 19 years or over Having a cesarean section Have one or more of the following a larger than average uterus, because of a large baby twins, triplets, etc a large volume of fluid around the baby have received oxytocin to help stimulate labor for eight or more hours before cesarean section have infection inside the uterus that is treated with antibiotics bleeding after giving prior birth the placenta is in a position where it is more likely to bleed have had five or more pregnancies before current one Exclusion Criteria: Significant medical problem such that an oxytocin bolus might not be safe Active bleeding and their blood pressure or pulse rate are not normal Blood does not clot normally Aged less than 19 years Does not understand English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Douglas, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Women's Hospital, Department of Anesthesia
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20889945
Citation
King KJ, Douglas MJ, Unger W, Wong A, King RA. Five unit bolus oxytocin at cesarean delivery in women at risk of atony: a randomized, double-blind, controlled trial. Anesth Analg. 2010 Dec;111(6):1460-6. doi: 10.1213/ANE.0b013e3181f8930a. Epub 2010 Oct 1.
Results Reference
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Does the Rapid Intravenous Administration of Oxytocin After Delivery of the Baby Decrease the Bleeding During Cesarean Section in Women at Risk of Bleeding During Cesarean Section?

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