Bacterial VaginosesPhase 1NCT03954990
Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity
A Phase 1 study testing Metronidazole Oral in people with Bacterial Vaginoses, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Bacterial vaginosis (BV) is the most common cause of vaginal discharge among repro-ductive aged women. It is been linked to adverse maternal and neonatal outcomes. Our objective is to evaluate if the use of a single dose of metronidazole in women with BV at time of delivery reduces infectious morbidities 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 Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2019to 26 Sep 2022
- Phase
- Phase 1
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women ≤50 years at the time of admission with the ability to give informed con-sent.
- Admission for induction of labor or early spontaneous labor with cervix ≤3 cm.
- Diagnosed with bacterial vaginosis at time of admission or in the week prior to admission if not treated
- Gestational age ≥ 34 weeks
Who cannot join
- Spontaneous rupture of membranes
- Plan for elective cesarean delivery
- Allergy or contraindications to metronidazole
- Receipt of metronidazole or clindamycin in the admission for delivery for other in-dications.
- Hemodialysis
- Severe liver dysfunction
- Diagnosis of chorioamnionitis at the time of admission
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity: A Randomized Controlled Trial
Bacterial vaginosis (BV) is the most common cause of vaginal discharge among repro-ductive aged women. It is been linked to adverse maternal and neonatal outcomes. Our objective is to evaluate if the use of a single dose of metronidazole in women with BV at time of delivery reduces infectious morbidities
Read the detailed description
The investigators are proposing a double-blinded, placebo controlled, randomized trial of 525 pregnant women undergoing induction or admitted in early labor and who are diagnosed with bacterial vaginosis. On admission to labor and delivery, patient will be counseled about the study. Patients who agree to be enrolled, will sign informed consent. Following enrollment patients will be screened for Bacterial vaginosis by doing a speculum exam and testing for Amsel's criteria. BV +ve patients will be randomized to receive either metronidazole 2 grams PO once or identically appearing placebo. The PI, study coordinator, or a collaborator will be responsible for the informed consent.
This will be a double-blinded randomized clinical trial. Neither the patient nor provider will be aware of treatment assignment. As with any other in-stance in which antibiotics are administered, there is a chance of an allergic or other adverse reaction. The patient will receive standard inpatient monitoring during the labor course and in the postpartum period, and so any immediate adverse reaction would be promptly detected.
Patient will be assessed intrapartum for development of chorioamninoitis. Postpartum patient will be assessed for infective complications up to 4 weeks. Neonates will be assessed for morbidities by chart review for 90 days.
- Conditions
- Bacterial Vaginoses
- Being tested
- Metronidazole Oral, Placebo Oral Tablet
- Keywords
- Bacterial Vaginoses in pregnancy
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole OralDrug
Also called Flagyl
4 tablets (2 g of metronidazole)
Placebo Oral TabletDrug
4 tablets
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | Placebo tablets oral, 4 tablets once. Receives: Drug: Placebo Oral Tablet |
| Treatment Arm | Active comparator | Will receive 4 tablets (2g) of metronidazole oral once. Receives: Drug: Metronidazole Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Composite outcome of maternal infections
Including Chorioamnionitis, postpartum endometritis, wound infection, pelvic septic thrombosis, pelvic or abdominal abscess
Measured: Labor to 4 weeks postpartum
Secondary outcomes (15)
Rate of Chorioamnionitis
Presumptive or confirmed diagnosis
Measured: From beginning of labor process until time of delivery
Rate of Postpartum Endometritis
Postpartum intrauterine infection
Measured: From time of delivery to 4 weeks postpartum
Rate of Surgical Site Infection
Including superficial or deep incisional surgical site infection
Measured: 4 weeks postpartum
Rate of Pelvic Septic Thrombosis
Infection and thrombosis of pelvic vessels
Measured: 4 weeks postpartum
Rate of Pelvic abscess
Detection of pelvic abscess on imaging
Measured: 4 weeks postpartum
Rate of Puerperal fever
Temperature of ≥ 100.4 F at least twice 30 minutes apart or once ≥ 101F
Measured: From beginning of labor process until time of delivery
Rate of Maternal Death
Death of mother while pregnant or within 28 days of pregnancy termination from any cause related to pregnancy or its management.
Measured: During labor and up to 4 weeks postpartum
Rate of additional postpartum procedures
Additional imaging and invasive procedures to diagnose or treat postpartum infections
Measured: 4 weeks postpartum
Rate of Postpartum Antibiotics use
Number of patients requiring antibiotics secondary to postpartum infections
Measured: 4 weeks postpartum
Rate of ER and unscheduled postpartum clinic visit
Number of unscheduled clinic visits and ER visits secondary to infections.
Measured: 4 weeks postpartum
Number of days of hospital stay postpartum
Number of days patients admitted to the hospital secondary to infections postpartum
Measured: 4 weeks postpartum
Rate of Adverse events
Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis), Gastrointestinal symptoms (nausea, vomiting, diarrhea, constipation, ileus, etc)
Measured: 4 weeks postpartum
Rate of Confirmed neonatal sepsis
Findings indicating positive cultures of blood, cerebrospinal fluid or urine obtained by catheterization or suprapubic aspiration, or cardiovascular collapse, or an unequivocal X-ray confirming infection in a clinically septic neonate.
Measured: 7 days of delivery
Rate of Suspected neonatal sepsis
Presence of clinical signs/symptoms (hypothermia, fever, irritability, poor feeding, hypotonia, etc) causing the clinician to perform a sepsis work-up (blood, urine and/or cerebrospinal fluid, or chest X-ray), excludes routine work-up solely for positive maternal Group B Streptococcus (GBS) status.
Measured: 7 days of delivery
Rate of Neonatal morbidities
Including Respiratory Distress syndrome(RDS), Necrotizing enterocolitis(NEC), Intraventricular hemorrhage (IVH), Bronchopulmonary Dysplasia (BPD)
Measured: 90 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start11 Oct 2019
- Primary completion26 Sep 2022
- Study completion26 Sep 2022
Why it stopped: Lack of significance/futile study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosesStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient with bacterial vaginosis will be randomized to either treatment group to receive 2 g of metronidazole or control group to receive 2 g of placebo. Randomization to either control or treatment group will be done according to a randomization sequence that is computer generated and maintained by investigational drug pharmacy.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sangeeta Jain, MD, Principal investigator, University of Texas medical branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954990
- Sponsor's protocol ID
- 18-0103
- Status last verified
- Dec 2023
- First submitted
- 23 Apr 2019
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03954990
- Acronym / sponsor ID
- 18-0103
- Conditions
- Bacterial Vaginoses
- Keywords
- Bacterial Vaginoses in pregnancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of significance/futile study
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 26 Sep 2022 (actual)
- First posted
- 17 May 2019 (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.
Bacterial vaginosis (BV) is the most common cause of vaginal discharge among repro-ductive aged women. It is been linked to adverse maternal and neonatal outcomes. Our objective is to evaluate if the use of a single dose of metronidazole in women with BV at time of delivery reduces infectious morbidities
Detailed description
The investigators are proposing a double-blinded, placebo controlled, randomized trial of 525 pregnant women undergoing induction or admitted in early labor and who are diagnosed with bacterial vaginosis. On admission to labor and delivery, patient will be counseled about the study. Patients who agree to be enrolled, will sign informed consent. Following enrollment patients will be screened for Bacterial vaginosis by doing a speculum exam and testing for Amsel's criteria. BV +ve patients will be randomized to receive either metronidazole 2 grams PO once or identically appearing placebo. The PI, study coordinator, or a collaborator will be responsible for the informed consent.
This will be a double-blinded randomized clinical trial. Neither the patient nor provider will be aware of treatment assignment. As with any other in-stance in which antibiotics are administered, there is a chance of an allergic or other adverse reaction. The patient will receive standard inpatient monitoring during the labor course and in the postpartum period, and so any immediate adverse reaction would be promptly detected.
Patient will be assessed intrapartum for development of chorioamninoitis. Postpartum patient will be assessed for infective complications up to 4 weeks. Neonates will be assessed for morbidities by chart review for 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patient with bacterial vaginosis will be randomized to either treatment group to receive 2 g of metronidazole or control group to receive 2 g of placebo. Randomization to either control or treatment group will be done according to a randomization sequence that is computer generated and maintained by investigational drug pharmacy.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Drug: Placebo Oral TabletPlacebo tablets oral, 4 tablets once. |
| Treatment Arm | Active comparator | Drug: Metronidazole OralWill receive 4 tablets (2g) of metronidazole oral once. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women ≤50 years at the time of admission with the ability to give informed con-sent.
- Admission for induction of labor or early spontaneous labor with cervix ≤3 cm.
- Diagnosed with bacterial vaginosis at time of admission or in the week prior to admission if not treated
- Gestational age ≥ 34 weeks
Key exclusion criteria (7 listed)
- Spontaneous rupture of membranes
- Plan for elective cesarean delivery
- Allergy or contraindications to metronidazole
- Receipt of metronidazole or clindamycin in the admission for delivery for other in-dications.
- Hemodialysis
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 |
|---|---|---|
| Metronidazole OralAlso: Flagyl4 tablets (2 g of metronidazole) | Drug | Treatment Arm |
| Placebo Oral Tablet4 tablets | Drug | Control Arm |
Primary outcome
Rate of Composite outcome of maternal infections
Time frame: Labor to 4 weeks postpartum
Including Chorioamnionitis, postpartum endometritis, wound infection, pelvic septic thrombosis, pelvic or abdominal abscess
15 secondary outcomes
Rate of Chorioamnionitis
Time frame: From beginning of labor process until time of delivery
Rate of Postpartum Endometritis
Time frame: From time of delivery to 4 weeks postpartum
Rate of Surgical Site Infection
Time frame: 4 weeks postpartum
Rate of Pelvic Septic Thrombosis
Time frame: 4 weeks postpartum
Rate of Pelvic abscess
Time frame: 4 weeks postpartum
Rate of Puerperal fever
Time frame: From beginning of labor process until time of delivery
Rate of Maternal Death
Time frame: During labor and up to 4 weeks postpartum
Rate of additional postpartum procedures
Time frame: 4 weeks postpartum
Rate of Postpartum Antibiotics use
Time frame: 4 weeks postpartum
Rate of ER and unscheduled postpartum clinic visit
Time frame: 4 weeks postpartum
Number of days of hospital stay postpartum
Time frame: 4 weeks postpartum
Rate of Adverse events
Time frame: 4 weeks postpartum
Rate of Confirmed neonatal sepsis
Time frame: 7 days of delivery
Rate of Suspected neonatal sepsis
Time frame: 7 days of delivery
Rate of Neonatal morbidities
Time frame: 90 days after delivery
Results and safety
The study was stopped early (reason given: Lack of significance/futile study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
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.
Sangeeta Jain, MD principal investigator
University of Texas medical branch, Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metronidazole Oral in people with Bacterial Vaginoses, run by The University of Texas Medical Branch, Galveston 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 7 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 12 Dec 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of significance/futile study). Results are not available in the source record.
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?
Rate of Composite outcome of maternal infections (time frame: Labor to 4 weeks postpartum). 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 12 Dec 2023.