Cervical Incompetence, Miscarriage in Second Trimester, Miscarriage in Third Trimester, Preterm Birth, Preterm Labor, Preterm Premature Rupture of Membrane
Conditions
Keywords
Pregnancy, Preterm labour, Preterm delivery, Vaginal microbiome, Infection, Next generation sequencing, Lactobacillus
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTLACTIN-V
Vaginal supplementation with L. crispatus CTV-05.
Sponsors
Imperial College Healthcare NHS Trust
Imperial College London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Women at risk of preterm labour * Women referred to the prematurity clinic * Women with previous LLETZ (large loop excision of the transformation zone) * Women with previous preterm birth * Women with previous second trimester loss
Exclusion criteria
* HIV positive women * Women who are unable to provide informed consent * Women aged \<18 * Women receiving antibiotic treatment within 1 week of recruitment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of participants that demonstrate a change in vaginal colonisation during and following LACTIN-V use. | 2-4 years | Microbiological effects of LACTIN-V by laboratory analysis, next generation sequencing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of participants with treatment related adverse events following LACTIN-V supplementation in pregnant women at high risk of preterm birth. | 2-4 years | Participants will be asked about adverse events during clinical review and the safety profile will be recorded. |
| The number of patients using LACTIN-V that go on to experience preterm birth, PPROM or cervical shortening. | 2-4 years | Clinical outcomes of participants will be analysed, in accordance with colonisation results |
Countries
United Kingdom
Contacts
Primary ContactPhillip Bennett, BSc PhD MD
Backup ContactDavid MacIntyre, BSc PhD
Outcome results
None listed