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Serial Screening and Treatment of Bacterial Vaginosis Trial
The purpose of this investigator-initiated randomized control trial is to determine if bacterial vaginosis infection increases the likelihood of preterm delivery in women with history of preterm delivery. Subjects will be randomized in a two-arm study to undergo predetermined intervals of testing for bacterial vaginosis or control.
Conditions:
🦠 Bacterial Vaginosis 🦠 Preterm Delivery
🗓️ Study Start (Actual) 20 October 2022
🗓️ Primary Completion (Estimated) December 2027
✅ Study Completion (Estimated) December 2027
👥 Enrollment (Estimated) 600
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Loma Linda, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Female
    • * Age greater than or equal to 18 years old
    • * Pregnancy at less than 32 weeks gestational age at initial obstetric visit with Loma Linda Maternal Fetal Medicine (MFM) Clinic
    • * History of at least one prior preterm delivery \>16 and \<37 weeks not due to iatrogenic indications, or short cervical length \<2.5cm
    • * Willing to receive prenatal standard of care and comply with treatment plan and other study procedures at Loma Linda

    Exclusion Criteria:

    • * Patients not deemed to be high risk for preterm delivery
    • * Patient with cervical dilation ≥1cm on initial exam or with protruding membranes
    • * Current pregnancy is multigestation
    • * Medical indications for iatrogenic preterm delivery during this pregnancy (e.g. preeclampsia with severe features)
    • * Desires termination during this pregnancy
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 January 2022
  • First Submitted that Met QC Criteria 11 March 2022
  • First Posted 14 March 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 18 December 2023
  • Last Update Posted 19 December 2023
  • Last Verified December 2023
I'm interested ...!!