An interventional study of Additional vaginal swabs in Bacterial Vaginosis and Preterm Delivery, sponsored by Loma Linda University. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Loma Linda University · Not applicable, Interventional, and Diagnostic
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.
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.
220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.
Browse Vaginosis, Bacterial studies →Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
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Exclusion Criteria:
The intervention-arm will have a pelvic exam performed with vaginal swab collection at their initial obstetric visit (standard of care). 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. Subjects will be informed of the results of the vaginal swab. If positive for an infection, subjects will be provided with the appropriate treatment in pregnancy.
Other: Additional vaginal swabs
The control arm will undergo the standard of care with vaginal swab collection at their initial obstetric visit. The control arm will not undergo additional vaginal swab collections unless otherwise indicated under standard of care (further testing for bacterial vaginosis is completed in women who describe symptoms with the diagnosis or present for preterm contractions and/or pelvic cramping). There will be no placebo for the control group.
Every 2 weeks from 16 weeks gestational age to 34 weeks gestational age
Number of participants with premature delivery (before 37 weeks gestation)
Time frame: At delivery
Length of hospital stay of mothers
The length of hospital stay for mothers will be measured in hours from the time of admission to labor and delivery unit to the time of discharge from the post-partum unit.
Time frame: Number of hours between time of admission to time of discharge, up to 4 weeks from time of admission
Length of hospital stay of neonates
The length of hospital stay for neonates will be measured in hours from the time of admission (birth) to discharge from the postpartum unit or neonatal intensive care unit
Time frame: Number of hours between time of admission (birth) to time of discharge, up to 1 year from time of admission (birth)
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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