Status:
WITHDRAWN
Serial Screening and Treatment of Bacterial Vaginosis Trial
Lead Sponsor:
Loma Linda University
Conditions:
Bacterial Vaginosis
Preterm Delivery
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 deliv...
Detailed Description
Preterm delivery affects 10% of all pregnancies in the United States. This risk is further increased in pregnant women with a history of preterm delivery. There are multiple etiology contributing of p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05278130
Start Date
October 20 2022
End Date
December 1 2027
Last Update
September 10 2025
Active Locations (1)
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1
Loma Linda University Children's Hospital
Loma Linda, California, United States, 92354