Bacterial VaginosesPhase 4NCT04578015
A Randomized Controlled Trial of Treatment of Bacterial Vaginosis
A Phase 4 study testing Metronidazole in people with Bacterial Vaginoses, run by Ohio State University at 1 site in United States.
Trial summary
This is a double-blinded, placebo controlled, multi-center randomized trial of 482 pregnant women who are diagnosed with Bacterial Vaginosis (BV) in the late 3rd trimester (>34 weeks). During routine clinic visit after 34 weeks, prospective patients will be counseled about the study. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Bacterial Vaginoses
- What is being tested?
- Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2021to 9 Feb 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women 18 to ≤50 years with the ability to give informed consent.
- Patients expected to have a vaginal delivery with no obstetric contraindication for vaginal delivery at time of screening.
- Diagnosed with bacterial BV per Amsel criteria at time of screening in clinic.
- Gestational age ≥ 35 weeks
Who cannot join
- Plan for elective cesarean delivery
- Allergy or contraindications to metronidazole
- Receipt of metronidazole or clindamycin on admission for delivery for other indications.
- Hemodialysis
- Severe liver dysfunction
- Patient reports BV to nurse or clinician provider at current clinic visit or has been treated for BV within the past 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, 43210
About this study
Official title: A Randomized Controlled Trial of Treatment of Bacterial Vaginosis in Late Third Trimester to Prevent Maternal Peripartum Infection
This is a double-blinded, placebo controlled, multi-center randomized trial of 482 pregnant women who are diagnosed with Bacterial Vaginosis (BV) in the late 3rd trimester (>34 weeks). During routine clinic visit after 34 weeks, prospective patients will be counseled about the study. Patients who agree to be enrolled, will sign informed consent. Following enrollment, patients will be screened for BV. Those patients who are BV positive by clinical diagnosis, will be randomized to receive either metronidazole 500 mg BID orally for 7 days or identically appearing placebo.
- Conditions
- Bacterial Vaginoses
- Being tested
- Metronidazole, Placebo
- Keywords
- Bacterial Vaginoses, Cesarean delivery, Surgical site infection, Endometritis, Infection, Vaginitis
- Medical subject headings
- Vaginosis, Bacterial, Surgical Wound Infection, Endometritis, Infections, Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days
PlaceboDrug
Participants in this arm will receive placebo
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole 500 mg | Active comparator | Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days Receives: Drug: Metronidazole |
| Placebo | Placebo comparator | Participants in this arm will receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating Composite of Chorioamnionitis, Postpartum Endometritis, SSI, Wound Infection, or Other Post-cesarean Infections (Occurring Within 6 Weeks After Delivery)
Measured: Through study completion, approximately 9.5 months
Secondary outcomes (9)
Evaluating Incidence of Individual Infections.
Chorioamnionitis, endometritis, wound infection (including necrotizing fascitis), other infections including abscess, septic thrombosis, pneumonia, pyelonephritis and breast infection.
Measured: At the time of admission for labor trough study completion, approximately 9.5 months
Evaluating Incidence of Maternal Death
Measured: After delivery through study completion, approximately 9.5 months
Evaluating Incidence of Puerperal Fever.
Temperature > 100.4 F at least twice 30 minutes apart, or once with the use of antipyretic, or ≥101 F once.
Measured: Through study completion, approximately 9.5 months
Evaluating Incidence of Use of Resources.
Hospital stay, postpartum clinic or emergency room visit within 4 weeks of delivery, need for imaging or other invasive procedures, postpartum antibiotic use.
Measured: Through study completion, approximately 9.5 months
Evaluating Incidence of Adverse Events
Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis), GI symptoms (nausea, vomiting, diarrhea, constipation, ileus, etc)
Measured: Through study completion, approximately 9.5 months
Evaluating Incidence of Suspected Sepsis for Newborns
Measured: Within 7 days of delivery
Evaluating Incidence of Confirmed Sepsis for Newborns
Measured: Within 7 days of delivery
Evaluating Incidence of Newborn Intensive Care Unit (NICU) Admission and Duration
Measured: After delivery through study completion, approximately 9.5 months
Evaluating Incidence of Neonatal Morbidities
Measured: After delivery through study completion, approximately 9.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start26 Apr 2021
- Primary completion9 Feb 2022
- Study completion9 Feb 2022
Why it stopped: After screening many patients for BV, it was determined that the rate of BV is less in our population that the 30% rate mentioned in the literature. It was determined that completing the study will not be feasible due to cost and time constraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bacterial VaginosesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kartik K Venkatesh, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578015
- Sponsor's protocol ID
- 2020H0476
- Status last verified
- May 2023
- First submitted
- 1 Oct 2020
- Last updated
- 15 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Treatment of Bacterial Vaginosis in Late Third Trimester to Prevent Maternal Peripartum Infection
- ClinicalTrials.gov ID
- NCT04578015
- Acronym / sponsor ID
- 2020H0476
- Conditions
- Bacterial Vaginoses
- Keywords
- Bacterial Vaginoses, Cesarean delivery, Surgical site infection, Endometritis, Infection, Vaginitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After screening many patients for BV, it was determined that the rate of BV is less in our population that the 30% rate mentioned in the literature. It was determined that completing the study will not be feasible due to cost and time constraints.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Posted 15 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blinded, placebo controlled, multi-center randomized trial of 482 pregnant women who are diagnosed with Bacterial Vaginosis (BV) in the late 3rd trimester (>34 weeks). During routine clinic visit after 34 weeks, prospective patients will be counseled about the study. Patients who agree to be enrolled, will sign informed consent. Following enrollment, patients will be screened for BV. Those patients who are BV positive by clinical diagnosis, will be randomized to receive either metronidazole 500 mg BID orally for 7 days or identically appearing placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole 500 mg | Active comparator | Drug: MetronidazoleParticipants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in this arm will receive placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women 18 to ≤50 years with the ability to give informed consent.
- Patients expected to have a vaginal delivery with no obstetric contraindication for vaginal delivery at time of screening.
- Diagnosed with bacterial BV per Amsel criteria at time of screening in clinic.
- Gestational age ≥ 35 weeks
Key exclusion criteria (6 listed)
- Plan for elective cesarean delivery
- Allergy or contraindications to metronidazole
- Receipt of metronidazole or clindamycin on admission for delivery for other indications.
- Hemodialysis
- Severe liver dysfunction
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 |
|---|---|---|
| MetronidazoleParticipants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days | Drug | Metronidazole 500 mg |
| PlaceboParticipants in this arm will receive placebo | Drug | Placebo |
Primary outcome
Evaluating Composite of Chorioamnionitis, Postpartum Endometritis, SSI, Wound Infection, or Other Post-cesarean Infections (Occurring Within 6 Weeks After Delivery)
Time frame: Through study completion, approximately 9.5 months
9 secondary outcomes
Evaluating Incidence of Individual Infections.
Time frame: At the time of admission for labor trough study completion, approximately 9.5 months
Evaluating Incidence of Maternal Death
Time frame: After delivery through study completion, approximately 9.5 months
Evaluating Incidence of Puerperal Fever.
Time frame: Through study completion, approximately 9.5 months
Evaluating Incidence of Use of Resources.
Time frame: Through study completion, approximately 9.5 months
Evaluating Incidence of Adverse Events
Time frame: Through study completion, approximately 9.5 months
Evaluating Incidence of Suspected Sepsis for Newborns
Time frame: Within 7 days of delivery
Evaluating Incidence of Confirmed Sepsis for Newborns
Time frame: Within 7 days of delivery
Evaluating Incidence of Newborn Intensive Care Unit (NICU) Admission and Duration
Time frame: After delivery through study completion, approximately 9.5 months
Evaluating Incidence of Neonatal Morbidities
Time frame: After delivery through study completion, approximately 9.5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Bacterial Vaginoses
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
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 Phase 4 study testing Metronidazole in people with Bacterial Vaginoses, run by Ohio State 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 15 Jun 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluating Composite of Chorioamnionitis, Postpartum Endometritis, SSI, Wound Infection, or Other Post-cesarean Infections (Occurring Within 6 Weeks After Delivery) (time frame: Through study completion, approximately 9.5 months). 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 15 Jun 2023.