Bacterial VaginosisSECRETIVANCT05278130
Serial Screening and Treatment of Bacterial Vaginosis Trial
A study testing Additional vaginal swabs in people with Bacterial Vaginosis and Preterm Delivery, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis, Preterm Delivery
- What is being tested?
- Additional vaginal swabs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2022to Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Children's Hospital
Loma Linda, California, 92354
About this study
Official title: Serial Screening and Treatment of Bacterial Vaginosis in Pregnancy to Prevent Preterm Delivery: A Randomized Control Trial
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.
Read the 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
- Being tested
- Additional vaginal swabs
- Keywords
- Bacterial Vaginosis, Vaginoses, Bacterial
- Medical subject headings
- Vaginosis, Bacterial, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional vaginal swabsOther
Every 2 weeks from 16 weeks gestational age to 34 weeks gestational age
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with premature delivery (before 37 weeks gestation)
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start20 Oct 2022 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Study was never initiated/no study participants were ever enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278130
- Sponsor's protocol ID
- 5220115
- Acronym
- SECRETIVA
- Status last verified
- Sep 2025
- First submitted
- 21 Jan 2022
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Screening and Treatment of Bacterial Vaginosis in Pregnancy to Prevent Preterm Delivery: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05278130
- Acronym / sponsor ID
- SECRETIVA / 5220115
- Conditions
- Bacterial Vaginosis, Preterm Delivery
- Keywords
- Bacterial Vaginosis, Vaginoses, Bacterial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never initiated/no study participants were ever enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 20 Oct 2022 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Active comparator | Other: Additional vaginal swabsThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional vaginal swabsEvery 2 weeks from 16 weeks gestational age to 34 weeks gestational age | Other | Intervention Arm |
Primary outcome
Number of participants with premature delivery (before 37 weeks gestation)
Time frame: At delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional vaginal swabs in people with Bacterial Vaginosis and Preterm Delivery, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with premature delivery (before 37 weeks gestation) (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.