Serial Screening and Treatment of Bacterial Vaginosis Trial

NCT ID: NCT05278130

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2027-12-31

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 delivery. Subjects will be randomized in a two-arm study to undergo predetermined intervals of testing for bacterial vaginosis or control.

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 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.

Conditions

Bacterial Vaginosis; Preterm Delivery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intervention Arm

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.

Group Type: ACTIVE_COMPARATOR

Additional vaginal swabs

Intervention Type: OTHER

Every 2 weeks from 16 weeks gestational age to 34 weeks gestational age

Control Arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Additional vaginal swabs

Every 2 weeks from 16 weeks gestational age to 34 weeks gestational age

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Loma Linda University Children's Hospital

Loma Linda, California, United States

Countries

United States

Other Identifiers

5220115

Identifier Type: -

Identifier Source: org_study_id