An exploratory pilot study evaluating the supplementation of standard antibiotic therapy with probiotic lactobacilli in south African women with bacterial vaginosis.

BACKGROUND: To reduce acquisition and relapse of bacterial vaginosis (BV), lactobacilli must be maintained in the vaginal microbiome. Probiotic lactobacilli may aid this purpose. We investigated whether vaginal probiotics (containing Lactobacillus rhamnosus DSM 14870 and Lactobacillus gasseri DSM 14869) would result in vaginal colonisation with lactobacilli in women with and without BV. METHODS: This prospective, partially randomised, exploratory pilot study was conducted in Soweto, South Africa. Thirty-nine sexually-active, HIV negative women were enrolled from October 2014 to May 2016 into three arms. Women who did not have BV (Group 1, n = 13) self-administered probiotic capsules vaginally once daily for 30 days, then once a week until Day 190. Women diagnosed with BV were randomized into Group 2 (n = 12) or Group 3 (n = 14) and treated with the triple oral antibiotic combination for vaginal discharge syndrome per South African guidelines (cefixime 400 mg stat, doxycycline 100 mg BD for 7 days and metronidazole 2 g stat). Immediately after antibiotic treatment, women in Group 2 self-administered probiotic capsules vaginally once daily for 30 days then vaginally once a week until Day 190. Women in Group 3 were not given lactobacilli. RESULTS: During the study, L. rhamnosus DSM 14870 or L. gasseri DSM 14869, were isolated in 5/13 (38.5%) women in Group 1 compared to 10/12 (83.3%) women in Group 2 (p = 0.041). The 1-month and 6-month BV cure rates were similar (P >  0.05) between Group 2 (42 and 25%) compared to Group 3 (36 and 25%). In Group 2, no correlation was observed between the frequency of isolation of the two Lactobacillus strains and the 1-month or 6-month cure rate. CONCLUSIONS: Supplementation with vaginal probiotic capsules resulted in colonisation of the vagina by the Lactobacillus strains (L. rhamnosus DSM 14870 and L. gasseri DSM 14869) contained in the capsules. We observed low initial cure rates of BV after a stat dose of metronidazole and that the probiotic did not improve BV cure rates or alleviate recurrence which could be due to treatment failure or very limited power of the study. TRIAL REGISTRATION: Registered at the Pan African Clinical Trial Registry ( www.pactr.org ) on April 13, 2018 (retrospectively registered). Trial identification number: PACTR201804003327269.

Effect of a structured follow-up visit to a midwife on women with early miscarriage: a randomized study.

BACKGROUND: Women's grief after miscarriage is substantial and important. Women who experience early miscarriage do not constitute a homogenous group. The aim of this study is to measure whether a structured follow-up visit to a midwife (group 1) at 21-28 days after early miscarriage could reduce the women's grief, measured using the perinatal grief scale Swedish short version (PGS) after a further 3 months (i.e. 4 months after the miscarriage), compared to a regular follow-up visit to a midwife (group 2). METHODS: We performed an open randomized study of women who experienced early miscarriage (n = 88). The midwife's attitude in group 1 came from Swanson science theory of midwifery. In group 2, the women were offered only the ordinary type of consultation at a regular visit. A questionnaire with the PGS was used in both groups. Four months after the miscarriage, a second questionnaire with the same perinatal grief scale was sent by post. RESULTS: There was a 30% greater reduction in grief in group 1 than that in group 2, when comparing the first and second measurements (not significant). The biggest differences were in the subscales active grief and difficulty in coping. Women with the subdiagnosis missed abortions had, as a group, significantly higher PGS scores at both visits, especially in active grief and difficulty in coping, regardless of the type of follow-up visit. CONCLUSIONS: A structured follow-up visit did not, in comparison with a regular follow-up visit, imply any significant reduction in grief as measured using the PGS scale. However, the subgroup missed abortion had more extensive grief than the other women with miscarriage. Structured follow-up visits are not imperative for all women with early miscarriage.