Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550089
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study of High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth HOLDOUT Pilot
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOLDOUT
Brief Summary:
This is a study to investigate whether it is feasible to conduct a randomized controlled trial RCT of a high dose of oxytocin versus the standard low-dose oxytocin Further the investigators aim to assess whether there are differences in health outcomes between both arms of the study
Detailed Description:
Due to risks of postpartum hemorrhage defined by the American College of Obstetricians and Gynecologists as an estimated or quantitative blood loss of greater than 1000 milliliters uterotonics or medications aimed at increasing uterine tone and reducing blood loss at the time of birth are commonly administered Based on a Cochrane network meta-analysis most organizations endorse the administration of 10 international units IU of oxytocin during delivery However the World Health Organization specifies that during a cesarean birth the 10 IU should be administered using a bolus dose and an infusion though an optimal infusion rate has yet to be agreed upon
The use of a higher rate of oxytocin may confer a reduction in overall blood loss and subsequent maternal health outcomes eg postoperative anemia hypotension and healthcare resource utilization eg need for additional uterotonics and surgical procedures to control bleeding administration of blood products However it is unknown whether it is feasible to conduct a randomized controlled trial to investigate the use of high ie oxytocin rate of 900 mLhr immediately after the delivery of the placenta versus low-dose oxytocin ie 300 mLhr for planned cesarean births or 600 mLhr for intrapartum cesarean births
The use of a higher rate of oxytocin may confer a reduction in overall blood loss and subsequent maternal health outcomes eg postoperative anemia hypotension and healthcare resource utilization eg need for additional uterotonics and surgical procedures to control bleeding administration of blood products However it is unknown whether it is feasible to conduct a randomized controlled trial to investigate the use of high ie oxytocin rate of 900 mLhr immediately after the delivery of the placenta versus low-dose oxytocin ie 300 mLhr for planned cesarean births or 600 mLhr for intrapartum cesarean births
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