Status:
COMPLETED
Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection
Lead Sponsor:
Alan Tita
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Texas
Conditions:
Endometritis
Wound Infection
Eligibility:
FEMALE
14+ years
Phase:
NA
Brief Summary
The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) study is a large pragmatic multi-center randomized clinical trial designed to evaluate the comparative effectiveness and safety of azithrom...
Eligibility Criteria
Inclusion
- \-
- Pregnant Women aged 14 years and over at ≥ 24 weeks' viable gestation who will undergo unscheduled/non-elective cesareans with either:
- 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
- Membrane rupture (standardized to duration of at least 4 hours prior to randomization).
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
2013 Patients enrolled
Trial Details
Trial ID
NCT01235546
Start Date
May 1 2011
End Date
December 1 2015
Last Update
July 28 2017
Active Locations (9)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
3
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
4
Columbia University
New York, New York, United States, 10032