Serial Screening and Treatment of Bacterial Vaginosis Trial

NCT05278130 | Withdrawn

• 1 other identifier: 5220115
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis; Preterm Delivery

Keywords

Bacterial Vaginosis; Vaginoses, Bacterial

Outcome Measures

Primary Outcomes (1)

• Number of participants with premature delivery (before 37 weeks gestation)

  At delivery

Other Outcomes (2)

• Length of hospital stay of mothers

  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

  Number of hours between time of admission (birth) to time of discharge, up to 1 year from time of admission (birth)

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

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

Control Arm

NO INTERVENTION

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.

Interventions

Additional vaginal swabs OTHER

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

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Children's Hospital

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial; Premature Birth

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: March 14, 2022
• Study Start: October 20, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)