Objective To ascertain whether metronidazole treatment of women with a heavy growth of Gardnerella Design A multicentre, randomised, placebo-controlled trial Setting Four metropolitan hospitals.Participants Eight hundred and seventy-nine singleton women with a heavy growth of G. vaginalis or Interventions Oral metronidazole (400 mg) or placebo twice daily for two days at 24 weeks of gestation, Main outcome measures Spontaneous preterm birth less than 37 weeks.Results Intention-to-treat analysis showed no difference between metronidazole and placebo groups in overall preterm birth (3 1

Objective— To study the vaginal flora of women in preterm labour (PTL) and determine whether the presence of specific vaginal microflora is significantly associated with onset of PTL.Design— A comprehensive prospective study of the vaginal microflora of women in early labour comparing women in PTL with term controls. Microbiological assessment included cultures for aerobic and anaerobic bacteria, yeasts, genital mycoplasmas and Trichomonas vaginalis. Multiple logistic regression analysis was used to adjust for confounding obstetric and demographic variables.Setting— The Queen Victoria Hospital, Adelaide.Patients— 428 Women in PTL compared to 568 women in labour at term.Main outcome measure— PTL and preterm prelabour rupture of membranes (PPROM) in relation to specific vaginal microflora.Results— After multiple logistic regression analysis, two distinct bacteriological groupings were associated with PTL <37 weeks gestation, namely, the bacterial vaginosis group of organisms, Gardnerella vaginalis and Bacteroides spp., and a group of enteropharyngeal organisms, E. coli, Klebsiella spp., Haemophilus spp. and S. aureus. G. vaginalis was found in 12% of women in PTL compared to 6% at term [regression odds ratio (ROR) 1.8, 95% confidence intervals (CI) 1.1–3.1] whereas Bacteroides spp. were detected in 45% of women in PTL compared with 35% at term (ROR 1.6, CI 1.2–2.1). The prevalence of G. vaginalis (17%) and Bacteroides spp. (50%) was even higher in women in PTL <34 weeks gestation. The enteropharyngeal group of organisms were more commonly present in women in PTL <37 weeks (E. coli 10% vs 6%, ROR 1.4, CI 0.8–2.4; Klebsiella spp. 3% vs <1%, ROR 5.4, CI 1.1–26.7; Haemophilus spp. 2% vs <1%, ROR 5.5, CI 1.1–28.6; aureus 6% vs 4%, ROR 1.8, CI 0.9–3.3) and were isolated even more frequently in women in PTL <34 weeks (E. coli 15%; Klebsiella spp. 4%; S. aureus 7%). Bacteroides spp., Klebsiella spp., and Haemophilus spp. were all found to be associated with PPROM.Conclusion— There are two distinct bacteriological groupings commonly found in women in PTL, especially in PTL <34 weeks gestation. These bacteriological groups are women with bacterial vaginosis in pregnancy and women who demonstrate enteropharyngeal bacteria in the vagina.

SPL7013 Gel applied vaginally once daily for 7 days at concentrations of 0.5% to 3% was safe and well tolerated in healthy, sexually abstinent women, with no evidence of systemic toxicity or absorption.

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A prospective study of the vaginal flora changes between midtrimester and labor was undertaken in 560 women; 337 had intact membranes and were in labor when swabs were taken. Of these, 45 delivered preterm. Gardnerella vaginalis, Ureaplasma urealyticum (both associated with preterm birth when present in midtrimester), and Mycoplasma hominis commonly persisted between midtrimester and labor, particularly in the preterm cohort (24 [65%] of 37 midtrimester isolates), and these organisms were seldom acquired late in pregnancy. A second group, Bacteroides species, had both a high persistence (9 [60%] of 15 midtrimester isolates) and high late acquisition rate (10 [53%] of 19 labor isolates) in the preterm cohort. These findings provide a rationale for treatment of bacterial vaginosis in pregnancy. A third group, comprising enteropharyngeal bacteria and Peptostreptococcus species, were almost all acquired late in the preterm cohort (14 [88%] of 16 labor isolates), and persistence from midtrimester was rare.

Recent publications have highlighted the controversy regarding the significance of Lancefield Group B Streptococcal (GBS) colonization in pregnancy and preterm delivery. In this prospective study vaginal swabs from 692 women at approximately 24 weeks' gestation were cultured for GBS. GBS was detected in 91 (13.2%) women. The rate of preterm labour (PTL) (less than 37 weeks) was significantly higher in GBS positive women than in GBS negative women (18.7% versus 5.5%; p less than 0.001). This association remained significant even when patients with other recognized factors predisposing to PTL were excluded (11.5% versus 3.9%; p less than 0.001). The rate of premature rupture of membranes (PROM) was also significantly higher in GBS positive women (9.9% versus 2.7%; p less than 0.005) and remained significantly higher when patients with other recognized risk factors were excluded (6.1% versus 1.8%; p less than 0.025). These results unequivocably show that pregnant women who are vaginal carriers of GBS have a significantly increased risk of PROM and PTL.

Objective To study the vaginal flora of pregnant women at 22–28 weeks gestation to determine whether the presence of specific micro‐organisms is significantly associated with preterm birth and prelabour rupture of the membranes. Design A comprehensive descriptive prospective study of the vaginal micro‐flora of women between 22–28 weeks gestation comparing those who gave birth preterm (<37 weeks) with those who gave birth at term. Microbiological assessment included cultures for aerobic and anaerobic bacteria, yeasts, genital mycoplasmas and Tri‐chomonas vaginalis. Multiple logistic regression analysis was used to account for confounding obstetric and demographic variables. Setting The Queen Victoria Hospital, Adelaide, South Australia. Subjects 135 women who gave birth preterm compared to 651 women who gave birth at term. Main outcome measure Preterm birth and preterm prelabour rupture of membranes (PROM) Results The prevalence of Gardnerella vaginalis between 22–28 weeks was significantly higher in women who gave birth preterm compared to women who gave birth at term (23%vs 15%; multiple logistic regression odds ratio (OR) 1.8, 95% confidence intervals (CI) 1.01–3.2, P<0.05. Ureaplasma urealyticum was also found in a higher proportion of women who gave birth preterm (49% vs 32% OR 1.7, 95% CI 1.1–2.6, P<0.0005). Preterm PROM occurred in 42% of whom 60% were carriers of U. urealyticum between 22–28 weeks, compared with 32% in the term group (OR 3.2, CI 1.7–6.1, f<0.0005). When women who received antibiotics between the mid‐trimester swab and labour were excluded, G. vaginalis was also significantly associated with preterm PROM (OR 2.7, CI 1.1–6.5, P<0.05). The presence of vaginal enteropharyngeal bacteria (E. coli, Klebsiella spp., Haemophilus spp., Staph. aureus) in the midtrimester was not predictive of preterm birth, but when these organisms were found in labour, they appeared to have been acquired later in the pregnancy. Conclusion Women carrying G. vaginalis or U. urealyticum during the midtrimester had nearly twice the risk of preterm birth, while women positive for U. urealyticum had more than a threefold risk of preterm PROM.

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