Dataset Information

Clarithromycin use for adjunct surgical prophylaxis before non-elective cesarean deliveries to adapt to azithromycin shortages in COVID-19 pandemic.

ABSTRACT:

Objective

This study aimed to evaluate safety and effectiveness of clarithromycin as adjunctive antibiotic prophylaxis for patients undergoing non-elective cesarean delivery in comparison with no macrolides, to adapt to azithromycin shortages in COVID-19 pandemic.

Study design

We conducted a multi-center, prospective observational cohort study from March 23, 2020 through June 1, 2020. We followed all women receiving either clarithromycin or no macrolide antibiotic for adjunct surgical prophylaxis for non-elective cesarean deliveries. The primary outcome was development of postpartum endometritis. Secondary outcomes included meconium-stained amniotic fluid at time of cesarean delivery, neonatal sepsis, neonatal intensive care unit admission, and neonatal acute respiratory distress syndrome. All patients in this study were tested for SARS-CoV-2 infection and resulted negative.

Results

This study included 240 patients, with 133 patients receiving clarithromycin and 107 patients receiving no adjunct macrolide prophylaxis. Patients receiving clarithromycin were noted to have significantly lower rates of postpartum endometritis as compared to those who did not receive adjunct prophylaxis (4.5% versus 11.2%, p = 0.025). In crude (unadjusted) analysis, a significantly lower risk of developing endometritis was noted in the clarithromycin group as compared to the control group (66% decreased risk, 95% CI 0.12 to 0.95, p = 0.040). When adjusted for perceived confounders, a significant difference was again noted (67% decreased risk, 95% CI 0.11 to 0.97, p = 0.034). Stratified analysis of significantly different demographic factors including Black race, BMI, and age was performed. A significantly decreased risk of development of endometritis when taking clarithromycin versus no adjunct macrolide was noted for Black race women in crude and adjusted models (crude: 87% decreased risk, 95% CI 0.08 to 0.83, p = 0.032; adjusted: 91% decreased risk, 95% CI 0.06 to 0.79, p = 0.026). This was also noted for women aged 18-29 years in crude and adjusted models (crude: model, 79% decreased risk, 95% CI 0.06 to 0.80, p = 0.014; adjusted model: 75% decreased risk, 95% CI 0.06 to 0.94, p = 0.028). All other stratified analyses did not yield significant differences in endometritis risk.

Conclusion

Our study suggests that administration of clarithromycin for adjunctive surgical prophylaxis for non-elective cesarean deliveries may be a safe option that may provide suitable endometritis prophylaxis in cases where azithromycin is unavailable, as was the case during the start of COVID-19 pandemic, most especially for Black race women and women ages 18-29 years.

SUBMITTER: Martingano D

PROVIDER: S-EPMC7751852 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Clarithromycin use for adjunct surgical prophylaxis before non-elective cesarean deliveries to adapt to azithromycin shortages in COVID-19 pandemic.

Martingano Daniel D Nguyen Ashley A Nkeih Claudia C Singh Shailini S Mitrofanova Antonina A

PloS one 20201221 12

<h4>Objective</h4>This study aimed to evaluate safety and effectiveness of clarithromycin as adjunctive antibiotic prophylaxis for patients undergoing non-elective cesarean delivery in comparison with no macrolides, to adapt to azithromycin shortages in COVID-19 pandemic.<h4>Study design</h4>We conducted a multi-center, prospective observational cohort study from March 23, 2020 through June 1, 2020. We followed all women receiving either clarithromycin or no macrolide antibiotic for adjunct surg ...[more]

PMID: 33347510

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Project description:Postpartum infections are polymicrobial and typically include Ureaplasma, an intracellular microbe that is treated by macrolides such as azithromycin. The aim of this study was to evaluate the perinatal pharmacokinetics of azithromycin after a single preincision dose before cesarean delivery.Thirty women who underwent scheduled cesarean delivery were assigned randomly to receive 500 mg of intravenous azithromycin that was initiated 15, 30, or 60 minutes before incision and infused over 1 hour. Serial maternal plasma samples were drawn from the end of infusion up to 8 hours after the infusion. Samples of amniotic fluid, umbilical cord blood, placenta, myometrium, and adipose tissue were collected intraoperatively. Breast milk samples were collected 12-48 hours after the infusion in 8 women who were breastfeeding. Azithromycin was quantified with high performance liquid chromatography separation coupled with tandem mass spectrometry detection. Plasma pharmacokinetic parameters were estimated with the use of noncompartmental analysis and compartmental modeling and simulations.The maximum maternal plasma concentration was reached within 1 hour and exceeded the in vitro minimum inhibitory concentration (MIC50) of 250 ng/mL of Ureaplasma spp in all 30 patients. The concentrations were sustained with a half-life of 6.7 hours. The median concentration of azithromycin in adipose tissue was 102 ng/g, which was below the MIC50. The median concentration in myometrium was 402 ng/g, which exceeded the MIC50. Azithromycin was detectable in both the umbilical cord plasma and amniotic fluid after the single preoperative dose. Azithromycin concentrations in breast milk were high and were sustained up to 48 hours after the single dose. Simulations demonstrated accumulation in breast milk after multiple doses.A single dose of azithromycin achieves effective plasma and tissue concentrations and is transported rapidly across the placenta. The tissue concentrations that are achieved in the myometrium exceed the MIC50 for Ureaplasma spp.

Project description:BackgroundDelayed cord clamping (DCC) results in decreased iron deficiency in infancy. The American College of Obstetrics and Gynecology has called for research on the optimal time to clamp the cord during cesarean deliveries (CD). Our objective was to conduct a pilot trial examining the safety of delayed cord clamping (DCC) for maternal-infant dyads during elective cesarean delivery (CD).MethodsWe enrolled 39 dyads [23 at 90 s, 16 at 120 s; (DCC Pilot)] between 10/2013 and 9/2014. We abstracted data from the electronic medical record (EMR) for historical controls (HC) birthing between 1/2012-6/2013 for whom DCC was not performed (n = 112).ResultsAvailable data for 37 mothers and 30 infants compared to HC revealed 174 (95% CI: 61-286) mL lower mean estimated maternal blood loss [(EBL) mean (SD) mL]: DCC Pilot 691(218) vs. HC 864(442), p = 0.003 and lower incidence of maternal transfusions, DCC Pilot 2.7% vs. HC 18.8%, p = 0.016. There was no significant between group difference between DCC Pilot and HC in other a priori definitions of excess maternal blood loss: a) EBL > 800 ml, 21.6% vs. 38.8%, p = 0.07 or b) post-op hgb/pre-op hgb < 80%, 16.7% vs. 20.6%, p = 0.81. There were also no statistically significant between group differences in rates of NICU admission DCC Pilot 8.1% vs. HC 7.1%, p = 1.0., but there was a higher rate of newborn cold stress or hypothermia ≤36.2 °C in study subjects, DCC Pilot 27.0% vs. HC 11.9%, p = 0.038.Prevalence of newborn anemia was decreased [DCC pilot 3.3% (1 of 30) vs. HC 40.0% (4 of 10 infants with data), p = 0.012. No infants were polycythemic.ConclusionsThese pilot data suggest cord clamping can be delayed to 120 s during elective CD without increased risk of excessive maternal blood loss. More aggressive prevention of infant heat loss may be warranted. A randomized trial to evaluate long-term maternal and infant outcomes is indicated.Trial registrationClinical trials.gov, NCT02229162; registered: 1 September, 2014.

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Dataset Information

Clarithromycin use for adjunct surgical prophylaxis before non-elective cesarean deliveries to adapt to azithromycin shortages in COVID-19 pandemic.

Objective

Study design

Results

Conclusion

Publications

Clarithromycin use for adjunct surgical prophylaxis before non-elective cesarean deliveries to adapt to azithromycin shortages in COVID-19 pandemic.

Similar Datasets

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