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Serial Screening and Treatment of Bacterial Vaginosis Trial — SECRETIVA  

Bacterial Vaginosis Clinical Trial

Official title:
Serial Screening and Treatment of Bacterial Vaginosis in Pregnancy to Prevent Preterm Delivery: A Randomized Control Trial

Clinical Trial 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.

Clinical Trial 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 preterm labor. Of these, the presence of inflammation and infection have been a well-established cause. Bacterial vaginosis (BV), a common vaginal infection in pregnancy, may often be asymptomatic. Studies demonstrate a strong association between BV and preterm labor. Therefore it is recommended that women at high risk for preterm delivery are treated for this infection irregardless of symptoms. In this study the investigators hypothesize that increased testing for bacterial vaginosis, with subsequent timely treatment, may decrease the risk of preterm delivery in patients who are at high risk. The investigators suspect that the increase in monitoring will help diagnose asymptomatic bacterial vaginosis infections allowing for prompt treatment and avoidance of preterm labor. Subjects will be randomized in a two-arm study to undergo predetermined intervals of testing for bacterial vaginosis or control. No experimental drugs or devices will be used. - The intervention-arm will have a pelvic exam performed with vaginal swab collection at their initial obstetric visit. The women undergoing the intervention will then subsequently undergo additional vaginal swab collections in 2 week intervals starting at 16 weeks gestational age until 34 weeks gestational age. - The control arm will undergo the standard of care. There will be no placebo for the control group. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05278130
Study type Interventional
Source Loma Linda University
Contact Ashra Denise Tugung, BSc
Phone 9095584000
Email atugung@llu.edu
Status Recruiting
Phase N/A
Start date October 20, 2022
Completion date December 2027
View Details
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