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Search / Trial NCT00217308

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Withdrawn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.

Locations

Toronto, Ontario, Canada

Patients applied

0 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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