Clinical trial NCT05278130: Serial Screening and Treatment of Bacterial Vaginosis Trial
Official title: Serial Screening and Treatment of Bacterial Vaginosis in Pregnancy to Prevent Preterm Delivery: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bacterial Vaginosis
Preterm Delivery
Keywords: Bacterial Vaginosis
Vaginoses, Bacterial
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of participants with premature delivery (before 37 weeks gestation)
timeFrame: At delivery
Secondary outcomes:
Other outcomes:
measure: Length of hospital stay of mothers
timeFrame: Number of hours between time of admission to time of discharge, up to 4 weeks from time of admission
measure: Length of hospital stay of neonates
timeFrame: Number of hours between time of admission (birth) to time of discharge, up to 1 year from time of admission (birth)
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Children's Hospital
state: California
Study officials:
References: