Randomized study of vaginal and neonatal cleansing with 1% chlorhexidine.
OBJECTIVE
To determine the safety, acceptability, and antimicrobial effect of 1% chlorhexidine (CHX) vaginal washing of women in labor and their neonates.


METHODS
Randomized controlled trial of 1% CHX vaginal and neonatal washing compared with no washing (usual care [UC]). The study included 502 women (334 CHX, 168 UC) who delivered 508 liveborn neonates (335 CHX, 173 UC). Main outcome measures were the incidence of maternal adverse effects, the incidence of neonatal skin rash, the axillary temparature before and after neonatal wiping, and vaginal culture results.


RESULTS
Maternal demographics did not differ between the groups. No case of maternal rash occurred; 4% of women experienced vaginal burning. An axillary temperature drop of more than 1 °C after CHX cleansing occurred in 8 neonates; 2 neonates had a minor rash. In the subset of women with positive vaginal cultures as baseline, 1% CHX eliminated culture growth in 56% after 1 wash, and in 86% after 2 washes.


CONCLUSIONS
Use of 1% CHX is safe for neonates, well tolerated by laboring mothers, and effective in treating vaginal infections during labor. A randomized controlled trial using 1% CHX and powered for a reduction in neonatal septic mortality is justified based on these data.
Division of Maternal-Fetal Medicine, Oregon Health and Science University, Portland 97239, USA. pereiral@ohsu.edu
Leonardo
L
Pereira
Tsungai
T
Chipato
Alexio
A
Mashu
Velda
V
Mushangwe
Simbarashe
S
Rusakaniko
Shrikant I
SI
Bangdiwala
Office Samson
OS
Chidede
Gary L
GL
Darmstadt
Lovemore
L
Gwanzura
Gwendoline
G
Kandawasvika
Simon
S
Madzime
Pisake
P
Lumbiganon
Jorge E
JE
Tolosa
D000282:Administration, Intravaginal; D000328:Adult; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage* / Q000009:adverse effects; D001724:Birth Weight; D002710:Chlorhexidine / Q000008:administration & dosage* / Q000009:adverse effects; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D006801:Humans; D007226:Infant Mortality; D007231:Infant, Newborn; D008297:Male; D011247:Pregnancy; D011256:Pregnancy Outcome; D018805:Sepsis / Q000401:mortality / Q000517:prevention & control*; D016896:Treatment Outcome; D014621:Vagina / Q000382:microbiology*; D044364:Vaginal Douching / Q000379:methods*; D055815:Young Adult
D000891:Anti-Infective Agents, Local; D002710:Chlorhexidine