Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06273891
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-02-14
Brief Title:
Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes
Sponsor:
Inova Fairfax Hospital
Organization:
Inova Fairfax Hospital
Study Overview
Official Title:
Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes A Cluster Randomized Comparative Effectiveness Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
PRACET
Brief Summary:
The goal of this study is to help identify the best antibiotic treatment for pregnant people when their water breaks prematurely a condition abbreviated as PPROM Current practice is to attempt to maintain the pregnancy until at least 34 weeks gestational age when the risks of prematurity to the baby are lessened Research shows that antibiotics help the pregnancy last longer but there have been limited studies about which combination works best Currently both azithromycin and erythromycin are accepted antibiotic treatments in addition to ampicillin and amoxicillin Participants diagnosed with PPROM will be randomized to receive ampicillin and amoxicillin plus either azithromycin or erythromycin in addition to the care they would normally receive Studying these two drugs will help decide the best care for future patients with PPROM
Detailed Description:
Preterm pre-labor rupture of membranes PPROM complicates 3 of pregnancies and accounts for one-fourth to one-third of preterm births PPROM is associated with significant maternal and neonatal morbidities including chorioamnionitis endometritis neonatal sepsis prematurity-related pathologies In the absence of labor or indication for immediate delivery patients who present at less than 34 weeks gestational age are treated with antibiotics to prolong pregnancy until 34 weeks when the risks of prematurity are decreased Based on randomized trials both the American College of Obstetrics and Gynecology ACOG and the Society of Maternal Fetal Medicine SMFM recommend IV ampicillin and IV erythromycin for 2 days followed by an oral regimen of amoxicillin and erythromycin for 5 days Due to the recent limited availability of erythromycin azithromycin has been used a substitute There have been observational studies showing no difference in duration of pregnancy between azithromycin and erythromycin however no randomized controlled trial has been carried out to our knowledge This study performs a cluster randomized controlled trial to examine the efficacy of azithromycin versus erythromycin as a component of the latency antibiotics used to prolong pregnancy in PPROM patients
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 23-08-WC-0198 | OTHER | Eastern Virginia Medical School | None |