Efficacy of an acidic vaginal gel on vaginal pH and interleukin-6 levels in low-risk pregnant women: a double-blind, randomized placebo-controlled trial.
BACKGROUND
Increased interleukin-6 (IL-6) levels and a vaginal pH of > 4.7 are associated with obstetric complications such as preterm delivery and low birth weight. Topical treatments, able to maintain a physiological vaginal pH, could help in the prevention of vaginal infections.


OBJECTIVE
In a randomized, double-blind, placebo-controlled trial, we evaluated the effects of an acidic buffering vaginal gel (Miphil) on vaginal pH and IL-6 levels in pregnant women.


METHODS
Seventy low-risk women pregnant with a singleton (second trimester) were enrolled in the trial. Thirty-five were randomized to the acidic gel, 2.5 g every 3 days for 12 weeks, and 35 to the corresponding placebo. Vaginal pH and vaginal IL-6 level were measured at baseline and after 12 weeks. Women were then followed until delivery. The main outcome measures were vaginal pH, vaginal pH normalization (pH < 4.5) and vaginal IL-6 levels.


RESULTS
Vaginal pH at baseline was 4.6 +/- 0.4 and 4.4 +/- 0.3 in the acidic gel and the placebo group, respectively. At baseline, a total of 40% (14/35) and 22% (8/35) of women in each group, respectively, had a vaginal pH of > or = 4.7. At week 12, the vaginal pH was 4.3 +/- 0.3 in the acidic gel group and 4.3 +/- 0.3 in the placebo group (NS). The acidic gel normalized the vaginal pH in ten out of 14 women (p = 0.04) in comparison with only one out of eight women in the placebo group (NS). The acidic gel induced a significant (p < 0.02) reduction of vaginal IL-6 from 12.0 +/- 7 to 8.9 +/- 5 pg/l (-36%). In the placebo group, IL-6 increased from 9.0 +/- 5 to 13.5 +/- 6.8 pg/l (+50%) (p = 0.05). Birth weight was 2978 +/- 700 g in the placebo group and 3241 +/- 477 g in the acidic gel group (p = 0.06).


CONCLUSIONS
The use of the acidic gel in low-risk pregnant women is able to maintain a physiological vaginal ecosystem and prevents the increases of vaginal pH and vaginal IL-6. Prospective and controlled trials are warranted to evaluate whether this acidic gel can reduce obstetric complications linked to vaginal inflammation during pregnancy.
Department of Gynecology and Physiopathology of Reproduction, University of Padua, Padua, Italy.
D M
DM
Paternoster
L
L
Tudor
M
M
Milani
T
T
Maggino
A
A
Ambrosini
D000143:Acids; D000293:Adolescent; D000328:Adult; D001724:Birth Weight / Q000187:drug effects; D002021:Buffers; D004311:Double-Blind Method; D005260:Female; D005865:Gestational Age; D006801:Humans; D006863:Hydrogen-Ion Concentration / Q000187:drug effects; D015850:Interleukin-6 / Q000378:metabolism*; D011247:Pregnancy; D011446:Prospective Studies; D016896:Treatment Outcome; D014621:Vagina / Q000187:drug effects / Q000502:physiology*; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage* / Q000494:pharmacology
D000143:Acids; D002021:Buffers; D015850:Interleukin-6; D014622:Vaginal Creams, Foams, and Jellies