Antibiotics for operative vaginal delivery: practice-changing data
Authors: Vincenzo Berghella, Federica Bellussi
Journal: The Lancet (2019)

The large randomised controlled trial on the effect of antibiotics to prevent infection after operative vaginal delivery by Marian Knight and colleagues1Knight M Chiocchia V Partlett C et al.Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial.Lancet. 2019; (published online May 13.)http://dx.doi.org/10.1016/S0140-6736(19)30773-1Summary Full Text Full Text PDF Scopus (59) Google Scholar in The Lancet is practice changing. Operative vaginal deliveries include either vacuum or forceps, and are used in about 2–15% of births.2Gei AF Pacheco LD Operative vaginal deliveries: practical aspects.Obstet Gynecol Clin North Am. 2011; 38: 323-349Summary Full Text Full Text PDF PubMed Scopus (5) Google Scholar Even if one conservatively estimates 2% of babies are born by operative vaginal delivery globally, about 2 700 000 of the world's 135 million annual births are operative vaginal deliveries. Up to 16% of these births can be associated with infection without antibiotics prophylaxis,3Mohamed-Ahmed O Hinshaw K Knight M Operative vaginal delivery and postpartum infection.Best Pract Res Clin Obstet Gynaecol. 2018; 56: 93-106Crossref PubMed Scopus (23) Google Scholar representing about 432 000 annual infections associated with operative vaginal delivery worldwide. The most common infections increased with operative vaginal delivery compared with spontaneous vaginal delivery, include endometritis, perineal wound, and urinary tract infections—all of which, in rare cases, can lead to sepsis.3Mohamed-Ahmed O Hinshaw K Knight M Operative vaginal delivery and postpartum infection.Best Pract Res Clin Obstet Gynaecol. 2018; 56: 93-106Crossref PubMed Scopus (23) Google Scholar Compared with spontaneous vaginal delivery, operative vaginal delivery can introduce microorganisms into the genital tract, is associated with longer labour, more vaginal examinations, with bladder catheterisation before the procedure, and with more perineal lacerations and use of episiotomy, all of which can increase the risk of infections. These infections can occur even after discharge, and the risk peaks at about 6–7 days post partum.3Mohamed-Ahmed O Hinshaw K Knight M Operative vaginal delivery and postpartum infection.Best Pract Res Clin Obstet Gynaecol. 2018; 56: 93-106Crossref PubMed Scopus (23) Google Scholar The incidence of infections is higher with forceps than with vacuum. Episiotomy also increases the risk of perineal infections compared with no episiotomy,4Macleod M Strachan B Bahl R et al.A prospective cohort study of maternal and neonatal morbidity in relation to use of episiotomy at operative vaginal delivery.BJOG. 2008; 115: 1688e94Crossref Scopus (92) Google Scholar possibly also because of the association with more and worse perineal lacerations.5Jiang H Qian X Carroli G Garner P Selective versus routine use of episiotomy for vaginal birth.Cochrane Database Syst Rev. 2017; 2 (CD000081.)Google Scholar Unfortunately, the evidence on the effect of technical characteristics of the repair of perineal lacerations or episiotomies, or both, on perineal infections is scarce.6Kettle C Dowswell T Ismail KMK Continuous and interrupted suturing techniques for repair of episiotomy or second-degree tears.Cochrane Database Syst Rev. 2012; 11 (CD000947.)PubMed Google Scholar, 7Kettle C Dowswell T Ismail KMK Absorbable suture materials for primary repair of episiotomy and second degree tears.Cochrane Database Syst Rev. 2010; 6 (CD000006.)Google Scholar Perineal infections are associated with wound dehiscence, need for repair, and perineal pain, and influence women's quality of life and sexual wellbeing.3Mohamed-Ahmed O Hinshaw K Knight M Operative vaginal delivery and postpartum infection.Best Pract Res Clin Obstet Gynaecol. 2018; 56: 93-106Crossref PubMed Scopus (23) Google Scholar In Knight and colleagues' study,1Knight M Chiocchia V Partlett C et al.Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial.Lancet. 2019; (published online May 13.)http://dx.doi.org/10.1016/S0140-6736(19)30773-1Summary Full Text Full Text PDF Scopus (59) Google Scholar 3427 women with mostly singleton gestations at 36 weeks or later were randomly assigned to receive either amoxicillin 1 g and clavulanic acid 200 mg or placebo within 6 h of operative vaginal delivery. The primary outcome, confirmed or suspected maternal infection within 6 weeks of delivery, was defined by one of the following: a new prescription of antibiotics for presumed perineal wound-related infection, endometritis or uterine infection, urinary tract infection with systemic features (pyelonephritis or sepsis), or other systemic infection (clinical sepsis); confirmed systemic infection on culture; or endometritis. This primary outcome was significantly less common in the antibiotic (11%) versus the placebo (19%) group (risk ratio [RR] 0·58, 95% CI 0·49–0·69). The incidences of perineal infection, perineal pain, use of pain relief for perineal pain, need for additional perineal care, wound breakdown, perineum ever too uncomfortable to feed the baby, and any visits in relation to perineal concerns were all each statistically significantly decreased in the antibiotics group compared with placebo. The primary outcome was more common in forceps versus vacuum deliveries, but the magnitude of the beneficial effect of the antibiotic versus placebo was similar (forceps 13% vs 22%, RR 0·62, 95% CI 0·45–0·86, respectively; vacuum 8% vs 14%, RR 0·56, 95% CI 0·39–0·80, respectively). The main strengths of this study are that it is large, methologically well done, covers an important clinical issue, and is practice changing. Only one small study8Heitmann JA Benrubi GI Efficacy of prophylactic antibiotics for the prevention of endomyometritis after forceps delivery.South Med J. 1989; 82: 960-962Crossref PubMed Scopus (15) Google Scholar had been previously done on this issue. Other strengths are the use of only one dose of antibiotics, limiting the effect on microbiota of both mother and baby (effect through breastfeeding). Risks of negative effects on the baby, such as necrotising enterocolitis or asthma,3Mohamed-Ahmed O Hinshaw K Knight M Operative vaginal delivery and postpartum infection.Best Pract Res Clin Obstet Gynaecol. 2018; 56: 93-106Crossref PubMed Scopus (23) Google Scholar can be minimised if the antibiotic is given after delivery, and this antibiotic has been shown to be safe for infant breastfeeding.9Campbell AC McElnay JC Passmore CM The excretion of ampicillin in breast milk and its effect on the suckling infant.Br J Clin Pharmacol. 1991; 31: 230Google Scholar The main limitation of the study is the primary outcome, which was driven mostly by a new prescription for antibiotics for presumed perineal infection. Although the trial was blinded, the prescribing of antibiotics is more subjective than culture-proven infection. The study shows that the results for the cumulative primary outcome are the same as those for new prescription for antibiotics for presumed perineal infection. The criteria used by practitioners to decide to whom to give antibiotics was unclear. Nonetheless, confirmed culture-proven sepsis was significantly less in the amoxicillin and clavulanic acid group than in the placebo group (0·6% vs 1·5%, respectively; RR 0·44, 95% CI 0·22–0·89). The timing of antibiotics was 3·2 h after delivery, which is late; in practice, administration of the antibiotic intravenously right after delivery would be feasible. Indeed, prophylaxis for caesarean section is more effective when given before skin incision than after cord clamping. The choice of antibiotics is debatable, but Knight and colleagues have made a good case for their choice of amoxicillin and clavulanic acid.3Mohamed-Ahmed O Hinshaw K Knight M Operative vaginal delivery and postpartum infection.Best Pract Res Clin Obstet Gynaecol. 2018; 56: 93-106Crossref PubMed Scopus (23) Google Scholar Another limitation of the study is that women with third-degree and fourth-degree lacerations were excluded because they get antibiotics anyway.10Tsakiridis I Mamopoulos A Athanasiadis A Dagklis T Obstetric anal sphincter injuries at vaginal delivery: a review of recently published national guidelines.Obstet Gynecol Surv. 2018; 73: 695-702Crossref PubMed Scopus (20) Google Scholar The majority (89%) of women enrolled had an episiotomy—a proportion that is too high, even for operative vaginal delivery, as admitted by authors. Unfortunately, a subgroup analysis for just those women without an episiotomy is not available. Moreover, neonatal outcomes are not reported; although the antibiotic was given after birth, it is secreted in breastmilk, and could affect neonates. Another potential issue is the development of antibiotic resistance. More emphasis should be placed on prevention of perineal trauma, and therefore perineal infection, in future research. The use of perineal massage11Aquino CI Guida M Saccone G et al.Perineal massage during labor: a systematic review and meta-analysis of randomized controlled trials.J Matern Fetal Neonatal Med. 2018; 19: 1-13Google Scholar and warm compresses to the perineum12Aasheim V Nilsen ABV Reinar LM Lukasse M Perineal techniques during the second stage of labour for reducing perineal trauma.Cochrane Database Syst Rev. 2017; 6 (CD006672.)PubMed Google Scholar in the second stage of labour have each been associated with a significant decrease in perineal trauma. Clinical guidelines should be updated to reflect the new recommendation of giving a single dose of intravenous amoxicillin and clavulanic acid within 6 h after operative vaginal delivery, in particular to women who also have an episiotomy. More research is needed for operative vaginal deliveries not necessitating an episiotomy. We declare no competing interests. Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trialThis 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. Full-Text PDF Open Access