A Systematic Review and meta-analysis of the effect of administration of azithromycin during pregnancy on perinatal and neonatal outcomes

Hume-Nixon, Maeve; Quach, Alicia; Reyburn, Rita; Nguyen, Cattram; Steer, Andrew C.; Russell, Fiona M.

doi:10.1016/j.eclinm.2021.101123

Cited by 11 publications

(13 citation statements)

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“…One study [9] showed that a single oral dose of azithromycin (2 g) for parturient women could signi cantly reduce the prevalence of Staphylococcus aureus, group B Streptococcus and Streptococcus pneumoniae infection among newborns and mothers and may reduce the incidence of neonatal sepsis. A meta-analysis of 14 studies [21] revealed that the majority of studies utilized azithromycin as an intermittent malaria preventative therapy during pregnancy. Compared to those in the control group, the patients in the azithromycin group had a lower risk of low birth weight and preterm delivery, but there was no convincing evidence that azithromycin had an effect on infant death, infection, or hospitalization rates.…”

Section: Discussionmentioning

confidence: 99%

Can the use of azithromycin during labour reduce the incidence of infection among puerperae and newborns? A systematic review and meta-analysis of randomized controlled trials

Ye,

Hu,

et al. 2024

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Objective This systematic review and meta-analysis investigated whether the use of azithromycin during labour or caesarean section reduces the incidence of sepsis and infection among mothers and newborns. Data sources We searched the PubMed, Embase and Web of Science databases from inception to June 19, 2023. Methods Review Manager 5.4 was used to analyse 6 randomized clinical trials involving 44,448 mothers and 44,820 newborns. Primary outcomes included the incidence of maternal sepsis and all-cause mortality and neonatal sepsis and all-cause mortality; secondary outcomes included maternal (endometritis, mastitis and breast abscess, wound and surgical site infections, chorioamnionitis, and urinary tract infections) and neonatal outcomes (infections of the eyes, ears and skin). A random-effects model was used to test for overall effects and heterogeneity. Results The pooled odds ratios (ORs) were as follows: 0.65 for maternal sepsis (95% CI, 0.55–0.77; I2, 0%; P < 0.00001); 0.62 for endometritis (95% CI, 0.52–0.74; I2, 2%; P < .00001); 0.55 for mastitis and breast abscess (95% CI, 0.34–0.89; I2, 40%; P < .02); and 0.43 for maternal wound or surgical site infection (95% CI, 0.24–0.78; P < .005); however, there was great heterogeneity among the studies (I2, 75%). The pooled OR for pyelonephritis and urinary tract infections was 0.3 (95% CI, 0.17–0.52; I2, 0%; P < .0001), and that for neonatal skin infections was 0.48 (95% CI, 0.35–0.65; I2, 0%, P < .00001). There was no significant difference in maternal all-cause mortality or incidence of chorioamnionitis between the two groups. No significant differences were observed in the incidence of neonatal sepsis or suspected sepsis, all-cause mortality, or infections of the eyes or ears. Conclusion In this meta-analysis, azithromycin use during labour reduced the incidence of maternal sepsis, endometritis, incisional infections, mastitis and breast abscess, and urinary tract infections but did not reduce the incidence of neonatal-associated infections, except for neonatal skin infections.

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Section: Discussionmentioning

confidence: 99%

Can the use of azithromycin during labour reduce the incidence of infection among puerperae and newborns? A systematic review and meta-analysis of randomized controlled trials

Ye,

Hu,

et al. 2024

Preprint

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“…36,37 greater in-vitro activity than metronidazole against A vaginae, of which strains resistant to metronidazole have been reported. 38 Azithromycin is an inexpensive, well-tolerated antibiotic and is already administered in pregnancy for several conditions, such as sexually transmitted infections and intermittent preventive treatment for malaria. 39…”

Section: Discussionmentioning

confidence: 99%

Effectiveness and Costs of Molecular Screening and Treatment for Bacterial Vaginosis to Prevent Preterm Birth

et al. 2023

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ImportanceBacterial vaginosis (BV) is a well-known risk factor for preterm birth. Molecular diagnosis of BV is now available. Its impact in the screening and treatment of BV during pregnancy on preterm births has not been evaluated to date.ObjectiveTo evaluate the clinical and economic effects of point-of-care quantitative real-time polymerase chain reaction screen and treat for BV in low-risk pregnant women on preterm birth.Design, Setting, and ParticipantsThe AuTop trial was a prospective, multicenter, parallel, individually randomized, open-label, superiority trial conducted in 19 French perinatal centers between March 9, 2015, and December 18, 2017. Low-risk pregnant women before 20 weeks’ gestation without previous preterm births or late miscarriages were enrolled. Data were analyzed from October 2021 to November 2022.InterventionsParticipants were randomized 1:1 to BV screen and treat using self-collected vaginal swabs (n = 3333) or usual care (n = 3338). BV was defined as Atopobium vaginae (Fannyhessea vaginae) load of 108 copies/mL or greater and/or Gardnerella vaginalis load of 109 copies/mL or greater, using point-of-care quantitative real-time polymerase chain reaction assays. The control group received usual care with no screening of BV.Main Outcomes and MeasuresOverall rate of preterm birth before 37 weeks’ gestation and total costs were calculated in both groups. Secondary outcomes were related to treatment success as well as maternal and neonate health. Post hoc subgroup analyses were conducted.ResultsAmong 6671 randomized women (mean [SD] age, 30.6 [5.0] years; mean [SD] gestational age, 15.5 [2.8] weeks), the intention-to-treat analysis of the primary clinical and economic outcomes showed no evidence of a reduction in the rate of preterm birth and total costs with the screen and treat strategy compared with usual care. The rate of preterm birth was 3.8% (127 of 3333) in the screen and treat group and 4.6% (153 of 3338) in the control group (risk ratio [RR], 0.83; 95% CI, 0.66-1.05; P = .12). On average, the cost of the intervention was €203.6 (US $218.0) per participant, and the total average cost was €3344.3 (US $3580.5) in the screen and treat group vs €3272.9 (US $3504.1) in the control group, with no significant differences being observed. In the subgroup of nulliparous women (n = 3438), screen and treat was significantly more effective than usual care (RR, 0.62; 95% CI, 0.45-0.84; P for interaction = .003), whereas no statistical difference was found in multiparous (RR, 1.30; 95% CI, 0.90-1.87).Conclusion and RelevanceIn this clinical trial of pregnant women at low risk of preterm birth, molecular screening and treatment for BV based on A vaginae (F vaginae) and/or G vaginalis quantification did not significantly reduce preterm birth rates. Post hoc analysis suggests a benefit of screen and treat in low-risk nulliparous women, warranting further evaluation in this group.Trial RegistrationClinicalTrials.gov Identifier: NCT02288832

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“…17 There is emerging evidence that azithromycin may prevent vertical transmission of these pathogens during labour in low-resource settings, and a recent systematic review showed that administration during pregnancy reduced the risk of LBW and prematurity. 18 Azithromycin has Gram-positive (GBS, SA, SPN, GAS) and some Gramnegative bacterial activity and can also treat organisms associated with STIs. A randomised control trial (RCT) of single-dose oral azithromycin during labour in Gambian women reduced GBS, SA and SPN carriage and reduced maternal and infant infections, including infant skin infections by 50% (3.1% vs 6.4%, p=0.034) and maternal mastitis by 70% (1.4% vs 5.1%, p=0.005) up to 2 months postdelivery.…”

Section: Strengths and Limitations Of This Studymentioning

confidence: 99%

“…There is emerging evidence that azithromycin may prevent vertical transmission of these pathogens during labour in low-resource settings, and a recent systematic review showed that administration during pregnancy reduced the risk of LBW and prematurity 18. Azithromycin has Gram-positive (GBS, SA, SPN, GAS) and some Gram-negative bacterial activity and can also treat organisms associated with STIs.…”

Section: Introductionmentioning

confidence: 99%

Prevention of young infant infections using oral azithromycin in labour in Fiji (Bulabula MaPei): study protocol of a randomised control trial

et al. 2022

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IntroductionInfections are a leading cause of neonatal mortality globally and can be transmitted from mother-to-child vertically or horizontally. Fiji has higher rates of serious neonatal infections and infant skin and soft tissue infections (SSTIs) than high-income countries. Research from the Gambia found that a single dose of oral azithromycin in labour decreased bacterial carriage and infections in mothers and infants, particularly infant skin infections. The Bulabula MaPei clinical trial evaluates the safety and efficacy of a single dose of azithromycin in labour in reducing the incidence of maternal and infant SSTIs and other infections and the impact on bacterial carriage. It will also describe the effect of azithromycin on antimicrobial (AMR) resistance, the maternal and infant microbiome, and infant dysbiosis.Methods and analysisWe are conducting a blinded, placebo-controlled randomised clinical trial administering 2 g of oral azithromycin, or placebo, given to healthy, pregnant women (≥18 years) in labour in Suva, Fiji. The primary outcome is the cumulative incidence of SSTIs in infants by 3 months of age. Secondary outcomes include the incidence of other infant and maternal infections, and safety and tolerability of azithromycin in mother and infant. Following informed consent, 2110 pregnant women will be randomised in a 1:1 ratio, with all study staff and participants masked to group allocation. Mother/infant pairs will be followed up for 12 months over six visits collecting clinical data on infections, antimicrobial use, safety and anthropometrics, in addition to nasopharyngeal, oropharyngeal, rectovaginal and vaginal swabs, maternal breastmilk and infant stool samples, in order to compare bacterial carriage, AMR rates and microbiome. Recruitment for Bulabula MaPei started in June 2019.Ethics and disseminationThis trial was approved and is being conducted according to the protocol approved by The Royal Children’s Hospital Human Research Ethics Committee, Australia, and the Fiji National Health Research and Ethics Review Committee. The findings of this study will be disseminated in peer-reviewed journals and presented at conferences.Trial registration numberNCT03925480.

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A Systematic Review and meta-analysis of the effect of administration of azithromycin during pregnancy on perinatal and neonatal outcomes

Cited by 11 publications

References 42 publications

Can the use of azithromycin during labour reduce the incidence of infection among puerperae and newborns? A systematic review and meta-analysis of randomized controlled trials

Can the use of azithromycin during labour reduce the incidence of infection among puerperae and newborns? A systematic review and meta-analysis of randomized controlled trials

Effectiveness and Costs of Molecular Screening and Treatment for Bacterial Vaginosis to Prevent Preterm Birth

Prevention of young infant infections using oral azithromycin in labour in Fiji (Bulabula MaPei): study protocol of a randomised control trial

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