Ignite Creation Date:
2024-05-06 @ 7:11 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02487797
Status:
COMPLETED
Last Update Posted:
2022-02-11
First Post:
2015-06-09
Brief Title:
Comparison of Low-dose and High-dose Oxytocin Regimens for Labor Augmentation
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Randomized Double Blind Clinical Trial Comparing Oxytocin Low-dose and High-dose Regimens for Labor Augmentation
Status:
COMPLETED
Status Verified Date:
2022-02
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 a medication that is often used to strengthen contractions to overcome delayed labor progress The primary aim of this study is to determine whether receiving a higher dose of oxytocin lowers the chance of needing a cesarean section when compared to a lower dose of oxytocin Other aims include examining the relationship between dose of oxytocin regimen and length of labor postpartum hemorrhage intrauterine infection umbilical cord gas neonatal Apgar score 5 at 5 minutes and need for neonatal intensive care
Detailed Description:
This randomized double blind clinical trial of consenting nulliparous women in spontaneous labor who require oxytocin for labor augmentation seeks to determine whether use of a high dose oxytocin regimen improves obstetric outcomes when compared with a low dose oxytocin regimen in a manner that is safe for both mother and neonate
This project will include 1002 women recruited from the obstetrical service at Prentice Womens Hospital Women will be included if they are at least 36 weeks gestation have a singleton pregnancy and have been diagnosed with spontaneous labor or spontaneous rupture of membranes Women will be exposed to oxytocin for the indication of labor augmentation at the discretion of their obstetric provider
Women will be randomized with equal probability to intervention group using a fixed allocation procedure To maintain a double blind design the Prentice Womens Hospital pharmacy will carry out the randomization of oxytocin solutions according to the random assignment so that neither the women or their care providers nor the investigators will know the identity of the intervention assignment The low-dose oxytocin regimen group will receive a starting oxytocin regimen concentration rate of 2 milliunitsminute that can be increased at increments of 2 milliunitsminute as per the discretion of their obstetric provider The high-dose oxytocin regimen group will receive a starting oxytocin regimen concentration rate of 6 milliunitsminute that can be increased at increments of 6 milliunitsminute as per the discretion of their obstetric provider
Once the women are enrolled randomized and in receipt of their assigned interventions further clinical management will be left to the discretion of each womans obstetric provider
Prior to discharge from the hospital baseline demographic and clinical data will be obtained via chart review
This project will include 1002 women recruited from the obstetrical service at Prentice Womens Hospital Women will be included if they are at least 36 weeks gestation have a singleton pregnancy and have been diagnosed with spontaneous labor or spontaneous rupture of membranes Women will be exposed to oxytocin for the indication of labor augmentation at the discretion of their obstetric provider
Women will be randomized with equal probability to intervention group using a fixed allocation procedure To maintain a double blind design the Prentice Womens Hospital pharmacy will carry out the randomization of oxytocin solutions according to the random assignment so that neither the women or their care providers nor the investigators will know the identity of the intervention assignment The low-dose oxytocin regimen group will receive a starting oxytocin regimen concentration rate of 2 milliunitsminute that can be increased at increments of 2 milliunitsminute as per the discretion of their obstetric provider The high-dose oxytocin regimen group will receive a starting oxytocin regimen concentration rate of 6 milliunitsminute that can be increased at increments of 6 milliunitsminute as per the discretion of their obstetric provider
Once the women are enrolled randomized and in receipt of their assigned interventions further clinical management will be left to the discretion of each womans obstetric provider
Prior to discharge from the hospital baseline demographic and clinical data will be obtained via chart review
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