PREPS - Vaginal Preparation at caesarean section.

• Research type

  Research Study

• Full title

  Vaginal Preparation at caesarean section to Reduce Endometritis and Prevent Sepsis – a feasibility study of Chlorhexidine Gluconate

• IRAS ID

  220172

• Contact name

  R Katie Morris

• Contact email

  r.k.morris@bham.ac.uk

• Sponsor organisation

  Birmingham Womens and Childrens NHS Foundation Trust

• Duration of Study in the UK

  1 years, 3 months, 1 days

• Research summary

  Feasibility randomised controlled trial (telephone randomisation) of vaginal cleansing at caesarean section with chlorohexidine gluconate vs no cleansing to prevent infection. Combined with a qualitative arm for development of women centered outcomes of wellbeing after delivery.
  Three maternity units in West Midlands, UK, recruiting women undergoing elective or emergency CS and able to give informed consent. We will follow women up until 6 weeks post natal and evaluate if infection/sepsis develops.
  Intervention Chlorhexidine gluconate 4% vaginal cleansing before CS. This is an antiseptic solution that is routinely applied to the abdominal skin to reduce surgical site infection; this solution can also be applied inside the vagina (safety profile established in other obstetric and gynaecological procedures).

• REC name

  London - City & East Research Ethics Committee

• REC reference

  17/LO/0874

• Date of REC Opinion

  24 May 2017

• REC opinion

  Favourable Opinion