WithdrawnNot Applicable

Serial Screening and Treatment of Bacterial Vaginosis Trial

Stopped: Study was never initiated/no study participants were ever enrolled.

United States0Started 2022-10-20

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of participants with premature delivery (before 37 weeks gestation)

Timeframe: At delivery

Trial details

NCT IDNCT05278130

SponsorLoma Linda University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

View on ClinicalTrials.gov More Bacterial Vaginosis trials