Evidence map›Paper›PMID 35675601›Full record

Trial reportObstetrics and gynecology2022

Timing of Adjunctive Azithromycin for Unscheduled Cesarean Delivery and Postdelivery Infection.

Ayodeji Sanusi, Yuanfan Ye, Kim Boggess, George Saade, Sherri Longo, Erin Clark, Sean Esplin, Kirsten Cleary, Ron Wapner, Michelle Owens and 4 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Obstetrics and gynecology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01235546 (Cesarean Section Optimal Antibiotic Prophylaxis Trial), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01235546 nacompletednot on this map

Cesarean Section Optimal Antibiotic Prophylaxis Trial

TypeinterventionalSponsorAlan TitaRan2011 to 2015Enrolled2,013ConditionsEndometritis, Wound Infection, Abscess, Surgical Site InfectionArmsAzithromycin and standard of care, Placebo and standard of care
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Necrotizing Enterocolitis: What's New and What's Next?International journal of molecular sciences · 2025
    Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 1 institution in 1 country.

Ayodeji SanusiDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, the Center for Women's Reproductive Health, and the Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama; the Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, and Mission Hospital, Asheville, North Carolina; and the Departments of Obstetrics and Gynecology, University of Texas Medical Branch at Galveston, Galveston, Texas, Ochsner Health System, New Orleans, Louisiana, University of Utah and Intermountain Health Care, Salt Lake City, Utah, Columbia University, New York, New York, University of Mississippi, Jackson, Mississippi, University of Texas Health Sciences Center, Houston, Texas.
Yuanfan Ye
Kim Boggess
George Saade
Sherri Longo
Erin Clark
Sean Esplin
Kirsten Cleary
Ron Wapner
Michelle Owens
Sean Blackwell
Jeff M Szychowski
Alan T N Tita
Akila Subramaniam
University of North Carolina at Chapel Hill · US

Funding

Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) TrialR01HD064729 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI TITA, ALAN THEVENET N. · 2010 to 2013
$2.8M
NICHD NIH HHS R01 HD064729
6 · The paper itself

Abstract

objectiveTo estimate the association between timing of administration of adjunctive azithromycin for prophylaxis at unscheduled cesarean delivery and maternal infection and neonatal morbidity.

methodsWe conducted a secondary analysis of a randomized trial of adjunctive azithromycin prophylaxis in patients with singleton gestations who were undergoing unscheduled cesarean delivery. The primary exposure was the timing of initiation of the study drug (after skin incision or 0-30 minutes, more than 30-60 minutes, or more than 60 minutes before skin incision). The primary outcome was a composite of endometritis, wound infection, and other maternal infections occurring up to 6 weeks after cesarean delivery. Secondary outcomes included composite neonatal morbidity, neonatal intensive care unit admission for longer than 72 hours, and neonatal sepsis. The association of azithromycin with outcomes was compared within each antibiotic timing group and presented as risk ratios (RRs) with 95% CIs. A Breslow-Day homogeneity test was applied to assess differences in association by antibiotic timing.

resultsOf 2,013 participants, antibiotics were initiated after skin incision (median 3 minutes, range 0-229 minutes) in 269 (13.4%), 0-30 minutes before skin incision in 1,378 (68.5%), more than 30-60 minutes before skin incision in 270 (13.4%), and more than 60 minutes before skin incision (median 85 minutes, range 61-218 minutes) in 96 (4.8%). The RRs (95% CIs) of the infectious composite outcome for azithromycin compared with placebo were significantly lower for groups that initiated azithromycin after skin incision or within 1 hour before skin incision (after skin incision: RR 0.31, 95% CI 0.13-0.76; 0-30 minutes before: RR 0.62, 95% CI 0.44-0.89; more than 30-60 minutes before: 0.31, 95% CI 0.13-0.66). Risks were not significantly different in patients who received azithromycin more than 60 minutes before skin incision (RR 0.59, 95% CI 0.10-3.36). Results were similar when endometritis and wound infections were analyzed separately. Neonatal outcomes were not significantly different for azithromycin compared with placebo across all timing groups.

conclusionAdjunctive azithromycin administration up to 60 minutes before or at a median of 3 minutes after skin incision was associated with reduced risks of maternal composite postoperative infection in unscheduled cesarean deliveries. CLINICAL

trial registrationClinicalTrials.gov, NCT01235546.

Indexed as

AzithromycinEndometritisAnti-Bacterial AgentsAntibiotic ProphylaxisFemaleHumansInfant, NewbornPregnancySurgical Wound InfectionAnti-Bacterial AgentsAzithromycin

Identifiers

PMID35675601
PMCPMC9199590
OpenAlexW4281701902

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.