Broad-spectrum antibiotics for spontaneous preterm labour: the ORACLE II randomised trial. ORACLE Collaborative Group.
Background: Preterm birth after spontaneous preterm labour is associated with death, neonatal disease, and long-term disability. Previous small trials of antibiotics for spontaneous preterm labour have reported inconclusive results. We did a randomised multicentre trial to resolve this issue.Methods...
| Publicado en: | Lancet Vol. 357; no. 9261; pp. 989 - 995 |
|---|---|
| Autores principales: | , , , , , |
| Formato: | clinical trial research tables/charts Journal Article |
| Publicado: |
Lancet
3/31/2001
|
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=107076754&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 107076754 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 01406736 LAN jtl: Lancet issn: 01406736 maglogo: N pubinfo: dt: 3/31/2001 vid: 357 iid: 9261 pid: 1297 pub: Lancet place: Philadelphia, Pennsylvania artinfo: ui: 107076754 107076754 NLM11293641 2001114063 10.1016/s0140-6736(00)04234-3 NLM11293641 107076754 ppf: 989 ppct: 6 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Broad-spectrum antibiotics for spontaneous preterm labour: the ORACLE II randomised trial. ORACLE Collaborative Group. aug: au: Kenyon SL Taylor DJ Tarnow-Mordi W Kenyon, S L Taylor, D J Tarnow-Mordi, W affil: Department of Obstetrics and Gynaecology, Leicester Royal Infirmary, UK sug: subj: Fetal Membranes, Premature Rupture Drug Therapy Labor, Premature Drug Therapy Antibiotics Therapeutic Use Erythromycin Therapeutic Use Amoxicillin Therapeutic Use Antibiotics, Combined Therapeutic Use Pregnancy Pregnancy Outcomes Enterocolitis, Necrotizing Chemically Induced Treatment Outcomes Clinical Trials Placebos T-Tests Mann-Whitney U Test Female Funding Source Human Female ab: Background: Preterm birth after spontaneous preterm labour is associated with death, neonatal disease, and long-term disability. Previous small trials of antibiotics for spontaneous preterm labour have reported inconclusive results. We did a randomised multicentre trial to resolve this issue.Methods: 6295 women in spontaneous preterm labour with intact membranes and without evidence of clinical infection were randomly assigned 250 mg erythromycin (n=1611), 325 mg co-amoxiclav (250 mg amoxicillin and 125 mg clavulanic acid; n=1550), both (n=1565), or placebo (n=1569) four times daily for 10 days or until delivery, whichever occurred earlier. The primary outcome measure was a composite of neonatal death, chronic lung disease, or major cerebral abnormality on ultrasonography before discharge from hospital. Analysis was by intention to treat.Findings: None of the trial antibiotics was associated with a lower rate of the composite primary outcome than placebo (erythromycin 90 [5.6%], co-amoxiclav 76 [5.0%], both antibiotics 91 [5.9%], vs placebo 78 [5.0%]). However, antibiotic prescription was associated with a lower occurrence of maternal infection.Interpretation: This trial provides evidence that antibiotics should not be routinely prescribed for women in spontaneous preterm labour without evidence of clinical infection. pubtype: Academic Journal doctype: clinical trial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
|---|