Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396078
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-04-25
Brief Title:
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy iPROMPT
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy
Status:
RECRUITING
Status Verified Date:
2024-07
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:
To conduct an unblinded pragmatic randomized controlled trial pRCT Improvement of PPROM Management with Prophylactic Antimicrobial Therapy iPROMPT of a seven-day course of ceftriaxone clarithromycin and metronidazole versus the current standard of care of a seven-day course of ampicillinamoxicillin and azithromycin or erythromycin to prolong pregnancy and decrease adverse perinatal outcomes among hospitalized pregnant individuals undergoing expectant management of PPROM 34 weeks
Detailed Description:
Preterm prelabor rupture of membranes PPROM is the most common identifiable risk factor associated with preterm birth and affects 1 in 3 pregnant individuals in the United States with spontaneous preterm birth Individuals diagnosed with PPROM who meet criteria for expectant management are currently admitted to the hospital for observation until delivery which is generally recommended at 34 weeks gestation unless indicated sooner Initially upon admission a course of prophylactic antibiotics is administered as this has been shown to prolong pregnancy and improve neonatal outcomes The standard antibiotic regimen primarily based on data published in 1997 includes ampicillin followed by amoxicillin with erythromycin or azithromycin for a total of 7 days Ongoing studies are needed to determine the optimal prophylactic antibiotic regimen given changes in bacterial sensitivities over time lack of adequate coverage for common organisms including genital mycoplasma inadequate placental transfer of currently used antibiotic agents ineffective antibiotic response at reducing the fetal inflammatory response and new promising antibiotic agents that address these limitations A promising expanded-spectrum alternative regimen with proof-of-concept is ceftriaxone clarithromycin and metronidazole Observational studies have shown successful eradication of intraamniotic inflammationinfection using this new regimen This regimen offers multiple potential advantages including higher bioavailability higher transplacental transfer and effectiveness against genital mycoplasma clarithromycin greater anaerobic coverage metronidazole and a longer half-life and expanded coverage against gram-negative bacteria ceftriaxone compared with the current standard regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None