Broad-spectrum antibiotics for spontaneous preterm labour: the ORACLE II randomised trial

Kenyon, Sara; Taylor, D. J.; Tarnow-Mordi, W.

doi:10.1016/s0140-6736(00)04234-3

Cited by 349 publications

(96 citation statements)

References 9 publications

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“…ORACLE was a double blind randomised controlled trial of antibiotics in pregnancy, funded by the UK Medical Research Council 7 8. It was designed to test the hypothesis that treatment with broad spectrum antibiotics prolongs labour and reduces neonatal mortality and morbidity for women who are less than 37 weeks pregnant, and who are either in preterm labour or have prelabour rupture of the membranes.…”

Section: Methodsmentioning

confidence: 99%

Receiving a summary of the results of a trial: qualitative study of participants' views

Dixon‐Woods

Jackson

Windridge³

et al. 2006

BMJ

104

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Objective To explore trial participants' responses to receiving a summary of the results of a trial in pregnancy. Design Qualitative study with semistructured interviews. Participants 20 women who had when pregnant participated in the ORACLE trial of antibiotics for preterm labour and preterm rupture of the membranes and requested a copy of the trial results. Results Less than a fifth of women who participated in the ORACLE trial indicated that they wished to receive the trial results. Reactions to the leaflet summarising the trial results were generally positive or neutral, although some women had difficulty in understanding the leaflet, and there was evidence of possible negative implications for women who had adverse outcomes. Women requested the results because they were interested in being able to complete their own personal narrative. They wished to know to which arm of the trial they had been allocated and the implications for their own pregnancy, and they were disappointed with receiving a generic summary. Women's accounts indicated some confusion about the trial findings. Conclusions Recommendations that research participants be routinely provided with the results of studies have been made without the benefit of research to show the consequences of doing this or how it should best be managed. Caution is needed, as is more evaluation of how feedback of results should be handled, and assessment of the risks, benefits, and costs.

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Section: Methodsmentioning

confidence: 99%

Receiving a summary of the results of a trial: qualitative study of participants' views

Dixon‐Woods

Jackson

Windridge³

et al. 2006

BMJ

104

View full text Add to dashboard Cite

show abstract

“…Maternal antibiotic administration during pregnancy has become widespread over the years, both as intrapartum antibiotic prophylaxis (IAP) against early-onset neonatal sepsis (EONS) with group b Streptococcus (GBS) [1] and as treatment of potentially infectious maternal conditions as associated with premature/prolonged rupture of membranes (PROM) and suspected chorioamnionitis [2,3,4,5]. …”

Section: Introductionmentioning

confidence: 99%

Correlation of Bacterial Type and Antibiotic Sensitivity with Maternal Antibiotic Exposure in Early-Onset Neonatal Sepsis

Bromiker¹,

Ernest

Meir

et al. 2012

Neonatology

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Background: Antibiotic administration during pregnancy as group B Streptococcus prophylaxis or as treatment of maternal conditions has become widespread. Objective: To assess whether bacterial type and antibiotic resistance in early-onset neonatal sepsis are associated with maternal antibiotic use. Methods: All positive blood and/or cerebrospinal fluid cultures (case-only study) and respective antibiotic sensitivities from newborns delivered in Shaare Zedek Medical Center, Jerusalem, Israel, between 01/01/1997 and 31/01/2007, taken during the first 72 h of life, were studied. Clinical and demographic data were obtained from the medical records of the infant/mother dyads. Three groups were defined by type of maternal antibiotic exposure: (1) no exposure, (2) intrapartum antibiotic prophylaxis (IAP), (3) antepartum antibiotic exposure during the month prior to delivery and extending into delivery or with subsequent IAP (AAE). Factors potentially associated with Gram-negative bacteremia and resistance to ampicillin were analyzed using multivariate logistic regression. Results: Ninety-seven different organisms grew from 94 infants (1.03 per 1,000 live births). By univariate analysis, AAE, gestational age ≤32 weeks, chorioamnionitis and rupture of membranes ≥18 h, were significantly associated with both Gram-negative sepsis and antibiotic resistance. By multivariate analysis, AAE was significantly associated with both outcomes, while gestational age ≤32 weeks was only associated with antibiotic resistance. Conclusions: AAE for more than 24 h is associated with an increased proportion of Gram-negative organisms and ampicillin resistance in early-onset neonatal sepsis. Antepartum antibiotic therapy and its ramifications need to be continuously monitored and prospectively studied.

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“…However, macrolides in pregnant women have not shown an alteration in maternal outcomes 26 27. Antenatal exposure to erythromycin close to birth improved some neonatal outcomes in the ORACLE trial 28 29. Antenatal exposure to azithromycin in the second trimester was not associated with any differences in outcomes in the APPLE trial 30.…”

Section: Rationale For Use Of Azithromycin In Neonatesmentioning

confidence: 89%

Azithromycin,Ureaplasmaand chronic lung disease of prematurity: a case study for neonatal drug development: Figure 1

2011

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Chronic lung disease of prematurity (CLD) remains a major cause of morbidity and mortality in preterm infants. Ureaplasma has received intermittent attention over the last two decades as a possible contributory factor. In addition, pulmonary inflammation is associated with the development of CLD. The macrolide azithromycin provides an attractive option to determine if it can decrease the development of CLD as it has both anti-inflammatory and anti-infective properties. In this article, the authors review the evidence for the role of Ureaplasma in the development of CLD and the obstacles faced in the development of a drug before it reaches clinical practice.

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Broad-spectrum antibiotics for spontaneous preterm labour: the ORACLE II randomised trial

Cited by 349 publications

References 9 publications

Receiving a summary of the results of a trial: qualitative study of participants' views

Receiving a summary of the results of a trial: qualitative study of participants' views

Correlation of Bacterial Type and Antibiotic Sensitivity with Maternal Antibiotic Exposure in Early-Onset Neonatal Sepsis

Azithromycin,Ureaplasmaand chronic lung disease of prematurity: a case study for neonatal drug development: Figure 1

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