Vaginal clindamycin did not decrease the rate of preterm deliveries or peripartum infections, but recurrent or persistent BV increased the risk for these complications.

Pregnant women who are in preterm labor with intact fetal membranes and who have a positive phIGFBP-1 test result in cervical secretion have an increased risk of preterm delivery.

We evaluated a study setting for assessment of the long-term vaccine efficacy (VE) of human papillomavirus (HPV) virus-like-particle (VLP) vaccine against cervical carcinoma. A total of 22,412 16- to 17-year old adolescent women from seven cities in Finland were invited by letter to participate in a phase III study of a quadrivalent HPV (types 6, 11, 16, 18) VLP vaccine, between September 2002 and March 2003. A total of 30,947 18-year old women were invited to participate as unvaccinated controls. These women were asked about their willingness to participate in an HPV vaccination trial and to fill a health questionnaire. These three population-based cohorts of adolescent women, including women vaccinated with HPV vaccine or placebo vaccine and unvaccinated control women, are systematically followed over time. The study cohort database will be linked with the Finnish Cancer Registry using cervical carcinoma in situ (CIS) and invasive cervical carcinoma (ICC) as endpoints. Assuming that the cumulative incidence of CIS and ICC over 15 years is 0.45%, and that there is no loss to follow-up, and power of 80%, the determination of 70% total VE will require 3357 HPV vaccine recipients, 3357 placebo vaccine recipients, and 6714 unvaccinated controls. At the baseline, 2632 (12%) of the invited adolescents volunteered to the phase III vaccination trial, and 6790 (22%) responded to the questionnaire study. During a recruitment period of 10 months, 874 HPV vaccine recipients, 875 placebo recipients and 1919 unvaccinated controls were enrolled. Population-based enrollment of large cohorts of vaccinated and unvaccinated adolescents for passive registry-based follow-up with cervical carcinoma as the end-point is feasible and currently going on in Finland.

Objective To determine whether treatment of bacterial vaginosis (BV) with vaginal clindamycin affects pregnancy outcome. Materials and methodsMothers with singleton pregnancies and without previous preterm delivery in 17 health centres in Oulu from March 1996 Until March 1998, in whom BV was diagnosed by Gram stain of a vaginal swab at the first antenatal visit (at the 12th gestational week) were randomised at Oulu University Hospital to have a one-week course of vaginal clindamycin, or placebo. A follow up sample of Gram stain was taken two weeks after randomisation and at the 30th gestational weeks. Pregnancy outcome data was obtained from hospital records. Primary outcome was preterm birth, and puerperal infectious morbidity the other outcome measure.Results During the study period 1956 women were screened, of whom 143 (7.3%) were BV-positive. One hundred and one were randomised. The total preterm birth rate of BV+ women randomised was 9.9% (lO/lOl). Preterm birth occurred in 20.7% (6/29) vs 0% (0/26) according to whether BV persisted or not (P < 0-01). The preterm birth rate was 13.7% (7/51) in the clindamycin group vs 6.0% (3/50) in the placebo group (OR 2.5,95% CI 06-10). BV was cured just after treatment in 17 out of 51 (33%) of the clindamycin-treated patients vs 17 out of 50 (34%) of the placebo-treated patients (OR 1.0,95% CI 0.4-2.2). There was a difference in puerperal infectious morbidity in patients where BV persisted (31%, 9/29) compared with those in which BV did not persist (7.7%, 1/26) (OR 5.4, 95% CI 1-04-28). Infections were seen in 4/51 (8%) of the clindamycin treated vs 10/50 (20%) of the placebo treated cases, (OR 0.3,95% CI 0.1-1.2). ConclusionThe prevalence of BV was lower than expected in this low risk population, but nevertheless it increased the risk of preterm birth and puerperal infectious morbidity, the risk being highest in cases where BV persisted during pregnancy. Vaginal clindamycin treatment for BV in the fist trimester of pregnancy did not appear to reduce the risk of preterm birth or puerperal infections.

Pregnant women who are in preterm labor with intact fetal membranes and who have a positive phIGFBP-1 test result in cervical secretion have an increased risk of preterm delivery.