Vaginal cleansing before unscheduled cesarean delivery to reduce infection: a randomized clinical trial.

BACKGROUND: Cesarean delivery is the most performed major surgery among women, and surgical-site infections following a cesarean delivery are a significant source of postoperative morbidity. It is unclear if vaginal cleansing before a cesarean delivery decreases post-cesarean delivery infectious morbidity. OBJECTIVE: This study aimed to evaluate if preoperative vaginal cleansing with povidone-iodine among women undergoing a cesarean delivery after labor decreases postoperative infectious morbidity. STUDY DESIGN: This randomized clinical trial was conducted from August 3, 2015 to January 28, 2021, with 30 days of follow-up and the final follow-up completed on February 27, 2021. Patients met the inclusion criteria if they underwent a cesarean delivery after regular contractions with cervical dilation, rupture of membranes, or any cesarean delivery performed at >4 cm dilation. Participants were randomly assigned in a 1:1 ratio to either abdominal cleansing plus vaginal cleansing with 1% povidone-iodine or abdominal cleansing alone. The primary outcome was composite infectious morbidity including surgical-site infection, fever, endometritis, and wound complications within 30 days after the cesarean delivery. Secondary outcomes included individual components of the composite, length of hospital stay, postoperative hospitalization or outpatient treatment related to infectious morbidity, and empirical treatment for neonatal sepsis. RESULTS: A total of 608 subjects (304 vaginal cleansing group, 304 control group) were included in the intention-to-treat analysis. Patient characteristics were similar between groups. There was no significant difference in the primary composite outcome between the 2 groups (11.8% vs 11.5%; P=.90; relative risk, 1.0; 95% confidence interval, 0.7-1.6). Individual components of the composite and secondary outcomes were also not significantly different between the groups. Similar findings were observed in the as-treated analysis (11.3% vs 11.8%; P=.9; relative risk, 1.0; 95% confidence interval, 0.7-1.6). CONCLUSION: Vaginal cleansing with povidone-iodine before an unscheduled cesarean delivery occurring after labor did not reduce the postoperative infectious morbidity. These findings do not support the routine use of vaginal cleansing for women undergoing a cesarean delivery after labor.

Preoperative vaginal cleansing with chlorhexidine solution in preventing post-cesarean section infections in a low resource setting: A randomized controlled trial.

INTRODUCTION: Infection is one of the most common causes of maternal morbidities and mortality and has been reported to be responsible for about 15% of maternal deaths. Any woman is at risk of infection during childbirth, but women undergoing cesarean section are at higher risk. Improvement in surgical procedures with asepsis and the use of antibiotics have helped reduce postoperative infectious morbidities. However, ascending infection from the lower to the upper genital tract is a common but often neglected source of infection. Cleaning the vagina with chlorhexidine antiseptic solution before cesarean section can be a cheap and affordable source of infection control. This study is aimed at evaluating the efficacy of preoperative vaginal cleansing using 1.0% chlorhexidine in the reduction of post-cesarean section infectious morbidities. MATERIAL AND METHODS: This prospective randomized control trial was conducted among 322 pregnant women who underwent an emergency cesarean section at Alex Ekwueme Federal University Teaching Hospital, Abakaliki (AE-FUTHA). The women were randomized into two groups. The interventional group received vaginal cleansing with three standard gauzes soaked in 30 mL 1.0% chlorhexidine gluconate solution preoperatively in addition to surgical skin cleaning with chlorhexidine-alcohol. The women in the control group only had surgical skin cleaning with chlorhexidine-alcohol. All the women received pre- and postoperative antibiotics. The primary outcomes were endometritis and wound infections. RESULTS: Infectious morbidity was significantly reduced from 36.8% in the control group to 12.0% in the intervention group (P = .001). Endometritis occurred significantly less frequently in the intervention group than the control group (respectively 6.6% compared with 27.6%: relative risk [RR] 0.29, 95% confidence interval [CI] 0.16-0.53; P < .05). Foul-smelling vaginal discharge was significantly more common in the control group than in the intervention group (11.8% vs 1.3%, respectively) but the CI was wide (RR 8.5, 95% CI 1.30-64.55; P < .001). Fever and wound infection were more common in the control group (5.9% vs 3.3% and 9.2% vs 5.3%) but the difference was not significant. The hospital stay was significantly shorter among the intervention group (5.54 ± 1.04 days compared with 6.01 ± 1.55 days, P < 0.05). The most common microbial isolate implicated in endocervical colonization was Staphylococcus aureus followed by Klebsiella species. CONCLUSIONS: Vaginal cleansing with 1.0% chlorhexidine gluconate solution before emergency cesarean section appears to be effective in reducing rates of post-cesarean section infectious morbidity in the study area. We recommend its use among women undergoing cesarean section to help reduce the contribution of infections to a poor obstetrics outcome.

Management of clinical chorioamnionitis: an evidence-based approach.

This review aimed to examine the existing evidence about interventions proposed for the treatment of clinical chorioamnionitis, with the goal of developing an evidence-based contemporary approach for the management of this condition. Most trials that assessed the use of antibiotics in clinical chorioamnionitis included patients with a gestational age of ≥34 weeks and in labor. The first-line antimicrobial regimen for the treatment of clinical chorioamnionitis is ampicillin combined with gentamicin, which should be initiated during the intrapartum period. In the event of a cesarean delivery, patients should receive clindamycin at the time of umbilical cord clamping. The administration of additional antibiotic therapy does not appear to be necessary after vaginal or cesarean delivery. However, if postdelivery antibiotics are prescribed, there is support for the administration of an additional dose. Patients can receive antipyretic agents, mainly acetaminophen, even though there is no clear evidence of their benefits. Current evidence suggests that the administration of antenatal corticosteroids for fetal lung maturation and of magnesium sulfate for fetal neuroprotection to patients with clinical chorioamnionitis between 24 0/7 and 33 6/7 weeks of gestation, and possibly between 23 0/7 and 23 6/7 weeks of gestation, has an overall beneficial effect on the infant. However, delivery should not be delayed to complete the full course of corticosteroids and magnesium sulfate. Once the diagnosis of clinical chorioamnionitis has been established, delivery should be considered, regardless of the gestational age. Vaginal delivery is the safer option and cesarean delivery should be reserved for standard obstetrical indications. The time interval between the diagnosis of clinical chorioamnionitis and delivery is not related to most adverse maternal and neonatal outcomes. Patients may require a higher dose of oxytocin to achieve adequate uterine activity or greater uterine activity to effect a given change in cervical dilation. The benefit of using continuous electronic fetal heart rate monitoring in these patients is unclear. We identified the following promising interventions for the management of clinical chorioamnionitis: (1) an antibiotic regimen including ceftriaxone, clarithromycin, and metronidazole that provides coverage against the most commonly identified microorganisms in patients with clinical chorioamnionitis; (2) vaginal cleansing with antiseptic solutions before cesarean delivery with the aim of decreasing the risk of endometritis and, possibly, postoperative wound infection; and (3) antenatal administration of N-acetylcysteine, an antioxidant and antiinflammatory agent, to reduce neonatal morbidity and mortality. Well-powered randomized controlled trials are needed to assess these interventions in patients with clinical chorioamnionitis.

Vaginal preparation with chlorhexidine at cesarean section to reduce endometritis and prevent sepsis: A randomized pilot trial (PREPS).

INTRODUCTION: Cesarean sections are the most common major operation worldwide. One in 10 women develops a surgical-site infection after cesarean section. The PREPS pilot trial was developed to assess the feasibility of a randomized controlled trial of vaginal cleansing with chlorhexidine before cesarean section, to reduce infectious morbidity. MATERIAL AND METHODS: A multi-center, open-label, parallel-group pilot randomized controlled trial across 4 UK maternity units. Women aged ≥16 years, undergoing elective or emergency cesarean section, ≥34 weeks of gestation, and able to give informed consent were eligible. Women were randomized 1:1 to chlorhexidine 0.05% or no cleansing and were followed up until 6 weeks after cesarean section. The feasibility of a larger randomized controlled trial was assessed by the pilot trial's recruitment, ability to use verbal consent in an emergency, adherence, follow-up and withdrawal rates. The main clinical outcome collected was Center for Disease Control and Prevention (CDC) classification of endometritis at 30 days. Trial registration number is ISRCTN33435996. RESULTS: A total of 320 women (128% of target) were randomized. Of these, 93% (95% CI 89%-95%) received their allocated intervention. Of the 88 women who had an emergency cesarean section, verbal consent was initially given by 32 (36%) women, with the remainder having sufficient time to give written consent. Endometritis (CDC definition) was collected from medical notes of 96% of women, 68% (95% CI 63%-73%) were followed up at both 14 and 30 days by telephone, and we were able to collect patient-reported outcomes. In the vaginal cleansing arm 2/152 (1.3%) women had endometritis compared with 1/155 (0.7%) in the no cleansing arm (RR 2.08, 95% CI 0.19-22.31). CONCLUSIONS: It is possible to perform a randomized controlled trial in women undergoing an elective or emergency cesarean section, using a verbal-followed-by-written consent process, while maintaining high adherence and retaining women in the trial.

Preoperative vaginal cleansing with chlorhexidine and cetrimide solution for reduction of postoperative infectious morbidity at a tertiary care center in North India: A prospective cohort study.

OBJECTIVE: To determine the effect of preoperative vaginal cleansing with chlorhexidine and cetrimide solution on postoperative infectious morbidity. METHODS: This prospective cohort study was conducted over a period of 18 months in the Department of Obstetrics and Gynecology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India. Women undergoing cesarean section were alternately allotted to study and control groups. Women with chorioamnionitis, antepartum hemorrhage, rupture of membranes for more than 24 h, and fever in the preoperative period were excluded. The study group received preoperative vaginal cleansing with antiseptic solution (7.5% chlorhexidine w/v and 15% cetrimide w/v); the control group did not receive vaginal cleansing. Both groups were followed for the presence of any infectious morbidity until they were discharged from the hospital. RESULTS: Age, body mass index (calculated as weight in kilograms divided by the square of height in meters), gestational age, and the parity of the women in the study and control groups were comparable (n = 760). The rate of endometritis was lower in the study group, but the difference was not statistically significant (P = 0.054). Post-cesarean febrile morbidity and wound sepsis were significantly lower in the study group (P = 0.017 and P = 0.02, respectively). On subgroup analysis, women in the study group with rupture of the membranes before cesarean delivery had lower wound sepsis and a reduced duration of hospital stay. Women in the study group with emergency cesarean delivery showed a significant reduction in wound sepsis, febrile morbidity, and length of hospital stay. CONCLUSION: Preoperative vaginal cleansing with chlorhexidine and cetrimide solution before a cesarean section reduces postoperative infectious morbidity.

Analyses of the Chemical Composition of Plasma-Activated Water and Its Potential Applications for Vaginal Health.

This study aimed to elucidate the unique chemical compositions of plasma-activated water (PAW) and the potential antibacterial efficacy of PAW as a novel vaginal cleanser. We analyzed the ion compositions (four anions: F-, Cl-, NO3-, SO42-; five cations: Na+, NH4+, K+, Mg2+, Ca2+) of several formulations of PAW generated at different electrical powers (12 and 24 V) at various treatment time points (1, 10, and 20 min), and stay durations (immediate, 30, and 60 min). As treatment duration increased, hypochlorous acid (HOCl), Ca2+, and Mg2+ concentrations increased and Cl- concentration decreased. Higher electrical power and longer treatment duration resulted in increased HOCl levels, which acts to prevent the growth of general microorganisms. Notably, PAW had no antibacterial effects against the probiotic, Lactobacillus reuteri, which produces lactic acid and is important for vaginal health. These findings indicate that PAW contains HOCl and some cations (Ca2+ and Mg2+), which should help protect against pathogens of the vaginal mucosa and have a cleansing effect within the vaginal environment while not harming beneficial bacteria.

Effect of vaginal antiseptic prior to caesarean section on the rate of post-caesarean complications: a blinded randomised controlled trial.

BACKGROUND: Rates of caesarean section (CS) delivery are increasing worldwide. CS delivery is often complicated by post-surgical infection, estimated to have ten times higher risk of infections than that of vaginal delivery. While widespread use of prophylactic antibiotics with CS has reduced post-CS infection, incidence may be reduced further by cleansing the vagina with betadine antiseptic wash prior to CS. However, reports are not consistent, and different antiseptics have been practised variably. Therefore, in order to ensure that the risks to the mother are as minimal as possible, it is important to determine whether vaginal irrigation with antiseptic wash reduces post-CS infection rate, and if so, which antiseptic is paramount. METHODS: Women giving birth by elective or emergency CS will be assigned into either the intervention (1% povidone iodine (n = 125) or chlorhexidine (n = 125)) or the control (no-irrigation (n = 125)) group by using a block randomisation technique. Participants will receive vaginal cleansing with an intervention or no vaginal cleansing prior to CS. Follow-up will occur at day 14 and day 28 post-CS. A predeveloped questionnaire will be completed with patients' socio-demographic characteristics and required clinical and pregnancy-related information. All the fever, infection and readmission-related information will be completed from either the patient's or their record or at follow-up visits. Occurrence of post-CS infection, as measured by primary and secondary outcomes, will be compared between the groups. DISCUSSION: The results of this study may provide important data to define the future uniform use of vaginal antiseptic wash immediately prior to CS and to determine the best antiseptic wash details in reducing post-operative infections or complications. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000971932p . Registered on 28 September 2020.

Stepwise implementation of vaginal cleansing and azithromycin at cesarean: a quality improvement study.

OBJECTIVE: We aimed to decrease our surgical site infection (SSI) rate by 30% by sequential implementation of vaginal cleansing and azithromycin for women who underwent a cesarean delivery (CD) after having labored or experienced rupture of membranes. METHODS: This is a quality improvement project that assessed the stepwise implementation of two interventions within three time periods: (1) 12 months prior to implementation of either intervention; (2) 14 months of vaginal cleansing as infection prophylaxis; (3) 16 months of vaginal cleansing and azithromycin as infection prophylaxis. The primary outcome measure was the SSI as defined by the Center for Disease Control and Prevention and analyzed by control charts. The process measures were compliance rates of vaginal cleansing and azithromycin. Significance was detected by rules for determining a special cause variation. This study followed the SQUIRE 2.0 guidelines for reporting on quality improvement. RESULTS: There were 1033 patients included from the three study periods. The total rate of SSI decreased from 22.8% to 15.2% after implementing vaginal cleansing. Special cause variation was detected with an 8-point shift starting 4 months after implementation of vaginal cleansing. This decrease was sustained during the following 26 months. Adding azithromycin did not significantly lower the SSI rate further. When examined separately, deep SSI (p = .009) and endometritis (p = .001) significantly decreased in the post-intervention periods. Pre-operative vaginal cleansing compliance rose to 74%, and then further increased to 85% 1 year after implementation. Azithromycin compliance rose to 75%. Total length of postpartum stay decreased over the study periods from 3.5 ± 1.4 days to 3.2 ± 0.8 days (p = .001). CONCLUSION: In this quality improvement study, implementation of vaginal cleansing decreased the SSI rate by 33%, from 22.8% to 15.2%. The addition of azithromycin did not result in any additional change in SSI rate.

Preoperative vaginal cleansing with chlorhexidine vs placebo in patients with rupture of membranes: a prospective, randomized, double-blind, placebo-control study.

BACKGROUND: XXX OBJECTIVE: This study aimed to demonstrate that vaginal cleansing with a 4% chlorhexidine solution before cesarean delivery in patients with a history of rupture of membranes prevents postoperative infectious complications (endometritis, surgical site infections). STUDY DESIGN: A total of 204 patients with premature rupture of membranes or who were in labor for more than 6 hours after membranes ruptured were randomized before a cesarean delivery to preoperative vaginal cleansing with a chlorhexidine solution (n=97 patients) or to placebo cleansing with saline solution (n=107 patients). The management of the rupture of membranes and the cesarean delivery procedure were conducted according to standard local protocols for both groups, including the use of antibiotics. RESULTS: Vaginal cleansing with chlorhexidine reduced the risk for endometritis after cesarean delivery in patients with rupture of membranes when compared with placebo cleansing (chlorhexidine, 7.21% vs placebo, 18.8%; relative risk, 0.39; 95% confidence interval, 0.17-0.87; P=.015). Likewise, there was a statistically significant reduction in the number of cases of puerperal fever (chlorhexidine, 9.28% vs placebo, 19.8%; relative risk, 0.47; 95% confidence interval, 0.23-0.98; P=.037). There was a statistical difference between the groups in prolongation of hospitalization for >72 hours (chlorhexidine, 1.03% vs placebo, 7.55%; relative risk, 0.14; 95% confidence interval, 0.02-1.08; P=.02), although the confidence interval suggests that the effect was by chance. There were no statistical differences in surgical site infection at 7 days (chlorhexidine, 1.03% vs placebo, 0.94%; relative risk, 1.1; 95% confidence interval, 0.07-17.4; P=.94) and 15 days after the procedure (chlorhexidine, 1.03% vs placebo, 0%; relative risk, 3.31 [using a continuity correction]; 95% confidence interval, 0.14-80.21; P=.29). CONCLUSION: The use of chlorhexidine for vaginal cleansing before a cesarean delivery in patients with rupture of membranes reduced the risk for endometritis and puerperal fever. It also reduced the number of cases that required hospitalization for more than 3 days, but the confidence interval suggests that it could be by chance. It has no effect on the number of cases with surgical site infection.

A randomized trial of the bactericidal effects of chlorhexidine vs povidone-iodine vaginal preparation.

BACKGROUND: Precesarean vaginal preparation significantly reduces postpartum infections. Although povidone-iodine is the most commonly used vaginal antiseptic, evidence suggests that chlorhexidine gluconate may be more effective. OBJECTIVE: We aimed to compare the bactericidal effect of chlorhexidine gluconate and povidone-iodine on vaginal bacterial colony counts in pregnancy. MATERIALS AND METHODS: We conducted a prospective randomized controlled trial of vaginal preparation with 0.5% chlorhexidine gluconate vs 10% povidone-iodine vs saline in women undergoing cesarean delivery at ≥34 weeks' gestation. Women in labor or those with ruptured membranes, chorioamnionitis, abnormal placentation, or allergy to study agents were excluded. Vaginal specimens were collected aseptically in the operating room immediately before and 5-10 minutes after vaginal cleansing with 3 sterile sponge sticks. Our primary outcome was postintervention aerobic and anaerobic bacterial colony counts, assessed by blinded investigators. Two-way analysis of variance with simple-effects analysis and Tukey post hoc test were used for multiple group comparisons. Secondary outcomes included baseline colony counts, change in colony counts, adverse events, and maternal infections. RESULTS: A total of 29 women consented and underwent vaginal preparation with chlorhexidine gluconate (n=10), povidone-iodine (n=9), or saline (n=10). Groups were similar with respect to maternal age, body mass index, race, ethnicity, parity, group B streptococcus status, and gestational age. There were no differences in baseline colony counts. Vaginal preparation with povidone-iodine resulted in lower aerobic and anaerobic colony counts compared with chlorhexidine gluconate and saline (P≤.01 and P≤.0001, respectively). Povidone-iodine eliminated more than 99.9% of bacteria, whereas chlorhexidine gluconate and saline eliminated more than 99% and 95% of bacteria, respectively. Although all agents decreased aerobic and anaerobic bacterial counts, 0.5% chlorhexidine gluconate was no more effective than saline in reducing anaerobic bacteria. There were no reported adverse effects or postpartum infections. CONCLUSION: Compared with 0.5% chlorhexidine gluconate, 10% povidone-iodine was more effective in reducing vaginal bacterial colony counts before cesarean delivery.

Implementation of vaginal cleansing prior to cesarean delivery to decrease endometritis rates.

BACKGROUND: Endometritis is a postpartum complication that is more common after cesarean delivery. It frequently requires intravenous antibiotic administration, prolonged hospital stays, and carries a risk of sepsis or abscess formation. Precesarean vaginal preparation has been shown to decrease the risk of endometritis in patients who have labored or have ruptured membranes. OBJECTIVE: The objective of this study was to assess the practical implementation of a protocol for vaginal cleansing prior to cesarean delivery and the subsequent effect on endometritis rates in a clinical setting. STUDY DESIGN: This is a before-after retrospective cohort study evaluating the first 6 months of implementation of a vaginal cleansing protocol at a single institution. The primary outcome was the rate of implementation. Secondary outcomes included endometritis and other postoperative complications. RESULTS: The rate of implementation after 6 months was 68.3% (p < .001) and postoperative endometritis rates decreased from 14.0% before implementation to 11.7% after implementation (p .49, OR 0.77, CI 0.36-1.62). Postoperative fever decreased from 22.3% to 18.3% (p .256, OR 0.70, CI 0.37-1.30) and infectious wound complications were 4.5% and 5.8%, respectively (p .76, OR 1.07, CI 0.69-3.64). CONCLUSIONS: Implementation of a protocol for vaginal cleansing prior to cesarean delivery in women with ruptured membranes or in labor has high uptake, but in almost a third of eligible women it was not performed. The implementation, has led to a clinical, although not statistical, decrease in postoperative endometritis. Continued research is needed to explore how to improve uptake of this quality improvement measure.

Vaginal cleansing with chlorhexidine gluconate or povidone-iodine prior to cesarean delivery: a randomized comparator-controlled trial.

BACKGROUND: Several randomized controlled trials have demonstrated that preoperative abdominal skin preparation with chlorhexidine gluconate is superior to povidone-iodine for the prevention of surgical site infections. Despite these results, povidone-iodine is still the most commonly used agent for vaginal preparation, even though it may not be ideal. OBJECTIVES: The objectives of the study were as follows: (1) to determine whether vaginal cleansing with a 4% chlorhexidine gluconate solution results in fewer wound infections as compared with povidone-iodine when used for vaginal antisepsis prior to cesarean delivery and (2) to compare rates of patient reported side-effects associated with vaginal application of 4% chlorhexidine gluconate solution and 10% povidone-iodine. STUDY DESIGN: This is a block randomized, comparator-controlled, open-label trial. Women undergoing nonemergent cesarean delivery were randomized to receive vaginal cleansing with either 4% chlorhexidine solution or 10% povidone-iodine solution prior to skin incision. The primary outcome was wound site infection occurring within 14 days of cesarean delivery including superficial or deep surgical site infection. Secondary outcomes included rates of endometritis, postoperative fever, and side effects (vaginal dryness, irritation, and desquamitization) occurring within 14 days of cesarean delivery. Risks were reported as odds ratios with 95% confidence intervals, with P < .05 considered as significant. RESULTS: From Dec. 1, 2016, through Feb. 28, 2018, a total of 1,114 patients met the inclusion criteria: 524 were randomized to the chlorhexidine gluconate arm and 590 to the povidone-iodine arm. Both arms were similar with regard to age, parity, body mass index, gestational age at delivery, indication for cesarean delivery, and incidence of membrane rupture. The rate of wound infection was significantly lower in the chlorhexidine arm as compared with povidone-iodine (0.6% vs 2.0%; P = .039, odds ratio, 0.28, 95% confidence interval, 0.08-0.98). Rates of endometritis (0.4% vs 0.5%, P = 1.000) and postoperative fever (2.5% and 2.7%, P = 0.892) were similar for the chlorhexidine and povidone-iodine groups, respectively. No adverse effects on the vaginal mucosa were noted for either solution. CONCLUSION: Vaginal cleansing with a 4% chlorhexidine solution prior to cesarean delivery resulted in fewer overall wound infections when compared with povidone-iodine solution with no patient-reported adverse reactions.

Chlorhexidine vaginal preparation versus standard treatment at caesarean section to reduce endometritis and prevent sepsis-a feasibility study protocol (the PREPS trial).

BACKGROUND: Worldwide caesarean section (CS) delivery is the most common major operation. Approximately 25% of pregnant women undergo a CS in the UK for delivery of their babies. Sepsis and post-natal infection constitute significant maternal mortality and morbidity. Infection following a CS has a number of primary sources including endometritis occurring in 7-17% of women. Sepsis reduction and reduction in antibiotic use have been identified as a national and international priority. The overarching aim of this research is to reduce infectious morbidity from caesarean sections. METHODS: This is a parallel group feasibility randomised controlled trial comparing vaginal cleansing using chlorhexidine gluconate versus no cleansing (standard practice) at CS to reduce infection. Women will be recruited from four National Health Service maternity units. Two hundred fifty women (125 in each arm) undergoing elective or emergency CS, who are aged 16 years and above, and at least 34 weeks pregnant will be randomised. Allocation to treatment will be on a 1:1 ratio. The study includes a qualitative aspect to develop women centred outcomes of wellbeing after delivery. DISCUSSION: The success of the feasibility study will be assessed by criteria related to the feasibility measurements to ascertain if a larger study is feasible in its current format, needs modification or is unfeasible, and includes recruitment, adherence, follow-up and withdrawal measures. TRIAL REGISTRATION: The PREPS trial has been registered with ISRCTN (ISRCTN 33435996).

Surgical site infections after cesarean delivery: epidemiology, prevention and treatment.

Cesarean delivery (CD) is one of the most common procedures performed in the United States, accounting for 32% of all deliveries. Postpartum surgical site infection (SSI), wound infection and endometritis is a major cause of prolonged hospital stay and poses a burden to the health care system. SSIs complicate a significant number of patients who undergo CD - 2-7% will experience sound infections and 2-16% will develop endometritis. Many risk factors for SSI have been described. These include maternal factors (such as tobacco use; limited prenatal care; obesity; corticosteroid use; nulliparity; twin gestations; and previous CD), intrapartum and operative factors (such as chorioamnionitis; premature rupture of membranes; prolonged rupture of membranes; prolonged labor, particularly prolonged second stage; large incision length; subcutaneous tissue thickness > 3 cm; subcutaneous hematoma; lack of antibiotic prophylaxis; emergency delivery; and excessive blood loss), and obstetrical care on the teaching service of an academic institution. Effective interventions to decrease surgical site infection include prophylactic antibiotic use (preoperative first generation cephalosporin and intravenous azithromycin), chlorhexidine skin preparation instead of iodine, hair removal using clippers instead of razors, vaginal cleansing by povidone-iodine, placental removal by traction of the umbilical cord instead of by manual removal, suture closure of subcutaneous tissue if the wound thickness is >2 cm, and skin closure with sutures instead of with staples. Implementation of surgical bundles in non-obstetric patients has been promising., Creating a similar patient care bundle comprised evidence-based elements in patients who undergo CD may decrease the incidence of this major complication. Each hospital has the opportunity to create its own CD surgical bundle to decrease surgical site infection.