zithromax and Endometritis

Cesarean delivery (CD) wound complications disrupt the time a mother spends with her newborn. Surgical site infections (SSI) may result in unplanned office visits, emergency room visits, and hospital readmissions. Despite increasing attention to preoperative preparation, the CD SSI rate remains high. Local practices must be evaluated, and new methods to reduce CD SSI must be used.

Topics: Adult; Anti-Bacterial Agents; Antibiotic Prophylaxis; Azithromycin; Cesarean Section; Endometritis; Female; Humans; Infant, Newborn; Negative-Pressure Wound Therapy; Pregnancy; Preoperative Care; Risk Factors; Surgical Wound Dehiscence; Surgical Wound Infection; Wound Closure Techniques

To review the current status of antibiotic prophylaxis for cesarean delivery, emerging strategies to enhance the effectiveness of antibiotic prophylaxis in reducing postcesarean infection, and the implications of the emerging practices.. We conducted a full PubMed (January 1966 to July 2008) search using the key words "cesarean" and "antibiotic prophylaxis." A total of 277 articles were identified and supplemented by a bibliographic search.. We selected a total of 15 studies, which included all published clinical trials, meta-analyses of clinical trials, and observational studies evaluating either the timing of antibiotics or the use of extended-spectrum prophylaxis. We also reviewed nine reports involving national recommendations or technical reviews supporting current standards for antibiotic prophylaxis.. We conducted an analytic review and tabulation of selected studies without further meta-analysis. Although current guidelines for antibiotic prophylaxis recommend the administration of narrow-spectrum antibiotics (cefazolin) after clamping of the umbilical cord, the data suggest that antibiotic administration before surgical incision or the use of extended-spectrum regimens (involving azithromycin or metronidazole) after cord clamp may reduce postcesarean maternal infection by up to 50%. However, these two strategies have not been compared with each other. In addition, their effect on neonatal infection or infection with resistant organisms warrants further study.. The use of either cefazolin alone before surgical incision or an extended-spectrum regimen after cord clamp seems to be associated with a reduction in postcesarean maternal infection. Confirmatory studies focusing additionally on neonatal outcomes and the effect on resistant organisms, as well as studies comparing both strategies, are needed.

Topics: Anti-Bacterial Agents; Antibiotic Prophylaxis; Azithromycin; Cefazolin; Cesarean Section; Endometritis; Female; Humans; Length of Stay; Metronidazole; Pregnancy; Puerperal Infection; Surgical Wound Infection; United States

To evaluate the yearly prevalence and annual transition of multi-drug-resistant-chronic endometritis (MDR-CE) in infertile women with a history of repeated implantation failure (RIF) and to establish the third-line antibiotic treatment regimen against MDR-CE.. This retrospective/prospective cohort and pilot study included 3473 RIF women between April 2010 and September 2021. The endometrial stromal plasmacyte density index (ESPDI) was calculated in 3449 CD138-immunostained endometrial sections to evaluate CE. The microbiota in the vaginal secretions and endometrial fluid was compared between 17 patients with MDR-CE and 16 patients with antibiotics-sensitive CE. In a pilot study, oral moxifloxacin (400 mg/day, 10 days, n = 24) or azithromycin (500 mg/day, 3 days, n = 24) was administered to eligible patients with MDR-CE.. From April 2010 to March 2020, CE was detected in 31.4% of RIF women and MDR was detected in 7.8% of CE. While the prevalence of CE was stable for a decade, MDR in CE increased steadily (OR 8.27, 95% CI 2.58-26.43, p trend < 0.001). The bacterial species/communities unique to MDR-CE were not found. The histopathologic cure rate of MDR-CE was similar between the moxifloxacin and azithromycin groups (79.2% vs 75.0%, OR 1.27, 95% CI 0.32-4.89, p value 0.73), as well as reproductive outcomes in subsequent embryo transfer cycles.. In RIF women, MDR in CE increased over the decade. As a third-line treatment for MDR-CE, azithromycin may have a clinical advantage due to its shorter time administration periods.. ClinicalTrials.gov Identifier: UMIN-CTR 000029449/000031909.

Topics: Anti-Bacterial Agents; Azithromycin; Chronic Disease; Embryo Implantation; Endometritis; Endometrium; Female; Humans; Infertility, Female; Moxifloxacin; Pharmaceutical Preparations; Pilot Projects; Prospective Studies; Retrospective Studies

To estimate the association between timing of administration of adjunctive azithromycin for prophylaxis at unscheduled cesarean delivery and maternal infection and neonatal morbidity.. We conducted a secondary analysis of a randomized trial of adjunctive azithromycin prophylaxis in patients with singleton gestations who were undergoing unscheduled cesarean delivery. The primary exposure was the timing of initiation of the study drug (after skin incision or 0-30 minutes, more than 30-60 minutes, or more than 60 minutes before skin incision). The primary outcome was a composite of endometritis, wound infection, and other maternal infections occurring up to 6 weeks after cesarean delivery. Secondary outcomes included composite neonatal morbidity, neonatal intensive care unit admission for longer than 72 hours, and neonatal sepsis. The association of azithromycin with outcomes was compared within each antibiotic timing group and presented as risk ratios (RRs) with 95% CIs. A Breslow-Day homogeneity test was applied to assess differences in association by antibiotic timing.. Of 2,013 participants, antibiotics were initiated after skin incision (median 3 minutes, range 0-229 minutes) in 269 (13.4%), 0-30 minutes before skin incision in 1,378 (68.5%), more than 30-60 minutes before skin incision in 270 (13.4%), and more than 60 minutes before skin incision (median 85 minutes, range 61-218 minutes) in 96 (4.8%). The RRs (95% CIs) of the infectious composite outcome for azithromycin compared with placebo were significantly lower for groups that initiated azithromycin after skin incision or within 1 hour before skin incision (after skin incision: RR 0.31, 95% CI 0.13-0.76; 0-30 minutes before: RR 0.62, 95% CI 0.44-0.89; more than 30-60 minutes before: 0.31, 95% CI 0.13-0.66). Risks were not significantly different in patients who received azithromycin more than 60 minutes before skin incision (RR 0.59, 95% CI 0.10-3.36). Results were similar when endometritis and wound infections were analyzed separately. Neonatal outcomes were not significantly different for azithromycin compared with placebo across all timing groups.. Adjunctive azithromycin administration up to 60 minutes before or at a median of 3 minutes after skin incision was associated with reduced risks of maternal composite postoperative infection in unscheduled cesarean deliveries.. ClinicalTrials.gov, NCT01235546.

Topics: Anti-Bacterial Agents; Antibiotic Prophylaxis; Azithromycin; Endometritis; Female; Humans; Infant, Newborn; Pregnancy; Surgical Wound Infection

To compare the effectiveness of single-dose azithromycin, with or without amoxicillin, with placebo to prevent peripartum infection in laboring women.. We conducted a multicenter, three-group, double-blind randomized controlled trial of women with viable term nonanomalous pregnancies with either prolonged labor of 18 hours or longer or rupture of membranes for 8 hours or longer in Cameroon. Women with chorioamnionitis before randomization, study drug contraindications, or planned cesarean births were excluded. Women were randomized to oral azithromycin 1 g-placebo (group 1), oral azithromycin 1 g-oral amoxicillin 2 g (group 2), or placebo-placebo (group 3). All groups received usual care, including antibiotics given at the health care professional's discretion. The primary outcome was a composite of maternal peripartum infection or death from any cause up to 6 weeks postpartum. Two primary comparisons (group 1 vs group 3 and group 2 vs group 3) were planned. We estimated that 241 women per group (planning for 750 total) would provide 80% power at two-sided α=0.05 (0.025 per comparison) to detect a 50% effect size assuming 20% baseline composite infection rate.. From January 6, 2018, to May 15, 2020, 6,531 women were screened, and 756 (253 in group 1, 253 in group 2, and 250 in group 3) were randomized. Baseline characteristics (including body mass index, duration of rupture of membranes or labor, and parity) were balanced across groups, except for maternal age. More than 60% of women in each group received usual-care antibiotics: more than 90% penicillin and approximately 50% for prolonged rupture of membranes across all study groups. Composite outcome incidences were similar in antibiotic groups 1 (6%) and 2 (7%) compared with placebo group 3 (10%) (RR 0.6, 95% CI 0.3-1.2; 0.7, 95% CI 0.4-1.3, respectively). Chorioamnionitis and wound infection were significantly lower in group 2 (3.2% vs 0.4% and 4% vs 0.8% respectively, both P=.02) compared with group 3. There were no differences in other maternal or neonatal outcomes including neonatal infection.. A single dose of oral azithromycin with or without amoxicillin for prolonged labor or rupture of membranes at term did not reduce maternal peripartum or neonatal infection. Observed lower than expected infection rates and frequent usual-care antibiotic use may have contributed to these findings.. ClinicalTrials.gov, NCT03248297.. Merck for Mothers Investigator Studies Program grant.

Topics: Abscess; Administration, Oral; Adult; Amoxicillin; Anti-Bacterial Agents; Antibiotic Prophylaxis; Azithromycin; Bacterial Infections; Cameroon; Cesarean Section; Chorioamnionitis; Double-Blind Method; Endometritis; Female; Humans; Infant, Newborn; Infection Control; Labor, Obstetric; Peripartum Period; Pregnancy; Pregnancy Complications, Infectious; Sepsis; Treatment Outcome; Wound Infection

To explore whether the effect of azithromycin (AZI) on postcesarean infections varied by the presence/absence of genital mycoplasmataceae placental colonization.. This was a single-center substudy of multicenter double-blind C/SOAP (Cesarean Section Optimal Antibiotic Prophylaxis) trial of women randomized to AZI or placebo (+cefazolin) antibiotic prophylaxis at cesarean. Chorioamnion/placenta specimens were tested for genital mycoplasmataceae colonization by polymerase chain reaction. Primary outcome was a composite of endometritis, wound infection, or other infections up to 6 weeks postpartum. Analysis was intent-to-treat; logistic regression was used to evaluate interactions between treatment assignment (AZI/placebo) and the presence/absence of mycoplasmataceae and to quantify effects of AZI in analyses stratified by the presence/absence of these microorganisms.. The reduction in postcesarean infection with AZI does not vary based on the presence or absence of genital mycoplasmataceae placental colonization.

Topics: Adult; Anti-Bacterial Agents; Antibiotic Prophylaxis; Azithromycin; Cesarean Section; Endometritis; Female; Humans; Mycoplasma; Placenta; Pregnancy; Puerperal Infection; Sepsis; Surgical Wound Infection; Ureaplasma

To identify maternal clinical risk factors for postcesarean maternal infection in a randomized clinical trial of preincision extended-spectrum antibiotic prophylaxis.. We conducted a planned secondary analysis of a randomized clinical trial. Patients were 24 weeks of gestation or greater and delivered by cesarean after a minimum of 4 hours of ruptured membranes or labor. All participants received standard preincision prophylaxis and were randomized to receive azithromycin or placebo. The primary outcome for this analysis is maternal infection: a composite outcome of endometritis, wound infection (superficial or deep), or other infections occurring up to 6 weeks postpartum. Maternal clinical characteristics associated with maternal infection, after controlling for azithromycin assignment, were identified. These maternal factors were included in a multivariable logistic regression model for maternal infection.. Of 2,013 patients, 1,019 were randomized to azithromycin. Overall, 177 (8.8%) had postcesarean maternal infection. In the final adjusted model, compared with the reference groups, women of black race-ethnicity, with a nontransverse uterine incision, with duration of membrane rupture greater than 6 hours, and surgery duration greater than 49 minutes, were associated higher odds of maternal infection (all with adjusted odds ratios [ORs] of approximately 2); azithromycin was associated with lower odds of maternal infection (adjusted OR 0.4, 95% confidence interval 0.3-0.6).. Despite preincision azithromycin-based extended-spectrum antibiotic prophylaxis, postcesarean maternal infection remains a significant source of morbidity. Recognition of risk factors may help guide innovative prevention strategies.. ClinicalTrials.gov, https://clinicaltrials.gov, NCT012235546.

Topics: Adult; Anti-Bacterial Agents; Antibiotic Prophylaxis; Azithromycin; Black or African American; Cesarean Section; Drug Therapy, Combination; Endometritis; Extraembryonic Membranes; Female; Humans; Labor, Obstetric; Operative Time; Postoperative Period; Pregnancy; Risk Factors; Surgical Wound Infection; Time Factors; Young Adult

The addition of azithromycin to standard regimens for antibiotic prophylaxis before cesarean delivery may further reduce the rate of postoperative infection. We evaluated the benefits and safety of azithromycin-based extended-spectrum prophylaxis in women undergoing nonelective cesarean section.. In this trial conducted at 14 centers in the United States, we studied 2013 women who had a singleton pregnancy with a gestation of 24 weeks or more and who were undergoing cesarean delivery during labor or after membrane rupture. We randomly assigned 1019 to receive 500 mg of intravenous azithromycin and 994 to receive placebo. All the women were also scheduled to receive standard antibiotic prophylaxis. The primary outcome was a composite of endometritis, wound infection, or other infection occurring within 6 weeks.. The primary outcome occurred in 62 women (6.1%) who received azithromycin and in 119 (12.0%) who received placebo (relative risk, 0.51; 95% confidence interval [CI], 0.38 to 0.68; P<0.001). There were significant differences between the azithromycin group and the placebo group in rates of endometritis (3.8% vs. 6.1%, P=0.02), wound infection (2.4% vs. 6.6%, P<0.001), and serious maternal adverse events (1.5% vs. 2.9%, P=0.03). There was no significant between-group difference in a secondary neonatal composite outcome that included neonatal death and serious neonatal complications (14.3% vs. 13.6%, P=0.63).. Among women undergoing nonelective cesarean delivery who were all receiving standard antibiotic prophylaxis, extended-spectrum prophylaxis with adjunctive azithromycin was more effective than placebo in reducing the risk of postoperative infection. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; C/SOAP ClinicalTrials.gov number, NCT01235546 .).

Topics: Adult; Anti-Bacterial Agents; Antibiotic Prophylaxis; Azithromycin; Cesarean Section; Endometritis; Female; Humans; Infant, Newborn; Pregnancy; Puerperal Infection; Sepsis; Surgical Wound Infection; Survival Analysis; Young Adult

To describe the effect of an extended-spectrum prophylactic antibiotic regimen on postcesarean endometritis.. This is a cohort study of trends in postcesarean endometritis using data both from prospective surveillance by the infection control unit and from query of our obstetric computerized database to compare three periods of antibiotic prophylaxis: standard narrow-spectrum with intravenous first- or second-generation cephalosporin (1992-1996), clinical trial of extended-spectrum with addition of intravenous doxycycline and oral azithromycin (1997-1999), and routine use of extended-spectrum with addition of intravenous azithromycin (2001-2006) to standard cephalosporin prophylaxis.. A total of 48,913 deliveries at 24 weeks or more of gestation occurred from 1992 to 2006, of which 10,966 (22.4%) were cesarean deliveries. Annual cesarean rates increased from 16% to 27.5%. Trends in the incidence of postcesarean endometritis revealed a biphasic decrease consistent with the phased introduction of extended-spectrum prophylaxis. Incidence (95% confidence interval [CI]) of endometritis by prospective surveillance dropped from 19.9% (95% CI 18.6-21.3%) to 15.4% (95% CI 13.2-17.9%) during the clinical trial period: relative risk (RR) 0.77 (95% CI 0.66-0.91), P=.002; and then to 6.3% (95% CI 5.0-7.9%) during routine use of extended-spectrum prophylaxis: RR 0.41 (95% CI 0.31-0.54), P<.001. Corresponding incidence by database query dropped from 23% (95% CI 21.5-24.4%) to 16% (95% CI 14.4-17.9%): RR 0.69 (95% CI 0.61-0.79), P<.001; and then to 2.1% (95% CI 1.8-2.6%): RR 0.13 (95% CI 0.11-0.16), P<.001. These findings were unchanged after adjusting for potential confounders.. Extended-spectrum antibiotic prophylaxis involving the addition of azithromycin to standard narrow-spectrum prophylaxis was associated with a significant reduction in postcesarean endometritis.. II.

Topics: Adult; Anti-Bacterial Agents; Antibiotic Prophylaxis; Azithromycin; Cephalosporins; Cesarean Section; Cohort Studies; Endometritis; Female; Humans; Longitudinal Studies; Pregnancy; Puerperal Infection; Retrospective Studies; Risk; Surgical Wound Infection

To evaluate the equivalence of ceftriaxone plus doxycycline or azithromycin for cases of mild pelvic inflammatory disease (PID).. Patients with PID received an intramuscular injection of 250 mg of ceftriaxone, and were randomly assigned to receive 200 mg/d of doxycycline for 2 weeks, or 1 g of azithromycin per week, for 2 weeks. The degree of pain was assessed on days 2, 7, and 14 and clinical cure was assessed on day 14.. From 133 patients eligible for the study, 13 were excluded for having conditions other than PID, 11 were lost on follow-up, and three had oral intolerance to the antibiotics, yielding 106 for protocol analysis. No significant difference was observed regarding the degree of pain between the doxycycline and azithromycin groups. Clinical cure per protocol was 98.2% (56 of 57; 95% confidence interval [CI], 0.9-0.99) with azithromycin, and 85.7% (42 of 49; 95% CI, 0.72-0.93) with doxycycline (P=0.02). In a modified intention to treat analysis, clinical cure was 90.3% (56 of 62; 95% CI, 0.80-0.96) with azithromycin, and 72.4% (42 of 58; 95% CI, 0.58-0.82) with doxycycline (P=.01); a relative risk of 0.35, and a number needed to treat of six for benefit with azithromycin.. When combined with ceftriaxone, 1g of azithromycin weekly for 2 weeks is equivalent to ceftriaxone plus a 14-day course of doxycycline for treating mild PID.

Topics: Adult; Anti-Bacterial Agents; Azithromycin; Ceftriaxone; Doxycycline; Drug Therapy, Combination; Endometritis; Endometrium; Female; Humans; Injections, Intramuscular; Pelvic Inflammatory Disease; Pelvic Pain; Treatment Outcome

The purpose of this study was to explore whether endometrial microbial colonization and plasma cell endometritis are risk factors for adverse pregnancy outcomes, and whether these outcomes are influenced by interactions between interconceptional antibiotics and the micro-flora.. Subgroup analyses of data from a double-blind, randomized, placebo-controlled trial of a course of metronidazole plus azithromycin given every 4 months to women with a prior preterm delivery to prevent recurrent preterm delivery. Endometrial cultures and histology were obtained at randomization and repeated 2 weeks after the first treatment. Fifty-nine on antibiotics versus 65 on placebo had pregnancy outcomes. Prevalence of adverse pregnancy outcomes (pregnancy loss or preterm birth < 37 weeks) was stratified by treatment group and endometrial characteristics. Subgroups were assessed and screened for potential interaction (P values for significance set a priori at < .01), prior to formal statistical testing for interaction (P values < .05).. The prevalence of adverse pregnancy outcome was 62.7% in the presence of endometrial microbial colonization at baseline (any microbe) and 50% in the absence of colonization (RR = 1.25; 99% CI 0.42-3.7). Prevalence of adverse pregnancy outcomes was 61.9% with plasma cell endometritis, and 70.8% without; RR = 0.87 (0.50-1.5). There was a nonsignificant reduction in adverse pregnancy outcome in the absence of Gardnerella vaginalis or gram-negative rods with RR (95% CI) = 0.60 (0.3-1.2) and 0.66 (0.4-1.2), respectively. In the presence of these microbes, antibiotics appeared to increase adverse outcomes: RR = 1.5 (1.1-2.0) and 1.5 (1.1-2.1), respectively. This reversal of impact represents a crossover interaction.. Neither baseline endometrial microbial colonization nor plasma cell endometritis were risk factors for adverse pregnancy outcome. However, colonization with specific microbes interacted with antibiotics to increase adverse outcomes.

Topics: Adult; Anti-Bacterial Agents; Antibiotic Prophylaxis; Azithromycin; Bacterial Infections; Double-Blind Method; Endometritis; Endometrium; Female; Humans; Metronidazole; Pregnancy; Pregnancy Complications, Infectious; Pregnancy Outcome; Premature Birth

This prospective study was carried out to determine the antimicrobial susceptibility of Neisseria gonorrhoeae isolates by disc diffusion method and minimum inhibitory concentration (MIC) by E -test with special reference to azithromycin. Also, the correlation between in vitro susceptibility and treatment outcome with single 2 g oral dose azithromycin was assessed.. The study included 75 gonococcal isolates from males with urethritis, females with endocervicitis and their sexual contacts. All isolates were subjected to susceptibility testing for penicillin, ciprofloxacin, tetracycline, ceftriaxone, spectinomycin, cefixime and azithromycin. Males with gonococcal urethritis were randomised to receive a single dose of either azithromycin or ceftriaxone. Forty-two men with urethritis received 2 g single oral dose azithromycin, while all other patients were given 250 mg parentral ceftriaxone. All patients were called for follow-up to assess clinical and microbiological cure rates.. While all the isolates were susceptible to ceftriaxone, spectinomycin, cefixime and azithromycin; 74 (98.7%), 24 (32%) and 23 (30.7%) strains were resistant to ciprofloxacin, penicillin and tetracycline respectively, by both disc diffusion method and E -test. The MIC range, MIC50 and MIC90 of N. gonorrhoeae strains, to azithromycin were 0.016-0.25, 0.064 and 0.19 microg/mL, respectively. Follow-up attendance of the patients was 52.4 with 100% clinical and microbiological cure rates.. Results of our study indicate that 2 g single oral dose azithromycin is safe and effective in the treatment of uncomplicated gonorrhoea.

Topics: Administration, Oral; Anti-Bacterial Agents; Azithromycin; Ceftriaxone; Drug Resistance, Bacterial; Endometritis; Female; Gonorrhea; Humans; Injections, Intravenous; Male; Microbial Sensitivity Tests; Neisseria gonorrhoeae; Prospective Studies; Treatment Outcome; Urethritis

To determine if extended spectrum prophylactic antibiotic treatment (with efficacy against Ureaplasma urealyticum) reduces post-cesarean delivery clinical endometritis.. After cord clamping at cesarean delivery, subjects received prophylaxis with cefotetan. Subjects were then simultaneously randomized (double blind) to receive doxycyline plus azithromycin versus placebo. Post-cesarean delivery endometritis was defined clinically as fever of 100.4F or higher with one or more supporting clinical signs or a physician diagnosis of endometritis plus the absence of a nonpelvic source of fever.. A total of 597 women were enrolled, 301 in the doxycycline/azithromycin group and 296 in the placebo group. The study population was 56% black, 25.5 +/- 6.2 years of age, and 43% nulliparous. The groups were similar (P >.05) for black race, parity, maternal age, and most risk factors for post-cesarean delivery endometritis. The frequency of post-cesarean delivery endometritis (16.9% versus 24.7%, P =.020), wound infections (0.8% versus 3.6%, P =.030), and a combination of these two outcomes (19.0% versus 27.8%, P =.019) were significantly lower in the doxycycline/azithromycin group compared with the placebo-treated group. The doxycycline/azithromycin versus placebo groups were dissimilar for maternal leukocytosis (24.9% versus 12.5%, P =.042) and frequency of classic uterine incision (7.6% versus 12.5%, P =.048). Adjusting for these factors did not alter the risk ratio for post-cesarean delivery endometritis in the active versus placebo-treated group (relative risk 0.65, 95% confidence interval 0.43, 0.98). Length of stay was longer in the placebo group overall (104 +/- 56 versus 95 +/- 32 hours, P =.016) and among women with endometritis (146 +/- 52 versus 127 +/- 46 hours, P =.047).. Extended spectrum prophylactic antibiotic treatment (with presumed efficacy against U urealyticum) given to women undergoing cesarean delivery at term shortens hospital stay and reduces the frequency of post-cesarean delivery endometritis and wound infections.

Topics: Adult; Antibiotic Prophylaxis; Azithromycin; Cefotetan; Cesarean Section; Double-Blind Method; Doxycycline; Drug Therapy, Combination; Endometritis; Female; Humans; Pregnancy; Puerperal Infection; Surgical Wound Infection; Ureaplasma Infections; Ureaplasma urealyticum

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.. 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.. 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.

Topics: Anti-Infective Agents, Local; Azithromycin; Endometritis; Female; Humans; Pregnancy; Quality Improvement; Surgical Wound Infection

A recent large clinical trial demonstrated an approximately 50% decrease in the rate of postoperative infection in women who were laboring and/or had rupture of membranes for >4 hours and who received azithromycin in addition to standard preoperative antibiotic prophylaxis at the time of cesarean delivery. Given these results, our institution made a policy change in May 2017 to add azithromycin to standard preoperative prophylaxis for all cesarean deliveries.. This study aimed to evaluate the clinical effectiveness of adding azithromycin to preoperative antibiotic prophylaxis for cesarean delivery.. We conducted a before-and-after cohort study of women delivered via cesarean delivery at our institution. The preimplementation group included women who delivered from March 1, 2016, to February 28, 2017, (before an institutional practice change of adding azithromycin to standard preoperative prophylaxis), and the postimplementation group included women who delivered from September 1, 2017, to August 31, 2018 (allowing a 6-month period for uptake of the practice change). The primary outcome was a composite of postoperative infections (endometritis, wound infection, other maternal infections). Unadjusted and adjusted risk ratios and 95% confidence intervals were estimated using a modified Poisson regression model.. In the preimplementation (n=1171) and postimplementation (n=1168) groups, the incidence rates of the composite outcomes were 4.7% and 5.3%, respectively (P=.49). Both unadjusted (relative risk, 1.13; 95% confidence interval, 0.78-1.62) and adjusted (adjusted relative risk, 1.06; 95% confidence interval, 0.74-1.52) comparisons were not significantly different. In addition, results were statistically nonsignificant, but in the direction of lower rates of infection, in the after cohort for women in labor and/or with rupture of membranes for ≥4 hours (relative risk, 0.88 [95% confidence interval, 0.56-1.39]; adjusted relative risk, 0.82 [95% confidence interval, 0.52-1.30]) and for women with clinical chorioamnionitis (relative risk, 0.37 [95% confidence interval, 0.08-1.67]; data too sparse for adjusted analysis). In the subgroup of women who were not in labor, the after cohort had a statistically nonsignificant increased risk of the composite outcome in both unadjusted (relative risk, 1.53; 95% confidence interval, 0.86-2.72) and adjusted (adjusted relative risk, 1.48; 95% confidence interval, 0.83-2.65]) comparisons.. In clinical practice, the addition of azithromycin to standard preoperative antibiotic prophylaxis for cesarean delivery may have an effect size smaller than seen in the large clinical trial prompting this practice change. Extrapolation of this regimen to women not in labor may be ineffective.

Topics: Adult; Anti-Bacterial Agents; Antibiotic Prophylaxis; Azithromycin; Cefazolin; Cesarean Section; Cohort Studies; Controlled Before-After Studies; Drug Therapy, Combination; Endometritis; Female; Humans; Pregnancy; Preoperative Care; Surgical Wound Infection

To determine if antibiotic regimens including azithromycin versus erythromycin has an impact on pregnancy latency and development of clinical chorioamnionitis in the context of preterm prelabor rupture of membranes.. This study included 310 patients, with 142 receiving the azithromycin regimen and 168 receiving the erythromycin regimen. Patients receiving the azithromycin regimen had a statistically significant advantage in overall rates of clinical chorioamnionitis (13.4% versus 25%,. Our study suggests that latency antibiotic regimens substituting azithromycin for erythromycin have lower rates and decreased risk of clinical chorioamnionitis, neonatal sepsis, and postpartum endometritis with no difference in pregnancy latency.

Topics: Adolescent; Adult; Anti-Bacterial Agents; Antibiotic Prophylaxis; Azithromycin; Cesarean Section; Chorioamnionitis; Drug Administration Schedule; Endometritis; Erythromycin; Female; Fetal Membranes, Premature Rupture; Humans; Middle Aged; Neonatal Sepsis; Postpartum Period; Pregnancy; Prospective Studies; Young Adult

Postoperative infections remain a serious concern after cesarean delivery, the most common major surgical procedure in the United States. Multiple strategies have been proposed to combat this problem, including the addition of azithromycin to the standard preoperative antibiotic prophylaxis. However, as obstetricians, we have failed to uniformly adopt precesarean vaginal preparation despite convincing evidence from randomized controlled trials that this technique reduces postoperative rates of endometritis by more than 50%. This reduction is similar to that seen with the addition of azithromycin. Vaginal preparation with povidone-iodine solution may target the same genital pathogens as azithromycin, which are commonly implicated in endometritis, a polymicrobial infection that may be under-addressed by our current antiseptic techniques. A recent review of maternal-fetal medicine fellows' practices at the time of cesarean delivery and recent publications on precesarean vaginal cleansing suggest that this practice has not yet gained hold in the United States.

Topics: Anti-Infective Agents, Local; Antibiotic Prophylaxis; Azithromycin; Cesarean Section; Endometritis; Female; Humans; Obstetrics; Postoperative Complications; Povidone-Iodine; Pregnancy; Preoperative Care; Standard of Care; Surgical Wound Infection; Vagina

To compare the costs associated with adjunctive azithromycin compared with standard cefazolin antibiotic prophylaxis alone for unscheduled and scheduled cesarean deliveries.. A decision analytic model was created to compare cefazolin alone with azithromycin plus cefazolin. Published incidences of surgical site infection after cesarean delivery were used to estimate the baseline incidence of surgical site infection in scheduled and unscheduled cesarean delivery using standard antibiotic prophylaxis. The effectiveness of adjunctive azithromycin prophylaxis was obtained from published randomized controlled trials for unscheduled cesarean deliveries. No randomized study of its use in scheduled procedures has been completed. Cost estimates were obtained from published literature, hospital estimates, and the Healthcare Cost and Utilization Project and considered costs of azithromycin and surgical site infections. A series of sensitivity analyses were conducted by varying parameters in the model based on observed distributions for probabilities and costs. The outcome was cost per cesarean delivery from a health system perspective.. For unscheduled cesarean deliveries, cefazolin prophylaxis alone would cost $695 compared with $335 for adjunctive azithromycin prophylaxis, resulting in a savings of $360 (95% CI $155-451) per cesarean delivery. In scheduled cesarean deliveries, cefazolin prophylaxis alone would cost $254 compared with $111 for adjunctive azithromycin prophylaxis, resulting in a savings of $143 (95% CI 98-157) per cesarean delivery, if proven effective. These findings were robust to a multitude of inputs; as long as adjunctive azithromycin prevented as few as seven additional surgical site infections per 1,000 unscheduled cesarean deliveries and nine additional surgical site infections per 10,000 scheduled cesarean deliveries, adjunctive azithromycin prophylaxis was cost-saving.. Adjunctive azithromycin prophylaxis is a cost-saving strategy in both unscheduled and scheduled cesarean deliveries.

Topics: Anti-Bacterial Agents; Antibiotic Prophylaxis; Azithromycin; Cefazolin; Cesarean Section; Cost Savings; Endometritis; Female; Humans; Pregnancy; Surgical Wound Infection

To investigate the cost-effectiveness of adding azithromycin to standard cephalosporin regimens of cesarean delivery prophylaxis by considering the maternal outcomes in the current and potential subsequent pregnancies.. A cost-effectiveness model was created using TreeAge to compare the outcomes of using azithromycin-cephalosporin with cephalosporin alone in a theoretical cohort of 700,000 women, the approximate number of nonelective cesarean deliveries annually in the United States that occur during labor or after membrane rupture. Outcomes examined included endometritis, wound infection, sepsis, venous thromboembolism, and maternal death in the current pregnancy and uterine rupture, cesarean hysterectomy, and maternal death in subsequent pregnancies, including cost and quality-adjusted life-years for both pregnancies. Probabilities, utilities, and costs were derived from the literature, and a cost-effectiveness threshold was set at $100,000 per quality-adjusted life-year. Sensitivity analyses were used to determine the robustness of our results.. Compared with cephalosporin alone for prophylaxis, our model showed 16,100 fewer cases of endometritis, 17 fewer cases of sepsis, eight fewer cases of venous thromboembolism, and one fewer maternal death with azithromycin-cephalosporin. Additionally, this strategy prevented 36 uterine ruptures and four cesarean hysterectomies in the subsequent pregnancy. Overall, the addition of azithromycin led to both lower costs and higher quality-adjusted life-years when compared with standard cephalosporin prophylaxis. In sensitivity analysis, we found that as long as the cost of azithromycin remained below $930 (baseline cost $27), it was cost-effective.. For women who undergo cesarean delivery in labor or after membrane rupture, compared with cephalosporin alone, the addition of azithromycin to cesarean delivery infection prophylaxis is less costly and leads to better maternal outcomes in the index delivery and subsequent deliveries. These findings support the use of prophylactic azithromycin at the time of cesarean delivery.

Topics: Anti-Bacterial Agents; Antibiotic Prophylaxis; Azithromycin; Cephalosporins; Cesarean Section; Cost-Benefit Analysis; Endometritis; Female; Humans; Maternal Mortality; Models, Economic; Postoperative Complications; Pregnancy; Sepsis; Surgical Wound Infection

Prophylactic antibiotics are of proven value in decreasing the frequency of postcesarean endometritis. The beneficial effect of prophylaxis is enhanced when the antibiotics are administered before the surgical incision as opposed to after the clamping of the umbilical cord. However, the optimal antibiotic regimen for prophylaxis has not been established firmly.. The purpose of this study was to compare 3 different antibiotic regimens for the prevention of postcesarean endometritis.. This retrospective historical cohort study was conducted at the University of Florida, which is a tertiary care facility that serves a predominantly indigent patient population. In the period January 2003 to December 2007, our standard prophylactic antibiotic regimen for all women who had cesarean delivery was cefazolin (1 g) administered immediately after the baby's umbilical cord was clamped. In November 2008, we began to administer the combined regimen of cefazolin (1 g intravenously) plus azithromycin (500 mg intravenously); both were given 30-60 minutes before the skin incision. In the period of January-December 2014, we continued the dual agent regimen but based the dose of cefazolin on the patient's body mass index: 2 g intravenously if the body mass index was <30 kg/m(2) and 3 g if the body mass index was >30 kg/m(2). The surgical technique was consistent throughout all 3 time periods. Our primary endpoint was the frequency of endometritis in each time period. This diagnosis was based on fever ≥37.5°C, lower abdominal pain and tenderness, the exclusion of other localizing signs of infection, and the requirement for administration of therapeutic antibiotics. In the first year after beginning the new antibiotic regimen, we also monitored the frequency of neonatal sepsis evaluations and compared it with the frequency that was recorded during the year immediately preceding the change in antibiotic regimens.. During the entire period 2003-2014, 29,633 women delivered at our institution; 6455 women (22%) had a cesarean delivery. In the period January 2003 to December 2007, 1034 women had a primary or repeat cesarean delivery. One hundred seventy women (16.4%; 95% confidence interval, 14.4-18.4%) developed endometritis. In the period November 2008 to December 2013, 4484 women had a primary or repeat cesarean delivery. Fifty-nine patients (1.3%; 95% confidence interval, 1.0-1.7%) developed endometritis (P < .0001 compared with period 1). In the year 2014, 937 women had a cesarean delivery; 22 of them (2.3%, 95% confidence interval, 1.3-3.3%) developed endometritis (P < .0001 compared with period 1 and P > .5 and <.10 compared with period 2). The frequency of evaluations for suspected neonatal sepsis in infants who were delivered to mothers who had cesarean delivery was 17.6% in the period January to December 2007 and 19.3% in the period November 2008 to November 2009 (relative risk, 1.1; 95% confidence interval, 0.7-1.9). One infant had proven sepsis in the former period; 2 infants had proven sepsis in the latter period (not significant).. When administered before skin incision, the combination of cefazolin plus azithromycin was significantly more effective in the prevention of endometritis than the administration of cefazolin after cord clamping; the rate of endometritis was reduced to a very low level without increasing the rate of neonatal sepsis evaluations.

Topics: Anti-Bacterial Agents; Antibiotic Prophylaxis; Azithromycin; Body Mass Index; Cefazolin; Cesarean Section; Cohort Studies; Dose-Response Relationship, Drug; Endometritis; Female; Florida; Humans; Infant, Newborn; Neonatal Sepsis; Preoperative Care; Retrospective Studies

Topics: Anti-Bacterial Agents; Azithromycin; Endometritis; Female; Fluoroquinolones; Humans; Male; Moxifloxacin; Mycoplasma genitalium; Mycoplasma Infections; Salpingitis; Urethritis; Uterine Cervicitis; Vaginosis, Bacterial