Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Fetal Membranes, Premature Rupture
Premature Rupture of Membrane
Rupture

Clinical Trial Details

NCT number	NCT06273891
Study type	Interventional
Source	Inova Fairfax Hospital
Contact	Antonio Saad, MD, MBA
Phone	7037766040
Email	antonio.saad@inova.org
Status	Recruiting
Phase	Phase 3
Start date	March 8, 2024
Completion date	October 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04100252` - The Impact of Amniotic Fluid Index (AFI) on Maternal and Perinatal Outcomes in Pregnant Women With Preterm Premature Rupture of Membranes
Recruiting	`NCT04478942` - PROMMO Trial: Oral Misoprostol vs IV Oxytocin	Early Phase 1
Recruiting	`NCT02819570` - Comparison of Two Antibiotic Prophylactic Protocols in Preterm Premature Rupture of the Membranes	Phase 4
Withdrawn	`NCT03172858` - Randomized Control Trial of Intracervical Balloon Placement vs Oxytocin in Women With Term PROM and Unripe Cervices	N/A
Not yet recruiting	`NCT05134688` - Magnesium Sulphate in Premature Rupture of Membranes	Early Phase 1
Not yet recruiting	`NCT03689062` - Premature Rupture of Membranes at 34 to 37 Weeks' Gestation	N/A
Recruiting	`NCT04237142` - Preterm Premature Rupture of Fetal Membranes: Cervical Ultrasound and Biological Markers to Diagnose Prematurity (RECHOBIOL)	N/A
Recruiting	`NCT04558996` - Spanish Registry of Pregnant Women With COVID-19
Recruiting	`NCT04632017` - Computerized Cardiotocography Monitoring of Fetuses With pPROM
Recruiting	`NCT03607929` - HIDRATA Study: Efficacy of a Hydration Protocol in Nulliparous Women During Labor	N/A
Completed	`NCT03491826` - Fetal and Maternal Outcome in Preterm Premature Rupture of Membranes (PPROM)
Enrolling by invitation	`NCT04451109` - Dilapan-S®: A Multicenter US E-registry
Recruiting	`NCT04143685` - Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes	N/A
Completed	`NCT03251898` - Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections
Completed	`NCT03106311` - The Use of Quantitative Pregnancy Test in Amniotic Fluid as a Diagnostic Tool for Rupture of Fetal Membranes	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes — PRACET

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms