Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257803
Status:
COMPLETED
Last Update Posted:
2014-03-17
First Post:
2005-11-21
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
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NHR05-0206 | None | None | None |