Operative vaginal delivery and post-partum infection

Mohamed-Ahmed, Olaa; Hinshaw, Kim; Knight, Marian

doi:10.1016/j.bpobgyn.2018.09.005

Cited by 31 publications

(10 citation statements)

References 62 publications

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“…Risk factors for maternal sepsis can be easily recognised, including caesarean section and operative vaginal birth (forceps or vacuum extraction) 4, 6. Without prophylaxis, an estimated 20–25% of women have an infection following caesarean birth, 7 and up to 16% have an infection following operative vaginal birth 8 . There is strong evidence from a systematic review 7 in women giving birth by caesarean section, that the use of prophylactic antibiotics reduces the incidence of wound infection, endometritis, and serious maternal infection by 60–70%.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2019

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Summary Background 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. Methods 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. Findings 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<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. Interpretation This 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. Funding NIHR Health Technology Assessment programme.

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Section: Introductionmentioning

confidence: 99%

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

et al. 2019

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“…Such interconnectedness of interventions and associated traumatic complication was probably the main reason for wrongly attributing postpartum infection to OVD. A literature review by Kamel and Khaled overemphasized the association of postpartum infection with OVD without giving emphasis to the commonly associated episiotomy and perineal tear [ 35 ].…”

Section: Discussionmentioning

confidence: 99%

Still No Substantial Evidence to Use Prophylactic Antibiotic at Operative Vaginal Delivery: Systematic Review and Meta-Analysis

Berhan

Kirba

Gebre

2020

Obstetrics and Gynecology International

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Background. Postpartum maternal infection is still a common problem worldwide, mainly due to obstetric risk factors. The use of prophylactic antibiotic at operative vaginal delivery (OVD), taking it as a standalone risk factor, has been controversial. The purpose of this review was to rigorously evaluate the association of OVD with postpartum infection and shed light on such highly controversial issue. Methods. A computer-based literature search was done mainly in the databases of PUBMED, HINARI health research, and the Cochrane library. Systematic review and meta-analysis were done by including 14 articles published between 1990 and August 2019. Results. The average absolute risk of postpartum infection at OVD from seven large cohort studies was 1%. Few studies showed a weak association of OVD with postpartum infection without being adjusted to perineal wound, but the pooled meta-analysis showed statistically significant association with non-OVD. In the included randomized trial, 97% of the study participants had perineal wound for whom repairs were performed; the risks of maternal infection and perineal wound breakdown were comparable, and maternal infections other than perineal wound infection did not show significant difference between prophylactic antibiotic and placebo groups. The majority of included studies demonstrated a strong association of postpartum infection and perineal wound dehiscence with episiotomy and perineal tear. Conclusion. Both the relative and absolute risks of postpartum infection at OVD are extremely low unless accompanied by episiotomy and 3rd/4tht degree perineal tear. From previous studies, there is no substantial evidence to use prophylactic antibiotic at OVD, but episiotomy and perineal tear.

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“…This is higher than the infection rate reported in most other studies of complications following instrumental vaginal birth. 29 As noted previously, very few of these observational studies followed women beyond discharge, yet post-partum wound infections and endometritis have been reported to occur at a peak of 7 days post discharge in large data-linkage studies. 43 The ANODE trial shows very clearly a significant burden of confirmed or suspected infection and, most notably, both superficial and deep perineal wound infection after initial hospital discharge.…”

Section: Comparison With Existing Literaturementioning

confidence: 97%

“…28 There is, therefore, considerable scope for direct patient benefit from an effective preventative strategy. Other non-randomised studies suggest higher infection rates of up to 16%, 29 which would correspondingly lead to an even greater potential benefit from a preventative therapy.…”

Section: Fundingmentioning

confidence: 99%

“…Observational studies of operative vaginal birth estimate postnatal infection to occur in between 2% and 16% of women. 29 The single existing trial of antibiotic prophylaxis at operative vaginal birth found a 4% rate of postnatal infection. 10 We therefore used this more conservative estimate of the maternal infection rate following operative vaginal birth.…”

Section: Sample Sizementioning

confidence: 99%

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Intravenous co-amoxiclav to prevent infection after operative vaginal delivery: the ANODE RCT

Knight

Chiocchia

Partlett

et al. 2019

Health Technol Assess

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Background Sepsis is a leading cause of direct and indirect maternal death in both the UK and globally. All forms of operative delivery are associated with an increased risk of sepsis, and the National Institute for Health and Care Excellence’s guidance recommends the use of prophylactic antibiotics at all caesarean deliveries, based on substantial randomised controlled trial evidence of clinical effectiveness. A Cochrane review, updated in 2017 (Liabsuetrakul T, Choobun T, Peeyananjarassri K, Islam QM. Antibiotic prophylaxis for operative vaginal delivery. Cochrane Database Syst Rev 2017;8:CD004455), identified only one small previous trial of prophylactic antibiotics following operative vaginal birth (forceps or ventouse/vacuum extraction) and, given the small study size and extreme result, suggested that further robust evidence is needed. Objectives To investigate whether or not a single dose of prophylactic antibiotic following operative vaginal birth is clinically effective for preventing confirmed or presumed maternal infection, and to investigate the associated impact on health-care costs. Design A multicentre, randomised, blinded, placebo-controlled trial. Setting Twenty-seven maternity units in the UK. Participants Women who had an operative vaginal birth at ≥ 36 weeks’ gestation, who were not known to be allergic to penicillin or constituents of co-amoxiclav and who had no indication for ongoing antibiotics. Interventions A single dose of intravenous co-amoxiclav (1 g of amoxicillin/200 mg of clavulanic acid) or placebo (sterile saline) allocated through sealed, sequentially numbered, indistinguishable packs. Main outcome measures Primary outcome – confirmed or suspected infection within 6 weeks of giving birth. Secondary outcomes – severe sepsis, perineal wound infection, perineal pain, use of pain relief, hospital bed stay, hospital/general practitioner visits, need for additional perineal care, dyspareunia, ability to sit comfortably to feed the baby, maternal general health, breastfeeding, wound breakdown, occurrence of anaphylaxis and health-care costs. Results Between March 2016 and June 2018, 3427 women were randomised: 1719 to the antibiotic arm and 1708 to the placebo arm. Seven women withdrew, leaving 1715 women in the antibiotic arm and 1705 in the placebo arm for analysis. Primary outcome data were available for 3225 out of 3420 women (94.3%). Women randomised to the antibiotic arm were significantly less likely to have confirmed or suspected infection within 6 weeks of giving birth (180/1619, 11%) than women randomised to the placebo arm (306/1606, 19%) (relative risk 0.58, 95% confidence interval 0.49 to 0.69). Three serious adverse events were reported: one in the placebo arm and two in the antibiotic arm (one was thought to be causally related to the intervention). Limitations The follow-up rate achieved for most secondary outcomes was 76%. Conclusions This trial has shown clear evidence of benefit of a single intravenous dose of prophylactic co-amoxiclav after operative vaginal birth. These results may lead to reconsideration of official policy/guidance. Further analysis of the mechanism of action of this single dose of antibiotic is needed to investigate whether earlier, pre-delivery or repeated administration could be more effective. Until these analyses are completed, there is no indication for administration of more than a single dose of prophylactic antibiotic, or for pre-delivery administration. Trial registration Current Controlled Trials ISRCTN11166984. Funding This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 54. See the National Institute for Health Research Journals Library website for further project information.

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Operative vaginal delivery and post-partum infection

Cited by 31 publications

References 62 publications

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

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

Still No Substantial Evidence to Use Prophylactic Antibiotic at Operative Vaginal Delivery: Systematic Review and Meta-Analysis

Intravenous co-amoxiclav to prevent infection after operative vaginal delivery: the ANODE RCT

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