Screening and treating bacterial vaginosis to prevent preterm delivery
Serial Screening and Treatment of Bacterial Vaginosis in Pregnancy to Prevent Preterm Delivery: A Randomized Control Trial
This study is testing if regular screening and treatment for bacterial vaginosis can help pregnant women with a history of preterm births have healthier pregnancies and reduce the chances of delivering early.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Loma Linda University Academic / other |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT05278130 on ClinicalTrials.gov |
What this trial studies
This randomized control trial aims to investigate whether serial screening and treatment of bacterial vaginosis (BV) can reduce the risk of preterm delivery in pregnant women with a history of preterm births. Participants will be randomly assigned to either an intervention group, which will undergo regular testing for BV starting at 16 weeks of gestation, or a control group with standard care. The study hypothesizes that increased monitoring and timely treatment of asymptomatic BV will lead to better pregnancy outcomes. The trial will take place at Loma Linda University, focusing on women who are at high risk for preterm delivery.
Who should consider this trial
Good fit: Ideal candidates are pregnant women over 18 years old with a history of preterm delivery and less than 32 weeks gestational age at their initial visit.
Not a fit: Patients who are not considered high risk for preterm delivery or have medical indications for iatrogenic preterm delivery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of preterm delivery in high-risk pregnant women.
How similar studies have performed: Previous studies have shown a strong association between bacterial vaginosis and preterm labor, suggesting that this approach may be promising, though it may not have been extensively tested in this specific manner.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Loma Linda, California
- Loma Linda University Children's Hospital — Loma Linda, California, United States (Recruiting)
Study contacts
- Study coordinator: Ashra Denise Tugung, BSc
- Email: atugung@llu.edu
- Phone: 9095584000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.