Serial Screening and Treatment of Bacterial Vaginosis Trial

Last updated: January 2, 2025
Sponsor: Loma Linda University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sexually Transmitted Diseases (Stds)

Vaginal Infection

Gynecological Infections

Treatment

Additional vaginal swabs

Clinical Study ID

NCT05278130
5220115
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 LomaLinda Maternal Fetal Medicine (MFM) Clinic

  • History of at least one prior preterm delivery >16 and <37 weeks not due toiatrogenic indications, or short cervical length <2.5cm

  • Willing to receive prenatal standard of care and comply with treatment plan andother study procedures at Loma Linda

Exclusion

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

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Additional vaginal swabs
Phase:
Study Start date:
October 20, 2022
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Loma Linda University Children's Hospital

    Loma Linda, California 92354
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.