Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481533
Status:
COMPLETED
Last Update Posted:
2007-06-01
First Post:
2007-05-30
Brief Title:
Ergot and Oxytocin During Cesarean Delivery Following Failure to Progress in Labour
Sponsor:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Organization:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Study Overview
Official Title:
Prophylactic Ergonovine-Oxytocin Versus Oxytocin During Cesarean Delivery Following Failure to Progress in Labour
Status:
COMPLETED
Status Verified Date:
2007-05
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:
Despite of marked improvements in clinical management early postpartum hemorrhagePPHremains a significant contributor to maternal morbidity and mortality both in developing countries and in hospitals equipped with all that modern medicine has to offer This complication is amongst the most challenging that a clinician will face in the obstetric patient Prevention early recognition and prompt appropriate intervention are the keys to minimizing the impact of PPH on womens health
Patients undergoing Cesarean sections following failure to progress in labor are at great risk for PPH and should theoretically benefit from an additional uterotonic agent This study will be conducted to define whether the addition of ergonovine maleate to oxytocin administered in a prophylactic way reduces blood loss during Cesarean section for failure to progress in labor
Patients undergoing Cesarean sections following failure to progress in labor are at great risk for PPH and should theoretically benefit from an additional uterotonic agent This study will be conducted to define whether the addition of ergonovine maleate to oxytocin administered in a prophylactic way reduces blood loss during Cesarean section for failure to progress in labor
Detailed Description:
Despite of marked improvements in management early postpartum hemorrhagePPHremains a significant contributor to maternal morbidity and mortality both in developing countries and in hospitals equipped with all that modern medicine has to offer This complication is amongst the most challenging that a clinician will face in Obstetrics Prevention early recognition and prompt appropriate intervention are the keys to minimizing the impact of PPH on womens health
Prophylactic oxytocin commonly administered after fetal and placental delivery has been shown to reduce the incidence of PPH The main advantages of this drug are its rapid onset of action and the fact that it does not cause elevations of blood pressure or tetanic contractions like ergonovine The effect of oxytocin is limited by the number and status of the oxytocin receptors Increases in the dose of oxytocin will not necessarily improve uterine contraction if receptors are not adequate in quantity and qualityThis is the cause of patients exposed to oxytocin for labor augmentation in whom oxytocin receptors are known to reduce both number and response to oxytocin Therefore a different uterotonic agent involving a different mechanism of action should be used instead Alternative drugs include ergot derivatives and prostaglandins carboprost and misoprostol Although protection from PPH with ergot derivatives and prostaglandin appear to be similar prostaglandins are associated with more side effects
Patients undergoing Cesarean sections following failure to progress in labor are at great risk for PPH and should theoretically benefit from an additional uterotonic agent This study will be conducted to define whether the addition of ergonovine maleate to oxytocin administered in a prophylactic way reduces blood loss during Cesarean section for failure to progress in labor
Prophylactic oxytocin commonly administered after fetal and placental delivery has been shown to reduce the incidence of PPH The main advantages of this drug are its rapid onset of action and the fact that it does not cause elevations of blood pressure or tetanic contractions like ergonovine The effect of oxytocin is limited by the number and status of the oxytocin receptors Increases in the dose of oxytocin will not necessarily improve uterine contraction if receptors are not adequate in quantity and qualityThis is the cause of patients exposed to oxytocin for labor augmentation in whom oxytocin receptors are known to reduce both number and response to oxytocin Therefore a different uterotonic agent involving a different mechanism of action should be used instead Alternative drugs include ergot derivatives and prostaglandins carboprost and misoprostol Although protection from PPH with ergot derivatives and prostaglandin appear to be similar prostaglandins are associated with more side effects
Patients undergoing Cesarean sections following failure to progress in labor are at great risk for PPH and should theoretically benefit from an additional uterotonic agent This study will be conducted to define whether the addition of ergonovine maleate to oxytocin administered in a prophylactic way reduces blood loss during Cesarean section for failure to progress in labor
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 |
|---|---|---|---|
| 05-0042-A | None | None | None |