Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection

Inclusion Criteria:

Pregnant Women aged 14 years and over at ≥ 24 weeks' viable gestation who will undergo
unscheduled/non-elective cesareans with either:

1. Labor (spontaneous or induced): active labor (ongoing contractions and at least 4cm
dilated or contractions for at least 4 hours with documented cervical change of ≥1cm
dilatation or ≥50% effacement), or

2. Membrane rupture (standardized to duration of at least 4 hours prior to
randomization).

Exclusion Criteria:

- Patient unwilling or unable to provide consent

- Multiple pregnancy

- Known azithromycin (or other macrolide) allergy

- Vaginal delivery

- Elective or scheduled cesarean prior to labor or membrane rupture.

- Azithromycin, erythromycin or other macrolide antibiotic use within 7 days of
enrollment.

- Clinical chorioamnionitis or any other active bacterial infection (e.g.
pyelonephritis, pneumonia, abscess) at time of randomization.

- Patient is unable or unlikely to follow-up after delivery (e.g. no prenatal care or a
non-resident patient)

- Fetal demise or major congenital anomaly

- Significant liver disease defined as known cirrhosis or elevated transaminases of at
least 3-fold upper limit of normal

- Significant renal disease defined as serum creatinine known to be >2.0 mg/dl or on
dialysis.

- Active congestive heart failure (EF<45%) or pulmonary edema

- Active diarrhea at time of delivery

- Any patient with significant electrolyte abnormalities such as hypokalemia or
hypocalcemia

- Any patient with structural heart disease or arrhythmias, or taking any medications
known to prolong the QT interval

- Patient currently being treated with efavirenz, nelfinavir or fluconazole