Takeaway
- The ANODE study showed that single intravenous (IV) dose of prophylactic co-amoxiclav was effective in reducing the incidence of confirmed or suspected maternal infection after operative vaginal birth, as well as leading to better healing and less pain.
Why this matters
- Current national guidance on operative vaginal birth in the UK do not mention or do not recommend antibiotic prophylaxis after instrumental vaginal birth.
- These results may lead to reconsideration of official policy/guidance.
Study design
- 3420 women were randomly assigned to receive IV co-amoxiclav (1 g of amoxicillin/200 mg of clavulanic acid; n=1715) or placebo (sterile saline; n=1705).
- Primary outcome: confirmed or suspected infection within 6 weeks of delivery.
- Funding: The Health Technology Assessment programme of the National Institute for Health Research.
Key results
- Antibiotic vs placebo group had a lower risk for confirmed or suspected infection within 6 weeks of delivery (relative risk [RR], 0.58; 95% CI, 0.49-0.69),
- Antibiotic vs placebo group had a lower risk for most secondary outcomes including:
- superficial (RR, 0.53; 95% CI, 0.37-0.76) and deep (RR, 0.46; 95% CI, 0.28-0.77) perineal wound infection,
- perineal pain (RR, 0.84; 95% CI, 0.76-0.93),
- use of pain relief for perineal pain (RR, 0.72; 95% CI, 0.52-0.99),
- wound breakdown (RR, 0.52; 95% CI, 0.41-0.67),
- need for additional perineal care (RR, 0.72; 95% CI, 0.63-0.83),
- ability to sit comfortably to feed the baby (RR, 0.69; 95% CI, 0.53-0.90) and
- hospital (RR, 0.55; 95% CI, 0.40-0.75) or general (RR, 0.73; 95% CI, 0.63-0.84) practitioner visits.
- Overall, 2 adverse events were reported in the antibiotic group and 1 in the placebo group.
Limitations
- Follow-up rate achieved for most secondary outcomes was 76%.
References
References
