Antibiotic prophylaxis for operative vaginal delivery

Liabsuetrakul, Tippawan; Choobun, Thanapan; Peeyananjarassri, Krantarat; Islam, Q Monir

doi:10.1002/14651858.cd004455.pub4

Cited by 27 publications

(19 citation statements)

References 34 publications

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“…First, before pregnancy, it is suggested that women of child‐bearing age strengthen physical exercise, pay attention to nutritional regulation, actively prevent and control the reproductive system diseases, especially inflammatory diseases, reduce the frequency of uterine curettage, and make good preparation for pregnancy . During pregnancy, it is suggested that early pregnancy be determined in time, health management during pregnancy be actively implemented, the standard maternal manual be created before 13 weeks of gestation, the comprehensive physical examination be given, and high‐risk pregnancy and pathologic pregnancy be screened to improve the safety of pregnancy. During delivery, sterile operations should be strictly performed, the digital anal examination is strictly forbidden, the frequency of vaginal examination should be reduced as far as possible to reduce the incidence rate of retrograde infection, indications of cesarean section and lateral episiotomy should be strictly grasped, antibacterial drugs can be used for a short time for those undergoing cesarean section to prevent the infection, and the maternal management should be strengthened to improve the hospital delivery rate, prevent postpartum hemorrhage, and reduce the injury of birth canal due to delivery as far as possible .…”

Section: Discussionmentioning

confidence: 99%

Risk factors, changes in serum inflammatory factors, and clinical prevention and control measures for puerperal infection

et al. 2019

Clinical Laboratory Analysis

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Background To investigate the risk factors and changes in serum inflammatory factors in puerperal infection, and propose clinical prevention measures. Methods A total of 240 subjects with suspected puerperal infection treated in our hospital from January 2017 to December 2017 were collected, among which puerperal infection was definitely diagnosed in 40 cases, and it was excluded in 40 cases. Levels of interleukin‐6 (IL‐6), tumor necrosis factor‐α (TNF‐α), and high‐sensitivity C‐reactive protein (hs‐CRP) were compared between the two groups, and the change trends of IL‐6 and hs‐CRP were recorded. Results Levels of IL‐6, hs‐CRP, and TNF‐α in puerperal infection group were higher than those in non‐infection group (P < .05). Levels of IL‐6 and hs‐CRP at enrollment and 1‐3 days after enrollment in infection group were higher than those in non‐infection group (P < .05). The body mass index >25, placenta previa, placenta accreta, postpartum hemorrhage, premature rupture of membrane, gestational diabetes mellitus, and anemia during pregnancy were relevant and independent risk factors for puerperal infection. Puerperal infection occurred in uterine cavity, vagina, pelvic peritoneum, pelvic tissue, incision, urinary system, etc, and gram‐negative (G+) bacteria were dominated in pathogens. Conclusion The inflammatory response of patients with puerperal infection is significantly enhanced.

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Section: Discussionmentioning

confidence: 99%

Risk factors, changes in serum inflammatory factors, and clinical prevention and control measures for puerperal infection

et al. 2019

Clinical Laboratory Analysis

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“…Presentations of the data from the NIHR programme studies 3,[7][8][9] at national meetings clearly showed that the natural response of the clinical community is to introduce prophylactic management with antibiotics, without clear evidence for the effectiveness of this approach following operative birth, because antibiotic prophylaxis been shown to be effective in reducing the risk of infection following caesarean birth. 10 Giving antibiotic prophylaxis after operative vaginal birth has thus been introduced into local guidance unsupported by evidence. Although similar in some ways, there are clear differences between the wound sites and potential contaminating organisms at caesarean section and instrumental birth, so it cannot be assumed that single-dose prophylactic antibiotics will be equally effective in both circumstances.…”

Section: Fundingmentioning

confidence: 99%

“…Twelve per cent of women in the UK undergo forceps or ventouse deliveries, 13 which is an estimated 90,000 women annually. The conservatively estimated incidence of maternal infection following operative vaginal birth is 4%, based on the one previous trial, 10 which results in an estimated 3600 women potentially having an infection after instrumental vaginal birth. Of these women, around 200 will be diagnosed with severe infection 7 and up to four may die from their infection.…”

Section: Fundingmentioning

confidence: 99%

“…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. We assumed an estimated relative risk reduction of 50% in this rate with antibiotics to 2% in the treatment arm.…”

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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“…Studies conducted both in the UK and US have documented an additional risk associated with operative vaginal delivery [ 3 , 7 – 9 ]. A Cochrane review identified only one small previous trial of prophylactic antibiotics following operative vaginal delivery, which included a total of 393 women, with a relative risk of 0.07 (95% confidence interval 0.00 to 1.21) for postpartum infection [ 10 ]. Given the small study size and extreme result, the World Health Organisation (WHO) recommends that prophylactic antibiotics following operative vaginal delivery should not be used routinely and that further robust evidence is needed [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

Prophylactic antibiotics for the prevention of infection following operative vaginal delivery (ANODE): study protocol for a randomised controlled trial

Knight

Mottram

Gray

et al. 2018

Trials

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BackgroundSepsis is one of the most important causes of maternal death and severe morbidity worldwide. Studies conducted both in the UK and US have documented an additional risk associated with operative vaginal delivery. However, a Cochrane review, updated in 2017, identified only one small trial of prophylactic antibiotics following operative vaginal delivery, which included a total of 393 women. Given the small size of that trial, it recommended that further robust evidence is needed. Operative vaginal delivery rates vary worldwide, but typically 5–10% of women have operative vaginal births. A conservative estimated incidence of maternal infection following operative vaginal delivery is 4%, based on the one previous trial. There is, therefore, considerable scope for direct patient benefit from an effective preventive strategy.Methods/DesignThis protocol describes a multicentre, randomised, blinded, placebo-controlled trial aiming to recruit 3424 participants from over 20 hospital sites in the UK. Women who have undergone an operative vaginal delivery at 36+0 weeks or greater gestation with no indication for ongoing antibiotics in the postpartum period and no contra-indications to prophylactic co-amoxiclav, will be randomised to receive a single intravenous dose of co-amoxiclav or placebo.The primary outcome will be confirmed or suspected maternal infection within 6 weeks of delivery, as defined by one of (a) a new prescription of antibiotics for presumed perineal wound-related infection, endometritis or uterine infection, urinary tract infection with systemic features or other systemic infection, (b) systemic infection confirmed with a culture or (c) endometritis as defined by the US Centers for Disease Control and Prevention. Outcome information will be collected by a single telephone interview and questionnaire, with clinical data collected from medical records or the hospital laboratory if necessary, at 6 weeks post-delivery.DiscussionThis randomised trial will investigate whether a prophylactic dose of antibiotic following operative vaginal delivery can reduce the incidence of infection and sepsis. If shown to be effective, this could lead to a change in recommended practice and the prevention of infection. Conversely, if there is no significant difference between the two arms, then this could contribute to a reduction in antibiotic use and improved antimicrobial stewardship.Trial registrationISRCTN11166984. Registered on 23 September 2015.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2787-0) contains supplementary material, which is available to authorized users.

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Antibiotic prophylaxis for operative vaginal delivery

Cited by 27 publications

References 34 publications

Risk factors, changes in serum inflammatory factors, and clinical prevention and control measures for puerperal infection

Risk factors, changes in serum inflammatory factors, and clinical prevention and control measures for puerperal infection

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

Prophylactic antibiotics for the prevention of infection following operative vaginal delivery (ANODE): study protocol for a randomised controlled trial

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