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Danny Tucker
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Preterm pre-labour ruptured membranes close to term is associated with increased risk of neonatal infection, but immediate delivery is associated with risks of prematurity. The balance of risks is unclear. This study aimed to establish whether immediate birth in singleton pregnancies with ruptured membranes close to term reduces neonatal infection without increasing other morbidity (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2815%2900724-2/abstract)

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Danny Tucker
Created by Danny Tucker over 9 years ago
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PPROMT Lancet Nov 2015STUDY DESIGNRESULTSBACKGROUNDPROM 20% of all births & 40%of preterm birthsTerm: IOLpreferablePreterm: not clearfor >34/40Risks of delay: abruption, infection,fetal distress, cord prolapseRisk of IOL:even mild prematuritylinked with health burden65 centres in 11 countries2004-2013All able to care for >= 34/40babies34-36+6 weeksExclusions: labour,chorio, meconium.NOT GBS colonisation1:1 randomisationImmediate delivery:scheduled asap & within 24hoursExpectant: after spont labour,term IOL or for usual indicationsAntibiotics as perusual protocolsPrimary outcome: definitiveor probably neonatal sepsisDefinite: culture + from blood/CSF,treated >5 days & clinical signs ofinfection.Probable: clinical signs for whichbaby received ABx for >5d, plusabnormal pathologySecondary outcomesComposite neonatalmorbidity/mortality indicator:sepsis, ventilation >24h, SB/NNDRDS, perinatal mortality, any ventilation,NICU stay, hospital stay, birth weight,SGA, Apgar <7@5m, antibiotics, LP, artline use, inotropes, breastfeeding ondischargeMaternal: APH, IPH, VTE, cord prolapse,antibiotics postpartum, intrapartum fever,PPH, mode of delivery, labour onset, &hospital staySample size needed906 per group to detect reduction of 5%in expectant group vs 2.5% in immediategroup @5% sig/80% powerAll analyses intention to treat924 immediate delivery (ID) 915expectant management (EM)13 in immediate group & 1 inexpectant group did not receiveintervention1 lost to follow up & 2 withdrewin IM and 1 lost to follow up in EMPrimary outcomeassessed for 1835: 923ID & 912 EMBaseline maternal & pregnancycharacteristics similar (includingGBS status)At randomisation: 79/78% had swabscollected & 26/27% were abnormal.Overall 12% GBS rate in both groupsSteroids: 40% in each groupAntibiotics in previous48h: 86% each group'Any antibiotics'92% vs 93%EM: 75% managed as inpatientProbable/definiteneonatal sepsis: NSD(2% vs 3%)Composite neonatal outcome: NSD (8% vs 7%)Birthweight: SD - 2574g vs 2673gSecondary outcomesRDS: SD - 8% vs 5%Mechanical ventilation: SD - 12% vs 9%Days in SCN/NICU: SD - 4 vs 2 days3 deaths in each group: = SIDS x1(ID/EM), congen abn x1 (ID/EM),sepsis x1 (ID), uknown x1 (EM)APH: SD - 3% vs 5%Maternal outcomes favouringimmediate deliveryFever: SD - 1% vs 2%Maternal outcomes favouringexepctant managementMaternal outcomesLSCS: SD - 26% vs 19%6% of EM delivereddue to chorioCompared to EM, ID had noeffect on neonatal sepsisregardless of GA at PPROM,duration or antibiotic use & nodifference if GBS + atrandomisationMind map by Danny TuckerJonathan M Morris, Christine L Roberts, JenniferR Bowen, Jillian A Patterson, Diana M Bond,Charles S Algert, Jim G Thornton, Caroline ACrowther, on behalf of the PPROMT CollaborationDouble click this nodeto edit the textClick and drag this buttonto create a new node