Preterm Birth Clinical Trial
Official title:
Feasibility, Safety, Tolerance and Assessment of LACTIN-V Use in a Cohort of Pregnant Women at Risk of Preterm Birth
Preterm birth (PTB) is the primary cause of infant death worldwide. It has been shown that a vaginal microbiota deplete in Lactobacillus species is a risk factor for preterm labour. Conversely a vaginal microbiota dominated by Lactobacillus crispatus appears to be protective for these adverse outcomes. A wide range of 'over the counter' Lactobacillus spp. containing products targeted at 'vaginal health' and formulated for vaginal administration are available, but most of them do not contain vaginal species of Lactobacillus. The primary aim of this study is to determine whether vaginal supplementation with L. crispatus CTV-05 is associated with colonisation.
Pregnant women at Queen Charlotte's and Chelsea Hospital and St Mary's Hospital London who
are defined as being at a higher than background risk for preterm labour will be recruited
into this study. Women at risk of pre-term labour will include those with either previous
LLETZ, previous preterm birth, previous second trimester pregnancy loss or a combination of
these indications.
As part of this interventional study, subjects will be offered supplementation with L.
crispatus CTV-05. The preparation of LACTIN-V is administered vaginally using a specially
designed applicator.
The primary aim of this study is to determine whether vaginal supplementation with L.
crispatus CTV-05 is associated with colonisation.
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