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Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial

Knight, Marian; Chiocchia, Virginia; Partlett, Christopher; Rivero-Arias, Oliver; Hua, Xinyang; Hinshaw, Kim; Tuffnell, Derek; Linsell, Louise; Juszczak, Edmund


Marian Knight

Virginia Chiocchia

Assistant Professor of Medical Statistics and Clinical Trials

Oliver Rivero-Arias

Xinyang Hua

Kim Hinshaw

Derek Tuffnell

Louise Linsell


Risk factors for maternal infection are clearly recognised, including caesarean section and operative vaginal birth. Antibiotic prophylaxis at caesarean section is widely recommended because there is clear systematic review evidence that it reduces incidence of maternal infection. Current WHO guidelines do not recommend routine antibiotic prophylaxis for women undergoing operative vaginal birth because of insufficient evidence of effectiveness. We aimed to investigate whether antibiotic prophylaxis prevented maternal infection after operative vaginal birth.

In a blinded, randomised controlled trial done at 27 UK obstetric units, women (aged ≥16 years) were allocated to receive a single dose of intravenous amoxicillin and clavulanic acid or placebo (saline) following operative vaginal birth at 36 weeks gestation or later. The primary outcome was confirmed or suspected maternal infection within 6 weeks of delivery defined by a new prescription of antibiotics for specific indications, confirmed systemic infection on culture, or endometritis. We did an intention-to-treat analysis. This trial is registered with ISRCTN, number 11166984, and is closed to accrual.

Between March 13, 2016, and June 13, 2018, 3427 women were randomly assigned to treatment: 1719 to amoxicillin and clavulanic acid, and 1708 to placebo. Seven women withdrew, leaving 1715 in the amoxicillin and clavulanic acid group and 1705 in the placebo groups. Primary outcome data were missing for 195 (6%) women. Significantly fewer women allocated to amoxicillin and clavulanic acid had a confirmed or suspected infection (180 [11%] of 1619) than women allocated to placebo (306 [19%] of 1606; risk ratio 0·58, 95% CI 0·49–0·69; p


Knight, M., Chiocchia, V., Partlett, C., Rivero-Arias, O., Hua, X., Hinshaw, K., …Juszczak, E. (2019). Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial. Lancet, 393(10189), 2395-2403.

Journal Article Type Article
Acceptance Date Mar 21, 2019
Online Publication Date May 13, 2019
Publication Date Jun 15, 2019
Deposit Date Apr 9, 2019
Publicly Available Date Nov 14, 2019
Journal Lancet
Print ISSN 0140-6736
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 393
Issue 10189
Pages 2395-2403
Public URL
Publisher URL


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