The CesareanSection 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.
Paired with
standard prophylactic antibiotics, broad-spectrum intravenous azithromycin was
highly effective, with a number needed to treat of 17 to prevent one
postsurgical infection, and 43 to prevent one case of endometritis, Dr. Alan
Tita reported at the 36th annual Pregnancy Meeting sponsored by the
Society for Maternal-Fetal Medicine.
“We also saw
fewer maternal adverse events, and the protocol was safe for the newborn,” said
Dr. Tita, who is a professor of obstetrics and gynecology at the University of
Alabama, Birmingham.
This trial
enrolled 2,013 women at 14 sites, who had singleton pregnancy of at-least 24
weeks, not scheduled for elective LSCS and underwent surgery after being in active
labor for at-least 4 hours or 4 hours after rupture of membranes.
All women received
standard preoperative antibiotic prophylaxis with either cefazolin or
clindamycin. The women were than randomized to receiving either preincisional
intravenous azithromycin 500 mg or a placebo.
As the study
was multicentric, skin preparation was done according to standard protocols at
each center.
The primary
outcome measures were composite of endometritis and/or wound infection and/or
other post-cesarean infections (occurring within 6 weeks of delivery) and
the secondary outcomes were individual post-cesarean infections: Endometritis,
wound infection (including necrotizing fascitis), other infections including
abscess, septic thrombosis, pneumonia, pyelonephritis and breast infection.
The neonatal
outcome was a composite of death; primary or suspected sepsis; and serious
neonatal morbidities, including respiratory distress syndrome, necrotizing
enterocolitis, periventricular leukomalacia, intraventricular hemorrhage of
grade 3 or higher, and bronchopulmonary dysplasia.
It was seen that
the rate of primary composite outcome was reduced by half in the study group (6%
vs. 12%; relative risk, 0.49). Wound infection decreased by 65% (2.4% vs. 6.6%;
RR, 0.35).
Azithromycin significantly improved the maternal outcome like fever,
readmission, revisit also.
The use of azithromycin
was safe for neonates too and the researchers did not see much difference for
the composite neonatal safety outcome in study vs the placebo group. The rates for treatment and placebo
groups were not different for suspected or confirmed sepsis (11.8% vs. 12.5%),
serious neonatal morbidities (4.4% vs. 3.4%), or NICU admission (16.8% vs. 17%).
No maternal
deaths were reported, 11 patients had allergic reaction, while five women
admitted to intensive care, and five other had suspected cardiac events.
Concerns
regarding the alteration of the fetal microbiome by brief systemic exposure to
azithromycin were raised at the conference.
“We have
collected additional information and specimens and we will be looking at these
to try and answer this. We also hope to get funding to do a long-term
evaluation of these kids. I will say that we collected adverse event data on
them for 3 months and we did not see anything concerning, but I agree more
needs to be done,” he said. “Having said that, azithromycin is something we
already use quite a lot in obstetrics, and overall it has been shown to be safe
for the newborn.”
Dr. Tita
reported having no financial disclosures.
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