Larsson P-G, Fåhraeus L, Carlsson B, Jakobsson T, Forsum U
Department of Obstetrics and Gynaecology, Kärnsjukhuset, Skövde, Sweden.
BJOG. 2006 Jun;113(6):629-37. doi: 10.1111/j.1471-0528.2006.00946.x.
To screen for bacterial vaginosis (BV) and to investigate the effect of treatment with vaginal clindamycin in order to observe the effect on late miscarriage and delivery prior to 37 completed weeks (primary outcome).
Randomised consent design for clinical trials according to Zelen.
Southeast region of Sweden.
A total of 9025 women were screened in early pregnancy.
A total of 819 women with a Nugent score of 6 and above were considered to have BV and treated according to Zelen allocation. The incidence of late miscarriage and spontaneous (noniatrogenic) preterm birth was assessed.
Late miscarriage and spontaneous preterm delivery before 37 weeks.
Therapy with vaginal clindamycin had no significant impact on the incidence of spontaneous preterm delivery prior to 37 completed weeks; OR 0.90, 95% CI 0.40-2.02 (primary outcome variable). However, only 1 of 11 women in the treatment group versus 5 of 12 in the control group delivered prior to 33 completed weeks; OR 0.14, 95% CI 0.02-0.95. Treatment was associated with 32 days longer gestation for the 23 participants who had late miscarriage or spontaneous preterm birth (P= 0.024, Mann-Whitney U test) and significantly fewer infants had a birthweight below 2,500 g (secondary outcome). A follow up of infants born preterm 4 years postnatally indicated that extending gestational age did not increase the number of sequelae.
Clindamycin vaginal cream therapy was associated with significantly prolonged gestation and reduced cost of neonatal care in women with BV. Early screening for BV and treatment with clindamycin saved approximately 27 euro per woman.
筛查细菌性阴道病（BV），并研究阴道用克林霉素治疗的效果，以观察其对晚期流产及妊娠37足周前分娩（主要结局）的影响。
根据泽伦法进行的随机同意临床试验设计。
瑞典东南部地区。
共9025名女性在孕早期接受筛查。
共有819名Nugent评分6分及以上的女性被认为患有BV，并根据泽伦分配法进行治疗。评估晚期流产和自发（非医源性）早产的发生率。
晚期流产和妊娠37周前的自发早产。
阴道用克林霉素治疗对妊娠37足周前自发早产的发生率无显著影响；比值比（OR）为0.90，95%置信区间（CI）为0.40 - 2.02（主要结局变量）。然而，治疗组11名女性中只有1名在妊娠33足周前分娩，而对照组12名女性中有5名；OR为0.14，95% CI为0.02 - 0.95。对于23名发生晚期流产或自发早产的参与者，治疗使妊娠期延长了32天（P = 0.024，曼-惠特尼U检验），且出生体重低于2500g的婴儿明显减少（次要结局）。对早产婴儿进行4年的产后随访表明，延长孕周并未增加后遗症的数量。
克林霉素阴道乳膏治疗与BV女性的妊娠期显著延长及新生儿护理成本降低相关。早期筛查BV并用克林霉素治疗可为每位女性节省约27欧元。
