TY - JOUR
T1 - Randomized study of vaginal and neonatal cleansing with 1% chlorhexidine
AU - Pereira, Leonardo
AU - Chipato, Tsungai
AU - Mashu, Alexio
AU - Mushangwe, Velda
AU - Rusakaniko, Simbarashe
AU - Bangdiwala, Shrikant I.
AU - Chidede, Office Samson
AU - Darmstadt, Gary L.
AU - Gwanzura, Lovemore
AU - Kandawasvika, Gwendoline
AU - Madzime, Simon
AU - Lumbiganon, Pisake
AU - Tolosa, Jorge E.
N1 - Funding Information:
This research was supported by the Rockefeller Foundation , The United States Agency for International Development (USAID-CHR) and The International Clinical Epidemiology Network (INCLEN) .
PY - 2011/3
Y1 - 2011/3
N2 - 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 occured; 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.
AB - 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 occured; 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.
KW - Chlorhexidine
KW - Neonatal sepsis
KW - Vaginal washing
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U2 - 10.1016/j.ijgo.2010.09.009
DO - 10.1016/j.ijgo.2010.09.009
M3 - Article
C2 - 21247573
AN - SCOPUS:79951677259
SN - 0020-7292
VL - 112
SP - 234
EP - 238
JO - International Journal of Gynecology and Obstetrics
JF - International Journal of Gynecology and Obstetrics
IS - 3
ER -