Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes

Running, not enrolling · Phase 3

Conditions studied: Premature Rupture of Membrane

In brief

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.

Key facts

Study ID

NCT06273891

Run by

Inova Health Care Services

People needed

140

Starts

2024-03-08

Expected to finish

2026-10-01

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pregnancy at 22 weeks 0 days to 32 weeks 6 days of gestation.
• Rupture of membranes confirmed by biochemical testing.
• Membrane rupture within the past 36 hours.
• Cervical dilation 3 cm or less and 4 or fewer contractions within 60-minutes at the time of admission.
• Age ≥18 and <50 years.

You may not qualify if…

• Non-reassuring fetal heart tracing, vaginal bleeding, chorioamnionitis or any indication for delivery at admission.
• Allergy to penicillin, erythromycin, or azithromycin.
• Multiple gestations.

Where it is running

• Inova Fairfax Medical Campus — Falls Church, Virginia, United States
• Eastern Viriginia Medical School — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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