title: Chlorhexidine vaginal and neonatal wipes in home births in Pakistan: a randomized controlled trial.
abstract: OBJECTIVE
  To assess tolerance and safety of 0.6% chlorhexidine vaginal and neonatal wipes to improve perinatal outcomes in home deliveries in Pakistan and the ability of traditional birth attendants and project staff to perform a randomized trial of this intervention.
  
  
  METHODS
  Focus groups of pregnant and nonpregnant women and in-depth interviews of traditional birth attendants explored barriers to the use of chlorhexidine wipes. Then, a study was performed of women delivering at home attended by traditional birth attendants. Consenting women were randomly assigned to receive either 0.6% chlorhexidine or saline vaginal and neonatal wipes. Women and their infants were followed up on postpartum days 7, 14, and 28. Acceptability and tolerance of vaginal and neonatal wipes, as well as maternal and neonatal outcomes, were assessed.
  
  
  RESULTS
  The focus groups and interviews indicated that the chlorhexidine intervention would be acceptable to women and their providers. Of the 213 eligible pregnant women approached, 203 (95%) gave informed consent and were enrolled and allocated to groups. Traditional birth attendants had no difficulty administering chlorhexidine vaginal and neonatal wipes in a home setting. Of the 203 births, 103 (51%) of whom received 0.6% chlorhexidine, there were no allergic reactions, vaginal itching, burning, or requests for study termination. Follow-up at 28 days postpartum was more than 95%. Although this study was not powered to show significant differences in neonatal outcomes between treatment groups, the lower rates of some neonatal adverse clinical outcomes in the chlorhexidine group were encouraging.
  
  
  CONCLUSIONS
  Use of 0.6% chlorhexidine vaginal and neonatal wipes for the prevention of neonatal infection is well-tolerated and seems safe. A trial of this intervention by traditional birth attendants in a home-delivery setting is feasible.
  
  
  BACKGROUND
  ClinicalTrials.gov, www.clinicaltrials.gov, NCT00121394
  
  
  METHODS
  I.
authors.affiliation: Aga Khan University, Karachi, Pakistan.
authors.forename: S
authors.initials: S
authors.lastname: Saleem
authors.forename: T
authors.initials: T
authors.lastname: Reza
authors.forename: E M
authors.initials: EM
authors.lastname: McClure
authors.forename: O
authors.initials: O
authors.lastname: Pasha
authors.forename: N
authors.initials: N
authors.lastname: Moss
authors.forename: D J
authors.initials: DJ
authors.lastname: Rouse
authors.forename: J
authors.initials: J
authors.lastname: Bartz
authors.forename: R L
authors.initials: RL
authors.lastname: Goldenberg
mesh_terms: D000328:Adult; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use*; D002710:Chlorhexidine / Q000627:therapeutic use*; D005240:Feasibility Studies; D005260:Female; D017144:Focus Groups; D006700:Home Childbirth / Q000379:methods*; D006801:Humans; D007226:Infant Mortality; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000517:prevention & control; D007239:Infections / Q000635:transmission; D008297:Male; D008880:Midwifery; D010154:Pakistan / Q000453:epidemiology; D010349:Patient Compliance; D010865:Pilot Projects; D011247:Pregnancy
chemical_list: D000891:Anti-Infective Agents, Local; D002710:Chlorhexidine