Trial reportLancet (London, England)2019
Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial.
Trial report in Lancet (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 48 papers, 5 of them syntheses that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
48 citing papers in PubMed, 5 syntheses or guidelines pooled it, 131 citations in OpenAlex.
- Prognostic factors for wound complications after childbirth-related perineal trauma: A systematic review and meta-analysis.Acta obstetricia et gynecologica Scandinavica · 2026Pooled it
- Varying Incidence and Definitions of Infection and Wound Dehiscence After Second-Degree Tear or Episiotomy: A Systematic Review.International urogynecology journal · 2026Pooled it
- Synthesizing evidence to guide the design and implementation of effective strategies for discontinuing postoperative antibiotic prophylaxis in surgical settings: an umbrella review post-WHO 2018 recommendations.Systematic reviews · 2025Pooled it
- Antibiotic prophylaxis for childbirth-related perineal trauma: A systematic review and meta-analysis.PloS one · 2025Pooled it
- Antibiotic prophylaxis for operative vaginal delivery.The Cochrane database of systematic reviews · 2020Pooled it
- Risk of infection and wound dehiscence after use of prophylactic antibiotics in episiotomy or second degree tear (REPAIR study): single centre, double blind, placebo controlled randomised trial.BMJ (Clinical research ed.) · 2025Trial
- Intrapartum and postpartum antibiotic use in seven low- and middle-income countries: Findings from the A-PLUS trial.BJOG : an international journal of obstetrics and gynaecology · 2025Trial
- Lateral episiotomy or no episiotomy in vacuum assisted delivery in nulliparous women (EVA): multicentre, open label, randomised controlled trial.BMJ (Clinical research ed.) · 2024Trial
- Trial
- Developing a serocorrelate of protection against invasive group B streptococcus disease in pregnant women: a feasibility study.Health technology assessment (Winchester, England) · 2019Trial
- IUGA International Guidelines on Obstetric Anal Sphincter Injuries.International urogynecology journal · 2026Article
- Inflammatory bowel disease and risk of perineal injury in primiparous vaginal births: a retrospective cohort study.Inflammatory bowel diseases · 2026Article
- Risk factors associated with deep perineal wound dehiscence after second-degree perineal tears or episiotomy.Acta obstetricia et gynecologica Scandinavica · 2026Article
- Maternal risk factors for postpartum readmission following vacuum-assisted vaginal delivery: A retrospective cohort study.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026Article
- Patient and public involvement (PPI) reporting in maternal and neonatal clinical trials: an exploratory review.Trials · 2026Review
- Timing and Technique: Principles of Secondary Repair of Perineal Wound Dehiscence.International urogynecology journal · 2026Review
- Impact of gestational weight gain on perineal injury in overweight and obese primiparous women.Archives of gynecology and obstetrics · 2026Article
- Investigating factors affecting the increase in cesarean section rates in primiparity women.Journal of education and health promotion · 2026Article
- Complications After Childbirth-Related Perineal Trauma up to Six-Weeks Postpartum: A Prospective Cohort Study.BJOG : an international journal of obstetrics and gynaecology · 2026Article
- Effect of perinatal ampicillin or amoxicillin/clavulanate exposure on maternal and infant gut microbiome, metabolome, and infant responses to the 20-valent pneumococcal conjugate vaccine.Gut microbes reports · 2026Article
Corrections and comments
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- Erratum issued
Authors and funding
10 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRisk 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.
methodsIn 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.
findingsBetween 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<0·0001). One woman in the placebo group reported a skin rash and two women in the amoxicillin and clavulanic acid reported other allergic reactions, one of which was reported as a serious adverse event. Two other serious adverse events were reported, neither was considered causally related to the treatment.
interpretationThis trial shows benefit of a single dose of prophylactic antibiotic after operative vaginal birth and guidance from WHO and other national organisations should be changed to reflect this.
fundingNIHR Health Technology Assessment programme.
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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.