Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543290
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Azithromycin Before Induction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Azithromycin to Prevent Chorioamnionitis in Women Undergoing Induction of Labor a Randomized Control Trial
Status:
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:
None
Brief Summary:
This is a double blinded randomized control trial involving administration of 2 grams prophylactic azithromycin in third trimester patients undergoing induction of labor at our institution to demonstrate reduction in maternal and neonatal infection
Detailed Description:
Induction rates have more than tripled in the last quarter century and even more in the past five years in light of evidence that the 39th week is the optimal gestational age for birth Inductions are one of the most commonly performed medical procedures and may span several days One of the complications associated with induction include maternal infection which includes chorioamnionitis endometritis pyelonephritis neonatal infection perineal and cesarean wound infections There are many well-known risk factors for these infections that include longer duration of rupture of membrane prolonged labor nulliparity internal monitoring multiple vaginal examinations and several others Well-established guidelines are available for treating infection once diagnosed however the role of antibiotic prophylaxis to prevent infection in patients undergoing induction of labor is less clear In this study we propose that administration of 2 grams oral azithromycin prior to the start of induction of labor will decrease rates of intrapartum and postpartum infections Azithromycin is the ideal antibiotic to study in this trial since it is long acting inexpensive well tolerated and has proven benefits in prior studies for prevention of obstetrical infection in cesarean deliveries and spontaneous labor This is a double blinded randomized control trial involving administration of 2 grams prophylactic azithromycin in third trimester patients undergoing induction of labor at our institution to demonstrate reduction in maternal and neonatal infection Decreasing rates of infection will improve both maternal and neonatal outcomes as well as decrease hospital length of stay and associated costs
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