Effect of Probiotic Lactobacilli on Vaginal Flora of Pregnant Women at High Risk for Preterm Delivery
Launched by MOUNT SINAI HOSPITAL, CANADA · Sep 14, 2005
Trial Information
Current as of August 11, 2025
Withdrawn
Keywords
ClinConnect Summary
Preterm labour involves multiple causes - one of the most significant factors being a prior history of preterm birth. Infection is another major cause of preterm labour (PTL) and is estimated to cause up to 30% of PTL. Bacterial Vaginosis (BV) is an alteration in the endogenous vaginal microflora preceded by a decreased presence of Lactobacilli species and increased growth of gardnerella and other pathogens. BV is a strong risk factor for PTL, and is associated with a 40% increased risk in some populations. Initial studies suggested that the treatment of BV with antibiotics could decrease t...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • pregnant women with previous incidence of preterm labour
- • otherwise healthy
- • over 18 years of age
- • able to provide informed consent
- • less than or equal to 16 weeks gestation
- • singleton pregnancy
- • normal uterine cavity
- Exclusion Criteria:
- • significant medical complications (preeclampsia, thrombophilia, hypertension)
- • multiple pregnancy
- • less than 18 years of age
- • patients receiving antibiotics or other antimicrobial therapies at time of recruitment
- • fetal complications such as intrauterine growth restriction or other abnormalities
- • diabetes
- • documented need for cervical cerclage
- • patient enrolled in other clinical trials
About Mount Sinai Hospital, Canada
Mount Sinai Hospital, located in Canada, is a leading academic health institution renowned for its commitment to innovative research and high-quality patient care. As a sponsor of clinical trials, Mount Sinai Hospital leverages its extensive expertise in various medical disciplines to advance clinical knowledge and develop new therapies. The hospital collaborates with a diverse network of healthcare professionals, researchers, and institutions to conduct rigorous trials that aim to improve health outcomes and enhance the quality of life for patients. With a focus on ethical standards and patient safety, Mount Sinai Hospital is dedicated to translating scientific discoveries into effective clinical practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Toronto, Ontario, Canada
Patients applied
Trial Officials
Alan Bocking, MD, FRCSC
Principal Investigator
Chief, Department of Obstetrics and Gynaecology, Mount Sinai Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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