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.

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Background: The diagnosis of bacterial vaginosis (BV) is often made according to Nugent's classification, a scoring system based on bacterial counting of Gram stained slides of vaginal secretion. However as the image area of the microscope field will influence the number of morphotypes seen there is a need to standardise the area. Methods: A graph intended for recalculation of number of bacterial morphotypes seen by the observer using 10006 magnification from various microscope set-ups was constructed and applied to data sets typical for scoring BV. The graph was used in recalculation of Nugent scores, which were also compared with the Ison/Hay scores to evaluate the consequences for the diagnosis of BV. Results: The observed image area differed by 300% among the investigated microscope set-ups. In two different data sets, one treatment study and one screening study, a considerable change in the number of women classified as intermediate was seen when the graph was used to standardise the image area. The recalculated numbers were also compared to the Ison/Hay classification. Weighted kappa indexes between the different methods were 0.84, 0.88, and 0.90, indicating that the methods are comparable. Conclusion: Because of the considerable differences among image areas covered by different microscope set-ups used in Nugent and Ison/Hay scoring, there is a need to standardise the area in order to reach comparable scores reflecting the diagnosis of BV in different laboratories. The differences in the intermediate group will have a considerable effect on the results from both treatment and prevalence studies, even though the kappa indexes indicate very good agreement between the methods used.

Background: Bacterial vaginosis (BV) during pregnancy is associated with an increased risk of preterm delivery but little is known about factors that could predict BV. We have analyzed if it is possible to identify a category of pregnant women that should be screened for BV, and if BV would alter the pregnancy outcome at term; we have also studied the treatment efficacy of clindamycin.

Preoperative treatment for at least three days with clindamycin cream significantly reduced the risk for developing signs of post-abortion infection only among women with preoperative abnormal vaginal flora (BV and intermediate flora).

This study assessed the time course of decrease in plasma carnitine during pregnancy and compared the renal clearance of carnitine during late pregnancy with nonpregnant women. As early as the 8th wk of pregnancy, the mean (+/- SD) value of total plasma-carnitine concentration in 19 women was significantly decreased from 39.0 +/- 6.3 to 32.8 +/- 4.6 mumol/l and the values continued to fall to 17.3 mumol/l by the 36th wk. The pattern was due to a fall in free-carnitine level; acylcarnitine remained unchanged. In 12 other women examined during late pregnancy, the renal clearance of acylcarnitine was significantly higher than in nonpregnant women, 53.9 +/- 29.4 versus 13.3 +/- 3.0 ml/min, in contrast to free carnitine, 3.5 +/- 2.8 versus 2.8 +/- 1.9 ml/min. Urinary excretion of carnitine (expressed per mol creatinine) did not differ between the two groups. Pregnant women showed sustained excretion of carnitine in the presence of low plasma-carnitine concentrations.

Thirty eight women with menopausal vasomotor symptoms were randomly allocated to 6 months treatment with either 2-4 mg micronized estradiol given orally or 3 mg estradiol applied cutaneously. The concentrations of cholesterol (C) and phospholipids (PL) were determined in high density lipoprotein (HDL) and its subfractions HDL2 and HDL3 twice before treatment and after 2, 4, and 6 months of medication. Oral estradiol increased the C and PL concentration in the HDL2 fraction in a dose-dependent way. With 2 mg estradiol orally the HDL3 fraction did not change, whereas 4 mg estradiol orally increased the C and PL concentrations in the HDL3 fraction. Cutaneous treatment with estradiol did not influence the lipid level in HDL or its subfractions. It is concluded that the rise of HDL during estrogen treatment is mainly caused by an elevation of the HDL2 fraction. Furthermore, the route of administration of estrogens has a profound influence on the metabolism of the HDL subfractions.

Twenty-six postmenopausal women who had been on cutaneous oestradiol treatment for 3-6 months were given either 120 micrograms of 1-norgestrel (n = 13) or 300 mg of progesterone (n = 13) sequentially for another 6 months. The concentrations of cholesterol, phospholipids and triglycerides were determined in plasma and in the HDL, HDL2, HDL3, LDL and VLDL fractions before and after one, three and six cycles of progestin treatment. Already after 11 days on 1-norgestrel, the mean HDL cholesterol and the mean HDL phospholipid concentrations were reduced by 15%. The reduction of the HDL-lipids was mainly confined to the HDL2 fraction which was decreased by 25-30%. L-norgestrel also reduced the mean TG concentration both in the VLDL and the combined LDL + HDL fractions. Progesterone gave only minor changes of the plasma lipids and lipoproteins. Reduced HDL, especially HDL2, concentration, as induced by 1-norgestrel, might increase the risk for ischaemic heart disease. Therefore, it seems that, as regards the effects on the lipoproteins, progesterone might be more suitable than the 19-nortestosterone derivative 1-norgestrel for postmenopausal sequential hormonal therapy.