Late miscarriage and preterm birth after treatment with clindamycin: a randomised consent design study according to Zelen

Abstract

Objective 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).Design Randomised consent design for clinical trials according to Zelen.Setting Southeast region of Sweden.Population A total of 9025 women were screened in early pregnancy.Methods 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.Main outcome measures Late miscarriage and spontaneous preterm delivery before 37 weeks.Results 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 2500 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.Conclusions 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 e27 per woman.Keywords Bacterial vaginosis, late miscarriage, preterm birth, preterm prelabour rupture of membranes, treatment.Please cite this paper as: Larsson P, Fåhraeus L, Carlsson B, Jakobsson T, Forsum U. Late miscarriage and preterm birth after treatment with clindamycin: a randomised consent design study according to Zelen. BJOG 2006; 113:629-637.

Treatment of Bacterial Vaginosis in Early Pregnancy and its Effect on Spontaneous Preterm Delivery and Preterm Premature Rupture of Membranes

“…The prevalence of BV in the screened group was 10.8%, which is comparable to the result reported by Desseauve et al [14]. In an earlier study, we have showed that the treatment of BV during early gestation is likely to prolong the pregnancy by 30 days [15]. In that study, all miscarriages that occurred after the 16th week of gestation were included.…”

Key Agreement in Peer-to-Peer Wireless Networks

“…Motivated by the flaw in [15], Jakobsson [25] and Larsson [26] proposed two solutions. However, both solutions are based on a temporary secret shared between the two users (thus, for example, SHAKE stands for Shared key Authenticated Key Exchange).…”

Composition of Vaginal Microflora in Relation to Vaginal pH and Wet Mount Diagnostic Tests in the First Trimester of Pregnancy

“…Since the extent of the inflammatory reaction has a particularly important role in the pathogenesis of preterm deliveries (Jacobson et al, 2003), the association of E. coli in the presence of leucocytosis found in our study can be important. Increased vaginal leucocytosis is associated with higher concentration of pro-inflammatory cytokines present in the vagina and with enzymatic activity, leading to preterm contractions and intrauterine infections (Donders et al, 2002;Romero et al, 2002;Larsson et al, 2006). A study of metronidazole treatment of AVM in pregnancy showed no benefit from this treatment -even worse -rates of preterm birth increased in the metronidazole group, which was explained by increased E. coli and Klebsiella pneumoniae in the vagina at delivery (Carey et al, 2005).…”