Health Condition 1: null- Pregnant woman in their third trimester with Bacterial vaginosis
Conditions
Interventions
Intervention1: Lactobacillus rhamnosusGR-1
Lactobacillus reuteri RC-14: at a dose of 2-5x108 CFU/day orally will be administered daily till delivery from 28th week of gestational age along with antibi
Sponsors
INDIAN COUNCIL OF MEDICAL RESEARCH
Eligibility
Inclusion criteria
Inclusion criteria: 1.Pregnant woman in their third trimester with BV 2.Age 18 years and above 3.Signed Informed Consent
Exclusion criteria
Exclusion criteria: 1. Participation in any other clinical study during the study period/ 30 days before beginning of the present study 2. HIV infected 3. Multiple gestation 4. Cervical incompetence (circlage in current gestation) 5. Fetus with major congenital malformations in current gestation 6. Insulin dependent diabetes mellitus, 7. Systemic arterial hypertension under medication, 8. Chronic asthma requiring intermittent therapy 9. Continuous or recent corticosteroid therapy ( or any other medical or surgical complications in present gestation) 10. Women aged less than 18 11. Women who had intercourse in the last 24 hours will be excluded 12. Known or suspected hypersensitivity to any of the ingredients of the trial medication 13. Patient not willing to comply with the clinical study instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rate of BV in women with and without probiotics Timepoint: Assesed for BV cure by 38th week of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of recurrence of BV with probioticsTimepoint: 3 month post partum | — |
Countries
India
Contacts
Public ContactDr Hemalatha R
NATIONAL INSTITUTE OF NUTRITION
Outcome results
None listed