Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT00257803
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.
Study:
NCT00257803
Study Brief:
Protocol Section:
NCT00257803