Tuesday, June 7, 2016

Preincisional Azithromycin cuts postcesarean maternal infection by half.

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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