Preterm labour Pregnancy and Childbirth
Conditions
Interventions
LACTIN-V is supplied as a pre-filled, single-use vaginal applicator. Each applicator contains 200 mg of LACTIN-V powder at a dose of 2 x 109 CFU. The LACTIN-V powder formulation contains L. crispatus
Sponsors
Imperial College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women confirmed to be at risk of preterm labour, as defined by previous preterm birth and/or mid trimester loss 2. Able to provide written, informed consent 3. Confirmed viable intrauterine singleton pregnancy between 12-16 weeks gestational age
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 24/02/2026: 1. Women living with HIV 2. Women under the age of 17 years (updated 23/01/2026, previously under the age of 18 years) 3. Women with a multiple pregnancy 4. Known allergy or sensitivity to the investigational product 5. Participants taking part in an alternative interventional research study 6. Known congenital/structural or chromosomal anomaly in the fetus 7. Women with deep epithelial disruption observed on genital examination on or before the day of randomisation 8. Women with any condition requiring regular periodic use of systemic antibiotics during participation in the trial 9. Women with any social, medical, or psychiatric condition that in the opinion of the Investigator would complicate the evaluation or make it unlikely for the subject to comply with the study protocol 10. Use of immunosuppressive drugs within 60 days of randomisation 11. Women who are lactating. Previous key exclusion criteria: 1. Women living with HIV 2. Women under the age of 17 years (updated 23/01/2026, previously under the age of 18 years) 3. Women with a multiple pregnancy 4. Known allergy or sensitivity to the investigational product 5. Participants taking part in an alternative interventional research study 6. Known congenital/structural or chromosomal anomaly 7. Women with deep epithelial disruption observed on genital examination on or before the day of randomisation 8. Women with any condition requiring regular periodic use of systemic antibiotics during participation in the trial 9. Women with any social, medical, or psychiatric condition that in the opinion of the Investigator would complicate the evaluation or make it unlikely for the subject to comply with the study protocol 10. Use of immunosuppressive drugs within 60 days of randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of preterm birth, defined as delivery occurring before 37 completed weeks of pregnancy, measured at end of study and any interim reports to the data monitoring committee (DMC) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of cervical shortening (< or equal to 25 mm), measuring using transvaginal ultrasounds at the end of the study and any interim reports to the data monitoring committee (DMC) 2. The rate of preterm birth, defined as delivery occurring before 34 completed weeks of pregnancy measured at the end of study and any interim reports to the data monitoring committee (DMC) 3. Incidence of preterm prelabour rupture of membranes (PPROM) <34 weeks, measured at the end of study and any interim reports to the data monitoring committee (DMC) 4. Mean and median gestational age at delivery, measured at the end of study and any interim reports to the data monitoring committee (DMC) 5. Incidence of a neonatal outcome consisting of a composite of death, brain injury, or bronchopulmonary dysplasia (neonatal), measured at the end of study and any interim reports to the data monitoring committee (DMC) 6. Incidence of early onset neonatal sepsis measured through reported adverse events, measured at the end of study and any interim reports to the data monitoring committee (DMC) 7. Developmental progress of the child, measured using the Parent Report of Children’s Abilities (PARCA-R) parent questionnaire at 2 years of age 8. Safety assessment, measured through reported adverse events at end of study and any interim reports to the data monitoring committee (DMC) Measured at end of study and any interim reports to the data monitoring committee (DMC) or 2 years from birth of the child | — |
Countries
England, United Kingdom
Contacts
Public ContactImperial Clinical Trials Unit
Outcome results
None listed