2_PPROMT Lancet Nov 2015

STUDY DESIGN
1. 65 centres in 11 countries
  1. 2004-2013
  2. All able to care for >= 34/40 babies
2. 34-36+6 weeks
3. Exclusions: labour, chorio, meconium. NOT GBS colonisation
4. 1:1 randomisation
5. Immediate delivery: scheduled asap & within 24 hours
6. Expectant: after spont labour, term IOL or for usual indications
  1. Antibiotics as per usual protocols
7. Primary outcome: definitive or probably neonatal sepsis
  1. Definite: culture + from blood/CSF, treated >5 days & clinical signs of infection.
  2. Probable: clinical signs for which baby received ABx for >5d, plus abnormal pathology
8. Secondary outcomes
  1. Composite neonatal morbidity/mortality indicator: sepsis, ventilation >24h, SB/NND
  2. RDS, perinatal mortality, any ventilation, NICU stay, hospital stay, birth weight, SGA, Apgar <7@5m, antibiotics, LP, art line use, inotropes, breastfeeding on discharge
  3. Maternal: APH, IPH, VTE, cord prolapse, antibiotics postpartum, intrapartum fever, PPH, mode of delivery, labour onset, & hospital stay
9. Sample size needed
  1. 906 per group to detect reduction of 5% in expectant group vs 2.5% in immediate group @5% sig/80% power
10. All analyses intention to treat
RESULTS
1. 924 immediate delivery (ID) 915 expectant management (EM)
  1. 13 in immediate group & 1 in expectant group did not receive intervention
  2. 1 lost to follow up & 2 withdrew in IM and 1 lost to follow up in EM
2. Primary outcome assessed for 1835: 923 ID & 912 EM
  1. Probable/definite neonatal sepsis: NSD (2% vs 3%)
    1. 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
3. Baseline maternal & pregnancy characteristics similar (including GBS status)
4. At randomisation: 79/78% had swabs collected & 26/27% were abnormal. Overall 12% GBS rate in both groups
  1. Steroids: 40% in each group
  2. Antibiotics in previous 48h: 86% each group
    1. 'Any antibiotics' 92% vs 93%
5. EM: 75% managed as inpatient
6. Secondary outcomes
  1. Composite neonatal outcome: NSD (8% vs 7%)
  2. Birthweight: SD - 2574g vs 2673g
  3. RDS: SD - 8% vs 5%
  4. Mechanical ventilation: SD - 12% vs 9%
  5. Days in SCN/NICU: SD - 4 vs 2 days
7. 3 deaths in each group: = SIDS x1 (ID/EM), congen abn x1 (ID/EM), sepsis x1 (ID), uknown x1 (EM)
8. Maternal outcomes
  1. Maternal outcomes favouring immediate delivery
    1. APH: SD - 3% vs 5%
    2. Fever: SD - 1% vs 2%
  2. Maternal outcomes favouring exepctant management
    1. LSCS: SD - 26% vs 19%
  3. 6% of EM delivered due to chorio
BACKGROUND
1. PROM 20% of all births & 40% of preterm births
  1. Term: IOL preferable
  2. Preterm: not clear for >34/40
    1. Risks of delay: abruption, infection, fetal distress, cord prolapse
    2. Risk of IOL:even mild prematurity linked with health burden
Mind map by Danny Tucker
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

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2_PPROMT Lancet Nov 2015

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