TY - JOUR
T1 - Efficacy of an acidic vaginal gel on vaginal pH and interleukin-6 levels in low-risk pregnant women
T2 - A double-blind, randomized placebo-controlled trial
AU - Paternoster, D. M.
AU - Tudor, L.
AU - Milani, M.
AU - Maggino, T.
AU - Ambrosini, A.
PY - 2004/3
Y1 - 2004/3
N2 - 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. Study aim: 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. Patients and 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 ≥ 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.
AB - 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. Study aim: 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. Patients and 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 ≥ 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.
KW - Acidic vaginal gel
KW - Interleukin 6
KW - Pregnancy
KW - pH
UR - http://www.scopus.com/inward/record.url?scp=2542486539&partnerID=8YFLogxK
U2 - 10.1080/14767050410001668310
DO - 10.1080/14767050410001668310
M3 - Article
SN - 1476-7058
VL - 15
SP - 198
EP - 201
JO - Journal of Maternal-Fetal and Neonatal Medicine
JF - Journal of Maternal-Fetal and Neonatal Medicine
IS - 3
ER -