Strategies to reduce the vertical transmission of multi-drug resistant pathogens to neonates (NeoVT-AMR)
Prevention of infection in neonates
Randomisation is by permuted blocks to guard against bias introduced over time, such as outbreaks of pathogenic bacteria in the hospital. Maternal: Chlorhexidine gluconate (CHG) (1% or 2%) or Octenisept (OHP) vaginal and perineal application in varying frequency (once only or 4 hourly during labour), compared to control group with clean water application. Treatment will continue until 32 hours or birth. A factorial randomised design is used, with a 1:1:1:1:1:1:1 allocation into six interventions and one control arm: 1. 1% CHG once only 2. 1% CHG multiple application 3. 2% CHG once only 4. 2% CHG multiple application 5. OHP once only 6. OHP multiple application 7. Control group (clean water) Neonatal: Chlorhexidine gluconate (CHG) (1% or 2%) or Octenisept (OHP) whole-body application in varying frequency (once only or 24 hourly), compared to the control group with routine care. Treatment will continue until 72 hours or discharge (whichever is sooner). A factorial randomised design is used, with a 1:1:1:1:1:1:1 allocation into six interventions and one control arm: 1. 1% CHG once only 2. 1% CHG multiple application 3. 2% CHG once only 4. 2% CHG multiple application 5. OHP once only 6. OHP multiple application 7. Control group (routine care)
Mothers: 1. Presenting in labour with or without rupture of membranes Neonates: 1. Born in Zomba central hospital 2. Postnatal age at randomisation <12 hours 3. Birth weight >1000 g
Mothers: 1. Under the age of 18 years (minor in Malawi) 2. Any contra-indication to digital vaginal examination 3. In active labour 4. Poor perineal and vaginal skin condition as judged by a clinician 5. Planned elective caesarean-section delivery 6. Known or suspected allergy to chlorhexidine or octenidine 7. Intrauterine death confirmed or expected before randomsiation 8. Antiseptic application or enrolment in the trial determined inappropriate in the opinion of the enrolling clinician 9. Any recent or planned (within 4 hours) iodine application to the perineum or vagina 10. Unable to obtain consent Neonates: 1. Born by planned elective caesarean section 2. Born to mothers recruited in the trial 3. Poor skin condition (skin score of 2 or more in any of three domains at the time of enrolment) 4. Known congenital or acquired skin disorder or defect at the time of enrolment 5. Antiseptic application or enrolment in the trial determined inappropriate in the opinion of the enrolling clinician 6. Any recent or planned (within 4 hours) iodine application to the body 7. Any planned or previous lumbar puncture