Broad-spectrum antibiotics for preterm, prelabour rupture of fetal membranes: the ORACLE I randomised trial. ORACLE Collaborative Group.
Background: Preterm, prelabour rupture of the fetal membranes (pPROM) is the commonest antecedent of preterm birth, and can lead to death, neonatal disease, and long-term disability. Previous small trials of antibiotics for pPROM suggested some health benefits for the neonate, but the results were i...
| Publicado en: | Lancet Vol. 357; no. 9261; pp. 979 - 989 |
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| Autores principales: | , , , , , |
| Formato: | clinical trial research tables/charts Journal Article |
| Publicado: |
Lancet
3/31/2001
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| 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=107076748&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 107076748 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: 107076748 107076748 NLM11293640 2001114060 10.1016/s0140-6736(00)04233-1 NLM11293640 107076748 ppf: 979 ppct: 10 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Broad-spectrum antibiotics for preterm, prelabour rupture of fetal membranes: the ORACLE I 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, prelabour rupture of the fetal membranes (pPROM) is the commonest antecedent of preterm birth, and can lead to death, neonatal disease, and long-term disability. Previous small trials of antibiotics for pPROM suggested some health benefits for the neonate, but the results were inconclusive. We did a randomised multicentre trial to try to resolve this issue.Methods: 4826 women with pPROM were randomly assigned 250 mg erythromycin (n=1197), 325 mg co-amoxiclav (250 mg amoxicillin plus 125 mg clavulanic acid; n=1212), both (n=1192), or placebo (n=1225) four times daily for 10 days or until delivery. 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: Two women were lost to follow-up, and there were 15 protocol violations. Among all 2415 infants born to women allocated erythromycin only or placebo, fewer had the primary composite outcome in the erythromycin group (151 of 1190 [12.7%] vs 186 of 1225 [15.2%], p=0.08) than in the placebo group. Among the 2260 singletons in this comparison, significantly fewer had the composite primary outcome in the erythromycin group (125 of 1111 [11.2%] vs 166 of 1149 [14.4%], p=0.02). Co-amoxiclav only and co-amoxiclav plus erythromycin had no benefit over placebo with regard to this outcome in all infants or in singletons only. Use of erythromycin was also associated with prolongation of pregnancy, reductions in neonatal treatment with surfactant, decreases in oxygen dependence at 28 days of age and older, fewer major cerebral abnormalities on ultrasonography before discharge, and fewer positive blood cultures. Although co-amoxiclav only and co-amoxiclav plus erythromycin were associated with prolongation of pregnancy, they were also associated with a significantly higher rate of neonatal necrotising enterocolitis.Interpretation: Erythromycin for women with pPROM is associated with a range of health benefits for the neonate, and thus a probable reduction in childhood disability. However, co-amoxiclav cannot be routinely recommended for pPROM because of its association with neonatal necrotising enterocolitis. A follow-up study of childhood development and disability after pPROM is planned. pubtype: Academic Journal doctype: clinical trial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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