Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alan Tita
With
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Texas
University of North Carolina
Mission Hospital
Ochsner Health System
The University of Texas Health Science Center, Houston
Columbia University
University of Utah
University of Mississippi Medical Center
Age
14–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
\-
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).
You may not be if
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
