Treatment of ppROM With Erythromycin vs. Azithromycin Trial
Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
Preterm premature rupture of membranes (PPROM) complicates 4% of pregnancies annually. This
pregnancy complication is a major contributor to preterm births and results in neonatal
morbidity and mortality. The current standard of care for PPROM subjects between the
gestational age of 24 weeks and 0 days and 33 weeks and 6 days, is to administer ampicillin
and erythromycin for a total of 7 days. Erythromycin can cause GI upset and some subjects do
not tolerate this regimen over the course of 7 days. In addition, there is a national
shortage of erythromycin, and published expert opinion proposed to use a second-generation
macrolide (azithromycin) instead of erythromycin. Azithromycin can be taken once daily, is
cheaper than erythromycin and has less GI upset adverse effects. The investigators' objective
is to compare the effectiveness of the 2 regimens in prolonging pregnancy after PPROM. The
investigators' working hypothesis is that there is no measurable difference in the primary
outcome between the group randomized to the azithromycin regimen versus the group randomized
to the erythromycin regimen.