CompletedNot Applicable

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

United States2,013 participantsStarted 2011-05

Plain-language 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 azithromycin-based extended-spectrum antibiotic prophylaxis (azithromycin plus standard narrow-spectrum cephalosporin) relative to standard single-agent cephalosporin (preferably prior to surgical incision) to prevent post-cesarean infection. Hypothesis: Compared to narrow-spectrum prophylaxis (i.e. cefazolin alone, or clindamycin if cephalosporin allergy) prior to surgical incision, the addition of extended-spectrum prophylaxis (azithromycin + cefazolin) reduces the incidence of post-cesarean infection.

Who can participate

Age range14 Years

SexFEMALE

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Inclusion criteria

✓. 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).

What they're measuring

Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery)

Timeframe: Up to 6 weeks after delivery

Trial details

NCT IDNCT01235546

SponsorAlan Tita

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12

Results submitted2017-03-13

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