PPROMT Lancet Nov 2015

PPROMT Lancet Nov 2015

1. STUDY DESIGN

   • 65 centres in 11 countries
     • 2004-2013
     • All able to care for >= 34/40 babies
   • 34-36+6 weeks
   • Exclusions: labour, chorio, meconium. NOT GBS colonisation
   • 1:1 randomisation
   • Immediate delivery: scheduled asap & within 24 hours
   • Expectant: after spont labour, term IOL or for usual indications
     • Antibiotics as per usual protocols
   • Primary outcome: definitive or probably neonatal sepsis
     • Definite: culture + from blood/CSF, treated >5 days & clinical signs of infection.
     • Probable: clinical signs for which baby received ABx for >5d, plus abnormal pathology
   • Secondary outcomes
     • Composite neonatal morbidity/mortality indicator: sepsis, ventilation >24h, SB/NND
     • RDS, perinatal mortality, any ventilation, NICU stay, hospital stay, birth weight, SGA, Apgar <7@5m, antibiotics, LP, art line use, inotropes, breastfeeding on discharge
     • Maternal: APH, IPH, VTE, cord prolapse, antibiotics postpartum, intrapartum fever, PPH, mode of delivery, labour onset, & hospital stay
   • Sample size needed
     • 906 per group to detect reduction of 5% in expectant group vs 2.5% in immediate group @5% sig/80% power
   • All analyses intention to treat

2. RESULTS

   • 924 immediate delivery (ID) 915 expectant management (EM)
     • 13 in immediate group & 1 in expectant group did not receive intervention
     • 1 lost to follow up & 2 withdrew in IM and 1 lost to follow up in EM
   • Primary outcome assessed for 1835: 923 ID & 912 EM
     • Probable/definite neonatal sepsis: NSD (2% vs 3%)
       • Compared to EM, ID had no effect on neonatal sepsis regardless of GA at PPROM, duration or antibiotic use & no difference if GBS + at randomisation
   • Baseline maternal & pregnancy characteristics similar (including GBS status)
   • At randomisation: 79/78% had swabs collected & 26/27% were abnormal. Overall 12% GBS rate in both groups
     • Steroids: 40% in each group
     • Antibiotics in previous 48h: 86% each group
       • 'Any antibiotics' 92% vs 93%
   • EM: 75% managed as inpatient
   • Secondary outcomes
     • Composite neonatal outcome: NSD (8% vs 7%)
     • Birthweight: SD - 2574g vs 2673g
     • RDS: SD - 8% vs 5%
     • Mechanical ventilation: SD - 12% vs 9%
     • Days in SCN/NICU: SD - 4 vs 2 days
   • 3 deaths in each group: = SIDS x1 (ID/EM), congen abn x1 (ID/EM), sepsis x1 (ID), uknown x1 (EM)
   • Maternal outcomes
     • Maternal outcomes favouring immediate delivery
       • APH: SD - 3% vs 5%
       • Fever: SD - 1% vs 2%
     • Maternal outcomes favouring exepctant management
       • LSCS: SD - 26% vs 19%
     • 6% of EM delivered due to chorio

3. BACKGROUND

   • PROM 20% of all births & 40% of preterm births
     • Term: IOL preferable
     • Preterm: not clear for >34/40
       • Risks of delay: abruption, infection, fetal distress, cord prolapse
       • Risk of IOL:even mild prematurity linked with health burden

4. Mind map by Danny Tucker

5. Jonathan M Morris, Christine L Roberts, Jennifer R Bowen, Jillian A Patterson, Diana M Bond, Charles S Algert, Jim G Thornton, Caroline A Crowther, on behalf of the PPROMT Collaboration

Bilder und Dateien der Mindmap